Advancements in medical device technology have been instrumental in helping elderly and severely injured persons heal, increase their life expectancy and retain their mobility as they age. The most implanted devices in America include defibrillators, artificial hips, pacemakers, breast implants, and spinal fusion hardware. Hundreds of thousands of these procedures are completed in each of these categories each year. These devices, produced by an array of medical device companies, are often recalled by the Food and Drug Administration (FDA) when dangerous defects are revealed. Medical device research, design, and regulatory professionals reflected on the reasons behind large-scale medical device recalls.
Reasons Why Medical Devices Fail
The following responses offered by the professionals identified the top reasons that medical devices may experience failures:
- Limited knowledge. Many of the companies entering the medical device field lack the expertise and research knowledge necessary to build medical devices that are safe. Deficiencies in technical development are one reason that defects occur in medical devices.
- Human errors. Medical device professionals allege that human error may be the leading cause of medical device failures. Manufacturers may provide poor configuration instructions or fail to appreciate how humans will implant the devices. Such instructional deficiencies are a leading cause of dangerous medical devices on the market.
- Failures in human factors research. During the development stage, medical device companies may fail to utilize information from the full range of disciplines necessary to test the safety of their products. Human factors research elements require companies to consider disparate fields such as engineering, psychology, and industrial design in addition to many others. The FDA has emphasized the importance of human factors research in reducing the defects and failures in medical devices.
- Systemic failures at the hospital. Medical devices that are implanted in individuals may fail because of deficiencies at the hospital apart from any actual defects in the product. For example, devices that are maintained improperly, used past their expiration date, or inputted at the wrong settings can cause serious injury. Even a simple failure to clean the device or install the wires can lead to catastrophic consequences for patients.
- Poor manufacturing practices. Studies reveal that many medical devices are recalled because of errors at the assembly stage. A medical device may have been designed properly and still possess a dangerous defect because of poor or incorrect assembly. Companies as large as GE Healthcare have been forced to recall infant resuscitators because of errors during the assembly of the devices.
- Information dissemination failures. There are often individuals at a company who are aware of defects in the company’s products. Unfortunately, many medical device failures have originated in companies where risk was ignored and where there was no procedure for engineers and product managers to communicate their concerns. Medical device professionals found that poor communication chains greatly contributed to medical device defects.
- Reusing devices. Hospitals and healthcare providers who reuse single-use devices and parts greatly contribute to failures in medical devices. FDA regulations explicitly prohibit the reuse of medical devices. Despite the FDA regulations, many healthcare providers and hospitals continue the practice of reusing medical devices and parts.
- Failing to engage doctors. A critical cause of medical device failures occurs at the development stage when doctors are not consulted. Many companies develop the devices with technical experts but fail to consult with subject matter experts who could shed light on potential challenges down the road. By failing to consult the very experts who will be using the devices, medical device developers miss out on an opportunity to mitigate risk on the front end of the process.
- International labeling norm violations. Medical device companies distribute their products all over the world. Unfortunately, the labeling requirements are different for each country. When companies fail to properly label their devices, medical devices created in one country, may cause serious injuries in the country that imported the devices.
What to Do if A Medical Device is Recalled
It can be quite frightening to be faced with a recall notice of a medical device that is implanted in your body. When you receive a recall notice that a particular device is subject to an FDA recall, immediately consult your doctor to identify the next steps. Additionally, contact the defective medical device lawyers at Peterson & Associates, P.C. for a free consultation. We can help hold negligent manufacturers and hospitals accountable for the injuries that they cause.