Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health. A violation of that law is a crime. Existing law authorizes the department to establish performance standards for devices designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device.

This bill would require, beginning January 1, 2027, a device that collects or analyzes information originating from a physiological source and is not subject to specified federal regulations, to have a legible disclosure on the product, the packaging, or within informational materials included with the packaging for the device, or within user instructions, that includes limitations known by the manufacturer on the effectiveness of the device for the devices intended population because of certain characteristics of the person using the device or of the person on which the device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race. By expanding the scope of a crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health. A violation of that law is a crime. Existing law authorizes the department to establish performance standards for devices designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device.

This bill would require, beginning January 1, 2027, a device that collects or analyzes medical information or information originating from a physiological source and is not subject to specified federal regulations regulations, or any federal law or regulation, to have a legible disclosure on the product, the packaging, or within informational material included with the packaging for the device device, or within user instructions, to include limitations known by the manufacturer on the effectiveness of the device for the devices intended population because of certain characteristics of the patient person using the device or of the patient person on which the medical device is being used, including, but not limited to age, color, disability, ethnicity, gender, or race. By expanding the scope of a crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health. A violation of that law is a crime. Existing law authorizes the department to establish performance standards for devices designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device.

This bill would require a medical require, beginning January 1, 2027, a device that collects or analyzes medical information or information originating from a physiological source and is not subject to specified federal regulations to have a legible disclosure on the product, the packaging, or within informational material included with the packaging for the device to include known limitations known by the manufacturer on the effectiveness of the device for the devices intended population because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, disability, ethnicity, gender, or race. By expanding the scope of a crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law requires the Department of Technology to conduct, in coordination with other interagency bodies as it deems appropriate, a comprehensive inventory of all high-risk automated decision systems that have been proposed for use, development, or procurement by, or are being used, developed, or procured by, any state agency. Existing law defines an automated decision system as a computational process derived from machine learning, statistical modeling, data analytics, or artificial intelligence that issues simplified output, including a score, classification, or recommendation, that is used to assist or replace human discretionary decisionmaking and materially impacts natural persons.

This bill would state the intent of the Legislature to enact legislation relating to commercial algorithms and artificial intelligence-enabled medical devices.

GOVERNOR'S VETO

GV Bill Id:AB 2058

Author:(Weber)

As Enrolled Ver:September 3, 2024

2/3 vote

SUMMARY

Requires a device, commencing January 1, 2027, that collects or analyzes medical information, and is not subject to regulation under federal law or regulations to have a legible disclosure that includes limitations known by the manufacturer on the effectiveness of the device for the device's intended population because of certain characteristics of the patient using the device, including age, color, disability, ethnicity, gender, or race.

Senate Amendments

1. Revise and recast the provisions in this bill removing the reference to a "medical device" and instead requiring a device that collects or analyzes medical information or information originating from a physiological source, including, but not limited to, heartbeat, blood pressure, body temperature, or blood oxygen, and is not subject to the federal Food, Drug, and Cosmetic Act, the Medical Device Amendments of 1976, or any other federal law or regulations to have a legible disclosure affixed on the product, packaging, or within informational materials included within the packaging for the device, or within user instructions, or a combination thereof, that includes limitations known by the manufacturer on the effectiveness of the device for the device's intended population because of certain characteristics of the person using the device or of the person on which the device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race.
2. Delay implementation of the provisions of this bill to 2027.

Governor's Veto Message

This bill would require devices that analyze information originating from a physiological source - such as heartbeat, blood pressure, and body temperature - to include a disclosure about the device's limitations based on certain characteristics of the person using the device, including age, color, disability, ethnicity, gender, or race.

This bill has a well-intentioned health equity goal. However, I am concerned that the language may create confusion and implementation challenges for the state and manufacturers. "Medical devices" that read these same physiological measurements are subject to labeling standards that must comply with federal law including the U.S. Food and Drug Administration's (FDA) regulations. While this bill aims to apply to a subset of "devices" that are not subject to these federal laws, it is unclear which products this bill does and does not capture. I encourage the author and the Legislature to revisit this worthy goal in a manner that provides more clarity for regulatory agencies and product manufacturers.

COMMENTS

1. Racial disparities in the use of medical devices. The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated that: "a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients' oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity." A recent study by Emory University found that forehead thermometers were significantly less accurate (26% lower) than oral thermometers in detecting fevers for Black patients.
2. U.S. Food and Drug Administration (FDA) Guidance. In April 2022, the FDA updated its latest draft guidance to improve diversity in clinical trials, including the requirement that device applications must report clinical trial demographic data. On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act of 2023 which included a requirement that clinical trial sponsors submit to the Secretary of the U.S. Department of Health and Human Services, a "diversity action plan" for certain late-stage drug trials, as well as most medical device studies.
3. FDA discussion. On November 16, 2023, the FDA Center for Devices and Radiological Health published a discussion paper, "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity." The intent of the discussion paper was not to communicate the FDA's regulatory expectations, but to advance a broader discussion among stakeholders on this topic. The discussion paper highlighted a summary of three systematic reviews on the topic of potential bias of pulse oximetry in people with darker skin pigmentation published in 2022. Please see the Assembly Health Committee analysis for more background.

According to the Author

Medical technologies are the technologies that diagnose, treat and improve a person's health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. The author states that these technologies and devices are not without flaw; studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. The author continues that these types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. The author concludes that for these reasons, this bill requires a medical device manufacturer to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.

Arguments in Support

According to The California Pan-Ethnic Health Network (CPEHN), California's communities of color continue to experience discrimination and have poorer health outcomes on key health indicators including asthma and hypertension. CPEHN highlights the findings of the June 2023 final California Reparations Task Force Report, which highlighted the disparities that exist within the use of medical devices such as pulse oximeters and forehead, which diagnose, treat and improve a person's health and wellbeing, which have been shown to be less accurate among patients with darker skin and as a result can increase risk of adverse health outcomes for those patients. CPEHN continues that a 2023 study by a partner organization, Roots Community Health Center based in Oakland, showed that Black patients whose pulse oximeters overestimated blood oxygen levels waited an extra 4½ hours, on average, to start supplemental oxygen during the COVID pandemic. They were also slightly less likely to be admitted to the hospital or receive oxygen therapy at all. In response, Roots wrote to 13 major manufacturers of pulse oximeters, requesting they halt further sales of unreliable pulse oximeters or require manufacturers and distributors of the flawed devices to warn purchasers of their products' dangerous shortcomings, yet these manufacturers despite the evidence, chose to do nothing. According to Dr. Noha Aboelata, CEO of Roots, lighter skin or "whiteness" was "the default" for which pulse oximeters were designed, tested, manufactured, regulated and sold. "The pulse oximeter is an example of the tragic harm that occurs when the nation's health care industry and the regulatory agencies that oversee it prioritize white health over the realities of non-white patients CPEHN concludes that this bill is a simple, commonsense solution that addresses the shortcomings of medical devices by requiring certain devices for which there is a known disparity, to include a disclaimer that will help to ensure both patients and providers are aware of their limitations and can adequately address them.

Arguments in Opposition

There is no known opposition to this bill.

FISCAL COMMENTS

According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.

VOTES

ASM HEALTH: 15-0-1

YES: Bonta, Waldron, Aguiar-Curry, Arambula, Wendy Carrillo, Flora, Haney, Jones-Sawyer, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Schiavo, Weber

ABS, ABST OR NV: Sanchez

ASM APPROPRIATIONS: 13-0-2

YES: Wicks, Sanchez, Arambula, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Grayson, Haney, Hart, Pellerin, Villapudua

ABS, ABST OR NV: Jim Patterson, Ta

ASSEMBLY FLOOR: 69-0-11

YES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Davies, Dixon, Flora, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Petrie-Norris, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

ABS, ABST OR NV: Bauer-Kahan, Megan Dahle, Essayli, Vince Fong, Gallagher, Grayson, Mathis, McCarty, Jim Patterson, Quirk-Silva, Ta

SENATE FLOOR: 39-0-1

YES: Allen, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ABS, ABST OR NV: Alvarado-Gil

ASSEMBLY FLOOR: 75-0-4

YES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Chen, Connolly, Megan Dahle, Davies, Dixon, Flora, Mike Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Robert Rivas

ABS, ABST OR NV: Cervantes, Essayli, Ortega, Zbur

UPDATED

VERSION: September 3, 2024

CONSULTANT: Eliza Brooks / HEALTH / (916) 319-2097 FN: 0005135

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2058

Author:(Weber)

As Amended Ver:August 23, 2024

Majority vote

SUMMARY

Requires a device, commencing January 1, 2027, that collects or analyzes medical information, and is not subject to regulation under federal law or regulations to have a legible disclosure that includes limitations known by the manufacturer on the effectiveness of the device for the device's intended population because of certain characteristics of the patient using the device, including age, color, disability, ethnicity, gender, or race.

