Existing law, as of January 1, 2016, prohibits a health facility, as defined, from using an epidural connector or an enteral feeding connector, that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care. Existing law also requires a health facility to develop a patient safety plan and, until January 1, 2016, requires that plan to include measures to prevent adverse events associated with misconnecting enteral feeding and epidural lines. Violation of these provisions is a misdemeanor.

This bill would make the provisions relating to an epidural connector operative as of January 1, 2017, and would make the provisions relating to an enteral feeding connector operative as of July 1, 2016. The bill would make conforming changes.

Existing law, as of January 1, 2016, prohibits a health facility, as defined, from using an epidural connector or an enteral feeding connector, that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care. Existing law also requires a health facility to develop a patient safety plan and, until January 1, 2016, requires that plan to include measures to prevent adverse events associated with misconnecting enteral feeding and epidural lines. Violation of these provisions is a misdemeanor.

This bill would make the provisions relating to an epidural connector operative as of January 1, 2017, and would make the provisions relating to an enteral feeding connector operative as of July 1, 2016. The bill would make conforming changes.

Existing law, as of January 1, 2016, prohibits a health facility, as defined, from using an epidural connector or an enteral feeding connector, that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care. Existing law also requires a health facility to develop a patient safety plan and, as of until January 1, 2016, requires that plan to include measures to prevent adverse events associated with misconnecting enteral feeding and epidural lines. Violation of these provisions is a misdemeanor.

This bill would make these the provisions relating to an epidural connector operative as of January 1, 2017. 2017, and would make the provisions relating to an enteral feeding connector operative as of July 1, 2016. The bill would make conforming changes.

Existing law, as of January 1, 2016, prohibits a health facility, as defined, from using an epidural connector that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care. Existing law also requires a health facility to develop a patient safety plan and, as of January 1, 2016, requires that plan to include measures to prevent adverse events associated with misconnecting epidural lines. Violation of these provisions is a misdemeanor.

This bill would make these provisions operative as of January 1, 2017.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 444

Author:(Gipson)

As Amended Ver:June 1, 2015

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Delays, until July 1, 2016, the deadline prohibiting general acute care, acute psychiatric, special hospitals, and skilled nursing facilities (SNFs) from using certain enteral connector devices. Delays, until January 1, 2017, the deadline prohibiting general acute care, acute psychiatric, special hospitals, and SNFs from using certain epidural connector devices.

The Senate amendments added the delay, until July 1, 2016, of the deadline prohibiting general acute care, acute psychiatric, special hospitals, and SNFs from using certain enteral connector devices.

Although the deadline was met for developing Intravenous Therapy (IV) and enteral designs, complications between manufacturers and distributers have delayed the ability of the industry to adequately fill the supply chain with the syringes needed for the enteral systems. Accordingly, the industry has also requested a six month delay in implementation of standardized enteral systems.

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

COMMENTS: According to the author, that while worldwide experts participating in the development of the new international standards for IV connectors are highly committed to solving the problem of tubing misconnections, the process is, and should be, rigorous enough to ensure that the work is done correctly the first time. The wrong outcome, the author maintains, would lead to a far more dangerous healthcare environment than what currently exists by possibly creating new risks, or creating a solution that cannot be manufactured cost effectively or is too complicated for users. The author notes that this bill will ultimately improve patient safety.

Adverse events related to misconnections of devices and lines. Hospitals and other health care facilities depend on a variety of catheters, tubing, and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, and epidural (spinal) delivery systems. These delivery systems frequently employ fittings called Luer connectors to link various system components. The male and female components of Luer connectors join together to create secure yet detachable leak-proof connections. Multiple connections between medical devices and tubing are common in patient care. Today Luer connectors are used worldwide to connect a variety of medical devices, components, and accessories.

Unfortunately, the ubiquitous nature of the Luer connector design allows for connection between unrelated delivery systems. Because Luer connecters are easy-to-use and compatible between different delivery systems, patient care staff can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Numerous such errors have been documented, including many that have caused serious patient injuries and deaths.

