Failure of Medical Product or Device

Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients and as assistive technology. These do not include general workshop equipment such as power or machine tools or general purpose laboratory equipment.

A failure of a device is an event that causes or has the potential to cause an unexpected or unwanted effect involving the safety of the device users including patients or other persons. For example:-

  • If a patient, user, carer or professional is injured as a result of a medical device failure or its misuse;
  • A patient's treatment is interrupted or compromised by a medical device failure;
  • A misdiagnosis due to a medical device failure leads to inappropriate treatment;
  • A patient's health deteriorates due to medical device failure.

The cause of medical device and equipment failure may include design, unsuitable storage and use conditions, inappropriate modifications, poor user instructions or inadequate maintenance.

Medical device failures can be disastrous. For example, poorly designed knee and hip replacements which may fail from improper placement or loosening after surgery can result in bone fractures in the area around the implant. Dislocation can also occur if the joint slips out of alignment resulting in pain and swelling and in extreme cases, an inability to walk. To fix these complications, patients often require one or more corrective procedures known as revision surgeries.

For example, surgical mesh too, which is used in certain procedures can cause life changing health complications. Composed of synthetic material, surgical mesh is permanently implanted in patients to repair weak or damaged tissue. Mesh erosion is a common issue that is observed in patients. This occurs when the device migrates from its point of placement and cuts through the soft tissues of the patient. These adverse effects require surgical correction, but success is not guaranteed.