BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 444| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- CONSENT 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 SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8 ASSEMBLY FLOOR: 78-0, 4/23/15 (Consent) - See last page for vote SUBJECT: Health facilities: epidural and external feeding connectors 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. ANALYSIS: 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 AB 444 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. 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 AB 444 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 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. The ISO is an international standard-setting body composed of representatives from various national standards organizations, and promotes worldwide proprietary, industrial, and commercial AB 444 Page 4 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 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 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 AB 444 Page 5 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 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. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: No SUPPORT: (Verified6/30/15) AdvaMed (source) ALCOR Scientific, Inc. AB 444 Page 6 American Society of Health-System Pharmacists Association for the Advancement of Medical Instrumentation B. Braun Medical, Inc. Bard Peripheral Vascular Baxter Beckman, Dickinson, and Company 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 Novation 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 AB 444 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 **** END ****