Senate Amendments

1. Revises and recasts the provisions in this bill removing the reference to a "medical device" and instead requiring a device that collects or analyzes medical information or information originating from a physiological source, including, but not limited to, heartbeat, blood pressure, body temperature, or blood oxygen, and is not subject to the federal Food, Drug, and Cosmetic Act, the Medical Device Amendments of 1976, or any other federal law or regulations to have a legible disclosure affixed on the product, packaging, or within informational materials included within the packaging for the device, or within user instructions, or a combination thereof, that includes limitations known by the manufacturer on the effectiveness of the device for the device's intended population because of certain characteristics of the person using the device or of the person on which the device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race.
2. Delays implementation of the provisions of this bill to 2027.

COMMENTS

1. Racial disparities in the use of medical devices. The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated that: "a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients' oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity." A recent study by Emory University found that forehead thermometers were significantly less accurate (26% lower) than oral thermometers in detecting fevers for Black patients.
2. U.S. Food and Drug Administration (FDA) Guidance. In April 2022, the FDA updated its latest draft guidance to improve diversity in clinical trials, including the requirement that device applications must report clinical trial demographic data. On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act of 2023 which included a requirement that clinical trial sponsors submit to the Secretary of the U.S. Department of Health and Human Services, a "diversity action plan" for certain late-stage drug trials, as well as most medical device studies.
3. FDA discussion. On November 16, 2023, the FDA Center for Devices and Radiological Health published a discussion paper, "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity." The intent of the discussion paper was not to communicate the FDA's regulatory expectations, but to advance a broader discussion among stakeholders on this topic. The discussion paper highlighted a summary of three systematic reviews on the topic of potential bias of pulse oximetry in people with darker skin pigmentation published in 2022. Please see the Assembly Health Committee analysis for more background.

According to the Author

Medical technologies are the technologies that diagnose, treat and improve a person's health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. The author states that these technologies and devices are not without flaw; studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. The author continues that these types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. The author concludes that for these reasons, this bill requires a medical device manufacturer to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.

Arguments in Support

According to The California Pan-Ethnic Health Network (CPEHN), California's communities of color continue to experience discrimination and have poorer health outcomes on key health indicators including asthma and hypertension. CPEHN highlights the findings of the June 2023 final California Reparations Task Force Report, which highlighted the disparities that exist within the use of medical devices such as pulse oximeters and forehead, which diagnose, treat and improve a person's health and wellbeing, which have been shown to be less accurate among patients with darker skin and as a result can increase risk of adverse health outcomes for those patients. CPEHN continues that a 2023 study by a partner organization, Roots Community Health Center based in Oakland, showed that Black patients whose pulse oximeters overestimated blood oxygen levels waited an extra 4½ hours, on average, to start supplemental oxygen during the COVID pandemic. They were also slightly less likely to be admitted to the hospital or receive oxygen therapy at all.In response, Roots wrote to 13 major manufacturers of pulse oximeters, requesting they halt further sales of unreliable pulse oximeters or require manufacturers and distributors of the flawed devices to warn purchasers of their products' dangerous shortcomings, yet these manufacturers despite the evidence, chose to do nothing. According to Dr. Noha Aboelata, CEO of Roots, lighter skin or "whiteness" was "the default" for which pulse oximeters were designed, tested, manufactured, regulated and sold. "The pulse oximeter is an example of the tragic harm that occurs when the nation's health care industry and the regulatory agencies that oversee it prioritize white health over the realities of non-white patients CPEHN concludes that this bill is a simple, commonsense solution that addresses the shortcomings of medical devices by requiring certain devices for which there is a known disparity, to include a disclaimer that will help to ensure both patients and providers are aware of their limitations and can adequately address them.

Arguments in Opposition

There is no known opposition to this bill.

FISCAL COMMENTS

According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.

VOTES:

ASM HEALTH: 15-0-1

YES: Bonta, Waldron, Aguiar-Curry, Arambula, Wendy Carrillo, Flora, Haney, Jones-Sawyer, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Schiavo, Weber

ABS, ABST OR NV: Sanchez

ASM APPROPRIATIONS: 13-0-2

YES: Wicks, Sanchez, Arambula, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Grayson, Haney, Hart, Pellerin, Villapudua

ABS, ABST OR NV: Jim Patterson, Ta

ASSEMBLY FLOOR: 69-0-11

YES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Davies, Dixon, Flora, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Petrie-Norris, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

ABS, ABST OR NV: Bauer-Kahan, Megan Dahle, Essayli, Vince Fong, Gallagher, Grayson, Mathis, McCarty, Jim Patterson, Quirk-Silva, Ta

UPDATED

VERSION: August 23, 2024

CONSULTANT: Eliza Brooks / HEALTH / (916) 319-2097 FN: 0004733

 THIRD READING  

Bill No: AB 2058

Author: Weber (D)

Amended: 8/23/24 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 7/3/24

AYES: Roth, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Menjivar, Rubio, Smallwood-Cuevas, Wiener

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 69-0, 5/13/24 - See last page for vote

SUBJECT: Devices:disclosures

SOURCE: Author

DIGEST:

This bill requires a device, commencing January 1, 2027, that collects or analyzes medical information, and is not subject to federal medical device regulation, to disclose limitations known by the manufacturer on the effectiveness of the device because of certain characteristics of the patient using the device, including age, color, disability, ethnicity, gender, or race.

Senate Floor Amendments of 8/23/24 delete a reference to “medical information,” so that the bill just refers to “information,” excluded devices subject to any federal law or regulation, and added “within user instructions” to the places where the required disclosure can be included with the device.

ANALYSIS:

Existing federal law:

1. Establishes the Food, Drug, and Cosmetic Act (FDC Act) to regulate the safety of food, drugs, medical devices, and cosmetics. [21 United States Code (USC) §301, et seq.]
2. Defines a “medical device,” under the FDC Act, in part, as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body, which does not achieve its primary intended purposes through chemical action within the body or upon being metabolized. [21 USC §321(h)]
3. Prohibits a state from establishing any requirement, with respect to a medical device, that is different from, or in addition to, any requirement applicable under the FDC Act and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device. However, permits a state to apply for an exemption, which may be granted by the Food and Drug Administration (FDA) through the promulgation of regulations, if the requirement is more stringent than federal law, or the requirement is required by compelling local conditions. [21 USC §360k]

Existing state law:

1. Establishes the Sherman Food, Drug, and Cosmetic Law, to regulate the manufacture, production, processing, and packing of any food, drug, device, or cosmetic, enforced by the California Department of Public Health (CDPH). [Health and Safety Code (HSC) §109875, et seq.]
2. Permits CDPH to establish performance standards for devices that are required to be designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device. However, specifies that if a performance standard is established for a device pursuant to federal law, the federal standard is the performance standard in California for the device. [HSC §111245]
3. Establishes labeling standards for foods, drugs, devices and cosmetics, and specifies that a drug or device is misbranded if it does not conform to the labeling requirements, or if its labeling is false or misleading in any particular. [HSC §110290, et seq., §111330]

This bill requires a device, commencing January 1, 2027, that collects or analyzes information originating from a physiological source, including, but not limited to, heartbeat, blood pressure, body temperature, or blood oxygen, and is not subject to regulation under the FDC Act, or any other federal law or regulation, to have a legible disclosure affixed on the product, packaging, or within informational materials included in the packaging, or within user instructions, that includes limitations known by the manufacturer on the effectiveness of the device for the device’s intended population because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race.

Comments

1. Author’s statement. According to the author, medical technologies are the technologies that diagnose, treat and improve a person’s health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. Still, these technologies and devices are not without flaw. Studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. These types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. For these reasons, this bill requires a manufacturer of a device that collects health information to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.
2. Background on concerns with pulse oximeters and forehead thermometers. Pulse oximeters are widely used by many types of health care providers and consumers to obtain an indirect measure of arterial blood oxygen saturation. Pulse oximetry is a quick and non-invasive alternative to arterial blood sampling for estimating oxygen saturation. The COVID-19 pandemic resulted in an increased use of pulse oximeters, not only in the hospital setting but at home as well. In a safety communication issued on February 19, 2021, the FDA informed patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy, which should be considered. The FDA’s safety communication stated that multiple factors may affect the performance of a pulse oximeter’s reading, such as poor circulation, skin pigmentation, skin temperature, current tobacco use, and the use of fingernail polish. In an article published in the New England Journal of Medicine in 2020, it was reported that Black patients had nearly three times the frequency of occult hypoxemia (low oxygen level in the blood) as detected by blood gas measurements not detected by pulse oximetry, when compared with White patients. The FDA convened an Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to discuss concerns that pulse oximeters may perform disparately in individuals with darker skin pigmentations. In preparation for this Advisory Panel meeting, the FDA looked at several systematic literature reviews that addressed the topic of potential bias of pulse oximetry in people with darker skin pigmentation that were published in 2022. One of these reviews concluded, “there is growing evidence that pulse oximeters are less accurate in dark-skinned individuals at lower saturation resulting in overestimations.” Another review of the literature concluded, “Pulse oximetry may overestimate blood oxygen saturation levels for people with dark skin in hospital settings compared with gold standard oxygen saturation measures. The evidence for the measurement bias identified for other levels of skin pigmentation or ethnicities is more uncertain. Whilst the extent of measurement bias and overall accuracy meets current international thresholds, the variation of pulse oximetry measurements appears unacceptably wide. Such a small overestimation may be crucial for some patients: particularly at the threshold that informs clinical decision-making.”
   
