Studies shows that companies wait too long to recall medical devices

How long is too long?

It seems that medical device companies do not prioritise the safety of their products above profits and reputation, as a study conducted by the University of Minnesota revealed that these companies tend to delay in recalling defective products.

When problems are not reported to relevant authorities – like the MHRA here in the UK – healthcare professionals and the public may be unaware of the complaints, and thus may continue to use defective products that may carry a significant risk of harm.

An underwhelming reaction

Mr Kingshuk Sinha, the Department Chair and Professor of Corporate Responsibility at Carlson School of Management, condemned the “under-reaction” to the study’s results. He believes that, when problems are found, action needs to be taken.

“We should train our executives and decision makers just like fighter pilots, to make sure their reaction-time responses are optimal.”

Electrophysiologist Dr. Zian Tseng recently published a study in the Journal of American Medical Association for Internal Medicine looking into deaths caused by heart attacks. He found that between 2011 and 2013 around 5% of deaths caused by cardiac arrests involved pacemakers or defibrillators. He found that this number was concerning as these very devices were supposed to prevent death. When investigating the medical devices, he reportedly found that half were defective from faulty wires and batteries, and Dr Tseng was even more surprised by the underwhelming reaction from medical device companies.

“Some were very dismissive. Others were very appreciative,” he said. “It was startling, the range of responses we got.”

The regulating body in the U.K.

In the U.K, the Medicines and Healthcare Products Regulatory Agency (MHRA) are in charge of enuring medical device manufacturers provide products with no defects and are safe for consumer use. The MHRA alerts the public to any problems in two ways:

• Field safety notices: when a medical device manufacturer recalls their product for a clinical or technical reason
• Medical device alerts: information for healthcare providers and medical device users on what should be done about the defect.

However, a study conducted by researcher Mr Matthew Thompson found a lack of transparency of information. He was not able to access things like the “number and types of device files, their effects on morbidity and mortality.” Without this information and without timely recalls, consumers and users may be unable to find out whether devices are safe to use.

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