BILL ANALYSIS                                                                                                                                                                                                    Ó

          |SENATE RULES COMMITTEE            |                        AB 444|
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          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


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

           SUBJECT:   Health facilities: epidural and external feeding  

          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.

          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  


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                                                                    Page  2

            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.

          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  


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                                                                    Page  3

            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  

            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  

          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  


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            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  

          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  


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            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  

          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.:YesLocal:   No

          SUPPORT:   (Verified6/30/15)

          AdvaMed (source)
          ALCOR Scientific, Inc.


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          American Society of Health-System Pharmacists
          Association for the Advancement of Medical Instrumentation
          B. Braun Medical, Inc.
          Bard Peripheral Vascular
          Beckman, Dickinson, and Company
          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.
          Pajunk Medical Systems
          Premier Healthcare Alliance
          Teleflex Medical

          OPPOSITION:   (Verified6/30/15)

          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  


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                                                                    Page  7

          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

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