SB 158 (Florez), Chapter 294, Statutes of 2008, addressed a number of issues designed to improve patient safety, including a requirement that, as of January 1, 2011, certain health facilities must use separate, unique connectors for IV, enteral feeding, and epidural connections to prevent adverse events associated with misconnections. AB 818 (Hernandez), Chapter 476, Statutes of 2009, delayed the effective dates in SB 158 and established a new deadline – January 1, 2013, for enteral feeding and IV connections and January 1, 2014, for epidural connections. AB 818 also required certain health facilities to include in their patient safety plans measures to prevent adverse events associated with misconnections and required the Advanced Medical Technology Association (AdvaMed), to report annually to the Legislature regarding the progress of the International Organization for Standardization (ISO) in developing new design standards. AB 1867 (Pan), Chapter 194, Statutes of 2012, delayed the deadline for implementing the ban on compatible IV, epidural, and enteral feeding systems until January 1, 2016.

AdvaMed report on ISO progress. On December 15, 2014, AdvaMed provided the Assembly and Senate Health Committees with their statutorily required report on the progress of the ISO in solving the problem of tubing misconnections. According to the report, the 2016 deadline will be met for IV and enteral feeding lines; however, the epidural connector design was recently found to still have the ability to allow for misconnection with an IV and requires more time for redesign and testing. The AdvaMed report notes that, "…without a delay of the 2016 deadline to allow completion of the epidural effort, there could be a proliferation of proprietary new connectors that will add to the list of possible misconnections and create a cost burden for California hospitals."

The International Organization for Standardization. The ISO is an international standard-setting body composed of representatives from various national standards organizations. The organization promotes worldwide proprietary, industrial, and commercial standards. ISO launches the development of new standards in response to stakeholders that express a clearly established need for them. ISO standards are developed by technical committees comprising of experts from the industrial, technical, and business sectors which have asked for the standards.

The ISO has been working on an international standard for IV connectors since 2008. The work group is comprised of participants from 31 countries headed by a nurse from the federal Food and Drug Administration. The workgroup discovered the Luers in use were more complicated than previously thought. Nine different dimensions of the Luer had to be taken into consideration (for example, the length, the circumference at various points, etc.) It took until December of 2011 to develop what is called the Masa Cone, which allows for different size tubing dimensions to be attached to various points on the Luer. After that, the ISO moved forward designs for each type of tubing that connect to the Luer, which have taken roughly three years to get through the ISO process. At each phase of the process designs must be sent out for feasibility testing and member comment before draft international standards can be released. It was during this process that the working group discovered a design problem with the epidural connector after feasibility testing. The epidural connector was then re-designed and sent back out for comment, adding a year to the process.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0001129

 CONSENT  

Bill No: AB 444

Author: Gipson (D), et al.

Amended: 6/1/15 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 9-0, 6/17/15

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth, Wolk

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 78-0, 4/23/15 (Consent) - See last page for vote

SUBJECT: Health facilities: epidural and external feeding connectors

SOURCE: AdvaMed

DIGEST: This bill delays, until July 1, 2016, the deadline prohibiting general acute care, acute psychiatric, special hospitals, and skilled nursing facilities (SNFs) from using certain enteral connector devices. This bill delays, until January 1, 2017, the deadline prohibiting general acute care, acute psychiatric, special hospitals, and SNFs from using certain epidural connector devices.

ANALYSIS:

Existing law:

1. Provides for the licensing and regulation of health facilities, including general acute care hospitals, acute psychiatric hospitals, special hospitals, and SNFs by the Department of Public Health.

2. Requires the health facilities referenced in 1) above to develop, implement, and comply with a patient safety plan to reduce adverse events, and requires the safety plan to include measures to prevent adverse events associated with misconnecting intravenous (IV), enteral (intestinal) feeding, and epidural lines.

