BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 1867
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          Date of Hearing:  April 10, 2012

                            ASSEMBLY COMMITTEE ON HEALTH
                              William W. Monning, Chair
                     AB 1867 (Pan) - As Amended:  March 29, 2012
           
          SUBJECT  :  Health facilities: equipment standards.

           SUMMARY  :  Delays, until January 1, 2016, the current deadlines 
          for implementation of a prohibition against general acute care, 
          acute psychiatric, and special hospitals from using certain 
          connector devices for intravenous (IV), epidural, and enteral 
          feeding systems. 

           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 general acute care, acute psychiatric, and special 
            hospitals to develop, implement, and comply with a patient 
            safety plan for the purposes of reducing preventable patient 
            safety events.

          3)Requires general acute care, acute psychiatric, and special 
            hospitals to include in their patient safety plans measures to 
            prevent adverse events associated with misconnecting IV, 
            enteral feeding, and epidural lines.

          4)Prohibits general acute care, acute psychiatric, and special 
            hospitals from using an epidural connection that would fit 
            into a connection port other than the type for which it was 
            intended, beginning January 1, 2014 or 36 months after 
            specified prescribed standards are developed by the 
            International Organization for Standardization (ISO), 
            whichever comes first.  Prohibits general acute care, acute 
            psychiatric, and special hospitals from using an intravenous 
            or enteral feeding connection that would fit into a connection 
            port other than the type for which it was intended beginning 
            January 1, 2013 or 24 months after specified prescribed 
            standards are developed by the ISO, whichever occurs first.  
            Requires the Advanced Medical Technology Association, on 








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            January 1 of each year until the standards are developed, to 
            provide the Legislature with a report on the progress of the 
            ISO in developing the new design standards.

          5)Authorizes DPH to assess administrative penalties of up to 
            $125,000 against a general acute care, acute psychiatric, or 
            special hospital for licensing deficiencies that constitute 
            immediate jeopardy to the health or safety of a patient, 
            defined as a situation in which the facility's noncompliance 
            with one or more requirements of licensure has caused, or is 
            likely to cause, serious injury or death to the patient.

           FISCAL EFFECT  :   This bill has not yet been heard by a fiscal 
          committee.


           
          COMMENTS  :    

           1)PURPOSE OF THIS BILL  .  According to the author, hospitals and 
            other healthcare facilities depend on a variety of catheters, 
            tubing, and syringes to deliver medications and other 
            substances to patients through vascular, enteral feeding, 
            respiratory, and epidural delivery systems.  The author 
            maintains that these delivery systems frequently employ 
            fittings called Luer connectors to link various system 
            components and that multiple connections between medical 
            devices and tubings are common in patient care.  The author 
            asserts that thousands of these connectors are used in 
            hospital environments in California daily, with millions sold 
            annually.  

          According to the author, the Food and Drug Administration (FDA) 
            is and has been actively participating in an international 
            effort with the ISO to develop and implement standards for 
            non-interchangeable connectors used in IV, breathing systems, 
            enteral feeding, urethral/urinary, cuff inflation, and 
            epidural applications.  Once the ISO process is complete, 
            according to the author, international standards will be 
            established to facilitate correct connections and eliminate 
            incompatible tubing misconnections.  The author asserts that 
            while worldwide experts participating in the development of 
            the new international standards 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 








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            correctly the first time.  The wrong outcome, the author 
            maintains, would lead to a far more dangerous healthcare 
            environment than what currently exists by fostering unintended 
            consequences, possibly creating new risks, or creating a 
            solution that cannot be manufactured cost effectively or is 
            too complicated for users.  The author asserts, however, that 
            the ISO process to change the industry standard will not be 
            completed in time to be meet current deadlines required by AB 
            818 (Hernandez), Chapter 476, Statutes of 2009 and this bill 
            is needed to allow the industry to meet this important mandate 
            through a common design format.  According to the sponsor, the 
            Advanced Medical Technology Association (AdvaMed), the ISO 
            committee review is estimated to be completed mid-year 2014.  
            The AdvaMed maintains that approximately 18 months is needed 
            for FDA approval and to bring the new standardized products to 
            market.  The goal of this proposal, according to the author, 
            is to promote patient safety by allowing the appropriate 
            amount of time for the ISO to thoughtfully and correctly 
            create publicly available designs for each unique connection 
            through globally designed and recognized standards.

