Firms Not Making Progress In Improving Recall Notifications, FDA Says

Full article reprinted from "The Gray Sheet" - October 19, 2009

More than four years after it was revealed that Guidant failed to properly warn patients and physicians about potentially fatal product malfunctions, an FDA official says the overall quality of manufacturer recall notifications has not improved. Read more...

Firms Not Making Progress In Improving Recall Notifications, FDA Says

Full article reprinted from "The Gray Sheet" - October 19, 2009

More than four years after it was revealed that Guidant failed to properly warn patients and physicians about potentially fatal product malfunctions, an FDA official says the overall quality of manufacturer recall notifications has not improved.

Recall letters "are soft-pedaled, or there's clearly not adequate information about risk or what to do about [the problem device], or the notice sends mixed signals," said Cap Uldriks, CDRH associate director for regulatory guidance and government affairs.

Numerous recalls of Guidant implantable cardioverter defibrillators and pacemakers sparked vigorous industry and FDA debate in recent years about the quality of information included in recall letters. Guidant was purchased by Boston Scientific in 2006.

One reason for the lack of improvement in the content of some higher-profile recall notices is that manufacturers rush to release information before FDA does in an effort to control the message. The firms' hurried letters "end up being very inadequate, and [the companies] end up having to send out more information," Uldriks said.

As a person on the receiving end of recall notices, Bea Haupt, recall & safety manager for Inova Health System, knows exactly what information she needs. Inova operates several hospitals in Northern Virginia.

"I'm going to really want to see all three of these in a recall notice: the adverse effects statement, information on whether the government has knowledge of the recall, and the potential hazards," Haupt said at a Sept. 25 session of the Center for Business Intelligence's Bio/Pharmaceutical and Medical Device Product Recalls Summit in Alexandria, Va.

Haupt advises firms against issuing recall notices that offer incomplete, incoherent or little information, since this can frustrate customers. "The manufacturer must become part of the solution," she said.

[ Editor's note: An in-depth discussion of recall notifications appears in the October 2009 issue of "The Silver Sheet," Elsevier Business Intelligence's monthly newsletter on device quality and compliance issues. For a free trial click here.]

- Shawn M. Schmitt