Originally Published MDDI February 2003NEWSTRENDSExpanded Notification of Device Recalls UrgedGregg Nighswonger

Gregg Nighswonger

February 1, 2003

2 Min Read
Expanded Notification of Device Recalls Urged

Originally Published MDDI February 2003


Gregg Nighswonger

Broader and more timely distribution of product recall notices could help increase patient safety, say infection control experts from Johns Hopkins Hospital (Baltimore). The group suggested changes to the current voluntary system after studying a series of infections at the Maryland facility.

The Johns Hopkins team traced the source of infections in 32 patients last year to three faulty bronchoscopes. The group now argues that more stringent regulations and a faster recall of the devices could have prevented the outbreak. 

Between June 2001 and January 2002, the rate of Pseudomonas aeruginosa at Johns Hopkins was three times higher than the usual rate in patients undergoing bronchoalveolar lavage. The group's review showed that a potentially contaminated bronchoscope may have had a role in the increased infection rate and in three deaths. 

In November 2001, certain Olympus bronchoscopes, including those used at Johns Hopkins, were recalled nationwide because a loose port could allow contamination of the devices. The firm first sent letters to facilities using the scopes. But the letters were not addressed to individual physicians who use the devices, according to the group. The result was that individual physicians were not aware of the recall.

According to Arjun Srinivasan, MD, assistant professor of medicine at Johns Hopkins, a more effective recall of the devices could have shortened the duration of the outbreak and decreased the number of patients at risk. His group believes that the federal government should implement and enforce standards more like those used for drug recalls.

Asked whether such a recall strategy would be applied generally or required only for critical devices, Srinivasan told MD&DI, “Understandably, this type of regulation would be a lot of work, and thus the efforts need to be targeted where they are likely to have the highest yield. Clearly, the major concern is for the more serious recalls that may adversely impact patients. However, it would be helpful for information on all recalls to be readily available.”

Srinivasan explained that the problems encountered with the recall also prompted the facility to assess its own procedures. “The notice was sent to the same address that the equipment had been shipped to,” he says. “We have extensively studied and have worked to improve the way we handle recall notices in our hospital.” The group reported on their findings and recommendations in the January 16, 2003, issue of the New England Journal of Medicine.

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