Olympus officials acknowledge that the company is aware of scope cleaning problems. They say that the issue has increasingly been factored into the design of the devices. "Our focus is patient health and safety," said Laura Storms-Tyler, director of regulatory affairs and quality assurance. "We're very sympathetic to patients who have to live through the worry of potentially becoming infected by an endoscope."
Since 1999, there have been numerous health scares related to unclean endoscopes.
* Baltimore's Johns Hopkins Hospital in March sent letters to 400 patients warning that they might have been exposed to pneumonia bacteria through bronchoscopes during throat exams. More than 100 of those tested positive for the bacteria.
* New York City health officials in 2001 contacted 2,000 patients who underwent gastrointestinal exams at a Brooklyn clinic after at least eight patients tested positive for hepatitis C, a liver disease caused by a blood-borne virus. Although officials suspect the reuse of contaminated needles, others say the clinic's failure to sterilize biopsy forceps or properly clean the scopes was the more likely the cause of the outbreak. As a result, New York legislators are studying whether to toughen the state's disinfectant standards for endoscopes.
* Olympus, the No. 1 maker of medical scopes, in 2002 conducted a worldwide recall of 14,000 bronchoscopes -- including 4,000 in the U.S. -- after reports that a part that came loose could trap bacteria inside.
Joseph Long, a 65-year-old New Jersey grandfather, said common sense persuaded him to undergo a colonoscopy in September 2000. A few weeks later, a woman from the endoscopy clinic called to inform him that a machine that disinfects the scopes had malfunctioned
"I was floored," said the retired mechanical engineer.
For months, Long returned for blood tests. His daughter, meanwhile, was skittish over his touching his grandchildren. He surfed the Internet to investigate just what kinds of diseases he might be up against.
"All I could think of was that I was going to lose my husband," says Barbara Long. "You get this procedure to live longer and this is what happens."
Long never got sick. But another endoscopy patient from Los Angeles wasn't so fortunate.
The man, who asked that his name not be used, says a colonoscopy in 1998 to treat mild hemorrhoids exposed him to the human papilloma virus, a sexually transmitted disease usually spread through anal sex.
"When I got sick, my wife said it must be the colonoscopy and I said 'No way. That thing was clean.' I'd never dream in a million years they would stick something inside of me that was reused and not sterile," said the man, who is in his 40s. "It's incredibly humiliating to have a disease when you've done nothing remotely near what it takes to subject yourself to this."
There is wide consensus that it is difficult to sterilize the devices, which can cost $28,000 each, without using temperatures so high that the scopes themselves become damaged. The scopes have numerous cavities that are difficult to clean, even by hand, critics say.
Acknowledged Timothy Ulatowski, an FDA official who oversees endoscope compliance: "When these things were designed, cleaning and sterilization was obviously an afterthought."
Even the government can't agree on how long is needed to clean the devices. The FDA says endoscopes should be disinfected for 45 minutes to kill tuberculosis bacteria, but the Centers for Disease Control believes the job can be done in 20 minutes, Lewis says.
He and other microbiologists advocate sterile disposable parts for endoscopes as well as the use of a condom-like sheath for each new patient. But they say manufacturers and health-care providers have resisted such solutions because of added costs.
Lewis says Olympus, which provides 70% of endoscopes on the U.S.market, has long been aware of cleaning problems associated with its product. In a patent filed in 1993, he says, the company wrote that at times "satisfactory cleaning cannot be achieved."
Although Lewis says the company still makes some endoscopes in which all internal channels cannot be disinfected, the company insists it is moving toward improvements.
Federal Guidelines
Heath-care activists say many overworked hospital and clinic workers will cut corners on cleaning to save time. A 1997 survey in the Archives of Family Medicine showed that most primary care physicians in the United States failed to follow more than one-third of the federal guidelines for the proper use of sigmoidoscopes, used to detect colon cancer.
California public health officials say inspectors may soon begin to consider endoscope cleaning procedures when they make accreditation visits every three years at hospitals and clinics.
"We expect to hear from other hospitals that they've had similar problems," said Jon Rosenberg, a public health officer in the division of communicable disease control of the state Department of Health Services.
"Once five or 10 people inside a hospital become aware of a health problem," Rosenberg said, "somebody eventually comes forward."
