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Candor praised in scope problems

| Friday, April 1, 2005

Health watchdog groups on Thursday lauded Forbes Regional Hospital in Monroeville for disclosing earlier this week that some instruments used for bowel examinations weren't being properly cleaned. Other experts said the mistake should never have happened, pointing to failures in government regulation and in oversight by the hospital and equipment manufacturer.

Officials from West Penn Allegheny Health System, the parent company of Forbes, announced Wednesday that two of the hospital's colonoscopes weren't being disinfected adequately in between cancer-screening procedures.

A patient's chance of infection by blood-borne viruses through gastrointestinal endoscopy is estimated to be 1 in 1.8 million, according to Dr. Douglas Nelson, spokesman for the American Society for Gastrointestinal Endoscopy.

Despite the low risk, about 200 patients exposed to the unsanitary instruments at Forbes from Oct. 28 to Feb. 26 were advised to undergo free HIV and hepatitis testing.

Certified letters were sent to the patients last weekend, and more than 100 people have arranged for testing or have been tested, hospital spokesman Tom Chakurda said yesterday. Forbes has been flooded with more than 600 calls from other concerned patients, Chakurda said. So far, no cases of HIV or hepatitis have been linked to the mistake, according to the Allegheny County Health Department.

The hospital's decision to be upfront about this error rather than stay quiet should be applauded by the community, health care experts said.

"The public needs to be enormously reassured that here's a hospital that, when confronted with even a slight risk, chose to issue a warning to everyone who could possibly be affected rather than hide it," said Ken Segel. He is a principal in North Side-based Value Capture, a for-profit health care quality improvement group headed by former U.S. Treasury Secretary Paul O'Neill. "The fundamental first step in improving health care quality is to acknowledge errors so they can be addressed."

Historically, hospitals have been reluctant to reveal mistakes except in the most serious cases because of the risk of malpractice lawsuits and the unrealistic expectation that doctors are supposed to be perfect, Segel said.

"It's never easy to admit to an error," said Naida Grunden, a spokeswoman for the Pittsburgh Regional Healthcare Initiative, a watchdog group addressing health care problems in the region's hospitals. "We're not talking about bad people who want to hurt patients. We're talking about a system breakdown."

That's why hospitals must carefully re-examine their systems for catching and handling errors to make sure minor problems don't become major patient health risks, Grunden said.

"The truth is, for every risk like this one that bubbles to the surface, there are hundreds more present in every hospital that don't get called out," Segel said.

Wednesday's announcement was the second known case involving improper sanitizing of scopes at West Penn Allegheny Health System. In 2002, 16 patients at Allegheny General Hospital became infected with a deadly bacteria after they were tested with contaminated bronchoscopes. Those scopes, used to inspect the lungs, were tainted with pseudomonas aeruginosa, a bacteria that can be deadly in very sick people. One person died.

Endoscopy safety experts such as Lawrence F. Muscarella, a biomedical engineer who specializes in infection control, said there is no good excuse for the misstep at Forbes.

The problem with the improperly disinfected Forbes colonoscopes was an extra water jet inside updated instruments bought by the hospital last fall from New York-based Olympus America Inc.

Two years ago, the U.S. Food and Drug Administration published a safety alert cautioning hospitals to clean and disinfect this auxiliary channel after every colonoscopy. The warning was issued in response to reports of some hospitals not cleaning the jet because they didn't know it was there or because they didn't use it.

In addition to the FDA alert, Olympus officials said the user manual provided with the colonoscopes provides clear instructions about the need to clean the water channel.

The issue has been publicized extensively by the medical community and the popular media, Muscarella said.

Muscarella published a paper in December in the journal Gastroenterology Nursing -- which is well-read in the field -- that explicitly points to the need to routinely clean all of the colonoscope's channels.

Muscarella said he hears about a new breach in colonoscope disinfection like this every few months.

"It's the same story every time, like deja vu," said Muscarella, who works at Custom Ultrasonics Inc. of Ivyland, Bucks County, which makes medical cleaning equipment.

He first blames equipment manufacturers for not highlighting subtle changes in new instrument models. He also blames hospitals for not investing in proper training for endoscope processing technicians. Finally, he blames the FDA and states for not implementing quality assurance standards or imposing sanctions for noncompliance.

"This is a major public health problem caused by a perfect storm of factors," Muscarella said.

Patients aren't helpless when it comes to protecting their safety.

Patients can use Web sites like that of The Leapfrog Group in Washington, D.C., which rates hospitals nationwide on such issues as assessing and preventing risks of infection. Hospitals are starting to encourage patients to point out potentially unsafe practices. Muscarella hopes to develop a "cheat sheet" of questions that patients could use in choosing a hospital for their colonoscopy.

"When you have a properly processed scope, you have zero risk," he said. "When improperly done, all bets are off."

Additional Information:

Alert

Patients who underwent colonoscopies Oct. 28 through Feb. 26 at Forbes Regional Hospital should call toll-free (877) 854-5450 between 7 a.m. and 5 p.m. weekdays.

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