BILL ANALYSIS                                                                                                                                                                                                    



                                                                     AB 444


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          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.










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          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  








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               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.








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             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  








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               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.








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          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









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          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










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          None on file.


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