Healthcare Facilities Assess Recall Procedures in Light of Criticisms

August 1, 2002 | Healthcare Risk, Quality, & Safety Guidance

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Healthcare facilities should examine their policies and procedures for medical device recalls in light of widely reported problems with the recall of defective bronchoscopes at a Maryland medical center.

Earlier this year, Johns Hopkins Hospital and Health System, Baltimore, Maryland, announced a campaign to contact all patients who may have been exposed to bacteria from defective bronchoscopes that were part of a national recall, initiated by the manufacturer, Olympus America Inc., Melville, New York, in late November 2001. At least two of the November recall letters were sent to the Johns Hopkins hospital and medical school. But there is no evidence that the letter mailed to the hospital ever arrived there, and the letter sent to the medical school did not reach the appropriate hospital officials until almost two months later. Consequently, clinicians at the hospital did not become aware of the recall until early February—after the hospital had done its own preliminary investigation of an unexpectedly high rate of Pseudomonas infections among certain patients and traced the problem to the defective bronchoscopes.

According to press reports, other hospitals may have also been unaware of the recall until the Hopkins dilemma made headlines nationally in early March. Hopkins officials and others, including the American Hospital Association (AHA), are questioning whether the U.S. Food and Drug Administration's (FDA) oversight of manufacturers' recalls is effective. "A letter is not enough," says Rick Kidwell, director of risk management, Johns Hopkins Hospital and Health System. "In the future, the agency could more carefully and closely scrutinize the actions of manufacturers during recalls," he added.

Hopkins' experience also suggests that hospitals should ensure that they have a policy in place for medical device recalls and that they review the policy to identify and correct any deficiencies. Although Hopkins had a recall policy in place the incident with the Olympus bronchoscopes prompted the medical center to revise its recall procedures, says Kidwell. Other hospitals should use the experience as a learning tool,...

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