   In September of 2022, researchers at Emory University published research that found that the use of temporal artery (forehead) thermometers, which measure temperature through the skin using infrared technology, do not detect fevers as accurately as oral thermometers in hospitalized patients who are Black. The retrospective study involved 4,375 adult patients in hospitals between 2014 and 2021, about half of whom were Black and the other half White. For each patient, the first pair of oral and temporal temperatures measured within one hour of each other were recorded within the first day of hospitalization. The researchers found 26% lower odds of detecting fevers in Black patients using temporal compared to oral thermometers. In contrast, temporal thermometers were not significantly different from oral thermometers in White patients.
   
   The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated, “a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients’ oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity.”
3. Lack of diversity in clinical trials. At least part of the problem underlying the pulse oximeter issue, the temporal thermometer, and potentially other drugs and medical devices, is the documented lack of diversity in clinical trials. According to an analysis by the Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials, which is part of the National Academies of Sciences, Engineering, and Medicine, the lack of representation in clinical trials compromises generalizability of clinical research findings to the U.S. population. Over the past few decades, growing evidence has surfaced to challenge the assumption that results from randomized clinical trials could be generalizable to all patient populations. Specifically, research has demonstrated that many groups underrepresented and excluded in clinical research can have distinct disease presentations or health circumstances that affect how they will respond to an investigational drug or therapy. Such differences contribute to variable therapeutic responses and necessitate targeted efficacy and safety evaluation. Ensuring diverse participation in scientific studies allow for exploration of all of these factors and their interactions and is critical to the interpretations that allow for generalizability of findings to the population. The FDA states that participants in clinical trials should represent the patients that will use the medical products, but this is often not the case, as people from racial and ethnic minorities and other diverse groups are underrepresented in clinical research. The FDA states this is a concern because people of different ages, races, and ethnicities may react differently to certain medical products.
   
4. Background on the federal regulation of medical devices. Pursuant to the Medical Device Amendments to the FDC Act, enacted in 1976, the FDA is required to classify all devices into one of three regulatory control categories: Class I, Class II, or Class III, depending on the degree of regulation necessary to provide reasonable assurance of the safety and effectiveness of the device. Under the regulatory scheme, the safety and effectiveness of all medical devices is assured through general controls such as manufacturer registration and device listing, applicable good manufacturing practices, medical device reporting, reports of corrections and removals, unique device identification, and others. For Class II and III devices, there are special controls and premarket approval, respectively. Medical device reporting, which helps FDA assess significant adverse events and detect emerging problems associated with the use of medical devices, apply to manufacturers, importers of devices manufactured outside of the U.S., and user facilities. Under medical device reporting requirements, manufacturers are required to report to the FDA when their devices may have caused or contributed to a death or serious injury, or their device has malfunctioned and would be likely to cause or contribute to death or serious injury. Device user facilities, on the other hand, are required to report to the FDA and to the manufacturer when a device may have caused or contributed to a death, and to report to the manufacturer only when a device may have caused or contributed to a serious injury. A “device user facility” is defined as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility that is not a physician’s office.
5. Federal preemption on medical devices, which have since been amended out of bill. As described in existing federal law 3), the FDC Act contains an express preemption provision for medical devices that applies to state statutes. Under this express preemption provision, “no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement which is (1) different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” The implementing regulations provided that if a state requirement “has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition will be preempted if the requirement is different from , or in addition to, a Federal requirement established under the [FDC Act].” While there is an exception to this preemption, a state would have to request the FDA to promulgate regulations that exempt a particular requirement of a state that “is more stringent than a requirement” under the FDC Act.
   
   Based in part on this federal preemption of state labeling requirements on federally regulated medical devices, the author amended this bill to exempt products that are subject to federal regulation under the FDC Act. However, there are a number of devices available at retail that purport to measure heart rates or blood oxygen levels that are not marketed as “medical devices,” some of which are actually labeled “not for medical use.” As stated by the FDA, prescription oximeters undergo FDA review and are available only with a prescription and the FDA requires these pulse oximeters to undergo clinical testing to confirm their accuracy. These are most often used in hospitals and doctors’ offices, although they may sometimes be prescribed for home use. According to the FDA, over-the-counter oximeters are sold directly to consumers in stores or online as general wellness products or for sports or aviation use. These devices are not intended for medical purposes and do not undergo FDA review.

Related/Prior Legislation

SB 605 (Eggman, 2021) would have required a manufacturer of powered medical equipment to make available, to both owners of the powered medical equipment and independent repair providers, on fair and reasonable terms, any documentation, parts, and tools needed for purposes of inspection, diagnosis, maintenance, or repair of powered medical equipment. The bill was held on the Senate Appropriations Committee suspense file.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 8/6/24)

California Pan-Ethnic Health Network

Health Access California

National Union of Healthcare Workers

OPPOSITION: (Verified 8/6/24)

None received

ARGUMENTS IN SUPPORT: The California Pan-Ethnic Health Network states in support that the negative impact of disparities in medical device design, marketing and manufacturing are well documented. This bill is a simple, commonsense solution that addresses the shortcomings of medical devices by requiring certain devices for which there is a known disparity, to include a disclaimer that will help to ensure patients are aware of their limitations. Health Access, and the National Union of Healthcare Workers, state in support that while there are federal efforts to address diversity in the development of devices, consumers still need to be informed of the known potential limitations of the effectiveness of their medical devices because of the patient’s characteristics.

ASSEMBLY FLOOR: 69-0, 5/13/24

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Davies, Dixon, Flora, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Petrie-Norris, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

NO VOTE RECORDED: Bauer-Kahan, Megan Dahle, Essayli, Vince Fong, Gallagher, Grayson, Mathis, McCarty, Jim Patterson, Quirk-Silva, Ta

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

8/26/24 17:00:57

**** END ****

 THIRD ERADING  

Bill No: AB 2058

Author: Weber (D)

Amended: 6/24/24 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 7/3/24

AYES: Roth, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Menjivar, Rubio, Smallwood-Cuevas, Wiener

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 69-0, 5/13/24 - See last page for vote

SUBJECT: Medical device: disclosures

SOURCE: Author

DIGEST:

This bill requires a device, commencing January 1, 2027, that collects or analyzes medical information, and is not subject to federal medical device regulation, to have a disclosure that includes limitations known by the manufacturer on the effectiveness of the device because of certain characteristics of the patient using the device, including age, color, disability, ethnicity, gender, or race.

ANALYSIS:

Existing federal law:

1. Establishes the Food, Drug, and Cosmetic Act (FDC Act) to regulate the safety of food, drugs, medical devices, and cosmetics. [21 USC §301, et seq.]
2. Defines a “medical device,” under the FDC Act, in part, as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body, which does not achieve its primary intended purposes through chemical action within the body or upon being metabolized. [21 USC §321(h)]
3. Prohibits a state from establishing any requirement, with respect to a medical device, that is different from, or in addition to, any requirement applicable under the FDC Act and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device. However, permits a state to apply for an exemption, which may be granted by the Food and Drug Administration (FDA) through the promulgation of regulations, if the requirement is more stringent than federal law, or the requirement is required by compelling local conditions. [21 USC §360k]

Existing state law:

1. Establishes the Sherman Food, Drug, and Cosmetic Law, to regulate the manufacture, production, processing, and packing of any food, drug, device, or cosmetic, enforced by the California Department of Public Health (CDPH). [HSC §109875, et seq.]
2. Permits CDPH to establish performance standards for devices that are required to be designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device. However, specifies that if a performance standard is established for a device pursuant to federal law, the federal standard is the performance standard in California for the device. [HSC §111245]
3. Establishes labeling standards for foods, drugs, devices and cosmetics, and specifies that a drug or device is misbranded if it does not conform to the labeling requirements, or if its labeling is false or misleading in any particular. [HSC §110290, et seq., §111330]

This bill requires a device, commencing January 1, 2027, that collects or analyzes medical information or information originating from a physiological source, including, but not limited to, heartbeat, blood pressure, body temperature, or blood oxygen, and is not subject to regulation under the FDC Act, to have a legible disclosure affixed on the product, packaging, or within informational materials included in the packaging, that includes limitations known by the manufacturer on the effectiveness of the device for the device’s intended population because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race.