3. Prohibits, as of January 1, 2016, the health facilities reference in 1) from using an IV, epidural, or enteral connection that would fit into a connection port other than the type for it was intended, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care.

4. Requires that every year on January 1, until standards are adopted, the AdvaMed (also known as Advanced Medical Technology Association) provides the Legislature with a report on the progress of the International Organization of Standardizations (ISO) in developing new design standards for connectors for IV, epidural, or enteral applications.

This bill:

1. Extends the implementation date of the prohibition on the use of an enteral feeding connection that would fit into a connection port other than the type for which it was intended, from January 1, 2016 to July 1, 2016.

2. Extends the implementation date of the prohibition on the use of an epidural connection that fits into a connection port other than the type for which it was intended from January 1, 2016 to January 1, 2017.

Comments

1. Author’s statement. According to the author, AB 444 seeks to ensure enhanced patient safety by extending the deadline on hospital implementation of new standards for epidural and enteral medical connectors. When patients receive care, they often require connection to various hospital devices that may include epidural or enteral medical equipment. Current standards for medical connectors can lead to device misconnection, where devices that have compatible connectors are accidentally connected to the wrong device and can lead to serious medical complications. Existing law will make it so that new standards are put in place that resolve the problem of misconnection by making it so that certain connectors are no longer compatible across devices. However, due to complications in device development and distribution, the timeline for the epidural and enteral medical equipment standards need to be extended to ensure that hospitals are able to effectively implement the new standards in line with the statutory deadline.

2. Adverse events related to misconnections of devices and lines. Hospitals and other health care facilities depend on a variety of catheters, tubing, and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, and epidural (spinal) delivery systems. These delivery systems frequently employ fittings called Luer connectors to link various system components. The male and female components of Luer connectors join together to create secure yet detachable leak-proof connections. Multiple connections between medical devices and tubing are common in patient care. Today, Luer connectors are used worldwide to connect a variety of medical devices, components, and accessories.

Unfortunately, the ubiquitous nature of the Luer connector design allows for connection between unrelated delivery systems. Because Luer connecters are easy-to-use and compatible between different delivery systems, patient care staff can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Numerous such errors have been documented, including many that have caused serious patient injuries and deaths.

3. The International Organization for Standardization. The ISO is an international standard-setting body composed of representatives from various national standards organizations, and promotes worldwide proprietary, industrial, and commercial standards. ISO launches the development of new standards in response to sectors and stakeholders that express a clearly established need for them. ISO standards are developed by technical committees comprised of experts from the industrial, technical, and business sectors which have asked for the standards.

4. ISO progress and delays. Since beginning work on an international standard for IV connectors in 2008, the ISO workgroup discovered the Luers were more complicated than previously thought. Nine different dimensions of the Luer had to be taken into consideration (lengths, circumferences, etc.) These complications prompted the Legislature in 2009 to delay the implementation of standardization until January 1, 2013, for IV and enteral connectors, and January 1, 2014, for epidural connectors. Designs for unique types of tubing that connect to the Luer took roughly three years to get through the ISO process. At each phase of the process, designs must be sent out for feasibility testing and member comment before draft international standards can be released. The lengthiness of the ISO process prompted the Legislature, in 2012, to again delay implementation for all three connector types until January 1, 2016.

On December 15, 2014, AdvaMed, the sponsor of this bill, provided the Assembly and Senate Health Committees with their statutorily required report on the progress of the ISO in solving the problem of tubing misconnections. According to the report, the 2016 deadline was to be met for IV and enteral feeding lines; however, the epidural connector design was found to allow for misconnection with an IV, and required more time for redesign and testing. The AdvaMed report notes that, “…without a delay of the 2016 deadline to allow completion of the epidural effort, there could be a proliferation of proprietary new connectors that will add to the list of possible misconnections and create a cost burden for California hospitals.”

