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Safety in Question

Mon, 05/07/2012 - 11:55am
Sean Fenske

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A quick web search of “medical device safety” instantly tells the story of how much controversy there is currently swirling around regarding the testing of medical devices and the general level of safety provided in their operation. There’s no shortage of coverage, from industrial silicone found in breast implants to the hacking vulnerabilities of wireless devices to government officials, consumer groups, and the general publiccalling for stronger oversight. Whether warranted or not, the medical device industry currently finds itself knee deep in a PR struggle.

Let’s disregard the fact that the safety issues found in medical devices is significantly less than 1%. When dealing with human lives, one victim of a faulty medical device is going to be too much. However, when dealing with any type of product, is there any way to truly ensure a 0% defect rate?

While device makers are being blamed for the problems with medical devices, taking even more heat in this controversy is the FDA. There are people recommending changes to the FDA’s device review process, as well as its monitoring of products already on the market. Others call for the complete scraping of the current review process in favor of a better one. Some recommendations call for unreasonable levels of oversight that would likely spurn innovation. So what is the acceptable balance? What is the better system? These are the million (or more accurately, billion) dollar question.

Until a new oversight system is conceived or reforms in the FDA create a better perception that safety is its single greatest priority, medical device makers are left to fend for themselves in this PR struggle. Ensuring safety of a device is typically at the top of every device maker’s checklist before going to market, but it seems they cannot rely on the FDA’s OK to verify that. Safety testing of medical devices is more important than ever before, so device makers may want to look beyond the minimum requirements of an FDA approval and take the necessary measures to attempt to ensure that 0% defect rate.

[Note that news coverage of device safety and testing is the topic of the July/August issue’s Perspectives question. As readers are always welcome to share their response, e-mail me if you’d like the guidelines.]

Sean Fenske is the editor-in-chief of MDT.

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