FDA Introspection

Many medical device manufacturers have expressed their concern recently that the U.S. Food and Drug Administration (FDA) has not moved as swiftly as they’d like when it comes to product approvals—that the agency is evaluating with a more critical eye, is bogged down in new processes, and perhaps will get even slower as internal and external investigations examine the 510(k) clearance process.

The FDA may not be as nimble as industry would like when it comes to pulling the trigger on new device review, but it certainly hasn’t dawdled lately as its sets about remaking itself and its interactions with various medical device industry sectors. The “more critical eye” description certainly has teeth.

Among the rapid-fire announcements issued by the FDA last month were guidelines for home health product manufacturers, new procedures for premarket approval review panels and a tougher stance with embattled infusion pump makers.

On the home health front, as more complex medical products migrate to the home setting, the agency will establish guidelines for manufacturers, develop safe-use education for users and boost post-market oversight, officials said. Under its Medical Device Home Use initiative, the FDA will zero in on negative-pressure wound therapy devices, home infusion, ventilators, and dialysis machines, among others, to ensure safe use for patients and care givers, according to Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

“Using complex medical devices at home carries unique challenges,” Shuren said. “Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product’s functioning.”

According to Shuren, the FDA does not have a clear regulatory path for devices intended for home use that describes the unique factors manufacturers should take into consideration when designing, testing and labeling such products. For example, pets, sanitation issues and even electromagnetic interference from home wireless networks can affect the function of a medical device. From 1997 through 2009, the FDA received more than 19,000 reports of adverse events in the home, according to an agency white paper. To guard against such safety problems, the FDA will develop recommendations for approval or clearance of devices, including testing with home caregivers and patients; exercise its authority to require that certain devices are labeled that they have not been cleared for use in the home; and enhance post-market surveillance to identify and address adverse events. The FDA also announced a 10-month pilot program in which manufacturers of devices labeled for the home voluntarily can submit their labeling electronically to the agency for posting on its website.

Yet another announcement detailed how the agency also plans to strengthen regulation of infusion pumps, a move following repeated problems and recalls of the devices. Infusion pumps deliver intravenous antibiotics, chemotherapy and anesthesia drugs. The pumps also are used at home for patients who receive regular infusions of drugs such as insulin.

FDA officials have cited an increase in the number and severity of problems with external infusion pumps, receiving 56,000 reports of problems between January 2005 and December 2009, including more than 500 deaths. From 2004 to 2009, there were 87 infusion pump recalls. Under draft guidelines, the FDA would require additional testing of the pumps before they reach the market and ask for more information on software and other components. Shuren said many of the problems seem to be related to “deficiencies in device design and engineering” more often than user error. Shuren added that the initiative represents a “major shift” in the FDA’s device regulation. Instead of responding to each set of problems manufacturer by manufacturer, the agency wants to take an industry-wide
approach. While the FDA routinely inspects company facilities, it
hasn’t required that the inspections be completed before a product is approved, except for high-risk implanted devices such as heart defibrillators. The agency will sponsor a public workshop May 25-26 to discuss the issue. No official guidance will be released until feedback from the meeting is evaluated.

The agency also has revamped the review process for its premarket approval panels. The panels, which comprise outside industry experts and physicians, provide feedback to the FDA on approval applications submitted by industry, investigated internally and then debated in an open forum. The panel meeting process has operated the same way for years (trust me; I’ve covered more than my fair share of panel meetings in 10 years covering the device industry). For more details on the changes, turn to Top of the News on page 12.

With a new administration, the FDA promised a new era of enforcement—a better-organized, transparent and accountable group. They seem to be delivering on the enforcement part. Industry
hasn’t seen this kind of change (is it still all about change?) in a while. What’s the message? Stay vigilant—OEMs as well as outsourcing providers. It will affect us all.