Although the deadline was met for developing IV and enteral designs, complications between manufacturers and distributers have delayed the ability of the industry to adequately fill the supply chain with the syringes needed for the enteral systems. Accordingly, the industry has also requested a six month delay in implementation of standardized enteral systems.

Prior Legislation

SB 158 (Florez, Chapter 294, Statutes of 2008), among other provisions, required hospitals and SNFs to institute a patient safety plan for the purpose of improving the health and safety of patients and reducing preventable patient safety events. SB 158 also prohibited, beginning January 1, 2011, general acute care, acute psychiatric, and special hospitals, and SNFs from using an IV connection, epidural connection, or enteral feeding connection that would fit into a connection port other than the type for which it was intended, with exceptions, as specified.

AB 818 (Hernandez, Chapter 476, Statutes of 2009) delayed the January 1, 2011 implementation date of the portions of SB 158 related to medical connectors (Section 3) until 36 months after the publication of a new design standard or January 1, 2014, whichever occurs first, for epidural connections, and to 24 months after the publication of new design standards or January 1, 2013, whichever occurs first, for IV or enteral connections. AB 818 also required AdvaMed to provide the Legislature with an annual report on the progress of the ISO in developing the new design standards and required hospitals to include in their patient safety plan measures to prevent adverse events associated with misconnecting IV, enteral feeding, and epidural lines.

AB 1867 (Pan, Chapter 194, Statutes of 2012) delayed the deadline for implementation of the ban on compatible IV, epidural and enteral feeding systems until January 1, 2016.

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

SUPPORT: (Verified 6/30/15)

AdvaMed (source)

ALCOR Scientific, Inc.

American Society of Health-System Pharmacists

Association for the Advancement of Medical Instrumentation

B. Braun Medical, Inc.

Bard Peripheral Vascular

Baxter

Beckman, Dickinson, and Company

Biocom

California Association of Nurse Anesthetists

California Healthcare Institute

California Life Sciences Association

Corpak MedSystems, Inc.

Feeding Tube Awareness Foundation

Halyard Health, Inc.

Institute for Safe Medication Practices

Kentec Medical, Inc.

MedAssets

Medtronic

Novation

Pajunk Medical Systems

Premier Healthcare Alliance

Teleflex Medical

OPPOSITION: (Verified 6/30/15)

None received

ARGUMENTS IN SUPPORT: AdvaMed, this bill’s sponsor, states that, absent a standard connector design, industry would have to implement proprietary connectors, increasing cost to manufacturers, health care facilities, and ultimately patients, while creating unacceptable risk to patient safety.

This bill is supported by numerous organizations and medical technology companies. Halyard Health states it is imperative that all manufactures move forward in a coordinated, nation-wide transition to new, safer connections, and that supply concerns with syringes require a delayed implementation of new connections. Halyard Health, Medtronic, and MedAssets state that without this bill, there will be an unreasonable risk to patient safety. Beckman, Dickinson, and Company (BD) states that requiring healthcare facilities in California to adhere to non-interconnectibility requirements before the ISO process is complete could result in temporary, interim solutions that are complicated for healthcare providers, expensive to manufacture, and are not in the best interest of patients.

ASSEMBLY FLOOR: 78-0, 4/23/15

AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins

NO VOTE RECORDED: Campos, Salas

Prepared by: Shannon Muir / HEALTH /

7/1/15 14:56:50

**** END ****

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 444

SUBJECT: Health facilities: epidural connectors and external feeding connectors.

SUMMARY:

Delays, until July 1, 2016, the deadline prohibiting general acute care, acute psychiatric, special hospitals, and skilled nursing facilities (SNFs) from using certain enteral connector devices. Delays, until January 1, 2017, the deadline prohibiting general acute care, acute psychiatric, special hospitals, and SNFs from using certain epidural connector devices.

Existing law:

1. Provides for the licensing and regulation of health facilities, including general acute care hospitals, acute psychiatric hospitals, special hospitals, and SNFs by the Department of Public Health (DPH).

