Clinical Engineering Bank

Medical device safety

Alert and Recall

Alert:

An advisory communication by the FDA mandating dissemination of information

indicating that a particular medical device may present an unreasonable risk of substantial harm.

Alerts provide important information and recommendations about therapeutic products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe.

Recall:

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.

What to do when you receive an alert?

When notice of an equipment alert or recall is received by Clinical Engineering, the concerned staff will ensure that the equipment inventory database is reviewed to determine if any Hospital equipment is affected.

If there are no devices of the type identified in the alert or recall, then:

No action is required within the department.
Make an appropriate entry in the Alerts Access database
Document as Not Applicable (NA)

If there is equipment in the inventory which has been identified in the alert or recall, the Clinical Engineering will:

Locate the equipment.
Verify the alert/recall priority (Critical, High, Normal, Low) status.
Take the recommended steps described in the alert.
Communicate with the manufacturer and/or suppliers for action plan
Make an appropriate entry in the Alerts Access database
Document all actions taken.

Medical Device Reporting Requirements

Posted on 17. June, 2015 by Karl Kapp in Medical Device

Medical devices are life-saving pieces of equipment that allow many patients to have a quality of life they would not otherwise be able to experience. Officially, according to the FDA, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,

intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” (Source FDA.gov)” Would the end quotes go here, I guess?

Source: Medical Device Reporting Requirements