           2)BACKGROUND  .  Luer connector systems are common to almost all 
            healthcare catheters, tubes, and syringes, making it easy to 
            connect one system to another.  According to the FDA, Luer 
            connectors have male and female components which join together 
            to create secure yet detachable leak-proof connections.  
            Multiple connections between medical devices and tubing are 
            common in patient care, and because Luer connectors are 
            universal, easy to use, and compatible between different 
            delivery systems, clinicians can inadvertently connect wrong 
            systems together, causing medication or other fluids to be 
            delivered through the wrong route.  Such errors have caused 
            serious patient injuries and deaths.  

          SB 158 (Florez), Chapter 294, Statutes of 2008, was signed into 
            law and addressed a number of issues designed to improve 
            patient safety and decrease infections in a variety of 
            healthcare environments.  Included in SB 158 was 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.  In 2009, AB 818 (Hernandez) was passed into 
            law to delay the effective dates in SB 158 (Florez) and 
            established new deadlines - January 1, 2013 for enteral 
            feeding and IV connections and January 1, 2014 for epidural 








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            connections or by a period of time following the publication 
            of new ISO design standards.  AB 818 (Hernandez) also required 
            certain health facilities to include in their patient safety 
            plans measures to prevent adverse events associated with 
            misconnections and required the AdvaMed, a trade association 
            representing medical device manufacturers, to report annually 
            to the Legislature regarding the progress of the ISO in 
            developing new design standards.

          According to DPH, licensed health facilities are required to 
            report adverse events, as defined by law, that have occurred 
            in the facility within five days after the event has been 
            detected or, no later than 24 hours after the event has been 
            detected if the event is an ongoing urgent or emergent threat. 
             Upon review of 28 adverse events listed in current law, also 
            known as "never events," DPH determined that there are two 
            categories most likely to encompass occurrences of 
            misconnecting IV, enteral feeding or epidural lines.  These 
            categories include "death or serious disability associated 
            with the use of a device other than intended" or "death or 
            disability due to medication error."  DPH has confirmed 
            through manual review of each adverse event intake form in 
            these two categories during 2009-10 and 2010-11 that none of 
            the substantiated adverse events reported were the result of 
            IV, enteral feeding or epidural misconnections.  DPH asserts 
            that, because of the serious implications of events of this 
            type, it is unlikely to go unnoticed.

           3)ISO STANDARD DEVELOPMENT  .  The ISO is a global entity focused 
            on creating standards for commonly used materials including 
            medical and other devices.  The development of international 
            standards involves regulatory agencies such as the FDA, large 
            and small medical device manufacturers, and representatives 
            from the US, Canada, multiple European countries, and Japan.  

          According to the Association for the Advancement of Medical 
            Information (AAMI), an alliance of healthcare professionals 
            with an interest in medical devices, in late 2010, an umbrella 
            standard was approved and published and the FDA officially 
            recognized it in 2011.  This umbrella standard provides the 
            foundation for all of the more product-specific standards 
            currently under parallel development.  These more 
            product-specific device standards are in various stages of 
            development and must be measured and evaluated against the 
            umbrella standard for the Luer connector.  Initially, it was 








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            originally thought that the Luer connector was offered in two 
            well-established designs.  But based on the work done to date 
            by the ISO, it has been found that the Luer connector has at 
            least nine disparate dimensional features that require 
            clarification to reduce misconnection events.  If the ISO 
            fails to define all of the baseline critical dimensions, then 
            it will not be possible to ensure that connectors designed to 
            the new international standard will not interconnect with 
            another connector.  According to AAMI, final standards are not 
            expected to be published until the first half of 2014 and it 
            will take industry a minimum of 18 months to convert to the 
            new product, a process that cannot begin until there is strong 
            certainty that the final standard will be adopted as proposed. 
             

