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Can fast-tracking a medical device lead to injuries?

As a previous post discussed, medical device recalls might be necessary if it is determined that the device is defective or dangerous. While these situations might not medically harm the patients, there are some instances when a defective medical device could be very detrimental and harmful to a patient. If a medical provider or medical manufacturer fails to discover a defect or fails to make a medical device recall, a patient could suffer greatly.

Does fast-tracking a medical device lead to product liability claims? In the spring of 2014, the FDA approved a voluntary program that would fast track certain medical devices. In order to qualify for this program, the device must demonstrate that it could potentially address a currently unmet medical need for a life-threatening or irreversible debilitating disease or condition.

If the device meets this need and are subject to the premarket approval application or de novo requests, then it could be approved for use in this program. However, devices used in this program must still preserve the statutory standards for reasonable assurance of safety and effectiveness.

Patients using in this program assume greater risk for early access to a medical device; however, the FDA must ensure that the device is both safe and effective before it is used. In addition, as part of the expedited access for premarket approval, medical devices in the program must provide more interactive communication during the use and investigative review of these devices. This allows for data regarding the device to be collected, providing a review of the medical device.

And while patients are aware of and assume the risks of these fast tracked medical devices, this does not free the medical device manufacturer from responsibility when and if an error occurs or it is determined a device is dangerous or defective. These devices could still be subject of a products liability claim if it is determined the device is a dangerous product and resulted in injuries to a patient.

Those harmed by a defective medical device can often seek compensation for their losses and damages. A products liability claim could hold a negligent party responsible, helping the injured cover expenses such as medical bills, rehabilitation, lost wages and other related damages.

Source: FDA.gov, "Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions," April 23, 2014

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