2012年 12月 13日
New guidance published by the US Food and Drug Administration advises manufacturers of “home use” medical devices on how to ensure compliance with safety and effectiveness requirements when designing their products.
The guidance applies to both prescription and over-the-counter devices intended for users or patients outside of clinical or professional settings. Use of such devices has become more and more prevalent in the US healthcare market, prompting new recommendations from the FDA.
Design control recommendations
Among medical device design controls required under 21 CFR Part 820, the guidance highlights risk management processes as particularly important to home-use device manufacturers. If a home-use device includes a software component, the manufacturer should ensure that its risk management process covers performance, error detection and control issues as well.
Environmental factors
Home-use device design must take into account environmental factors that could compromise safety or effectiveness, according to the FDA guidance. Environmental issues manufacturers should bear in mind include:
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Location: where will the device intended to be used, and how will different settings affect safety and effectiveness? |
Dampness/humidity: how do variable humidity levels impact the device’s functionality? |
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Physical location: do different physical structures affect the device’s intended use? |
Water supply: type of water—tap versus distilled—required by device operation or maintenance should be specified by manufacturer |
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Contaminants: how would non-sterile settings impact the device’s functionality? |
Childproofing: home-use devices should be childproof regardless of whether they are designed for use by children |
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Temperature: can the device function during temperature fluctuations? |
Travel/international use: how would air travel, security screening technology and voltage rates affect the device? |
User factors
Manufacturers must also consider the differences between users of home-use products and healthcare professionals. Home-use devices whose designs do not maximize ease of use may pose greater risks for such users, warns the FDA. The four key user factors to consider are:
Electrical issues
For home-use medical devices that use electricity (that is, quite a lot of them), the FDA advises manufacturers to consult General Standard ANSI/AAMI/ES 60601-1:2005 on medical electrical equipment safety and performance. Design controls should address the standard’s recommendations for supply mains, internal electrical power sources, outlets and adaptors, battery life and other related electrical issues.
Bottom line: Although it does not appear that US regulators plan any additional requirements for home-use medical devices other than what FDA Quality System Regulations already mandate, manufacturers whose products the new guidance targets should now have a much clearer idea of which issues agency personnel will focus most keenly on during registration reviews and audits.