Hopkins, CDC say recall was flawed

Possible infection from bronchoscopes suspected in 2 deaths

March 05, 2002|By Tom Pelton | Tom Pelton,SUN STAFF

Doctors at Johns Hopkins Hospital and the U.S. Centers for Disease Control and Prevention criticized yesterday the manufacturer of a defective medical instrument, saying the company conducted a flawed, voluntary recall effort that put thousands of patients at risk of dangerous infections.

They also complained that the U.S. Food and Drug Administration left it up to the device's manufacturer, Olympus America Inc. of New York, to warn hospitals of the problems with the bronchoscopes - snake-like, pencil-thin cameras that are used to examine lungs.

Infections that may have been caused by contaminated bronchoscopes might have contributed to the deaths by pneumonia of two critically ill patients at Johns Hopkins, hospital officials said yesterday. Cultures from the lungs of another 100 patients showed the presence of the bacteria.

During a news conference yesterday, administrators at Johns Hopkins said they are trying to warn hospitals nationally of the dangers of continuing to use the devices. They are asking all 410 of their patients who underwent diagnostic tests with the instrument between June 1 and Feb. 4 to return to the hospital for additional tests to find out whether they also were exposed.

Dr. Paul J. Scheel Jr., vice chairman of the Hopkins department of medicine, said he and his colleagues had called several other hospitals to warn them of the risk of infection but that the universal reaction from other hospitals has been, "What recall?"

"I don't feel that a lot of institutions even knew about the recall. We were hopeful that the CDC and FDA would notify all of the institutions," said Scheel.

Hopkins administrators complain that the company sent a vaguely worded recall notice Nov. 30 to a loading dock at the medical school - the wrong address. The notice got lost in the in-house mail for a month and a half.

The notice said, "Olympus would like you to return the bronchoscope at your convenience" so that the company could "upgrade" the device.

As many as 4,400 faulty instruments were purchased by 2,361 hospitals across the country, said Olympus officials. The company maintains that it has been aggressive in notifying hospitals about the recall by certified mail. Nearly 40 percent of the flawed devices have been returned, an executive said.

"We take steps to communicate the best we can the urgency of the recall notices," said Sandra McDonald, executive director of professional services with Olympus. "They all state `urgent recall' and were sent to the attention of the pulmonology or infection control directors of the hospitals."

The problem with the bronchoscopes was discovered in September by a CDC investigator at a Nashville, Tenn., hospital. Doctors at the unnamed hospital found that cultures from 17 patients who had been examined with the devices tested positive for pseudomonas bacteria. A 50-year-old woman, a cancer patient, contracted pneumonia from the instrument but recovered.

The investigator, Dr. David Kirschke, concluded that a loose valve on the snake-like instruments allowed bacteria to form in a pocket where they couldn't be purged by sterilization equipment.

Dr. Bill Schaffner, a consultant with the Tennessee Department of Health, said he and Kirschke thought they had saved the public from the danger when they warned the FDA and Olympus about the problem in the Nashville hospital in October.

Schaffner and Kirschke both said by telephone yesterday that they were disturbed to learn that Hopkins and other hospitals didn't know until recently about the problems in Tennessee or about the recall.

"This is not how it's supposed to work - the bad experiences of one institution are not supposed to be repeated at another institution," said Schaffner, chairman of the department of preventive medicine at Vanderbilt Medical Center. "We expected an aggressive recall, but what we got was recall-lite. They weren't really serious about the recall."

Hopkins officials had to start from scratch in December when they began to investigate the causes of an unusual increase in cases where patients tested positive for the pseudomonas bacteria after undergoing examination with the bronchoscope.

After months of intensive work, Hopkins reached the same conclusion last month that officials in Tennessee had months earlier.

Hopkins officials criticized the company and the FDA yesterday, saying the company and agency failed to follow the more aggressive procedure used when drugs are recalled. In these circumstances, hundreds of recall letters are sent to the home and office addresses of all doctors who have prescribed or might prescribe the drugs.

In addition, the FDA often distributes advisories and warnings about the drugs. Company sales representatives mention the recalls to their customers. None of this happened with the bronchoscopy recall, critics say.

Baltimore Sun Articles
|
|
|
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.