Understanding medical device defects and reporting requirements

On Behalf of | Feb 15, 2021 | Medical Malpractice

A wide variety of health conditions require the use of medical devices, which include surgical equipment, hospital supplies, prosthetic devices, medical appliances, visual and hearing aids and diagnostic equipment. 

Unfortunately, these devices may have certain flaws that can result in serious injury and even death to patients. Understanding who is responsible for these defects and how to report flaws is important. 

Liability concerns and statute of limitations

According to FindLaw, when a medical device defect harms a patient, it is imperative to take action as soon as possible. Due to statute of limitations, there is a limited amount of time a patient or surviving family member can sue the party responsible for the defect. This statute varies from state to state, and the time limit begins once the injured party becomes aware of the damage. 

The next thing is to figure out who is the responsible party. Common defendants in these types of cases include manufacturers, suppliers, distributors and medical providers. It depends on who is negligent in causing harm. Many times, this type of case falls under product liability as opposed to medical malpractice, unless the healthcare provider was aware of the device’s flaw and used it anyways. 

Reporting requirements

According to the Food and Drug Administration, certain parties have mandatory requirements to report any product flaws and adverse events. These parties include: 

  • Manufacturers 
  • Importers 
  • Device user facilities such as a nursing home, hospital, surgical facility or outpatient facility 

To further improve the safety of medical devices, and to decrease the number of adverse reactions, the FDA urges voluntary reporting from patients, healthcare providers, consumers, caregivers and family members. The FDA also has databases that list all medical device recalls. 


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