Risks of Reusable Colonoscopy Endoscopes

Are the Medical Devices Used During a Colonoscopy Clean Enough?

Medical Device Reprocessing

The U.S. Food and Drug Administration, or FDA, has recently acknowledged that certain medical devices, including endoscopes and surgical tools used during a routine colonoscopy procedure, may be reused and do carry a health risk if medical device reprocessing, or standard cleaning procedure, is insufficient.

There are some medical devices that are designed only to be used once; these are called single-use devices, or SUDs, according to the FDA. While SUDs are reprocessed and used again (reprocessed SUDs), the standards for reprocessing are usually very involved and include submitting special documents to the FDA as well as completing multiple complicated tasks to list the device and track its effects on patients.

Reusable medical devices, however, are meant for multiple uses. After the original procedure is performed, the equipment undergoes an increasingly standardized cleaning process. One great example is the family doctor’s stethoscope—which can be used for multiple patients within the course of one day. The standard of reprocessing depends on what device is being reused. Reusable medical devices can generally be split into three categories, as mentioned on the FDA’s website, depending on how much of a risk there is that infection will occur upon reuse: critical devices (which touch only blood or sterile tissue), semi-critical devices (which touch mucous membranes inside the body) and non-critical devices (which touch only skin that has not been opened cut a cut or broken by rashes, etc.). A stethoscope is technically a non-critical device—thus, the requirements for cleaning one before reuse is relatively low.

Ask a Doctor about Reusable Medical Devices for Colonoscopy

In the case of colonoscopy, a colonoscope or other endoscopic device is considered to be a semi-critical device. Semi critical devices are constructed out of materials that can undergo multiple instances of reprocessing without significant wear even when reprocessing involves strong chemicals to sterilize the tool and forceful brushing techniques. As such, the colonoscope will need to undergo more vigorous cleaning than, say, the aforementioned stethoscope, before it can be reused for another patient’s colonoscopy. This is because the device has been placed for a long period of time inside one patient’s body and may carry on it contaminated blood, foreign organ tissue and residual bacteria from body tissue or mucous membranes—especially if a polyp removal or other minor surgery had been performed and had caused internal bleeding during the colonoscopy, in which case the colonoscope may even be categorized under critical devices.

Workers at the FDA have, indeed, encouraged patients all over to be open and communicative about their concerns with reusable medical equipment. It is most important to know the risks present when relying on reusable devices. Gastroenterologists or other doctors will not necessarily tell a patient about the practice’s compliance with the FDA’s standards of reprocessing medical devices unless the patient asks. Regardless if patients are being treated at a large hospital or a smaller medical facility, patients should feel free to ask the staff how the medical devices are cleaned and whether the facility is aware of the most recent and up-to-date standards set by the FDA.

Improving Standards of Reprocessing for the Future

The FDA is currently working to improve the reprocessing method, particularly by working with universities and colleges to clarify the written instructions for proper cleaning of medical devices and raising the standards of sterilization when it is discovered that old standards still leave too much room for residual contamination. This process is ongoing as FDA officials hope to come increasingly closer to a risk-free medical environment. They have developed a website that outlines their current research and achievements in terms of their work to improve safety standards. With the FDA working diligently to reduce any risks associated with reused medical equipment, patients should rest assured that the medical information and diagnoses received from doctors significantly outweighs any chances that a surgical tool, endoscope or stethoscope will cause a serious post-procedural infection.


Written by Colonoscopy.com administrator on 1/4/2012