Instrument maker faults bad cleaning for infections

Bronchoscope firm contradicts Hopkins

March 07, 2002|By Tom Pelton | Tom Pelton,SUN STAFF

The Japanese manufacturer of a medical instrument blamed for spreading dangerous bacteria said yesterday that the likely cause of the infections was sloppy cleaning in hospitals, not flaws in the device.

The statement by the Olympus Optical Co. of Tokyo contradicted the conclusion of Johns Hopkins Hospital doctors, who believe that two of their patients might have died and an additional 100 might have been exposed to pseudomonas bacteria because of defects in Olympus bronchoscopes.

An investigator with the U.S. Centers for Disease Control and Prevention said the company was not only wrong but also reversing its earlier admission that the problem was caused by a loose valve on the snake-like instruments.

Doctors use bronchoscopes to peer into the lungs of patients who have lung cancer, cystic fibrosis and other serious diseases.

The debate over the spread of the bacteria came as the company revealed yesterday that it was recalling three times the number of scopes - 14,000 worldwide - that it had previously disclosed. The company earlier had mentioned a recall of only the 4,700 scopes in U.S. hospitals.

More than half of those sold to American hospitals remain in circulation, more than three months after the company sent out letters urging that the instruments be returned for repair. During a news conference in Tokyo yesterday, Olympus officials said they volunteered to launch the recall in November because they were trying to be careful about a loose part, not because they admitted the devices were causing infections.

Company findings

The Olympus officials said that they knew in September that a valve could come loose and that bacteria could get trapped beneath the part. But the company's investigation revealed that the bronchoscopes would not pass on bacteria if they were sterilized properly by hospitals, Olympus senior executive officer Hiroyuki Furihata said yesterday.

"We decided on a voluntary recall," Furihata said. "The safety of the patients comes first."

Olympus sent recall letters Nov. 30 to 2,361 hospitals in the United States. But Hopkins officials said their notice went to the wrong address and got lost in Hopkins' in-house mail for 1 1/2 months. As a result, their doctors continued using the instruments until Feb. 4.

The company was spurred to issue the recall by complaints in September from Skyline Medical Center in Nashville. The hospital reported an unusually high number of patients testing positive for pseudomonas after being examined with bronchoscopes.

One 50-year-old woman, who entered the hospital for cancer treatment, contracted pneumonia because a bronchoscope inserted into her lungs was contaminated, according to the Tennessee Department of Health. Cultures taken from another 17 patients at the hospital tested positive for the bacteria after they were subjected to bronchoscopies.

The CDC investigator who discovered the cause of the Nashville infection, Dr. David Kirschke, said yesterday that cleaning was not the problem.

Investigator's experiment

In a test, Kirschke said, he ran a bronchoscope three times through a microwave-sized, countertop cleaning machine that Olympus inspectors said was working properly. After the third wash, the scope still harbored a pocket of bacteria underneath a defective and loose valve cap, Kirschke said.

"Company representatives themselves came out and said [in the fall] that the cleaning process used at the hospital was good and that the defect in the scope was preventing the machine from cleaning it," said Kirschke. "What they said back then contradicts what they said at the press conference today."

Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt Medical Center, who helped with the investigation, said, "We think the president of Olympus must have been misinformed."

While still unaware of the recall, Hopkins doctors detected the flaw in the instruments after noticing more than twice the normal rate of positive bacteria cultures among their bronchoscopy patients.

Dr. Trish Perl, an epidemiologist at Johns Hopkins Hospital, said that Olympus officials inspected the hospital's scope-washing machine and found that it was working properly.

In an experiment, investigators ran a bronchoscope with a loose valve through an extra-rigorous cleaning method - an ethylene oxide gas sterilization - and found that it still harbored bacteria afterward, Perl said.

"We were doing absolutely everything that would be considered appropriate for cleaning the scopes," said Perl. "But you can't clean a broken or faulty valve, no matter how hard you try."

About 82 percent of the 3,176 devices in Japan have been recalled. Recalls have begun in other locations, including about 4,700 such devices in Europe.

The recalls will cost the company about 100 million yen ($758,000), officials said. But they denied that the company's image or future operations had been hurt by the recall. Olympus shares closed down nearly 17 percent on the Tokyo Stock Exchange at 1,469 yen ($11).

The Associated Press contributed to this article.

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