BILL ANALYSIS                                                                                                                                                                                                    



          SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:                    AB 444    
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          |AUTHOR:        |Gipson                                         |
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          |VERSION:       |June 1, 2015                                   |
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          |HEARING DATE:  |June 17, 2015  |               |               |
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          |CONSULTANT:    |Shannon Muir                                   |
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           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.









          AB 444 (Gipson)                                    Page 2 of ?
          
          
          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  :  
          
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          |Assembly Floor:                     |78 - 0                      |
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          |Assembly Appropriations Committee:  |16 - 0                      |
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          |Assembly Health Committee:          |18 - 0                      |
          |                                    |                            |
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          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  








          AB 444 (Gipson)                                    Page 3 of ?
          
          
            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  








          AB 444 (Gipson)                                    Page 4 of ?
          
          
            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  








          AB 444 (Gipson)                                    Page 5 of ?
          
          
            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  








          AB 444 (Gipson)                                    Page 6 of ?
          
          
            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
          
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