Medical Device & Diagnostic Industry Magazine
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Originally Published MDDI August 2005

NEWSTRENDS

Maria Fontanazza

The Guidant Corp. (Indianapolis) defibrillator recalls should be a warning to other device companies to reexamine their handling of product performance issues.

“Manufacturers should evaluate their own procedures against what Guidant is experiencing,” says Larry Pilot, a partner at McKenna, Long & Aldridge LLP (Washington, DC). “They have a responsibility to apply good judgment in their evaluation of information. The potential always exists for FDA to second-guess that decision-making process.”

Guidant's recent troubles arose not because it failed to follow FDA guidelines, but because it didn't tell physicians or patients of defibrillator malfunctions for three years. The spotlight was put on the company after a college student died when his defibrillator short-circuited in March. Guidant issued a release in May that notified doctors of failures in one of its defibrillators, and it recalled three models in June. At the time of printing, FDA was also evaluating Guidant's recall of an additional set of defibrillators attributable to memory error.

Good judgment also comes from having a firm grasp of regulations, which can be an important preventive measure. Is an MDR report required? Is this a situation where a removal or correction is necessary? This may be a gray area, says Pamela Furman, principal at Olsson, Frank, and Weeda, PC (Washington, DC). “Companies can be extremely conservative, or they can be aggressive, depending on how much risk they want to incur.”

It's best to weigh the risks before taking any action. “Do the analysis, make a reasoned assessment about how it applies to your company, and understand the options,” says Furman.

When it comes to submitting a report and taking a corrective action, manufacturers can face difficult choices. “It's important that before a company makes a decision to continue to market a product, they inform themselves of all of the potential risks,” says Furman. If a company does not do so, it can be surprised either by regulatory actions or by product liability difficulties.
Although some companies worry about reputation, Furman finds the main reason that manufacturers do not come forward with device problems is a lack of understanding of the regulation. She offers three tips to ensure the effectiveness of complaint-handling and MDR systems. She stresses that this approach is neither reporting nor complaint handling, but rather the two working hand in hand.

• Establish written procedures that incorporate the appropriate FDA regulatory principles.
• Provide comprehensive training of relevant personnel. “If the person in charge of taking phone calls about product problems doesn't understand FDA's definition of a complaint, then you better believe that a malfunction isn't going to make its way up to being assessed for reportability,” says Furman. “That's a critical gap in the chain.”
• Develop a system that ensures thorough documentation. “In your complaint file, adequately describe the problem with the device, collect all the information, and document efforts to get the information. All of that is important in terms of assessing an event for reportability. If you have inadequate information, you can't even make the assessment as to whether you need to tell FDA about the incident.”

A better understanding of the regulation will come from a better relationship between FDA and industry. Pilot suggests an outreach program that would create a partnership between device companies and the agency to develop a method that reduces regulatory confusion.

For manufacturers of high-risk devices where a failure creates a condition hazardous to the user, internal reviews might also be an option to consider. A surveillance program that looks at manufacturers' actions in the areas of recalls, corrections, and removals could help FDA gauge how industry is functioning.

“It would be good for the agency to know whether industry is performing properly. The best way to determine that is to conduct a surveillance program, if it hasn't been done,” says Pilot. “Irrespective of the facts associated with the Guidant experience, it's going to put pressure on both FDA and industry. I think it's reasonable to assume that more attention will be applied to this issue.”

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