Comments

1. Author’s statement. According to the author, medical technologies are the technologies that diagnose, treat and improve a person’s health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. Still, these technologies and devices are not without flaw. Studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. These types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. For these reasons, this bill requires a manufacturer of a device that collects health information to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.
2. Background on concerns with pulse oximeters and forehead thermometers. Pulse oximeters are widely used by many types of health care providers and consumers to obtain an indirect measure of arterial blood oxygen saturation. Pulse oximetry is a quick and non-invasive alternative to arterial blood sampling for estimating oxygen saturation. The COVID-19 pandemic resulted in an increased use of pulse oximeters, not only in the hospital setting but at home as well. In a safety communication issued on February 19, 2021, the FDA informed patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy, which should be considered. The FDA’s safety communication stated that multiple factors may affect the performance of a pulse oximeter’s reading, such as poor circulation, skin pigmentation, skin temperature, current tobacco use, and the use of fingernail polish. In an article published in the New England Journal of Medicine in 2020, it was reported that Black patients had nearly three times the frequency of occult hypoxemia (low oxygen level in the blood) as detected by blood gas measurements not detected by pulse oximetry, when compared with White patients. The FDA convened an Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to discuss concerns that pulse oximeters may perform disparately in individuals with darker skin pigmentations. In preparation for this Advisory Panel meeting, the FDA looked at several systematic literature reviews that addressed the topic of potential bias of pulse oximetry in people with darker skin pigmentation that were published in 2022. One of these reviews concluded, “there is growing evidence that pulse oximeters are less accurate in dark-skinned individuals at lower saturation resulting in overestimations.” Another review of the literature concluded, “Pulse oximetry may overestimate blood oxygen saturation levels for people with dark skin in hospital settings compared with gold standard oxygen saturation measures. The evidence for the measurement bias identified for other levels of skin pigmentation or ethnicities is more uncertain. Whilst the extent of measurement bias and overall accuracy meets current international thresholds, the variation of pulse oximetry measurements appears unacceptably wide. Such a small overestimation may be crucial for some patients: particularly at the threshold that informs clinical decision-making.”
   
   In September of 2022, researchers at Emory University published research that found that the use of temporal artery (forehead) thermometers, which measure temperature through the skin using infrared technology, do not detect fevers as accurately as oral thermometers in hospitalized patients who are Black. The retrospective study involved 4,375 adult patients in hospitals between 2014 and 2021, about half of whom were Black and the other half White. For each patient, the first pair of oral and temporal temperatures measured within one hour of each other were recorded within the first day of hospitalization. The researchers found 26% lower odds of detecting fevers in Black patients using temporal compared to oral thermometers. In contrast, temporal thermometers were not significantly different from oral thermometers in White patients.
   
   The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated, “a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients’ oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity.”
3. Lack of diversity in clinical trials. At least part of the problem underlying the pulse oximeter issue, the temporal thermometer, and potentially other drugs and medical devices, is the documented lack of diversity in clinical trials. According to an analysis by the Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials, which is part of the National Academies of Sciences, Engineering, and Medicine, the lack of representation in clinical trials compromises generalizability of clinical research findings to the U.S. population. Over the past few decades, growing evidence has surfaced to challenge the assumption that results from randomized clinical trials could be generalizable to all patient populations. Specifically, research has demonstrated that many groups underrepresented and excluded in clinical research can have distinct disease presentations or health circumstances that affect how they will respond to an investigational drug or therapy. Such differences contribute to variable therapeutic responses and necessitate targeted efficacy and safety evaluation. Ensuring diverse participation in scientific studies allow for exploration of all of these factors and their interactions and is critical to the interpretations that allow for generalizability of findings to the population. The FDA states that participants in clinical trials should represent the patients that will use the medical products, but this is often not the case, as people from racial and ethnic minorities and other diverse groups are underrepresented in clinical research. The FDA states this is a concern because people of different ages, races, and ethnicities may react differently to certain medical products.
   
4. Background on the federal regulation of medical devices. Pursuant to the Medical Device Amendments to the FDC Act, enacted in 1976, the FDA is required to classify all devices into one of three regulatory control categories: Class I, Class II, or Class III, depending on the degree of regulation necessary to provide reasonable assurance of the safety and effectiveness of the device. Under the regulatory scheme, the safety and effectiveness of all medical devices is assured through general controls such as manufacturer registration and device listing, applicable good manufacturing practices, medical device reporting, reports of corrections and removals, unique device identification, and others. For Class II and III devices, there are special controls and premarket approval, respectively. Medical device reporting, which helps FDA assess significant adverse events and detect emerging problems associated with the use of medical devices, apply to manufacturers, importers of devices manufactured outside of the U.S., and user facilities. Under medical device reporting requirements, manufacturers are required to report to the FDA when their devices may have caused or contributed to a death or serious injury, or their device has malfunctioned and would be likely to cause or contribute to death or serious injury. Device user facilities, on the other hand, are required to report to the FDA and to the manufacturer when a device may have caused or contributed to a death, and to report to the manufacturer only when a device may have caused or contributed to a serious injury. A “device user facility” is defined as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility that is not a physician’s office.
5. Federal preemption on medical devices, which have since been amended out of bill. As described in existing federal law 3), the FDC Act contains an express preemption provision for medical devices that applies to state statutes. Under this express preemption provision, “no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement which is (1) different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” The implementing regulations provided that if a state requirement “has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition will be preempted if the requirement is different from , or in addition to, a Federal requirement established under the [FDC Act].” While there is an exception to this preemption, a state would have to request the FDA to promulgate regulations that exempt a particular requirement of a state that “is more stringent than a requirement” under the FDC Act.
   
   Based in part on this federal preemption of state labeling requirements on federally regulated medical devices, the author amended this bill to exempt products that are subject to federal regulation under the FDC Act. However, there are a number of devices available at retail that purport to measure heart rates or blood oxygen levels that are not marketed as “medical devices,” some of which are actually labeled “not for medical use.” As stated by the FDA, prescription oximeters undergo FDA review and are available only with a prescription and the FDA requires these pulse oximeters to undergo clinical testing to confirm their accuracy. These are most often used in hospitals and doctors’ offices, although they may sometimes be prescribed for home use. According to the FDA, over-the-counter oximeters are sold directly to consumers in stores or online as general wellness products or for sports or aviation use. These devices are not intended for medical purposes and do not undergo FDA review.

Related/Prior Legislation

SB 605 (Eggman, 2021) would have required a manufacturer of powered medical equipment to make available, to both owners of the powered medical equipment and independent repair providers, on fair and reasonable terms, any documentation, parts, and tools needed for purposes of inspection, diagnosis, maintenance, or repair of powered medical equipment. SB 605 was held on the Senate Appropriations Committee suspense file.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 8/6/24)

California Pan-Ethnic Health Network

Health Access California

National Union of Healthcare Workers

OPPOSITION: (Verified 8/6/24)

None received

ARGUMENTS IN SUPPORT: The California Pan-Ethnic Health Network states in support that the negative impact of disparities in medical device design, marketing and manufacturing are well documented. This bill is a simple, commonsense solution that addresses the shortcomings of medical devices by requiring certain devices for which there is a known disparity, to include a disclaimer that will help to ensure patients are aware of their limitations. Health Access, and the National Union of Healthcare Workers, state in support that while there are federal efforts to address diversity in the development of devices, consumers still need to be informed of the known potential limitations of the effectiveness of their medical devices because of the patient’s characteristics.

ASSEMBLY FLOOR: 69-0, 5/13/24

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Davies, Dixon, Flora, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Petrie-Norris, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

NO VOTE RECORDED: Bauer-Kahan, Megan Dahle, Essayli, Vince Fong, Gallagher, Grayson, Mathis, McCarty, Jim Patterson, Quirk-Silva, Ta

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

8/9/24 16:14:24

**** END ****

 CONSENT  

Bill No: AB 2058

Author: Weber (D)

Amended: 6/24/24 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 7/3/24

AYES: Roth, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Menjivar, Rubio, Smallwood-Cuevas, Wiener

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 69-0, 5/13/24 - See last page for vote

SUBJECT: Medical device: disclosures

SOURCE: Author

DIGEST:

This bill requires a device, commencing January 1, 2027, that collects or analyzes medical information, and is not subject to federal medical device regulation, to have a disclosure that includes limitations known by the manufacturer on the effectiveness of the device because of certain characteristics of the patient using the device, including age, color, disability, ethnicity, gender, or race.

