BILL ANALYSIS Ó AB 444 Page 1 Date of Hearing: April 7, 2015 ASSEMBLY COMMITTEE ON HEALTH Rob Bonta, Chair AB 444 (Gipson) - As Introduced 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. AB 444 Page 2 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. a) 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 AB 444 Page 3 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. AB 444 Page 4 b) 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." c) 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 AB 444 Page 5 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. AB 444 Page 6 4)PREVIOUS LEGISLATION. a) AB 1867 delayed the deadline for implementation of the ban on compatible IV, epidural and enteral feeding systems until January 1, 2016. b) 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. c) 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 AB 444 Page 7 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 AB 444 Page 8 None on file. Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097