Validation of Medical Devices—From a “Necessary Evil” to a Disaster
Medical devices and equipment—from sterilizers to thermal disinfectors (such as the MelaTherm)—are subject to mandatory periodic validation, revalidation, and performance qualification. Even though the benefits and frequency of these measures are certainly controversial among practitioners, there is a legal obligation to comply with them, which—for the reasons outlined below—should not (and cannot) be circumvented.Validation involves assessing a system, product, or reprocessing procedure to determine its suitability for reliably meeting the specified usage and hygiene objectives.
