Background: A number of years ago Dr. Muscarella wrote the Food and Drug Administration (FDA) requesting the Agency review for clarity and consistency, among other documents, its published guidance document for manufacturers seeking to market disposable sheaths used as protective barriers to cover ear, nose, and throat (“ENT”) endoscopes.10
Entitled “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers,”11 this guidance document (which has not been updated or revised as of the writing of this blog) was issued on March 12, 2000.
This and four other controversial infection-control topics, along with Dr Muscarella’s suggested “action” to resolve each of the topic’s potential deviation, may be read by downloading the more complete PDF version of this article at clicking here.
In this correspondence with the FDA,10 Dr. Muscarella focused on the following statements in this guidance document about sheaths used to cover ENT endoscopes (and comparable flexible endoscopes that may be used with a protective cover or sheath, to reduce the risk of contamination):11
ENT endoscopes are “semi-critical devices as they come in contact with mucous membranes, which may or may not be intact”; and
“the Center for Disease Control (CDC) and Association of Practitioners in Infection Control (APIC) recommend high-level disinfection as the minimum acceptable level of reprocessing for semi-critical medical devices such as endoscopes.”
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Suggesting that the use of an effective protective sheath, however, would “lower” the ENT endoscope’s infection-control device classification from semi-critical to non-critical, this same FDA guidance document also states that:11
“Reprocessing of the endoscope after removal of the used sheath and before application of a new sheath must be recommended and described in the user’s information manual (e.g., labeling). If the applicant (i.e., the manufacturer) sufficiently demonstrates protective barrier properties of the finished device, a cleaning procedure followed by an intermediate disinfection step will be required”; and
“In addition to cleaning, an intermediate disinfection step such as wiping with a 70% isopropyl alcohol soaked gauze pad should be recommended.* This step is added to reduce the likelihood that any viable organisms remain on the endoscope prior to application of a new sheath.”
Dr. Muscarella questions this recommendation to “wipe” an instrument’s surfaces with a gauze pad soaked with 70% isopropyl alcohol to achieve intermediate-level disinfection.*
[* Note: The suggestion to “wipe” an instrument’s surfaces with a gauze pad soaked with 70% isopropyl alcohol to achieve intermediate-level disinfection is questioned. Whereas … text continued in the footnote at the end of this blog.]
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Discussion: These statements in this FDA guidance document raise a number of questions, in part because they are seemingly inconsistent with:
the FDA’s current advice, which is provided in the Agency’s aforementioned draft guidance document on the reprocessing of medical devices (issued May, 2, 2011) – click here to read it;9
the FDA’s stated goal to improve the quality of instrument reprocessing and prevent HAIs; and
the CDC’s published guideline for the disinfection and sterilization of instruments in healthcare facilities (click here to read it).3
FDA: As previously noted, the FDA acknowledges that ENT endoscopes are semi-critical devices.11 But, whereas its guidance document discussing the clearance of protective sheaths (finalized on March 12, 2000; – click here to read it) recommends intermediate-level disinfection of the endoscope after removal of the used sheath,11 the FDA asserts in its draft guidance document on the reprocessing of medical devices9 that a reusable instrument’s reprocessing instructions “should assume (that) the device is used uncovered” (i.e., as if no sheath had been used during the procedure), “because of the potential for loss of cover integrity during use”9—which is an instruction that requires the reusable semi-critical instrument be at least high-level (not intermediate-level) disinfected after the sheath’s removal.