Medical devices manufacturing changes

Though the materials examined are expected to be representative of the materials delivered to medical device manufacturers it is possible that other changes could occur. Thus these results should not be extrapolated to carbon-containing medical devices until the actual carbon components have been surface analyzed. 

Medical device manufacturers are sensitized to patient safety. Product marketing is likely to tout how safe a particular device is to improve sales. Whether a device achieves a higher level of usability is not dependent on the rhetoric of marketing. The necessary changes to the processes by which devices are developed and released into the market requires the hiring of human factors and biomedical engineers who are able to perform these critical development tasks. However, manufacturers are not likely to change their processes to improve patient safety unless their potential customers require that their products must meet minimum human factors criteria. Thus, healthcare providers may eventually get what they demand and their patients deserve. 

Part 820 of 21CFR details the QSR that governs the manufacture of medical devices and addresses the subject of change control in the following subparts ... 

At this point it is worth mentioning how the ALARP approach to risk acceptability changes markedly when it comes to medical devices. For example. International Standard ISO 14971 [10] affords manufacturers the ability to justify risks on an ALARP basis. The European Commission Medical Device Directive (MDD) [11] cites ISO 14971 as a Harmonised Standard however the directive contains a number of Essential Requirements on risk acceptability which appear to conflict with ISO 14971. 

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