When is PPE not PPE?
August 15th 2008 One of the answers to this question appears to be "when the product is a medical device".
Ever since the Medical Devices Directive [MDD] has been published it has carried the statement that a medical device can only be a medical device, unlike other products which need to comply with several directives. Indeed, the CE marking directive makes it clear that if it is "affixed" on any product there is an assumption that that product complies with all relevant directives. For example, a belt mounted powered filtering respirator bearing a CE mark is required to comply with the PPE directive, the low voltage directive, the EMC directive and so on. However this is not so for a medical device.
Consequently there are two significant difficulties that arise. The first is the ability of a manufacturer to correctly mark medical devices providing protective features and the second is the difficulty of ensuring that health sector employees are adequately protected when they are also required to wear equipment to protect the patient from them.
Latest text very unclear
The BSIF has not sought to assist the resolution of these problems to date because it was always understood that the MDD would be adjusted in due course to resolve these difficulties affecting "dual use" products. The MDD has been revised and is now ratified but the text is even more unclear regarding whether Category III PPE can be surreptitiously marketed as a Category I MD or whether it is necessary for the manufacturer of a Category I MD to confirm its products protective features in the same way as it would need to do if it were PPE.
This might seem to be pedantic but there are a couple of wider issues that come into play. Do you really want to wear PPE that is a protective medical device if there have been no independent checks that it ‘does what it says on the tin?’ Also, how will health sector employers ensure that their dual duties of care, to their patients and their employees, are adequately satisfied if the products need to remain ‘single use’.
Absolute clarity sought
Readers can rest assured that the BSIF will be seeking to ensure that there is absolute clarity when the new regulations are launched in the UK and that the appropriate interpretation is adopted across the EU.
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