           4)SUPPORT  .  A number of organizations representing medical 
            device manufacturers, biotechnology, life sciences, academic 
            research institutions, and medical professionals write in 
            support that, while AB 818 (Hernandez) acknowledged the 
            international nature of the ISO process, the legislation 
            greatly understated the complexity and timing of the process.  
            Supporters maintain that it is clear today that the relevant 
            ISO standards will not be issued before the current 
            legislative deadlines.  Supporters argue that there are valid 
            reasons for this delay that largely relate to full 
            participation by key stakeholders in the health care system 
            and through standardization that is more likely to be 
            achievable and lasting.  Supporters maintain that without a 
            standard design for connectors, industry would have to 
            implement proprietary connectors which would increase cost to 
            manufacturers, health care facilities, and ultimately 
            patients, and create an unacceptable risk to patient safety.  
            Supporters describe the risks and increased costs to include:

             a)   Proprietary connectors from each manufacturer would 
               create situations where devices that are intended to be 
               used together can no longer be connected.  For example, 
               infusion pumps must be able to connect to a variety of 
               other medical devices such as catheters, filling extension 
               sets, and syringes;
             b)   Health facilities would have to purchase devices from 
               many different medical device manufacturers.  Therefore, 
               patients that go from one facility to another may have 
               medical devices that could not be connected to a new 
               facility's device;








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             c)   Health care providers would have to be trained on 
               hundreds or perhaps thousands of different types of 
               connectors; and,
             d)   Health care facilities would have increased costs in 
               their supply chain in order to accommodate proprietary 
               connectors.  For example, a hospital may need to purchase 
               epidural syringes from several different manufacturers in 
               order to connect to each of the proprietary epidural 
               connectors.

            Supporters applaud California's effort to keep misconnections 
            from occurring and support this bill's January 1, 2016 delayed 
            implementation date.
           
           5)  PREVIOUS LEGISLATION  .

             a)   AB 818 delays the January 1, 2011 date for 
               implementation of a prohibition against certain health 
               facilities using intravenous, epidural, and enteral feeding 
               connection devices that fit into connection ports other 
               than the type they are intended for to 36 months after the 
               publication of a new design standard for the connections by 
               the ISO, or January 1, 2014, whichever occurs first.  
               Requires AdvaMed, on January 1 of each year until the 
               standards are developed, to provide the Legislature with a 
               report on the progress of the ISO in developing the new 
               design standards.

             b)   SB 158 among other provisions, requires certain health 
               facilities to institute a patient safety plan for the 
               purpose of improving the health and safety of patients and 
               reducing preventable patient safety events.  Prohibits, 
               beginning January 1, 2011, general acute care, acute 
               psychiatric and special hospitals from using an intravenous 
               connection, epidural connection, or enteral feeding 
               connection that would fit into a connection port other than 
               the type it was intended for, with exceptions, as 
               specified.

             c)   SB 541 (Alquist), Chapter 605, Statutes of 2008 and SB 
               1312 (Alquist), Chapter 895, Statutes of 2006, among other 
               provisions, authorizes DPH to assess administrative 
               penalties against general acute care, acute psychiatric, or 
               special hospitals for licensing deficiencies that 
               constitute immediate jeopardy to the health or safety of a 








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               patient, defined as a situation in which the facility's 
               noncompliance with one or more requirements of licensure 
               has caused, or is likely to cause, serious injury or death 
               to the patient.

           REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          Advanced Medical Technology Association (sponsor)
          Abbott Laboratories
          American Society for Parenteral and Enteral Nutrition
          BayBio
          Baxter
          BIOCOM
          Boston Scientific
          California Association of Nurse Anesthetists, Inc.
          California Healthcare Institute
          California Society of Anesthesiologists
          Covidien
          Hospira
          I-Flow LLC
          Institute for Safe Medication Practices
          Kimberly-Clark Corporation
          National Patient Safety Foundation
          Phillips Electronics North America
          The Oley Foundation

           Opposition 
           
          None on file.
           
          Analysis Prepared by  :    Tanya Robinson-Taylor / HEALTH / (916) 
          319-2097