2. Requires the health facilities referenced in 1) above to develop, implement, and comply with a patient safety plan to reduce adverse events, and requires the safety plan to include measures to prevent adverse events associated with misconnecting intravenous (IV), enteral (intestinal) feeding, and epidural lines.

3. Prohibits, as of January 1, 2016, the health facilities reference in 1) from using an IV, epidural, or enteral connection that would fit into a connection port other than the type for it was intended, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care.

4. Requires that every year on January 1, until standards are adopted, the Advanced Medical Technology Association (AdvaMed) provides the Legislature with a report on the progress of the International Organization of Standardizations (ISO) in developing new design standards for connectors for IV, epidural, or enteral applications.

This bill:

1. Extends the implementation date of the prohibition on the use of an enteral feeding connection that would fit into a connection port other than the type for which it was intended, from January 1, 2016 to July 1, 2016.

2. Extends the implementation date of the prohibition on the use of an epidural connection that fits into a connection port other than the type for which it was intended from January 1, 2016 to January 1, 2017.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, this bill has negligible state fiscal impact.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, AB 444 seeks to ensure enhanced patient safety by extending the deadline on hospital implementation of new standards for epidural and enteral medical connectors. When patients receive care, they often require connection to various hospital devices that may include epidural or enteral medical equipment. Current standards for medical connectors can lead to device misconnection, where devices that have compatible connectors are accidentally connected to the wrong device and can lead to serious medical complications. Current law will make it so that new standards are put in place that resolve the problem of misconnection by making it so that certain connectors are no longer compatible across devices. However, due to complications in device development and distribution, the timeline for the epidural and enteral medical equipment standards need to be extended to ensure that hospitals are able to effectively implement the new standards in line with the statutory deadline.

2. Adverse events related to misconnections of devices and lines. Hospitals and other health care facilities depend on a variety of catheters, tubing, and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, and epidural (spinal) delivery systems. These delivery systems frequently employ fittings called Luer connectors to link various system components. The male and female components of Luer connectors join together to create secure yet detachable leak-proof connections. Multiple connections between medical devices and tubing are common in patient care. Today, Luer connectors are used worldwide to connect a variety of medical devices, components, and accessories.

Unfortunately, the ubiquitous nature of the Luer connector design allows for connection between unrelated delivery systems. Because Luer connecters are easy-to-use and compatible between different delivery systems, patient care staff can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Numerous such errors have been documented, including many that have caused serious patient injuries and deaths.

3. The International Organization for Standardization (ISO). The ISO is an international standard-setting body composed of representatives from various national standards organizations, and promotes worldwide proprietary, industrial, and commercial standards. ISO launches the development of new standards in response to sectors and stakeholders that express a clearly established need for them. ISO standards are developed by technical committees comprised of experts from the industrial, technical, and business sectors which have asked for the standards.

4. ISO progress and delays. Since beginning work on an international standard for IV connectors in 2008, the ISO workgroup discovered the Luers were more complicated than previously thought. Nine different dimensions of the Luer had to be taken into consideration (lengths, circumferences, etc.) These complications prompted the Legislature in 2009 to delay the implementation of standardization until January 1, 2013 for IV and enteral connectors, and January 1, 2014 for epidural connectors. Designs for unique types of tubing that connect to the Luer took roughly three years to get through the ISO process. At each phase of the process, designs must be sent out for feasibility testing and member comment before draft international standards can be released. The lengthiness of the ISO process prompted the State Legislature, in 2012, to again delay implementation for all three connector types until January 1, 2016.

On December 15, 2014, AdvaMed, the sponsor of this bill, provided the Assembly and Senate Health Committees with their statutorily required report on the progress of the ISO in solving the problem of tubing misconnections. According to the report, the 2016 deadline was to be met for IV and enteral feeding lines; however, the epidural connector design was found to allow for misconnection with an IV, and required more time for redesign and testing. The AdvaMed report notes that, “…without a delay of the 2016 deadline to allow completion of the epidural effort, there could be a proliferation of proprietary new connectors that will add to the list of possible misconnections and create a cost burden for California hospitals.”

