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Faster Recall of Medical Devices Urged

Doctors At Hopkins Seek Rule, Say '01 Infections Tied To Instrument Avoidable

Jan 16, 2003 | The Baltimore Sun

Doctors at the Johns Hopkins Hospital who traced a bacterial outbreak to a defective medical device say the problem might have been averted by a faster and broader product recall.

Writing this week in The New England Journal of Medicine, the physicians called for federal regulations that would require companies to send recall notices to all doctors who might conceivably use their products.

If such a rule had been in place two years ago, news that the device was capable of spreading a potentially deadly infection would have traveled widely among pulmonary specialists - perhaps in time to limit the outbreak that struck 32 patients at Hopkins.

"The regulation of devices used for medical procedures should be as rigorous as the regulation of drugs prescribed by doctors," said Dr. Arjun Srinivasan, associate hospital epidemiologist.

The outbreak of pseudomonas bacteria occurred between June 2001 and last January among patients who had been examined with a bronchoscope, a device that enables doctors to look inside the lungs and retrieve tissue samples for analysis. The bacterial infection was identified in 32 of 414 patients who had undergone the procedure - about three times the rate that normally would be expected. The bacteria can be lethal to patients with AIDS, cancer and other conditions that weaken the immune system.

At Hopkins, three of the patients died. Doctors were unable to determine whether they died of pseudomonas or their underlying disease, or whether they had been treated with the defective devices or others like them.

While infection-control specialists at Hopkins worked to find the outbreak's cause, a similar one at a Tennessee hospital was traced to a loose screw-on cap that was trapping bacteria. That discovery triggered a recall, but the recall notice sent to Hopkins was delivered to a loading dock where it apparently languished for several weeks before it was forwarded to the pulmonary division.

Last January, two months after the recall letter was mailed, Hopkins doctors learned of the recall in discussions with the U.S. Centers for Disease Control and Prevention, which had played a major role in the Tennessee investigation. By then, they strongly suspected that the device was to blame but had not identified the precise cause.

The devices were immediately taken out of service, and the outbreak stopped. Similar outbreaks at other hospitals were tied to the device, though they were not publicly identified.

"Medical technology is getting more and more advanced, and we're seeing newer and newer devices," said Dr. Trish Perl, chief of infection control at Hopkins. "There is a crying need for us to make sure that we have mechanisms in place to rapidly identify all potential sequelae [infections and other problems] resulting from these devices."

Under federal rules, drug companies are required to send notices about newly discovered side effects to doctors who might use the product.

Kathleen Hale, Hopkins' risk manager, said the hospital has tightened procedures. These include recording the serial number of any medical device used in each procedure and requiring that every piece of registered or certified mail is hand-delivered to the intended recipient.