ANALYSIS:

Existing federal law:

1. Establishes the Food, Drug, and Cosmetic Act (FDC Act) to regulate the safety of food, drugs, medical devices, and cosmetics. [21 USC §301, et seq.]
2. Defines a “medical device,” under the FDC Act, in part, as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body, which does not achieve its primary intended purposes through chemical action within the body or upon being metabolized. [21 USC §321(h)]
3. Prohibits a state from establishing any requirement, with respect to a medical device, that is different from, or in addition to, any requirement applicable under the FDC Act and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device. However, permits a state to apply for an exemption, which may be granted by the Food and Drug Administration (FDA) through the promulgation of regulations, if the requirement is more stringent than federal law, or the requirement is required by compelling local conditions. [21 USC §360k]

Existing state law:

1. Establishes the Sherman Food, Drug, and Cosmetic Law, to regulate the manufacture, production, processing, and packing of any food, drug, device, or cosmetic, enforced by the California Department of Public Health (CDPH). [HSC §109875, et seq.]
2. Permits CDPH to establish performance standards for devices that are required to be designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device. However, specifies that if a performance standard is established for a device pursuant to federal law, the federal standard is the performance standard in California for the device. [HSC §111245]
3. Establishes labeling standards for foods, drugs, devices and cosmetics, and specifies that a drug or device is misbranded if it does not conform to the labeling requirements, or if its labeling is false or misleading in any particular. [HSC §110290, et seq., §111330]

This bill requires a device, commencing January 1, 2027, that collects or analyzes medical information or information originating from a physiological source, including, but not limited to, heartbeat, blood pressure, body temperature, or blood oxygen, and is not subject to regulation under the FDC Act, to have a legible disclosure affixed on the product, packaging, or within informational materials included in the packaging, that includes limitations known by the manufacturer on the effectiveness of the device for the device’s intended population because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race.

Comments

1. Author’s statement. According to the author, medical technologies are the technologies that diagnose, treat and improve a person’s health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. Still, these technologies and devices are not without flaw. Studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. These types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. For these reasons, this bill requires a manufacturer of a device that collects health information to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.
2. Background on concerns with pulse oximeters and forehead thermometers. Pulse oximeters are widely used by many types of health care providers and consumers to obtain an indirect measure of arterial blood oxygen saturation. Pulse oximetry is a quick and non-invasive alternative to arterial blood sampling for estimating oxygen saturation. The COVID-19 pandemic resulted in an increased use of pulse oximeters, not only in the hospital setting but at home as well. In a safety communication issued on February 19, 2021, the FDA informed patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy, which should be considered. The FDA’s safety communication stated that multiple factors may affect the performance of a pulse oximeter’s reading, such as poor circulation, skin pigmentation, skin temperature, current tobacco use, and the use of fingernail polish. In an article published in the New England Journal of Medicine in 2020, it was reported that Black patients had nearly three times the frequency of occult hypoxemia (low oxygen level in the blood) as detected by blood gas measurements not detected by pulse oximetry, when compared with White patients. The FDA convened an Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to discuss concerns that pulse oximeters may perform disparately in individuals with darker skin pigmentations. In preparation for this Advisory Panel meeting, the FDA looked at several systematic literature reviews that addressed the topic of potential bias of pulse oximetry in people with darker skin pigmentation that were published in 2022. One of these reviews concluded, “there is growing evidence that pulse oximeters are less accurate in dark-skinned individuals at lower saturation resulting in overestimations.” Another review of the literature concluded, “Pulse oximetry may overestimate blood oxygen saturation levels for people with dark skin in hospital settings compared with gold standard oxygen saturation measures. The evidence for the measurement bias identified for other levels of skin pigmentation or ethnicities is more uncertain. Whilst the extent of measurement bias and overall accuracy meets current international thresholds, the variation of pulse oximetry measurements appears unacceptably wide. Such a small overestimation may be crucial for some patients: particularly at the threshold that informs clinical decision-making.”
   
   In September of 2022, researchers at Emory University published research that found that the use of temporal artery (forehead) thermometers, which measure temperature through the skin using infrared technology, do not detect fevers as accurately as oral thermometers in hospitalized patients who are Black. The retrospective study involved 4,375 adult patients in hospitals between 2014 and 2021, about half of whom were Black and the other half White. For each patient, the first pair of oral and temporal temperatures measured within one hour of each other were recorded within the first day of hospitalization. The researchers found 26% lower odds of detecting fevers in Black patients using temporal compared to oral thermometers. In contrast, temporal thermometers were not significantly different from oral thermometers in White patients.
   
   The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated, “a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients’ oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity.”
3. Lack of diversity in clinical trials. At least part of the problem underlying the pulse oximeter issue, the temporal thermometer, and potentially other drugs and medical devices, is the documented lack of diversity in clinical trials. According to an analysis by the Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials, which is part of the National Academies of Sciences, Engineering, and Medicine, the lack of representation in clinical trials compromises generalizability of clinical research findings to the U.S. population. Over the past few decades, growing evidence has surfaced to challenge the assumption that results from randomized clinical trials could be generalizable to all patient populations. Specifically, research has demonstrated that many groups underrepresented and excluded in clinical research can have distinct disease presentations or health circumstances that affect how they will respond to an investigational drug or therapy. Such differences contribute to variable therapeutic responses and necessitate targeted efficacy and safety evaluation. Ensuring diverse participation in scientific studies allow for exploration of all of these factors and their interactions and is critical to the interpretations that allow for generalizability of findings to the population. The FDA states that participants in clinical trials should represent the patients that will use the medical products, but this is often not the case, as people from racial and ethnic minorities and other diverse groups are underrepresented in clinical research. The FDA states this is a concern because people of different ages, races, and ethnicities may react differently to certain medical products.
   
4. Background on the federal regulation of medical devices. Pursuant to the Medical Device Amendments to the FDC Act, enacted in 1976, the FDA is required to classify all devices into one of three regulatory control categories: Class I, Class II, or Class III, depending on the degree of regulation necessary to provide reasonable assurance of the safety and effectiveness of the device. Under the regulatory scheme, the safety and effectiveness of all medical devices is assured through general controls such as manufacturer registration and device listing, applicable good manufacturing practices, medical device reporting, reports of corrections and removals, unique device identification, and others. For Class II and III devices, there are special controls and premarket approval, respectively. Medical device reporting, which helps FDA assess significant adverse events and detect emerging problems associated with the use of medical devices, apply to manufacturers, importers of devices manufactured outside of the U.S., and user facilities. Under medical device reporting requirements, manufacturers are required to report to the FDA when their devices may have caused or contributed to a death or serious injury, or their device has malfunctioned and would be likely to cause or contribute to death or serious injury. Device user facilities, on the other hand, are required to report to the FDA and to the manufacturer when a device may have caused or contributed to a death, and to report to the manufacturer only when a device may have caused or contributed to a serious injury. A “device user facility” is defined as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility that is not a physician’s office.
5. Federal preemption on medical devices, which have since been amended out of bill. As described in existing federal law 3), the FDC Act contains an express preemption provision for medical devices that applies to state statutes. Under this express preemption provision, “no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement which is (1) different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” The implementing regulations provided that if a state requirement “has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition will be preempted if the requirement is different from , or in addition to, a Federal requirement established under the [FDC Act].” While there is an exception to this preemption, a state would have to request the FDA to promulgate regulations that exempt a particular requirement of a state that “is more stringent than a requirement” under the FDC Act.
   
   Based in part on this federal preemption of state labeling requirements on federally regulated medical devices, the author amended this bill to exempt products that are subject to federal regulation under the FDC Act. However, there are a number of devices available at retail that purport to measure heart rates or blood oxygen levels that are not marketed as “medical devices,” some of which are actually labeled “not for medical use.” As stated by the FDA, prescription oximeters undergo FDA review and are available only with a prescription and the FDA requires these pulse oximeters to undergo clinical testing to confirm their accuracy. These are most often used in hospitals and doctors’ offices, although they may sometimes be prescribed for home use. According to the FDA, over-the-counter oximeters are sold directly to consumers in stores or online as general wellness products or for sports or aviation use. These devices are not intended for medical purposes and do not undergo FDA review.

Related/Prior Legislation

SB 605 (Eggman, 2021) would have required a manufacturer of powered medical equipment to make available, to both owners of the powered medical equipment and independent repair providers, on fair and reasonable terms, any documentation, parts, and tools needed for purposes of inspection, diagnosis, maintenance, or repair of powered medical equipment. SB 605 was held on the Senate Appropriations Committee suspense file.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 8/6/24)

California Pan-Ethnic Health Network

Health Access California

National Union of Healthcare Workers

OPPOSITION: (Verified 8/6/24)

None received

ARGUMENTS IN SUPPORT: The California Pan-Ethnic Health Network states in support that the negative impact of disparities in medical device design, marketing and manufacturing are well documented. This bill is a simple, commonsense solution that addresses the shortcomings of medical devices by requiring certain devices for which there is a known disparity, to include a disclaimer that will help to ensure patients are aware of their limitations. Health Access, and the National Union of Healthcare Workers, state in support that while there are federal efforts to address diversity in the development of devices, consumers still need to be informed of the known potential limitations of the effectiveness of their medical devices because of the patient’s characteristics.