Although the deadline was met for developing IV and enteral designs, complications between manufacturers and distributers have delayed the ability of the industry to adequately fill the supply chain with the syringes needed for the enteral systems. Accordingly, the industry has also requested a six month delay in implementation of standardized enteral systems.

5. Prior legislation. SB 158 (Florez, Chapter 294, Statutes of 2008), among other provisions, required hospitals and SNFs to institute a patient safety plan for the purpose of improving the health and safety of patients and reducing preventable patient safety events. SB 158 also prohibited, beginning January 1, 2011, general acute care, acute psychiatric, and special hospitals, and SNFs from using an intravenous connection, epidural connection, or enteral feeding connection that would fit into a connection port other than the type for which it was intended, with exceptions, as specified.

AB 818 (Hernandez, Chapter 476, Statutes of 2009), delayed the January 1, 2011, implementation date of the portions of SB 158 related to medical connectors (Section 3) until 36 months after the publication of a new design standard or January 1, 2014, whichever occurs first, for epidural connections, and to 24 months after the publication of new design standards or January 1, 2013, whichever occurs first, for intravenous or enteral connections. AB 818 also required the Advanced Medical Technology Association to provide the Legislature with an annual report on the progress of the ISO in developing the new design standards and required hospitals to include in their patient safety plan measures to prevent adverse events associated with misconnecting intravenous, enteral feeding, and epidural lines.

AB 1867 (Pan, Chapter 194, Statutes of 2012), delayed the deadline for implementation of the ban on compatible IV, epidural and enteral feeding systems until January 1, 2016.

6. Support. AdvaMed states that, absent a standard connector design, industry would have to implement proprietary connectors, increasing cost to manufacturers, health care facilities, and ultimately patients, while creating unacceptable risk to patient safety.

This bill is supported by numerous organizations and medical technology companies. Halyard states it is imperative that all manufactures move forward in a coordinated, nation-wide transition to new, safer connections, and that supply concerns with syringes require a delayed implementation of new connections. Halyard, Medtronic, and MedAssets state that without this bill, there will be an unreasonable risk to patient safety. BD states that requiring healthcare facilities in California to adhere to non-interconnectibility requirements before the ISO process is complete could result in temporary, interim solutions that are complicated for healthcare providers, expensive to manufacture, and are not in the best interest of patients.

SUPPORT AND OPPOSITION:

Support: AdvaMed (sponsor)

AAMI

ALCOR Scientific, Inc.

American Society of Health-System Pharmacists

B. Braun Medical, Inc.

Bard Peripheral Vascular

Baxter

BD

Biocom

California Association of Nurse Anesthetists

California Healthcare Institute

California Life Sciences Association

Corpak MedSystems, Inc.

Feeding Tube Awareness Foundation

Halyard Health, Inc.

Institute for Safe Medication Practices

Kentec Medical, Inc.

MedAssets

Medtronic

Pajunk Medical Systems

Premier Healthcare Alliance

Novation

Teleflex Medical

Oppose: None received

-- END --

Date of Hearing: April 15, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

ABPCA Bill Id:AB 444

Author:(Gipson) – As Introduced Ver:February 23, 2015

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

SUMMARY:

This bill delays, until January 1, 2017, the date by which hospitals are prohibited from using epidural (spinal) connector devices that would fit into a connector other than the type it was intended for.

FISCAL EFFECT:

Negligible state fiscal impact.

