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Mitigating Liability in Medical Device Recalls

1 November, 2012 | Cardiology Equipment, medical device, medical equipment, MedWOW, News, Pacemakers

Product recalls are nothing new; they exist in just about every industry. However in the medical device industry, 2012 saw a significant jump in recalls. According to the ExpertRECALL index, over 123 million device units were recalled alone in the first quarter of 2012.

Not surprising, there has been a noticeable increase in device failure and damage claims over the last few years. It’s interesting to note that although the number of unit recalls has increased, the amount of affected devices has not risen greatly.

Today’s market boasts many more medical devices that are smaller, less invasive and made of newer and lighter materials. New medical devices are designed to be more effective than previous technologies; with this in mind, why are there so many more product recalls? Industry professionals point the cause towards the baby boom generation. Representing the largest population segment at the age that requires life-saving medical devices, statistically baby boomers are increasing the magnitude of product recalls.

Medical device categories that are the most prone to recall are orthopedic implants and cardiac devices such as leads and pacemakers. These types of devices are subjected to the most friction and movement that can wear down materials leaving patients at risk to substance poisoning, electrocution or complications due to device failure.

It is known that products can fail and no medical device manufacturer is immune to product recalls. Companies Johnson & Johnson, St. Judes and Covidien are just a few that have been in the news over the past year for product recalls.

Health product recalls are big news. They increase public awareness of device failure and place pressure on government agencies to take action to protect the public. In the USA, the FDA is developing a device tracking system that will facilitate supply chain monitoring of some devices in order to improve recall efforts. Likewise in the UK, legislation is being drawn that will support greater product transparency and allow patients and doctors to make informed choices about medical products.

Other groups at play in recalls include patients and health insurance companies. Because of mounting costs from exponential increases in patient damage claims, health insurance companies are now holding medical device manufacturer’s financially responsible.

As a result of various groups passing on the liability hot potato to medical device manufacturers, clearly changes are necessary in order to mitigate damages. An obvious first step is the development of strong and easily deployed recall strategies to protect brands and limit risks to patients. However, it appears that medical manufacturers are facing a greater learning curve in order to work out issues from newer technologies and adopt procedures geared towards limiting product failure moving forward.