BILL ANALYSIS                                                                                                                                                                                                    



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          CONCURRENCE IN SENATE AMENDMENTS


          AB  
          444 (Gipson)


          As Amended  June 1, 2015


          Majority vote


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          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  








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          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  








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          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."










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          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













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