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Complaint Handling, Medical Device Reporting and Recalls should be effective Complaint handling is a critical aspect of a medical device manufacturing process. Once the product is out into the market after FDA approval and it still receives complaints, it is a sign that the device needs to be worked on, so that the complaint is redressed. The FDA requires a medical device manufacturer to put an effective complaint handling system in place. This is considered crucial for a quality system. Manufacturers see complaints as the platform from which to evaluate, investigate and analyze the device and later take corrective action. What should the evaluation point to? The purpose of having a complaint handling system is that it should lead the manufacturer to an understanding of a whole range of issues relating to complaints. Some of these could be: a) whether the complaint was valid; b) what is the root cause of the complaint, and c) what action is necessary to prevent further occurrences. Trending is all important Medical device manufacturers can ignore complaints at their own peril. Complaints, rather than being viewed as a nuisance, should be seen as an indicator of problems with the use, design, and/or manufacture of a product. Many a time, even one complaint, when it is thoroughly investigated, could lead the manufacturer to take remedial or corrective action. However, for a trend to be located, the manufacturer may have to analyze a series of different complaints. Spotting this trend is important to understand where the problem lies in the quality system: it could be in the product, labeling, packaging or distribution. Trending is thus a vital step in the complaint handling system. The MDR The FDA has a mechanism for receiving medical device adverse events from manufacturers, importers and user facilities –the Medical Device Reporting (MDR). The aim of having this mechanism in place is that it helps in quick detection and correction of adverse events. User Facilities (e.g., hospitals, nursing homes) need to report suspected medical device related deaths to both the FDA and the manufacturers. Recall This is a process by which a medical is removed from the market or corrected whenever the FDA finds that there is a plausible possibility that the device could cause serious, adverse health consequences or death. A recall is thus an action taken to address a problem a medical device that violates FDA law has. Recalls take place in either of these scenarios: a) when there is a defect in a medical device, b) there is a possibility that it could pose a risk to health, or c) when it both has a defect and could cause a risk to health. Quick Contact: GlobalCompliancePanel USA Phone:800-447-9407 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
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