COMMENTS:

1. Purpose. According to the author, hospitals and other healthcare facilities depend on a variety of catheters, tubing, and syringes to deliver medications and other substances to patients through vascular, enteral feeding, respiratory, and epidural delivery systems. Because many connectors are interchangeable, the potential exists for serious medical errors if different systems are connected by mistake. The author indicates an international effort led by the International Organization for Standardization (ISO) to develop and implement standards for non-interchangeable connectors is almost complete. AdvaMed, the sponsors of this legislation, contend an additional delay in the requirement to use non-interchangeable connectors for epidural connections is critical for patient safety, because the epidural connector design was recently found to still have the ability to allow for misconnection with an IV and requires more time for redesign and testing.

2. Prior Legislation. SB 158 (Florez), Chapter 294, Statutes of 2008, addressed a number of patient safety issues, including a requirement that, as of January 1, 2011, health facilities must use separate unique connectors for IV, enteral feeding and epidural connections to prevent adverse events associated with misconnections.

AB 818 (Hernandez), Chapter 476, Statutes of 2009, delayed the effective dates in SB 158 (Florez) and established new deadlines – January 1, 2013, for enteral feeding and IV connections and January 1, 2014, for epidural connections or by a period of time following the publication of new ISO design standards.

AB 1867 (Pan) further delayed the three deadlines until January 1, 2016, to ensure adequate time for development of ISO standards.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 7, 2015

ASSEMBLY COMMITTEE ON HEALTH

Rob Bonta, Chair

ABPCA Bill Id:AB 444

Author:(Gipson) – As Introduced Ver:February 23, 2015

SUBJECT: Health facilities: epidural connectors.

SUMMARY: Delays, until January 1, 2017, the deadline prohibiting general acute care, acute psychiatric, and special hospitals from using certain epidural (spinal) connector devices.

EXISTING LAW:

1. Provides for the licensing and regulation of health facilities, including general acute care hospitals, acute psychiatric hospitals, and special hospitals by the Department of Public Health (DPH).

2. Requires the hospitals referenced in 1) above to develop, implement, and comply with a patient safety plan to reduce adverse events, and requires the safety plan to include measures to prevent adverse events associated with misconnecting intravenous (IV), enteral (intestinal) feeding, and epidural lines.

3. Prohibits, as of January 1, 2016, general acute care, acute psychiatric, and special hospitals from using an epidural connection that would fit into a connection port other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care.

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

COMMENTS:

1. PURPOSE OF THE BILL. According to the author, that while worldwide experts participating in the development of the new international standards for IV connectors are highly committed to solving the problem of tubing misconnections, the process is, and should be, rigorous enough to ensure that the work is done correctly the first time. The wrong outcome, the author maintains, would lead to a far more dangerous healthcare environment than what currently exists by possibly creating new risks, or creating a solution that cannot be manufactured cost effectively or is too complicated for users. The author notes that this bill will ultimately improve patient safety.

2. BACKGROUND.

   1. Adverse events related to misconnections of devices and lines. Hospitals and other health care facilities depend on a variety of catheters, tubing, and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, and epidural (spinal) delivery systems. These delivery systems frequently employ fittings called Luer connectors to link various system components. The male and female components of Luer connectors join together to create secure yet detachable leak-proof connections. Multiple connections between medical devices and tubing are common in patient care. Today Luer connectors are used worldwide to connect a variety of medical devices, components, and accessories.

Unfortunately, the ubiquitous nature of the Luer connector design allows for connection between unrelated delivery systems. Because Luer connecters are easy-to-use and compatible between different delivery systems, patient care staff can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Numerous such errors have been documented, including many that have caused serious patient injuries and deaths.

SB 158 (Florez), Chapter 294, Statutes of 2008, addressed a number of issues designed to improve patient safety, including a requirement that, as of January 1, 2011, certain health facilities must use separate, unique connectors for IV, enteral feeding, and epidural connections to prevent adverse events associated with misconnections. AB 818 (Hernandez), Chapter 476, Statutes of 2009, delayed the effective dates in SB 158 and established a new deadline – January 1, 2013, for enteral feeding and IV connections and January 1, 2014, for epidural connections. AB 818 also required certain health facilities to include in their patient safety plans measures to prevent adverse events associated with misconnections and required the Advanced Medical Technology Association (AdvaMed), to report annually to the Legislature regarding the progress of the International Organization for Standardization (ISO) in developing new design standards. AB 1867 (Pan), Chapter 194, Statutes of 2012, delayed the deadline for implementing the ban on compatible IV, epidural, and enteral feeding systems until January 1, 2016.

