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A STERILIZATION STANDARD FOR ENDOSCOPES AND OTHER DIFFICULT TO CLEAN MEDICAL DEVICES
Citation:
Lewis, D L. A STERILIZATION STANDARD FOR ENDOSCOPES AND OTHER DIFFICULT TO CLEAN MEDICAL DEVICES. PRACTICAL GASTROENTEROLOGY 23(1):28-56, (1999).
Description:
An array of difficult to clean devices are used for diagnostic and surgical procedures involving various degrees of invasiveness. These range from prophylaxis angles used for cleaning and polishing teeth to flexible fiberoptic endoscopes for surgical procedures that penetrate the deepest recesses of the body. In 1992-93, the Food & Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) adopted a sterilization standard for all reused dental devices entering the patient?s mouth. For endoscopy, however, they retained the same high-level disinfection standard deemed unsafe for dentistry. Federal agencies, therefore, have
established an enigmatic set of standards recommending sterilization of devices used to clean teeth, but not surgical devices that pass through the mouth and into the esophagus, lungs, and stomach.
How uncertain is the science underpinning current infection control guidelines for endoscopy? To begin with, different federal agencies and professional organizations cannot agree on how long endoscopes should be soaked in a 2% glutaraldehyde solution, the most common germicide used on the devices. The system for reporting any resulting infections is equally unreliable. Even though endoscopes can infect patients with everything from virulent strains of enteric bacteria to sexually transmitted viruses, physicians usually have no way of knowing when it happens. The infected patients are diagnosed by their primary care physicians who
attribute their exposures to other risk factors.
Most patients assume that endoscopes are sterilized and, if they ask their physicians, are usually told that they are. Because of long incubation times for many diseases, months or years may pass before infections aremanifested, thus diminishing the likelihood that they will be associated with endoscopic procedures. Even when occasional transmissions are suspected, it is unlikely that medical facilities or public health organizations will expend the substantial resources needed to carry out an investigation and document results in the medical
literature. Despite this lack of documentation, data presented here conservatively indicate that 2.7% of the approximately 10 million procedures done each year in the U.S. with non-sterilized endoscopes cause infections. These 270,000 infections range in seriousness from subclinical to fatal. To provide patients with the widest margin of safety, endoscopes should meet certain minimum standards for cleanability and undergo an approved sterilization procedure after each use. Currently, the most practical approaches include automated reprocessing with liquid peracetic acid, which dissolves traces of patient materials, and sheathing the devices
so that patient-contaminated surfaces are discarded after each use.