Biggest Medical Device Product Development Errors

Updated on October 4, 2022
Biggest Medical Device Product Development Errors

If a medical device malfunctions, there are profound consequences for both the healthcare professionals and the patient. During the product development stages of medical devices, errors can lead to mistrust in the healthcare system and, more importantly, ongoing pain for the patient seeking help. Luckily, we can learn from some of the biggest medical device product development errors in the past and strive for more effective, reliable care in the future.

Infant Resuscitators With Assembly Errors

In the mid-2010s, a manufacturer had recalled its infant resuscitators due to assembly errors. This error leads to inaccurate oxygen regulation of the newborn during crucial, life-impacting moments. The FDA listed this as a Class I recall due to the potentially lethal impact of this failure.

Defibrillator Electrical Problems

The defibrillator’s purpose is to deliver electrical shocks to the patient who experienced sudden cardiac arrest requires the help of defib to help their heart restart and pump normally. The error in electrical charge may lead to the inability to resuscitate the patient. Over the years, a series of defibrillators have experienced recalls due to electrical problems or short battery life.

Faulty Cardiac Pacemakers

Among the most challenging recalls in recent history was a recall of tens of thousands of pacemakers. The devices, distributed for nearly a decade, had the potential to switch into a “safety mode” that could potentially impact pace. Fortunately, the recalled pacemakers did not result in any deaths to date.

Flawed Insulin Pumps

For people with diabetes, insulin is crucial for control and management. One medical device company recalled a thousand of these crucial insulin pump devices after a hacker proved they could remotely control the pump’s functionality. This incident proved that, as medical devices continue to advance, it’s crucial the healthcare community considers all possibilities during product development.

Deficient Glucose Monitoring System

Another hazardous recall event occurred when a glucose monitoring system continued to send false blood sugar alarms to diabetic patients, prompting them to medicate unnecessarily. The FDA promptly recalled millions of these devices to protect patients from potentially overdosing on their insulin.

It is crucial for companies who developed medical devices to consider every outcome and give each product the necessary trial periods. Finding a trustworthy medical device manufacturing team is another critical step in maintaining patient trust in the healthcare system and the doctors who care for them. It’s important to understand how the biggest medical device product development errors occurred so we can avoid moving forward.

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