ASSEMBLY FLOOR: 69-0, 5/13/24

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Davies, Dixon, Flora, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Petrie-Norris, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

NO VOTE RECORDED: Bauer-Kahan, Megan Dahle, Essayli, Vince Fong, Gallagher, Grayson, Mathis, McCarty, Jim Patterson, Quirk-Silva, Ta

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

8/7/24 13:38:10

**** END ****

SENATE COMMITTEE ON HEALTH

Senator Richard Roth, Chair

BILL NO: AB 2058

SUBJECT: Medical device: disclosures

SUMMARY:

Requires a device, commencing January 1, 2027, that collects or analyzes medical information, and is not subject to federal medical device regulation, to have a disclosure that includes limitations known by the manufacturer on the effectiveness of the device because of certain characteristics of the patient using the device, including age, color, disability, ethnicity, gender, or race.

Existing state law:

1. Establishes the Sherman Food, Drug, and Cosmetic Law, to regulate the manufacture, production, processing, and packing of any food, drug, device, or cosmetic, enforced by the California Department of Public Health (CDPH). [HSC §109875, et seq.]
2. Permits CDPH to establish performance standards for devices that are required to be designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device. However, specifies that if a performance standard is established for a device pursuant to federal law, the federal standard is the performance standard in California for the device. [HSC §111245]
3. Establishes labeling standards for foods, drugs, devices and cosmetics, and specifies that a drug or device is misbranded if it does not conform to the labeling requirements, or if its labeling is false or misleading in any particular. [HSC §110290, et seq., §111330]

Existing federal law:

1. Establishes the Food, Drug, and Cosmetic Act (FDC Act) to regulate the safety of food, drugs, medical devices, and cosmetics. [21 USC §301, et seq.]
2. Defines a “medical device,” under the FDC Act, in part, as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body, which does not achieve its primary intended purposes through chemical action within the body or upon being metabolized. [21 USC §321(h)]
3. Prohibits a state from establishing any requirement, with respect to a medical device, that is different from, or in addition to, any requirement applicable under the FDC Act and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device. However, permits a state to apply for an exemption, which may be granted by the Food and Drug Administration (FDA) through the promulgation of regulations, if the requirement is more stringent than federal law, or the requirement is required by compelling local conditions. [21 USC §360k]

This bill: Requires a device, commencing January 1, 2027, that collects or analyzes medical information or information originating from a physiological source, including, but not limited to, heartbeat, blood pressure, body temperature, or blood oxygen, and is not subject to regulation under the FDC Act, to have a legible disclosure affixed on the product, packaging, or within informational materials included in the packaging, that includes limitations known by the manufacturer on the effectiveness of the device for the device’s intended population because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, CDPH reports minor and absorbable costs to the Drug and Device Fund.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, medical technologies are the technologies that diagnose, treat and improve a person’s health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. Still, these technologies and devices are not without flaw. Studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. These types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. For these reasons, this bill requires a manufacturer of a device that collects health information to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.
2. Background on concerns with pulse oximeters and forehead thermometers. Pulse oximeters are widely used by many types of health care providers and consumers to obtain an indirect measure of arterial blood oxygen saturation. Pulse oximetry is a quick and non-invasive alternative to arterial blood sampling for estimating oxygen saturation. The COVID-19 pandemic resulted in an increased use of pulse oximeters, not only in the hospital setting but at home as well. In a safety communication issued on February 19, 2021, the FDA informed patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy, which should be considered. The FDA’s safety communication stated that multiple factors may affect the performance of a pulse oximeter’s reading, such as poor circulation, skin pigmentation, skin temperature, current tobacco use, and the use of fingernail polish. In an article published in the New England Journal of Medicine in 2020, it was reported that Black patients had nearly three times the frequency of occult hypoxemia (low oxygen level in the blood) as detected by blood gas measurements not detected by pulse oximetry, when compared with White patients. The FDA convened an Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to discuss concerns that pulse oximeters may perform disparately in individuals with darker skin pigmentations. In preparation for this Advisory Panel meeting, the FDA looked at several systematic literature reviews that addressed the topic of potential bias of pulse oximetry in people with darker skin pigmentation that were published in 2022. One of these reviews concluded, “there is growing evidence that pulse oximeters are less accurate in dark-skinned individuals at lower saturation resulting in overestimations.” Another review of the literature concluded, “Pulse oximetry may overestimate blood oxygen saturation levels for people with dark skin in hospital settings compared with gold standard oxygen saturation measures. The evidence for the measurement bias identified for other levels of skin pigmentation or ethnicities is more uncertain. Whilst the extent of measurement bias and overall accuracy meets current international thresholds, the variation of pulse oximetry measurements appears unacceptably wide. Such a small overestimation may be crucial for some patients: particularly at the threshold that informs clinical decision-making.”
   
   In September of 2022, researchers at Emory University published research that found that the use of temporal artery (forehead) thermometers, which measure temperature through the skin using infrared technology, do not detect fevers as accurately as oral thermometers in hospitalized patients who are Black. The retrospective study involved 4,375 adult patients in hospitals between 2014 and 2021, about half of whom were Black and the other half White. For each patient, the first pair of oral and temporal temperatures measured within one hour of each other were recorded within the first day of hospitalization. The researchers found 26% lower odds of detecting fevers in Black patients using temporal compared to oral thermometers. In contrast, temporal thermometers were not significantly different from oral thermometers in White patients.
   
   The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated, “a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients’ oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity.”
3. Lack of diversity in clinical trials. At least part of the problem underlying the pulse oximeter issue, the temporal thermometer, and potentially other drugs and medical devices, is the documented lack of diversity in clinical trials. According to an analysis by the Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials, which is part of the National Academies of Sciences, Engineering, and Medicine, the lack of representation in clinical trials compromises generalizability of clinical research findings to the U.S. population. Over the past few decades, growing evidence has surfaced to challenge the assumption that results from randomized clinical trials could be generalizable to all patient populations. Specifically, research has demonstrated that many groups underrepresented and excluded in clinical research can have distinct disease presentations or health circumstances that affect how they will respond to an investigational drug or therapy. Such differences contribute to variable therapeutic responses and necessitate targeted efficacy and safety evaluation. Ensuring diverse participation in scientific studies allow for exploration of all of these factors and their interactions and is critical to the interpretations that allow for generalizability of findings to the population. The FDA states that participants in clinical trials should represent the patients that will use the medical products, but this is often not the case, as people from racial and ethnic minorities and other diverse groups are underrepresented in clinical research. The FDA states this is a concern because people of different ages, races, and ethnicities may react differently to certain medical products.
   
4. Background on the federal regulation of medical devices. Pursuant to the Medical Device Amendments to the FDC Act, enacted in 1976, the FDA is required to classify all devices into one of three regulatory control categories: Class I, Class II, or Class III, depending on the degree of regulation necessary to provide reasonable assurance of the safety and effectiveness of the device. Under the regulatory scheme, the safety and effectiveness of all medical devices is assured through general controls such as manufacturer registration and device listing, applicable good manufacturing practices, medical device reporting, reports of corrections and removals, unique device identification, and others. For Class II and III devices, there are special controls and premarket approval, respectively. Medical device reporting, which helps FDA assess significant adverse events and detect emerging problems associated with the use of medical devices, apply to manufacturers, importers of devices manufactured outside of the U.S., and user facilities. Under medical device reporting requirements, manufacturers are required to report to the FDA when their devices may have caused or contributed to a death or serious injury, or their device has malfunctioned and would be likely to cause or contribute to death or serious injury. Device user facilities, on the other hand, are required to report to the FDA and to the manufacturer when a device may have caused or contributed to a death, and to report to the manufacturer only when a device may have caused or contributed to a serious injury. A “device user facility” is defined as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility that is not a physician’s office.
5. Federal preemption on medical devices, which have since been amended out of bill. As described in existing federal law 3), the FDC Act contains an express preemption provision for medical devices that applies to state statutes. Under this express preemption provision, “no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement which is (1) different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” The implementing regulations provided that if a state requirement “has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition will be preempted if the requirement is different from , or in addition to, a Federal requirement established under the [FDC Act].” While there is an exception to this preemption, a state would have to request the FDA to promulgate regulations that exempt a particular requirement of a state that “is more stringent than a requirement” under the FDC Act.
   
   Based in part on this federal preemption of state labeling requirements on federally regulated medical devices, the author amended this bill to exempt products that are subject to federal regulation under the FDC Act. However, there are a number of devices available at retail that purport to measure heart rates or blood oxygen levels that are not marketed as “medical devices,” some of which are actually labeled “not for medical use.” As stated by the FDA, prescription oximeters undergo FDA review and are available only with a prescription and the FDA requires these pulse oximeters to undergo clinical testing to confirm their accuracy. These are most often used in hospitals and doctors’ offices, although they may sometimes be prescribed for home use. According to the FDA, over-the-counter oximeters are sold directly to consumers in stores or online as general wellness products or for sports or aviation use. These devices are not intended for medical purposes and do not undergo FDA review.
6. Prior legislation. SB 605 (Eggman of 2021) would have required a manufacturer of powered medical equipment to make available, to both owners of the powered medical equipment and independent repair providers, on fair and reasonable terms, any documentation, parts, and tools needed for purposes of inspection, diagnosis, maintenance, or repair of powered medical equipment. SB 605 was held on the Senate Appropriations Committee suspense file.
7. Support. The California Pan-Ethnic Health Network states in support that the negative impact of disparities in medical device design, marketing and manufacturing are well documented. This bill is a simple, commonsense solution that addresses the shortcomings of medical devices by requiring certain devices for which there is a known disparity, to include a disclaimer that will help to ensure patients are aware of their limitations. Health Access, and the National Union of Healthcare Workers, state in support that while there are federal efforts to address diversity in the development of devices, consumers still need to be informed of the known potential limitations of the effectiveness of their medical devices because of the patient’s characteristics.

