Is endoscopy getting out of (infection) control?
Rapid growth in physician offices alarming
An increasing number of gastrointestinal endoscopy procedures are being performed in physician’s offices and outpatient clinics without adequate assurance of appropriate infection control measures, clinicians warn.
"As this [procedure] goes out more into private offices and into endoscopy centers, there are less people involved in making sure everything is being followed carefully," says Gerald Isenberg, MD, assistant professor of surgery at Jefferson Medical College in Philadelphia.
Representing the American Society for Colon and Rectal Surgeons, Isenberg recently joined other experts in Atlanta to discuss infection control issues in endoscopy and review draft guidelines by the Centers for Disease Control and Prevention (CDC). The comment period closed June 14, 2002, for the CDC’s Draft Guideline for Disinfection and Sterilization in Healthcare Facilities, 2003.
The recent meeting concluded with options being discussed in a closed session that included endoscopy experts, epidemiologists, and public health officials. "We talked about whether it will be necessary to convene a task force to look at this [concern] and try to find out what the best approach would be — to monitor the offices or just to ensure that they are doing the right procedures," Isenberg tells Hospital Infection Control. "You never like to have additional regulatory agencies, but that might be something [to consider]."
Other possibilities include getting the industry more involved in infection control education and working with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), he adds. There is little controversy about the CDC recommendations themselves, but experts fret over the rapid expansion of endoscopy in settings with little regulatory oversight.
"Currently, the office endoscopy setting is the least-regulated setting, but federal reimbursement actually favors doing endoscopy in that setting," says Douglas Nelson, MD, staff gastroenterologist at the Veterans Affairs Medical Center in Minneapolis. "So the federal government — through its reimbursement policy — is actually encouraging office endoscopy, which has the least regulation, rather than ambulatory endoscopy centers or hospitals where there is probably the most regulation."
Individual states primarily regulate endoscopy in the office setting, says Nelson, who represented the American Society for Gastrointestinal Endoscopy at the meeting. "The issue is really how do we implement [guidelines] to make sure everyone does them," Nelson says. "I think [compliance] is good, but obviously we are shooting for 100%. I can verify the compliance in the hospital because there are JCAHO standards. JCAHO does not regulate office practice," he adds.
Nelson emphasized that there are no data suggesting that more infections and adverse events are occurring in office-based endoscopy as opposed to institutional settings. "Overall, infection is an extremely rare event. There was a very broad consensus that current practices are safe. However, [endoscopy is] vulnerable to human error no matter what system you use. We want to make sure that people are cleaning endoscopes according to the right guidelines."
The problem is ensuring infection control safety for office endoscopy without scaring the public away from critical diagnostic procedures, Isenberg adds. "Then we’re not going to be picking up polyps and cancer, and that would be far worse."
While rare, infections related to any procedure can be subject to underreporting in outpatient populations not under the watchful eye of an infection control professional. "There probably is an underreporting," says Cathy Nutter, MS, a microbiology expert at the Food and Drug Administration (FDA). The FDA has voluntary and mandatory reporting programs, one of which requires facilities to report to the manufacturer and the FDA all device-related patient deaths and injuries. The problem is that those regulations do not apply to physician offices. Expanding the regulatory authority would require nothing less than an act of Congress, she says.
"That would have to come from Congress under the Safe Medical Devices Act," she says. "It did not cover physicians offices, I guess, because they are a way too numerous. It’s hard enough trying to get [reports] from hospitals."
Reviewing the available data, Nutter says, "there really weren’t that many directly related to GI endoscopy." Since 1992 there have been nine reports to the FDA regarding gastrointestinal endoscopy, including two deaths and three reports of infection. According to the FDA, one patient developed peritonitis two days after colonoscopy and died. An autopsy revealed death due to acute peritonitis associated with perforation of the colon. The patient had a history of diverticulitis.
The other death occurred in an 82-year-old patient who cultured positive for Klebsiella species one day after an endoscopy procedure. The duodenoscope used also cultured positive for the pathogen. The patient was administered antibiotics, but died 11 days after discharge. Other reports of infections include a 66-year-old patient who was infected with Pseudomonas species following endoscopy. The patient recovered after antibiotic treatment.
Three other FDA reports involved patients who complained of GI bleeding and cramping one day after undergoing sigmoidoscopy in a physician’s office. The patients were treated with prophylactic antibiotics and symptoms subsided within one day. The culture results and cause of symptoms were unknown.
While the office setting remains a concern, the clinical content of infection-control recommendations is fairly well defined. "There is no dearth of endoscope reprocessing guidelines," Nelson says. "If you look at them, since 1977, basically they have only changed in very small increments."
One change that was recommended in the CDC guidance was the inclusion of endoscopes with disposable components, he said. Instead of trying to reference specific products, the guidelines may state that users should follow FDA label guidelines and manufacturer’s cleaning instructions on any new device. "A guideline that addresses every new widget that comes out is going to have a very short shelf life," Nelson says. "[Including] FDA labeling is so the manufacturers will have to prove their claims. We think that is adequate."
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