Four key medical device recalls of 2015

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Covering recalls is challenging due to the sensitivity of the issue, and FierceMedicalDevices strives to be fair to all parties in its recall coverage.

Earlier this year, we decided to increase our coverage of recalls due to the importance of patient safety and strong reader interest in the topic.

Readers have responded positively to FierceMedicalDevices' reporting on the FDA recalls database, based on the high number of views those stories generate. Many other publications don't take the time to sift through the information there. And our own recall stories have been picked up by other industry publications, as well as general news outlets like Reuters.

Our coverage has earned us calls and emails from company representatives, mostly friendly, sometimes not. Overall, I'm pleased that the affected companies have been willing to provide helpful context and information that does not always appear in the FDA database of recall notices, which document corrective actions taken by medical device companies.

In addition to being voluntary, readers should know that the recalls in the database sometimes occurred in the past. The FDA subsequently reveals the recalls in a public database and classifies the corrective action into one of three categories, based on severity. The agency also publicizes some recalls via email or in a more accessible manner than the database, such as patient safety alerts.

As such, "corrective action" is the more accurate term, as not all "recalls" involve physical exchange of the affected devices. Sometimes recalls are the result of a letter communicating a potential safety issue or request to perform a simple test. These types of corrective actions account for two of the four recalls in this special report.

This report serves to highlight and provide additional perspective on some of the recalls we've covered. Like our recall coverage in general, the report focuses mainly on the most severe Class I recalls, or those reserved for "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

The recalls of devices made at Philips' ($PHG) Cleveland facility are in the less severe Class II category, but they have been numerous. In addition, the company has made it clear that the successful functioning of the plant is a key part of its corporate strategy.

The recall of Maquet's device to close the left atrial appendage highlights a key regulatory decision.

Meanwhile, the recalls of some GE ($GE) and HeartWare ($HTWR) devices were chosen because they show that sometimes devices fail due to usability issues rather than mechanical problems. The lesson is that, to the extent possible, companies should design against "human error" and ensure ease of operator and patient use. Perhaps the just-announced Patient Engagement Advisory Committee can help ensure that companies keep the end user in mind.

As always feel free to contact us with any feedback. -- Varun Saxena (email | Twitter)

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