SUPPORT AND OPPOSITION:

Support: California Pan-Ethnic Health Network

Health Access California

National Union of Healthcare Workers

Oppose: None received

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 2058

Author:(Weber)

As Amended Ver:March 18, 2024

Majority vote

SUMMARY

Requires a medical device to have a legible disclosure on the product, the packaging, or within informational material included with the packaging for the device to include known limitations on the effectiveness of the device because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, disability, ethnicity, gender, or race.

Major Provisions

COMMENTS

1. Racial disparities in the use of medical devices. The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated that: "a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients' oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity." A recent study by Emory University found that forehead thermometers were significantly less accurate (26% lower) than oral thermometers in detecting fevers for Black patients.
2. U.S. Food and Drug Administration (FDA) Guidance. In April 2022, the FDA updated its latest draft guidance to improve diversity in clinical trials, including the requirement that device applications must report clinical trial demographic data. On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act of 2023 which included a requirement that clinical trial sponsors submit to the Secretary of the U.S. Department of Health and Human Services, a "diversity action plan" for certain late-stage drug trials, as well as most medical device studies.
3. FDA discussion. On November 16, 2023, the FDA Center for Devices and Radiological Health published a discussion paper, "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity." The intent of the discussion paper was not to communicate the FDA's regulatory expectations, but to advance a broader discussion among stakeholders on this topic. The discussion paper highlighted a summary of three systematic reviews on the topic of potential bias of pulse oximetry in people with darker skin pigmentation published in 2022.
   1. Cabanas, et al. (2022) identified 41 references published between 1976 and 2022, which included 34 prospective and retrospective studies. Nine studies were considered at high risk of bias due to unstandardized classification of skin pigmentation such as "dark," "black," "light," or "white." The authors reported that there was a considerable upsurge of publications in 2021, due to the COVID-19 pandemic as well as increased concern about pulse oximeter performance across skin types. They concluded that "there is growing evidence that pulse oximeters are less accurate in dark-skinned individuals at lower saturation resulting in overestimations" and also that "a more accurate method for classifying the research participants into categories by degree of skin pigmentation should be employed in these studies.
   2. Shi, et al. (2022) identified 32 references published between 1985 and 2021. Meta-analysis of 15 studies using skin pigmentation levels and 22 studies using race/ethnicity showed that pulse oximetry probably overestimates oxygen saturation in people with high level of skin pigmentation and people described as Black/African American, although this evidence was considered moderate to low certainty. The authors concluded that "Pulse oximetry may overestimate blood oxygen saturation levels for people with dark skin in hospital settings compared with gold standard SaO2 measures. The evidence for the measurement bias identified for other levels of skin pigmentation or ethnicities is more uncertain. Whilst the extent of measurement bias and overall accuracy meet current international thresholds, the variation of pulse oximetry measurements appears unacceptably wide. Such a small overestimation may be crucial for some patients: particularly at the threshold that informs clinical decision-making".
   3. Poorzargar, et al. (2022) identified 22 references published between 1988 and 2020, looking specifically at pulse oximetry accuracy under poor perfusion conditions (including hypothermia, vasoactive drug use, or other factors not reported). Only one study controlled for skin pigmentation, by excluding participants with darker skin. The authors reported that most oximeter models were accurate in patients with poor perfusion, newer models were more accurate than older models, and earlobe placement was more accurate than fingertip. They also concluded that more trials are needed that incorporate FDA guidelines for a diverse range of skin pigmentation.

According to the Author

Medical technologies are the technologies that diagnose, treat and improve a person's health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. The author states that these technologies and devices are not without flaw; studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. The author continues that these types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. The author concludes that for these reasons, this bill requires a medical device manufacturer to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.

Arguments in Support

None on file.

Arguments in Opposition

None on file.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, the Department of Public Health reports minor and absorbable costs to the Drug and Device Fund.

VOTES

ASM HEALTH: 15-0-1

YES: Bonta, Waldron, Aguiar-Curry, Arambula, Wendy Carrillo, Flora, Haney, Jones-Sawyer, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Schiavo, Weber

ABS, ABST OR NV: Sanchez

ASM APPROPRIATIONS: 13-0-2

YES: Wicks, Sanchez, Arambula, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Grayson, Haney, Hart, Pellerin, Villapudua

ABS, ABST OR NV: Jim Patterson, Ta

UPDATED

VERSION: March 18, 2024

CONSULTANT: Eliza Brooks / HEALTH / (916) 319-2097 FN: 0002828

ASSEMBLY THIRD READING

ATR Bill Id:AB 2058

Author:(Weber)

As Amended Ver:March 18, 2024

Majority vote

SUMMARY

Requires a medical device to have a legible disclosure on the product, the packaging, or within informational material included with the packaging for the device to include known limitations on the effectiveness of the device because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, disability, ethnicity, gender, or race.

Major Provisions

COMMENTS

1. Racial disparities in the use of medical devices. The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated that: "a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients' oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity." A recent study by Emory University found that forehead thermometers were significantly less accurate (26% lower) than oral thermometers in detecting fevers for Black patients.
2. U.S. Food and Drug Administration (FDA) Guidance. In April 2022, the FDA updated its latest draft guidance to improve diversity in clinical trials, including the requirement that device applications must report clinical trial demographic data. On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act of 2023 which included a requirement that clinical trial sponsors submit to the Secretary of the U.S. Department of Health and Human Services, a "diversity action plan" for certain late-stage drug trials, as well as most medical device studies.
3. FDA discussion. On November 16, 2023, the FDA Center for Devices and Radiological Health published a discussion paper, "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity." The intent of the discussion paper was not to communicate the FDA's regulatory expectations, but to advance a broader discussion among stakeholders on this topic. The discussion paper highlighted a summary of three systematic reviews on the topic of potential bias of pulse oximetry in people with darker skin pigmentation published in 2022.
   1. Cabanas, et al. (2022) identified 41 references published between 1976 and 2022, which included 34 prospective and retrospective studies. Nine studies were considered at high risk of bias due to unstandardized classification of skin pigmentation such as "dark," "black," "light," or "white." The authors reported that there was a considerable upsurge of publications in 2021, due to the COVID-19 pandemic as well as increased concern about pulse oximeter performance across skin types. They concluded that "there is growing evidence that pulse oximeters are less accurate in dark-skinned individuals at lower saturation resulting in overestimations" and also that "a more accurate method for classifying the research participants into categories by degree of skin pigmentation should be employed in these studies.
   2. Shi, et al. (2022) identified 32 references published between 1985 and 2021. Meta-analysis of 15 studies using skin pigmentation levels and 22 studies using race/ethnicity showed that pulse oximetry probably overestimates oxygen saturation in people with high level of skin pigmentation and people described as Black/African American, although this evidence was considered moderate to low certainty. The authors concluded that "Pulse oximetry may overestimate blood oxygen saturation levels for people with dark skin in hospital settings compared with gold standard SaO2 measures. The evidence for the measurement bias identified for other levels of skin pigmentation or ethnicities is more uncertain. Whilst the extent of measurement bias and overall accuracy meet current international thresholds, the variation of pulse oximetry measurements appears unacceptably wide. Such a small overestimation may be crucial for some patients: particularly at the threshold that informs clinical decision-making".
   3. Poorzargar, et al. (2022) identified 22 references published between 1988 and 2020, looking specifically at pulse oximetry accuracy under poor perfusion conditions (including hypothermia, vasoactive drug use, or other factors not reported). Only one study controlled for skin pigmentation, by excluding participants with darker skin. The authors reported that most oximeter models were accurate in patients with poor perfusion, newer models were more accurate than older models, and earlobe placement was more accurate than fingertip. They also concluded that more trials are needed that incorporate FDA guidelines for a diverse range of skin pigmentation.

According to the Author

Medical technologies are the technologies that diagnose, treat and improve a person's health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. The author states that these technologies and devices are not without flaw; studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. The author continues that these types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. The author concludes that for these reasons, this bill requires a medical device manufacturer to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.

Arguments in Support

None on file.

Arguments in Opposition

None on file.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, the Department of Public Health reports minor and absorbable costs to the Drug and Device Fund.

