According to the FDA's CDRH, Olympus has history of problems
Mark A. DeSorbo
BALTIMORE, MD-A spokes person from Olympus America Inc. (Melville, NY) says the recall of some 4,700 faulty bronchoscopes is going well, and the hospital that recently traced a deadly lung virus to the medical device continues to evaluate how patients may have been infected.
“The recall efforts are going great actually, thanks to all the news coverage,” says Olympus spokesperson San dra McDonald.
Olympus, she adds, remains committed to seeing a complete recall through and is continuing to work with the U.S. Food and Drug Administration (FDA), the Centers for Disease Control (CDC) and hospitals around the world. McDonald declined further comment.
Meanwhile, doctors at Johns Hopkins Hospital continue to assess patients who had lung exams with Olympus bronchoscopes.
“We've evaluated 100 patients, and so far we have found less than ten infections,” says Johns Hopkins spokesman Gary Stephenson. “We don't know yet if the infections stem from the bronchoscope; that will take some time to evaluate with DNA tests.”
In early March, doctors at Johns Hopkins Hospital and CDC officials criticized Olympus for a botched voluntary recall that they say put thousands of patients at risk of pseudomonas, a life-threatening lung infection. They also charged that the FDA left it up to the manufacturer to warn hospitals of the valve that harbors contamination within the bronchoscopes, snake-like, pencil-thin cameras that are used to examine lungs.
Doctors at Johns Hopkins had already detected the contamination and located the source before they were even aware there was a recall on the bronchoscopes, Steph enson says.
In December, he says doctors realized that 128 patients, many of whom were already suffering from cystic fibrosis, AIDS and lung cancer, had been infected with pseudomonas at a rate two to three times higher that the hospital would expect.
By chance in early February, doctors became aware of a national recall letter from Olympus, dated November 30, that was mistakenly addressed to the loading dock of the John Hopkins physiology department. At that time, possible infection from two Olympus bronchoscopes was suspected in two deaths.
However, reported infections from Olympus bronchoscopes on the Web site of the FDA's Center for Devices and Radiological Health (CDRH) date back more than six years.
Along with bacterial contamination, incidents in the CDRH Internet database include cracked valves and rings falling off while the scope was in patients' lungs and laser surgery devices exploding into flames inside patients' throats.
In fact, 12 deaths and 60 infections are listed in federal health agency databases, many of which were not blamed on the bronchoscopes.
Sharon Snider, an FDA spokesperson, says the agency is investigating the Johns Hopkins matter and is reviewing other death and injury reports involving Olympus bronchoscopes as part of the investigation.
Some of the CDRH files indicate:
- In October 2001, doctors at an unidentified hospital began finding what they thought were contaminated bronchial washings soon after it received two new video bronchoscopes from Olympus. Doctors became concerned because they said although the patients were not clinically ill with pseudomonas, cultures from them were growing the bacterium, which they believed developed from bronchial washings taken from 16 different patients. Only one patient became ill with pneumonia. The infectious disease physician indicated that the patient developed pneumonia from the bronchoscopy and said the cleaning process did not address the sanitation needs of the medical device. Several other hospitals in late 2001 reported similar problems.
- On April 30, 2000, an unnamed hospital reported that two patients with lung transplants suffered from symptoms of pseudomonas. One became seriously ill, while 18 other patients tested positive for the bacterium following exams with an Olympus bronchoscope that was damaged and may have been inadequately cleaned.
- In August 2000, an unnamed hospital reported that seven patients became ill with pseudomonas following exams with Olympus bronchoscopes. One patient died, but the death was attributed to failing health before the bronchoscopy.
- In December 2000, four children came down with pseudomonas following bronchoscopies. The cause of the infection was unclear.
More than 460,000 people undergo bronchoscopies every year in the United States.