FDA looking into more complaints about Olympus bronchoscopes

At least 59 reports made beyond Hopkins problems

March 29, 2002|By Tom Pelton | Tom Pelton,SUN STAFF

Federal authorities investigating a bacterial outbreak at Johns Hopkins Hospital are also examining at least 59 other reports of problems with Olympus bronchoscopes at other hospitals over the past six years.

The incidents in Food and Drug Administration files range from bacterial contamination to cracked valves, rings tumbling off into patients' lungs and laser surgery devices bursting into flame inside throats.

Twelve deaths and 60 infections are listed in the reports, but most of these problems had unknown causes and were not blamed on the devices, according to the records.

Bronchoscopes are snake-like instruments that doctors insert into patients' lungs to conduct examinations and take tissue samples.

The FDA is investigating whether scopes made by the Olympus Optical Co. of Tokyo spread bacteria among patients and whether the company correctly handled a Nov. 30 recall of 4,700 of the instruments, FDA officials said.

Hopkins hospital officials complained this month that Olympus had run a sloppy recall effort, sending the notice meant for Hopkins to the wrong address. As a result, Hopkins doctors continued using the flawed Olympus scopes for two months after the recall date, exposing scores of patients to the potentially dangerous pseudomonas bacteria.

"We have an ongoing investigation into this matter, and we are looking at the death and injury reports as part of our investigation," Sharon Snyder, a spokeswoman for the FDA, said yesterday.

Medical experts say they have long known that bronchoscopes are among the medical devices most likely to spread disease inside hospitals because their irregular shape makes them difficult to clean properly.

The U.S. Centers for Disease Control and Prevention warned hospitals nationwide in July 1999 about the danger of infections from bronchoscopes after an outbreak of pseudomonas among 18 patients who had been examined in a New York hospital.

The 59 reports of problems with Olympus bronchoscopes from 1996 to this year do not mean that they are dangerous or more trouble-prone than other brands of scopes, said Mark Bruley, a vice president of ECRI of Pennsylvania, a nonprofit group that monitors medical device safety.

More than 500,000 bronchoscopies a year are performed in the United States, the majority of them with Olympus-made scopes. Olympus has sold 14,000 bronchoscopes in the United States since 1990.

"Bronchoscopes and endoscopes are valuable medical tools," said Laura Storms-Tyler, a spokeswoman for the company, and the devices are "generally regarded as safe and effective."

The files on the Olympus bronchoscopes show:

On April 3, 2000, an unidentified hospital reported that two patients with lung transplants had developed symptoms of pseudomonas infections, one becoming seriously ill, and 18 other patients tested positive for the bacteria, after being examined with an Olympus bronchoscope that was damaged and might have been cleaned poorly.

A hospital on Aug. 10, 2000, reported that seven patients were infected and treated for pseudomonas infections after Olympus bronchoscope exams and that one died, although the death was attributed to poor health before the exam.

A hospital on Dec. 14, 2000, reported that four children had been infected with pseudomonas bacteria after bronchoscopies, although the cause of infection was uncertain.

A hospital reported on Feb. 26, 1998, that a laser in a flexible bronchoscope started a fire in the chest of a patient suffering from a large cancerous mass.

The patient suffered a burn in his lungs and died, but the death was attributed to cancer and not the procedure.

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