VOTES

ASM HEALTH: 15-0-1

YES: Bonta, Waldron, Aguiar-Curry, Arambula, Wendy Carrillo, Flora, Haney, Jones-Sawyer, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Schiavo, Weber

ABS, ABST OR NV: Sanchez

ASM APPROPRIATIONS: 13-0-2

YES: Wicks, Sanchez, Arambula, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Grayson, Haney, Hart, Pellerin, Villapudua

ABS, ABST OR NV: Jim Patterson, Ta

UPDATED

VERSION: March 18, 2024

CONSULTANT: Eliza Brooks / HEALTH / (916) 319-2097 FN: 0002828

Date of Hearing: May 1, 2024

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Buffy Wicks, Chair

ABPCA Bill Id:AB 2058

Author:(Weber) – As Amended Ver:March 18, 2024

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill requires a medical device to have on the product, packaging, or included informational material a legible disclosure of known limitations on the effectiveness of the device because of certain characteristics of the patient using the device. Such characteristics may include age, color, disability, ethnicity, gender, or race.

FISCAL EFFECT:

The California Department of Public Health reports minor and absorbable costs to the Drug and Device Fund.

COMMENTS:

1. Purpose. According to the author:

Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. Still, these technologies and devices are not without flaw. Studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. These types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. For these reasons, AB 2058 requires a medical device manufacturer to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.

1. Racial Disparities in the Accuracy of Medical Devices. The final California Reparations Task Force Report noted:
   

A 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients’ oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity.

A recent study by Emory University found that forehead thermometers were significantly less accurate than oral thermometers in detecting fevers for Black patients.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: April 9, 2024

ASSEMBLY COMMITTEE ON HEALTH

Mia Bonta, Chair

ABPCA Bill Id:AB 2058

Author:((Weber) – As Amended Ver:March 18, 2024

SUBJECT: Automated decision systems.

SUMMARY: Requires a medical device to have a legible disclosure on the product, the packaging, or within informational material included with the packaging for the device to include known limitations on the effectiveness of the device because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, disability, ethnicity, gender, or race.

EXISTING LAW:

1. Regulates, under the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health (DPH). Makes a violation of that law a crime. [Health and Safety Code (HSC) § 109875-111915]
2. Authorizes the DPH to establish performance standards for devices designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device. [HSC § 11245]
3. Provides any drug or device is misbranded if its labeling is false or misleading in any particular. [HSC § 111330]
4. Provides that any device is misbranded if it the labeling fails to reveal facts concerning the food, drug, device or cosmetic or consequences of consumer use. [HSC § 111335]
5. Provides that any drug or device is misbranded unless its labeling bears all of the following information:
   1. Adequate directions for use. If DPH determines that
   2. Such adequate warnings against use in pathological conditions or by children where its use may be dangerous to health.
   3. Adequate warning against unsafe dosage or methods or duration of administration or application.
   4. Warnings must be in a manner and form as are necessary for the protection of users. If DPH determines that any requirement of subdivision (a), as applied to any drug or device, is not necessary for the protection of the public health, the department may adopt regulations exempting the drug or device from these requirements.
   5. Any drug or device exempted under federal law governing misbranded drugs and devices exempt from the requirement of this section. DPH is authorized adopt any regulation including a drug or device within, or excluding a drug or device from the requirements of this section, whether or not the inclusion or exclusion of the drug or device is in accord with federal law. [HSC § 111375]
6. Provides that any drug or device is misbranded unless it bears a label containing all of the following information:
   1. The name and place of business of the manufacturer, packer, or distributor.
   2. An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Authorizes reasonable variations from these requirements.
   3. Requirements for placement and prominence of the information and exemptions as to small packages shall be established in accordance with existing regulations. [HSC § 11340]
      
7. Provides that any drug or device is misbranded if any word, statement, or other information required by or under this part to appear on the label or labeling is not prominently placed on the label or labeling with conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. [HSC § 111345]
   

FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, medical technologies are the technologies that diagnose, treat and improve a person’s health and wellbeing, and include both low- and high-risk medical devices. These products may vary from tongue depressors, bedpans and medical thermometers to insulin pumps, complex pacemakers and in vitro diagnostics. Advancements in medical technology have resulted in significant positive impacts for patients, and the healthcare industry as a whole. The author states that these technologies and devices are not without flaw; studies have shown that both pulse oximeters and forehead thermometers are less accurate on individuals with darker skin. The author continues that these types of inaccuracies can lead to delays in diagnoses or drug administration, and could possibly have fatal implications. The author concludes that for these reasons, this bill requires a medical device manufacturer to include a disclosure on the device or its packaged materials, on the known limitations of the effectiveness of the device due to certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, gender, or race.
2. BACKGROUND.
   1. Racial disparities in the use of medical devices. The final California Reparations Task Force Report, released in June 2023, highlighted the disparities that exist within the use of medical devices. The report stated that: “a 2020 study on pulse oximeters, a medical device used especially in the COVID-19 pandemic to monitor patients’ oxygen levels, detailed that the devices are less accurate among patients with darker skin and could even increase risk of adverse health outcomes for those patients. A 2022 retrospective study found that patients of color, likely due to this known bias, received less supplemental oxygen than White patients, contributing to their morbidity.” A recent study by Emory University found that forehead thermometers were significantly less accurate (26% lower) than oral thermometers in detecting fevers for Black patients.
   2. U.S. Food and Drug Administration (FDA) Guidance. In April 2022, the FDA updated its latest draft guidance to improve diversity in clinical trials, including the requirement that device applications must report clinical trial demographic data. On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act of 2023 which included a requirement that clinical trial sponsors submit to the Secretary of the U.S. Department of Health and Human Services, a “diversity action plan” for certain late-stage drug trials, as well as most medical device studies.
      
   3. FDA discussion. On November 16, 2023, the FDA Center for Devices and Radiological Health published a discussion paper, “Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity.” The intent of the discussion paper was not to communicate the FDA’s regulatory expectations, but to advance a broader discussion among stakeholders on this topic. The discussion paper highlighted a summary of three systematic reviews on the topic of potential bias of pulse oximetry in people with darker skin pigmentation published in 2022.
      
      1. Cabanas, et al. (2022) identified 41 references published between 1976 and 2022, which included 34 prospective and retrospective studies. Nine studies were considered at high risk of bias due to unstandardized classification of skin pigmentation such as “dark,” “black,” “light,” or “white.” The authors reported that there was a considerable upsurge of publications in 2021, due to the COVID-19 pandemic as well as increased concern about pulse oximeter performance across skin types. They concluded that “there is growing evidence that pulse oximeters are less accurate in dark-skinned individuals at lower saturation resulting in overestimations” and also that “a more accurate method for classifying the research participants into categories by degree of skin pigmentation should be employed in these studies.
      2. Shi, et al. (2022) identified 32 references published between 1985 and 2021. Meta-analysis of 15 studies using skin pigmentation levels and 22 studies using race/ethnicity showed that pulse oximetry probably overestimates oxygen saturation in people with high level of skin pigmentation and people described as Black/African American, although this evidence was considered moderate to low certainty. The authors concluded that “Pulse oximetry may overestimate blood oxygen saturation levels for people with dark skin in hospital settings compared with gold standard SaO2 measures. The evidence for the measurement bias identified for other levels of skin pigmentation or ethnicities is more uncertain. Whilst the extent of measurement bias and overall accuracy meet current international thresholds, the variation of pulse oximetry measurements appears unacceptably wide. Such a small overestimation may be crucial for some patients: particularly at the threshold that informs clinical decision-making.
      3. Poorzargar, et al. (2022) identified 22 references published between 1988 and 2020, looking specifically at pulse oximetry accuracy under poor perfusion conditions (including hypothermia, vasoactive drug use, or other factors not reported). Only one study controlled for skin pigmentation, by excluding participants with darker skin. The authors reported that most oximeter models were accurate in patients with poor perfusion, newer models were more accurate than older models, and earlobe placement was more accurate than fingertip. They also concluded that more trials are needed that incorporate FDA guidelines for a diverse range of skin pigmentation.

Research makes clear that there are accuracy differences in the performance of medical devices such as pulse oximeter devices based on certain characteristics of the patient, such as skin color. It stands to reason that these types of inaccuracies can lead to delays in patient treatment, whether it be the diagnoses or the administration of drugs. This bill will provide necessary information regarding known limitations of device specific to characteristics such as their race, color, ethnicity, age, disability, or gender.

1. PREVIOUS LEGISLATION. SB 605 (Eggman) of 2021 would have required manufacturers of powered medical devices to make the documentation, software, and parts necessary to maintain and repair such devices available to a hospital and an independent service organization engaged by the hospital, on fair and reasonable terms, so that the hospital or its engaged repair service can conduct its own maintenance and repairs. SB 605 was held on the Senate Appropriations suspense file.
2. DOUBLE REFFERAL. This bill is double-referred, upon passage of this Committee, it will be referred to the Assembly Committee on Privacy and Consumer Protection.

REGISTERED SUPPORT / OPPOSITION:

Support

None on file.

Opposition

None on file.

Analysis Prepared by: Eliza Brooks / HEALTH / (916) 319-2097