This opinion, by Lawrence F Muscarella PhD, focuses on the cleaning and disinfection (or sterilization) of reusable skin electrodes used on the scalp during “EEG.” Disposable skin electrodes would be used once and then discarded, without being reprocessed.
April 16, 2013 — An FDA draft guidance document on the reprocessing of medical devices classifies skin electrodes as non-critical devices.
During their routine use, however, skin electrodes may contact non-intact or abraded skin with exposed blood, which suggests that these instruments might be classified as semi-critical.
An example of skin electrodes includes scalp electrodes used during “EEG,” or an electroencephalogram.
Blood pressure cuffs and stethoscopes are examples of non-critical devices. Flexible endoscopes, dental handpieces, and vaginal probes are examples of semi-critical devices. 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. — Lawrence F Muscarella, PhD
The FDA is respectfully requested to consider clarifying for manufacturers and healthcare practitioners whether EEG 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 quality, and minimize the risk of HAIs.
Note: As with many other types of semi-critical devices, disposable, single-use skin electrodes may be offered as an alternative to eliminate reprocessing and the risk of cross-infection.