Forbes zeros in on one of health care's conuundrums, recalling potentially unsafe medical devices. While Forbes says, "Recalls aren't what they used to be," they offer no proof of backsliding or laxness on the part of the FDA or medical device manufacturers.

Last year Baxter International recalled 256,000 of its Colleague
drug-infusion pumps, four times in the year issuing warnings of serious
flaws to doctors and hospitals. Seven people may have died as a result
of problems with the pumps, says Baxter. In October the Food & Drug
Administration seized 6,000 Colleagues from company warehouses in
northern Illinois. Yet the pumps remain in wide use with the blessing
of the FDA: 80,000 times a day patients in hospitals and nursing homes
get their drugs infused through what could be a faulty Colleague.

The word "recall" does have one meaning in a regulatory sense, and another in common usage. A regulatory recall entails formal verified customer notification of a problem and corrective action. The corrective action can entail staff training, product testing, defective parts replacement, software upgrades, and or component redesign and replacement. The corrective action may accompany the recall notification or follow some time later. Ironically, not all recalls are a result of an unsafe product. Vendors may be forced to issue a product recall if they have strayed outside of regulatory boundaries and thus creating "nonconforming" and thus "adulterated." For example, if a company determines that their device labeling is inconsistent with the intended use statement in their 510(k), their product instantly becomes adulterated and subject to recall.

As the Forbes article points out, rarely are devices yanked from service - especially ubiquitous devices like IV pumps. Sometimes, as in the case of implanted defibrillators and pacemakers, risks inherent in replacing the device could present a bigger safety risk than leaving a recalled device in place.

Recalls aren’t what they used to be. The term is popularly understood
to mean a product is dangerous and needs to be taken out of service.
But medical devices have become so prevalent and complex that it’s
impossible and impractical to remove them all. Last year the FDA
recalled 87,000 Medtronic


) defibrillators and 28,000 Guidant


) pacemakers but didn’t require they be exhumed from people’s chests.

You can get the latest info on the Colleague pump recall here.

Of course what Baxter needs is not an upgraded Colleague pump, but a completely new device - and one that incorporates connectivity.