Product or Device Alert/Recall
This section has been reviewed and updated as needed: April 2012
This policy is designed to identify a procedure to remove, repair, or replace, products or devices which may be unsafe for patient or employee use throughout the medical center.
University of North Carolina Hospitals Department of Environment, Health and Safety (EH&S) is responsible for product or device alert/recalls for the medical center which includes UNC Hospitals, Ambulatory Care, Dental School and Student Health Service. EH&S is a subscriber of the Food and Drug Administration (FDA) Enforcement Report and the ECRI Health Devices Alerts Report which contain information on products and/or devices that may require action by the user or other department(s). Alerts may also be sent directly from the manufacturer/distributor or the FDA. Upon receipt of notification, the recall/alert is reviewed by the appropriate departments and actions taken as needed to ensure that all products or devices are safe for use within the medical center.
- EH&S, upon notification of a Product Recall or Product Alert, will send a “Product or Device Alert/Recall” form to the applicable department. The responsible individual will determine if their department is in possession of the listed product or device and return the completed form to the EH&S within 5 working days indicating the action taken. If the product or device recall is life threatening, i.e. an Urgent or Class I recall, the recall form will be hand or fax delivered by EH&S to the responsible individuals and must be returned, by hand or fax delivery, to EH&S within 24 hours. The department who purchased the item is responsible for notifying the manufacturer of the information listed below, as applicable.
- No action required with reason(s) stated as to why no action necessary.
- Product or device taken out of service and date removed.
- Product or device repaired and date repaired.
- Product or device returned to manufacturer and date returned. The department who purchased the item is responsible for returning it to the manufacturer and maintaining all records relevant to the return.
- Product or device alert notice returned for referral to another department and date of referral.
- If Alert/Recall involves a device/product that has been implanted into a patient, Risk Management and the Attending Physician will be notified to coordinate any required action.
- All recalled equipment will be removed from service, if applicable under the terms of the recall, until certified safe by Medical Engineering, contracted service provider, the manufacturer, and/or the distributor.
- Departments receiving direct notification from the manufacturer, vendor, or FDA are to forward the notification to the EH&S for recording purposes as soon as possible. EH&S will reroute the notice to the appropriate department(s) and maintain the required documentation of Recall/Alert information.
- If the Product or Device Recall/Alert form is not returned to EH&S within the allocated time frame, a follow-up will be sent to the appropriate department head. A quarterly report of all Alert/Recall notices and their disposition shall be sent to the Medical Device Safety Subcommittee for review.
- Departments are required to maintain documentation regarding product/device alerts and recalls for five (5) calendar years including documentation regarding the disposition of recalled products such as repair, replacement or return to the manufacturer or vendor.
It is the responsibility of all department managers and departmental safety coordinators to implement this policy. Environment, Health and Safety shall oversee this implementation.