Initial remarks: This blog, by Lawrence F Muscarella, addresses the topic of the reprocessing (that is, the cleaning and disinfection or sterilization) of reusable skin electrodes used on the scalp during “EEG.” (Disposable skin electrodes would, of course, be used once and then discarded, without being reprocessed.)

Introduction: The FDA’s draft guidance document on the reprocessing of medical devices classifies skin electrodes as non-critical devices. (Click here to read this draft document.)

Discussion: During their routine use, however, skin electrodes may contact non-intact or abraded skin, with exposed blood, which is to suggest that these instruments would be therefore classified as semi-critical. An example of skin electrodes includes scalp electrodes used during “EEG.”Examples of non-critical devices include blood pressure cuffs and stethoscopes. Those of semi-critical devices include flexible endoscopes, dental hand-pieces, and vaginal probes. Critical devices include scalpels, implants, and biopsy forceps.

Whether confusion about the minimum reprocessing requirements of skin electrodes (i.e., high-level, intermediate-level, or low-level disinfection) has been directly or indirectly linked to healthcare-associated infections, or HAIs, is unclear.

Because skin electrodes contact non-intact skin, these reusable instruments would seemingly be classified as semi-critical devices.

Action: The FDA is respectfully requested to consider clarifying for manufacturers and healthcare practitioners whether skin electrodes are semi-critical devices requiring high-level disinfection (or sterilization). Standardization of the reprocessing requirements of skin electrodes is important to prevent user confusion, improve the quality of instrument reprocessing, and minimize the risk of HAIs.

(Note: As with many other types of semi-critical devices, disposable, single-use skin electrodes are offered as an alternative, to eliminate reprocessing and the risk of disease transmission.)

Blog by: Lawrence F Muscarella PhD, posted 4-16-2013

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