Company discovered defect in medical equipment two months before recall, CDC says

<br>BALTIMORE (AP) _ The maker of a medical device that may have spread a potentially life-threatening bacteria to patients knew the equipment was defective in September, but did nothing for two months,

Tuesday, March 5th 2002, 12:00 am

By: News On 6

BALTIMORE (AP) _ The maker of a medical device that may have spread a potentially life-threatening bacteria to patients knew the equipment was defective in September, but did nothing for two months, officials said.

In recall letters sent out in November, Melville, N.Y.-based Olympus said its bronchoscopes, which are used to inspect a patient's lungs and take tissue samples, had a loose valve that could trap bacteria.

Johns Hopkins Hospital alerted 415 patients Monday that they may have been received a dangerous lung infection from the devices. One hundred of those patients have tested positive for the Pseudomonas bacteria and two have died, but doctors were still trying to determine if the defective bronchoscopes were responsible.

It was not known whether patients who came in contact with the defective bronchoscopes at other hospitals had been infected or informed of the problem.

About 460,000 patients undergo bronchoscopies every year in the United States.

Dr. William Jarvis, who studies disease outbreaks for the Centers for Disease Control and Prevention, said Olympus learned of the problem in September but did not begin sending out recall letters to hospitals that used the defective devices until November.

Jarvis said the company didn't inform the Food and Drug Administration of the defect until December. FDA spokeswoman Kathleen Kolar said the recall and the FDA's response is being evaluated.

Olympus officials issued a statement saying the company ``initiated an immediate and vigorous investigation resulting in a prompt recall'' and that notices had been sent to 2,361 health-care institutions. However the company said fewer than 40 percent of the recalled bronchoscopes had been sent back to the company for inspection and repair.

The CDC said it is e-mailing medical centers to let epidemiologists nationwide know that the recalled bronchoscopes may be a serious problem.

Pseudomonas bacteria can cause pneumonia and be life-threatening in patients already suffering from critical illnesses, officials at Johns Hopkins Hospital said.

The recall started after a hospital in Tennessee noticed in September that an unusually high number of tests on lung fluids drawn with the faulty bronchoscopes were positive for Pseudomonas bacteria.

Hopkins physicians said they didn't learn of the recall until early February. A recall letter dated Nov. 30 was addressed to a loading dock at Johns Hopkins' physiology department, but it took at least a month to reach physicians, said Dr. Paul Scheel Jr. of the Hopkins department of medicine.

In the meantime, Hopkins physicians noted a two- to three-fold increase the number of patients infected with Pseudomonas in December. By early February, they realized the devices were the culprit.

But it wasn't until Friday that the hospital began calling patients. Doctors wanted to find out as much as they could about the devices and if each patient was infected before or after their bronchoscopy, Scheel said.

``It is a balancing act trying not to alarm the public versus doing something that's appropriate,'' he said.

Most of those treated at Johns Hopkins were suffering from cystic fibrosis, AIDS or lung cancer, or had recently had lung transplants.

Hopkins officials said they mailed certified letters Monday asking patients to call their doctors if they experience symptoms such as fever, coughing, phlegm or shortness of breath.

Jarvis said the recall was handled correctly but said he was ``perplexed'' that neither the FDA or Olympus posted the recall notice on their Web sites.

``Part of the problem is you're dealing with large bureaucracies, and large numbers of people are involved who may not be talking to each other,'' Jarvis said.