On March 23, 2016 the National Program Office for Sterile Processing put out a directive (attached) to all Veterans Health Facilities around the country. The directive was issued by David J. Shulkin, M.D., the Under Secretary for Health. The directive provides procedures for the decontamination, high-level disinfection (HLD), and/or sterilization of critical and semi-critical reusable medical instruments and equipment and storage of items reprocessed. In this directive, section 22, discusses the EndoSheath by brand name.
It states the following:
22. USE OF ENDOSHEATHS
a. The Food and Drug Administration (FDA) has cleared the use of sheath systems for flexible endoscopes and other medical devices. These devices are marketed under the FDA’s 510(k) cleared process. Sheaths provide a sterile, protective cover for their intended medical device and can reduce the frequency of sterilization or HLD. Only those sheaths which are cleared by the FDA and are specific to the device or equipment must be used.
b. The proper application and integrity of the protective sheath must be verified according to the manufacturer’s IFU prior to the start of each procedure.
c. Inspection of the medical device and the sheath must take place after the sheath is removed. Manufacturer’s IFU for the sheath must be followed to disinfect the flexible endoscope between each patient use.
d. Sheath compromise is indicated if there is evidence of moisture on the medical device or the sheath is not intact. If this occurs, the medical device must be fully reprocessed by HLD and/or sterilization according to the device manufacturer’s IFU prior to next use.
There are also statements within the document stating that the decontamination may take place outside of the SPS department (see below). There is also language within the stating that “Pre-Treating of the scopes must take place at the point of use.” It states that this can be done by the use of enzymatic gels or foams.(Section 14 e.).
15. DECONTAMINATION AREA
a. Decontamination of semi-critical RME may be performed in the SPS Decontamination Area or in areas outside of the main
SPS (e.g., endoscopy suite) if determined more feasible by medical facility leadership. The Chief, SPS is responsible for reviewing
these areas and verifying that the correct decontamination procedures are being followed.
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