Oley Supports Important Patient Safety Measure in California (see update 8/27/12)
Carrie Hartgen, Vice President, State Government & Regional Affairs, AdvaMed
The Oley Foundation recently engaged in an important patient safety measure in the state of California. The California General Assembly, in a rush to try to address the problem of inadvertent tubing misconnections, got ahead of itself by mandating that non-interchangeable connectors be used in the state before their designs were standardized. The goal is to create connectors that would make it much more difficult for someone to mistakenly administer enteral nutrition (EN), for example, through tubing (a catheter) intended for parenteral nutrition (PN), or vice versa.
While this mandate was well-intentioned, Oley and other groups, including the Advanced Medical Technology Association (AdvaMed), the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), the Infusion Nurses Society, the National Patient Safety Foundation and the Institute for Safe Medication Practices, argued that it was imperative that connector design first be standardized so that California did not create unintended consequences that could also harm patients. On April 18, Oley members Kathy and Charlie Cleberg testified before the Assembly Health Committee on the importance of this issue to EN consumers. The bill passed the Assembly and is expected to be heard before the Senate Health Committee on June 6.
Assembly Bill 1867, sponsored by Asm. (Dr.) Richard Pan (D-Sacramento), extends California’s existing mandate to ensure that the International Organization for Standardization (ISO) will have sufficient time to create standardized designs for various connectors. The ultimate goal of AB 1867 is to continue to promote patient safety through the creation of publicly available designs for each unique connection, but to do it thoughtfully and correctly through globally designed and recognized standards.
Not only will new connectors allow for standardization in all hospital environments—which is especially important when nurses, doctors, and patients move between departments within a hospital, among different hospitals, or even from state to state or across national border—they will also eliminate confusion that could be created with new equipment and training requirements.
Under AB 1867, the deadline for non-interchangeable connectors in California would be January 2016. This new deadline allows sufficient time for the ISO to complete the rigorous and critical standardization process, while also allowing time for device makers to get FDA approval of the new designs and bring their products to market. The impending common design formats are worth waiting for and will give consumers and their families peace of mind.
If California does not grant an extension that allows these new design standards to be developed, it could foster unintended consequences. It could create new risks, or a solution that could be too complicated for consumers to use or for companies to manufacture cost effectively.
The LifelineLetter, May-June 2012