2. AdvaMed report on ISO progress. On December 15, 2014, AdvaMed provided the Assembly and Senate Health Committees with their statutorily required report on the progress of the ISO in solving the problem of tubing misconnections. According to the report, the 2016 deadline will be met for IV and enteral feeding lines; however, the epidural connector design was recently found to still have the ability to allow for misconnection with an IV and requires more time for redesign and testing. The AdvaMed report notes that, “…without a delay of the 2016 deadline to allow completion of the epidural effort, there could be a proliferation of proprietary new connectors that will add to the list of possible misconnections and create a cost burden for California hospitals.”

3. The International Organization for Standardization. The ISO is an international standard-setting body composed of representatives from various national standards organizations. Founded on February 23, 1947, the organization promotes worldwide proprietary, industrial, and commercial standards. ISO launches the development of new standards in response to sectors and stakeholders that express a clearly established need for them. ISO standards are developed by technical committees comprising of experts from the industrial, technical, and business sectors which have asked for the standards.

The ISO has been working on an international standard for IV connectors since 2008. The work group is comprised of participants from 31 countries headed by a nurse from the federal Food and Drug Administration. The workgroup discovered the Luers in use were more complicated than previously thought. Nine different dimensions of the Luer had to be taken into consideration (for example, the length, the circumference at various points, etc.) It took until December of 2011 to develop what is called the Masa Cone, which allows for different size tubing dimensions to be attached to various points on the Luer. After that, the ISO moved forward designs for each type of tubing that connect to the Luer, which have taken roughly three years to get through the ISO process. At each phase of the process designs must be sent out for feasibility testing and member comment before draft international standards can be released. It was during this process that the working group discovered a design problem with the epidural connector after feasibility testing. The epidural connector was then re-designed and sent back out for comment, adding a year to the process.

3. SUPPORT. AdvaMed, the sponsor of this bill, states absent standard connector design, industry would have to implement proprietary connectors increasing cost to manufacturers, heath care facilities, and ultimately patients while creating unacceptable risk to patient safety. Given that risk, AdvaMed supports delaying implementation to January 1, 2017 to ensure standards with a common design for all epidural suppliers. Standardization will allow health care facilities to purchase compatible epidural devices from multiple suppliers and minimize costs.

Numerous manufacturers write that they are actively participating in the efforts of the ISO to develop and implement standardized solutions for non-interchangeable connectors, and while the ISO standards setting process has taken longer than anticipated, the new connector designs that result from the process will facilitate appropriate connections across an even broader range of high risk clinical applications and eliminate incompatible tubing misconnections.

4. PREVIOUS LEGISLATION.

   1. AB 1867 delayed the deadline for implementation of the ban on compatible IV, epidural and enteral feeding systems until January 1, 2016.

   2. AB 818 delayed the effective dates in SB 158 and established a new deadline – January 1, 2013, for enteral feeding and IV connections and January 1, 2014 for epidural connections.

   3. SB 158, among other provisions, established a deadline of January 1, 2011, for certain health facilities to use separate, unique connectors for IV, enteral feeding, and epidural connections.

REGISTERED SUPPORT / OPPOSITION:

Support

Advancing Safety in Medical Technology

American Society of Health-System Pharmacists

B. Braun Medical, Inc.

Baxter Healthcare

BD

Biocom

California Healthcare Institute

California Society of Anesthesiologists

Halyard Health

Institute for Safe Medication Practices

MedAssets, Inc.

Novation

PAJUNK Medical Systems

Premier Healthcare Alliance

Teleflex Medical

Opposition

None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097