UM hospital stops using lung probe

Hopkins suspects link between recalled tool, surge in infection

`A good detective job'

Officials share news of potential hazard from bronchoscope

March 04, 2002|By Stephanie Desmon | Stephanie Desmon,SUN STAFF

Following the lead of Johns Hopkins Hospital doctors who suspect that a faulty medical device might have spread a serious lung infection among patients, the University of Maryland Medical Center has stopped using the tool - and is searching its medical charts to see whether the same disease has beset its hospital.

Hopkins and state officials have started spreading the word about the potential hazards of the bronchoscope, a tiny instrument with a camera on one end used to probe the lungs. The device was quietly recalled in November by its New York-based manufacturer - so quietly that Hopkins doctors had been intensely investigating for weeks the higher-than-normal levels of a bacterium called Pseudomonas in some patients before learning last month of the recall.

Dr. Ross J. Brechner, the state's epidemiologist, said yesterday he has sent e-mails to colleagues throughout Maryland and the country detailing the Hopkins discovery and asking whether they have noticed the same elevated infection levels after using the popular device. He is awaiting responses.

"We don't know what the magnitude of the problem is yet," said Dr. Daniel B. Jernigan, a medical epidemiologist with the Centers for Disease Control and Prevention in Atlanta.

Hopkins used several bronchoscopes of the model recalled by Olympus America, a manufacturer well known for its camera equipment. Dr. Harold C. Standiford, medical director for infection control and antibiotic effectiveness at the University of Maryland Medical Center, said he doesn't know how many of the recalled devices his hospital was using. The hospital uses other brands of bronchoscope that will stay in circulation, he said.

Despite the recall, Standiford says, his doctors were not aware of warnings about the product - and continued to use them until last week, when told of Hopkins' experiences.

A voluntary recall such as the one done by Olympus often does not received as much publicity as a recall conducted by the Food and Drug Administration. Typically, a company will try to contact its customers directly. A recall letter sent to Hopkins, dated Nov. 30, was lost after it was mistakenly addressed to the loading dock of the Hopkins physiology department.

Olympus officials did not return calls to their homes and offices seeking comment yesterday. FDA officials also did not return calls.

"They've done such a good detective job at Hopkins," said Dr. Peter L. Beilenson, the city health commissioner.

Hopkins is sending certified letters today to more than 400 patients - or their families - informing them of the problem and asking them to call their doctors if they experience symptoms such as fever, coughing and shortness of breath. If they would like to be evaluated at no cost, Hopkins officials are asking them to call 410-955-0272. If they have other concerns, they are asked to call 800-347-8615.

The letter reads in part, "Because there is a chance that your bronchoscopy may have involved one of these defective bronchoscopes, you may have been or may be at increased risk of infection from a common bacteria called pseudomonas (su-doh-MO-nas)."

Some patients have died, officials said, but the hospital is unsure whether they died from their underlying diseases, from pre-existing Pseudomonas infection or from an infection introduced by the instrument. Most of those who died suffered from cystic fibrosis, AIDS or lung cancer, or recently had undergone lung transplants.

Bronchoscopy, performed to look into a patient's lungs and take tissue samples, is a relatively common procedure. About 460,000 patients undergo the procedure each year in the United States.

In recent years, infections caused by bronchoscopes have been reported. In 1999, the FDA and CDC issued a public health advisory, alerting hospitals to several incidents in which patients developed serious infections because bronchoscopes were poorly cleaned.

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