Connectors Bill Advances in California Legislature
A bill to give California medical device manufacturers more time to adopt international standards on small bore connectors, which are a key focus in the drive to eliminate tubing misconnections, cleared its first hurdle.
The bill, approved unanimously by the California Assembly Health Committee on April 10, would extend to Jan. 1, 2016, a deadline in a law requiring manufacturers to implement the standards. Backers of the bill say some of the standards are still under development, making it difficult for device makers to meet the current deadline of Jan. 1, 2013.
“I am pleased we are making progress, but there is a long way to go,” says Carrie Hartgen, vice president of state government relations and regional affairs for the Advanced Medical Technology Association (AdvaMed), a device trade group lobbying for the bill.
The legislation now goes before the Assembly Appropriations Committee to determine its financial impact on the state, which is likely to be minimal, says Hartgen. The state Assembly and Senate would both have to approve the bill in separate votes for the measure to reach the governor’s desk. Hartgen says if the bill is approved by the Assembly, it isn’t likely to head to the Senate until June.
The California State Legislature passed the original bill in 2009 to help stop tubing mix-ups or device misconnections, which can have deadly consequences for patients. It required state device makers to adopt a series of seven standards being developed by an International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) joint working group.
Manufacturers of interconnecting intravenous or enteral feeding sets were given 24 months after a standard’s publication or until Jan. 1, 2013 to implement it. Epidural manufacturers had an additional year.
The first standard was published in April 2011, and gives the general requirements for small bore connectors for liquids or gases. The other six will focus on how to make connectors for only certain clinical applications such as feeding or urinary tubing.
AAMI, the secretariat of the ISO/IEC working group, has provided AdvaMed with updates on the standards’ progress.
Posted: April 18, 2012