Imposing more stringent pre-market requirements on external infusion pumps may help reduce recalls, but could also slow market entry for safer pump designs, according to industry speakers at an FDA workshop.

The agency hosted the meeting in Silver Spring, Md., May 25-26 to gain feedback on its Infusion Pump Improvement Initiative, announced in April (¹ Also see "FDA To Impose New Pre-market Requirements On Infusion Pump Makers" - Medtech Insight, 3 May, 2010.).

The initiative includes new draft guidance and calls for pre-market manufacturing facility inspections, simulation testing and clinical validation tests for new infusion pumps or significant changes submitted for 510(k) clearance.

Anthony Watson, director of CDRH's Division of Anesthesiology, conceded that the agency struggled with the possibility of unintended consequences, such as lengthening the time current-generation infusion pumps stay on the market.

"It's a dilemma," Watson said. "Do you keep [the guidance] where it is now and allow something less than what we want, just to make sure products get on the market?"

Doing so, he argued, leaves open the chance that nothing better will ever enter the market.

"There has to be a starting point," he insisted.

Challenge Requires Multidisciplinary Efforts

The FDA initiative aims to address the high number of recalls and adverse event reports FDA has seen in recent years across various categories of infusion pumps.

FDA officials said they were gratified at the high level of attendance and participation at the safety improvements workshop.

Watson encouraged stakeholders to gather again at an Oct. 5-6 Infusion Device Summit in Rockville, Md., hosted by the Association for the Advancement of Medical Instrumentation (AAMI).

"Everybody has to fix this problem," Watson said. "We all have to figure out how to get rid of the residual risk."

AAMI president Mary Logan pledged that the organization would "step it up" to create better standards for infusion pump safety.

No quick fixes were promised at the FDA workshop, however.

"It will be a few years before the better product gets out the door," Watson predicted.

Melissa Eakle, an FDA nurse consultant and leader of the agency's Infection Control, Dental, General Hospital and Infusion Pump Network, said observers would judge the success of the new FDA initiative by whether they start noticing fewer recalls and adverse events.

However, she noted that there could be an initial bump in the number of reports as the topic draws more attention and stakeholders begin to file more mandatory and voluntary reports.

Mary Brooks, an FDA analyst in the post-market surveillance group, estimated that FDA receives reports of only 10% of all adverse events in the field. "There's a tremendous amount of underreporting," she said.

Many reasons were offered for nurses' underreporting, including busy schedules and liability concerns.

But some clinicians cited frustration with manufacturers for their lack of transparency about the scope of errors reported by other facilities, and for their tendency to blame most infusion pump adverse events on user error.

Speakers suggested that the impulse to assign blame when an adverse event occurs can hinder attempts to find the root causes of device failure that could ultimately lead to safer next-generation products.

FDA officials urged hospitals to file adverse event reports and to send all infusion pumps and supplies related to the event back to the manufacturer for evaluation.

In turn, device makers were instructed to give more detailed information in their reports to FDA on the root causes of device errors. "We ask you to do your robust best," said Brooks.

Eakle reminded clinicians that HIPPA privacy rules do not apply when a device-related death is under investigation. "It's now a public health issue," she said.

Manufacturers that are having trouble obtaining enough detailed data from hospitals can "bring FDA's presence to help you get that information," she added.

Extra Pre-market Requirements Could Offer Upside

FDA officials stressed that industry - and not just patients, hospitals and regulators - should ultimately benefit from some of the new pre-market requirements.

For example, earlier validation testing of human factors design could save manufacturers from discovering user interface problems later, when implementing a fix becomes more difficult and costly, FDA officials suggested.

The clinical validation process could also help mend manufacturers' relationships with their customers.

Dealing with device failures and recalls related to infusion pumps places a burden on a hospital's financial and human resources at a time when health care facilities have little of either to spare, suggested Michael Fraai, director of biomedical engineering at Brigham & Women's Hospital.

"The burden to hospitals is significant," he said.

Watson conceded that under the new guidance, it could take longer for a corrective action to get a 510(k) clearance.

He added that he does not see the pre-market testing requirement for a new user interface or other design flaw mitigation as an additional step, but a necessary step.

If a manufacturer plans to deliver a fix to correct a design problem, Watson explained, "We want to make sure it corrects the problem."

Watson predicted that most of the infusion pumps currently on the market would eventually be phased out as manufacturers start to meet the new pre-market requirements and introduce new devices.

"This appears to be a high turnover market," he said.

FDA officials suggested the Infusion Pump Improvement Initiative may serve as a template for other device categories that have similar human factors issues.

"Infusion pumps are not the only devices with these problems," Watson said. "It's the scope of the problem we're trying to address with the infusion pump initiative."

FDA's draft guidance on infusion pumps remains in flux pending written comments from the public due July 26.

However, FDA has signaled it may not wait to finalize guidance before implementing new practices such as pre-market inspections.

"We are getting ready to inspect all the infusion [pump] manufacturers, especially the ones that had problems," said Valerie Flournoy, chief of the Office of Compliance in CDRH's general hospital devices branch. "If you submit a 510(k), you rise to the top of the list."

Industry Seeks Additional Clarity On Guidance

Representing AdvaMed at the FDA workshop, CareFusion vice president of quality and regulatory affairs Krishna Uppugonduri said industry would collaborate with FDA, standards organizations and other stakeholders to enhance the safety of infusion devices and expedite the delivery of safer devices to market. He also suggested FDA should host educational workshops to help provide clarity on its guidance.

Interest in the topic remains high. During last week's workshop, FDA collected more than 100 written questions. The agency hopes to respond to any unanswered questions online in the next several weeks.

- Monica Hogan ( ² m.hogan@elsevier.com )

FDA, Industry Discuss Regulatory Impacts Of Infusion Pump Safety Steps

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