Patient Safety Impact of Medical Device Recalls

What is a Medical Device Recall? A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. The FDA classifies recalls in three categories depending on the health hazard presented by the product being recalled:

  • Class I – a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
  • Class II – a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III – a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

According to FDA data, there are typically between 13 and 75 devices each day. The manufacturer of the medical device has the primary responsibility of orchestrating the recall of the product. The majority of FDA recalls are voluntary, although the FDA has the authority to impose mandatory medical device recalls.

The recall of cardiac, vascular, ocular or orthopedic implant devices and any subsequent action is a serious matter that requires the collaborative efforts of manufacturers, insurers, regulatory bodies, hospitals, and surgeons in order to ensure effective remedies. Patient safety must be the highest priority in cases of recalled implant devices, and care should be taken to confirm the device’s failure when considering revision surgery as a treatment option. Depending on the patient’s health and age, risks of re-operation could be significant and must be carefully assessed and discussed with the patient before additional treatment is administered.

Hospitals, as end users, are charged with the mission of reaching the patient and putting a plan of action in place in a timely manner. Recordkeeping requirements such as manufacturer, product description, expiration date, lot and serial number are important to record as the can impact the response rate to a medical device recall. The current initiative for manufacturers to incorporate a Unique Device Identifier (UDI) for all medical devices will add another data element that must be tracked. Retrieval of all this information is time sensitive.

By embracing available tracking technology, hospitals will have the ability to search by vendor, catalogue number, lot or serial number, then remove recalled product from inventory in a timely manner and notify impacted patients sooner. The timeliness of communication of the recall to the patient, along with the professional course of action will not only significant impact patient safety, but could be a tipping point for patient satisfaction.

More information on FDA recalls can be obtained on the sites below: