SAN FRANCISCO — The California Department of Health Services has issued warnings to 1,000 hospitals and clinics statewide about the use of undisenfected probes in routine colon exams. The manufacturer of the devices, meanwhile, has alerted another 2,200 hospitals across the nation to take safeguards against similar contamination.
The warnings went out after two Sacramento-area hospitals last month advised 3,250 patients to take blood tests to ensure they had not contracted infectious diseases through exposure to an unsanitized chamber inside an instrument called a colonoscope.
Although none of the patients from Sutter Auburn Faith Hospital and Sonora Community Hospital have reported an illness so far, some patients in other parts of the country have contracted diseases such as hepatitis and the sexually transmitted human papilloma virus. Others suffered extreme anxiety when notified that they had been examined with dirty equipment and should return for follow-up blood tests.
Although officials acknowledge that improperly cleaned devices can transmit disease, the national governing organization of gastroenterologists says the threat of becoming infected by an endoscope is one in 1.8 million. Some health activists contend that the chances are much greater.
"Colonoscopes save thousands of lives every year," said Jan Emerson, a spokeswoman for the California Health Care Assn. "As long as health care is provided by humans, there's always the chance that unfortunate things are going to happen. But that absolutely should not mean that people should stop getting these critical tests."
The flexible hose-like probes -- known as bronchoscopes, sigmoidoscopes and colonoscopes, depending on what part of the body they examine -- use a fiber-optic lens to allow doctors to peer inside the throat, lungs and other parts of the body without surgery. They are used 15 million times a year by various medical providers.
But despite the fact that thousands of patients nationwide have received warning letters about the prospect of being made sick by dirty probes, government agencies have done little to address the problem, critics allege.
The nation's leading manufacturer of endoscopes has known for a decade that some scopes contain cavities inaccessible to cleaning by hand but has failed to fix the oversight, said David Lewis, a University of Georgia research microbiologist who has conducted research for the federal Environmental Protection Agency on the issue of dirty endoscopes.
Lawyers representing patients who have sued hospitals and clinics over the issue add that many clinicians ignore established cleaning guidelines and rush through the disinfecting process in a McDonald's-style push to serve more clients.
"This is the health-care industry's dirty little secret," said attorney Jamie Sheller, who represents patients who sued a New Jersey clinic.
The Society of Gastroenterology Nurses and Associates said no one government agency is solely responsible for monitoring the use of the devices. Said President Paulette Smith: "It's up to individual institutions to make sure the standards are being followed."
And a spokeswoman for the U.S. Food and Drug Administration, which regulates the manufacture of endoscopes, said the agency has not issued any citations against endoscope makers in the last five years.
That's not good enough for Lewis. "The industry's solution has been to bury its head in the sand," he said. "They just deny the problem exists."
Patients, meanwhile, say that the stress alone of receiving a warning letter takes its toll. Returning for repeat precautionary blood tests to ensure that they did not contract a communicable disease affects everything from their jobs to relationships with friends and family.
"Can you imagine being worried about colon cancer, so you go through this procedure only to be told that you were fine but now you could have a virus from the scope that causes colorectal cancer?" asks Lewis.
Blood Tests Urged
Officials at the two California hospitals say their patients stand little chance of becoming ill. But as a precaution they advised patients -- one letter explained that it was for their "peace of mind" -- to return for the follow-up blood tests.
"This was obviously not something you enjoy doing," Dr. John Barnsdale, chief of staff at the Sutter Auburn Faith Hospital, said of the recent round of warning letters. "But there was an error here. And people deserve to be told."
Olympus America Inc., which manufactures the colonoscope that prompted the patient warning letters, also contacted 2,200 hospitals nationwide to remind them of proper cleaning procedures.