FDA and the Association for the Advancement of Medical Instrumentation are launching an infusion device safety council to help implement improvements to infusion pump safety.

AAMI announced formation of the council during an Oct. 5-6 infusion device summit co-hosted by FDA. About 300 industry reps, clinicians, regulators, engineers and other experts gathered at FDA headquarters in Silver Spring, Md., to come up with a plan to improve the design, engineering, manufacturing and use of the devices.

Participants at the AAMI/FDA summit narrowed down a long list of issues related to infusion pump systems to focus on a dozen high-priority problems.

They include the need for a mechanism to allow manufacturers and clinicians to collaboratively address device problems and the lack of standardization and compatibility among different models (see sideabr: " ¹ Infusion Device Action Plan ").

FDA and AAMI will develop an action plan based on the list, and the safety council will help implement the plan, Carol Herman, director of standards at FDA's device center, explained in an interview.

AAMI is calling on individuals and organizations to participate in - and help fund - the new council.

Herman said she will look within FDA for some funding to contribute, but added the agency "can't make any promises yet." AAMI also said it does not have the resources to fund the council by itself.

Work groups within the council will address topics including adverse event reporting and monitoring; interoperability of pumps and other systems; failures and malfunctions; programming errors; and standardized drug libraries, the customized lists of medications embedded into the software of newer pumps.

Summit Participants Develop Action Plan

FDA and AAMI hope the safety council will be able to start solving the problems addressed at the meeting, many of which have come up in other recent forums, including a May 26 FDA workshop (² Also see "Better Interfaces, User Testing Could Improve Infusion Pumps, Says FDA" - Medtech Insight, 7 June, 2010.).

The activities stem from an FDA infusion pump safety initiative launched in April (³ Also see "FDA To Impose New Pre-market Requirements On Infusion Pump Makers" - Medtech Insight, 3 May, 2010.).

FDA and AAMI stressed the importance of a team approach to improving infusion pump safety, as the ubiquitous problems with the devices cannot be solved by manufacturers, regulators, standards groups or clinicians alone.

"No one group can address the summit action plan well in isolation, and no group is charged with addressing these issues in a coordinated, collaborative way," AAMI President Mary Logan wrote in an Oct. 6 letter to meeting participants.

Also, not all of the issues can be solved with new standards or FDA regulations, Logan continued.

William Maisel, CDRH's deputy center director for science and chief scientist, noted that while standards can help shorten time to market while ensuring new pumps are safe and effective, the "challenge is to determine what aspects should be standardized without overly restricting innovation."

Standardization Vs. Customizability

Manufacturers and clinicians alike are wrestling with the tension between standardizing system interfaces - which could reduce problems like programming errors where a nurse may enter the wrong dose or even the wrong drug - and customizability, which is key to meeting different clinicians' needs and also differentiating among pump brands.

Better interfaces are needed that address clinicians' needs and the complexity of clinical care, Matthew Weinger, a professor at Vanderbilt University School of Medicine, noted at the FDA/AAMI summit.

But "should we have one infusion device interface?" he asked. "No matter who makes the product, no matter who uses it, it always looks exactly the same?"

"I don't think so," he said. "If we tried to go that route, we would end up with a compromise solution which would by definition be mediocre. ... One size cannot fit all."

Indeed, several clinicians at the meeting said they want more, not fewer, options to configure pump interfaces to meet their needs in different situations.

But there are some aspects of the device interface that can be standardized to minimize user errors, Weinger suggested.

For instance, certain core or high-risk tasks should be standardized, such as the buttons to "start," "pause" and "stop" an infusion. Procedures for reporting usability test results should also be standardized, he said.

- Jessica Bylander ( ⁴ j.bylander@elsevier.com )

FDA, AAMI Form Action Plan, Safety Council To Fix Infusion Pump Problems

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