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In the Spotlight: Medical Device Safety and Quality Events


If you regularly watch TV news, visit online news sites or listen to news radio, you have probably seen a lot of medical devices in the mainstream media in recent years. Unfortunately, much of this attention has been negative, centered on adverse events resulting in patient harm from power morcellators, transvaginal mesh implants, duodenoscopes and other high-risk devices.

Media attention has prompted intense government scrutiny in many of these cases. Patient deaths related to drug-resistant bacterial infections spread through duodenoscopes prompted a Senate committee to issue a report last year. This document, entitled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients,” concluded that “FDA needs a more robust device safety surveillance system.” In the last several pages, the report issued several specific recommendations for FDA regarding its device postmarket surveillance programs.

Spurred on and empowered by Congress, FDA has been hard at work to make improvements. Several key agency programs, including the National Evaluation System for health Technology (NEST) and the Case for Quality initiative, are aimed at improving the reporting and monitoring of medical device safety and quality data.

And so the cycle often goes: media attention, Congressional attention, FDA attention. In recent years, FDA has become more and more vigilant in its efforts to ensure device patient safety. Data reporting requirements and agency enforcement actions are two of the tools in FDA’s kit, and it has been putting them to good use. More data is being collected electronically than ever before. Through initiatives such as Unique Device Identification (UDI), the agency is building the framework it needs to connect these data points and understand how to allocate its enforcement resources in the way that will most benefit patient safety.

You might wonder what the cost to industry is of these FDA initiatives coming down the pike. There is, of course, a cost to compliance. But there is also a cost to non-compliance, and it is significant. FDA enforcement actions are estimated to cost the medical device industry four billion dollars annually. This figure is based on a recent whitepaper by McKinsey and an analysis of FDA data by Reed Tech.

In light of these developments and the mounting costs, the next step should be to break the media, Congress, FDA chain through industry action. It has never been more important for device manufacturers to analyze and understand the data surrounding the safety and quality profiles of their products.

There are a lot of challenges surrounding postmarket surveillance and analysis of data sources, but the reward is well worth the effort. To learn more about strategies for tackling these challenges, watch our most recent educational webinar, Drowning in Big Data: Extracting Medical Device Quality and Safety Insights. You can also contact us to talk to an expert about how you can better interpret your company’s device safety data and understand your place in the market.

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