5.3 Medical Equipment/Device Recall
| Effective Date: | Last Date Revised: |
The Company handles all medication or device recalls or discontinuations for safety purposes by the manufacturer or the Food and Drug Administration in accordance with the instructions of the recall or discontinuation notice. The organization removes recalled products from distribution within the manufacturer’s designated timeframes, and follows manufacturer’s guidelines in determining whether to discard or return recalled products. Inventory is examined for recalled products. Patients/clients are informed of the product recall and, when appropriate, are instructed on how to return or safely dispose of the products. Disposition of recalled inventory is handled according to manufacturer’s requirements. In the event that a replacement item or medication is available and appropriate, the organization makes a reasonable attempt to replace the item or medication.
For all Class 1 or Class 2 recalls, all recalled products that are in use, or have been rented are exchanged for acceptable substitutes.
Following are procedures for handling a product recall:
- After receiving notification of a recall or a defective device, the Company confirms the action by verifying the information (i.e. via telephone call to the manufacturer).
- Staff members are informed immediately of equipment recalls and any potential or identified hazards and/or defects.
- Inventory and rental records are reviewed to determine the location of recalled items and patients/clients involved.
- It is determined whether there is adequate inventory in stock for equipment exchanges, or whether the manufacturer has substitute equipment available.
- The patient/client or caregiver is contacted by telephone to arrange for exchange of product. If the patient/client cannot be reached by phone, other notification methods may be used (e.g., contacting a friend or relative, or sending a certified letter).
- The primary prescriber is contacted for any client/patient affected by the recall and the situation is explained (as applicable).
- If needed, a new or revised order from the prescriber is obtained.
- The item is removed from service. Items must be removed within 24 hours if the recall is a Class 1 or Class 2. Equipment is identified appropriately as “recalled” before transporting.
- Staff ensures that recalled products are placed in a secure area so they are not inadvertently placed into circulation again (e.g., tag products as recalled).
- Staff follows the manufacturer’s recommended steps, and documents the steps on the product recall form along with the date and the signature of the person completing the form.
- A copy of the product recall information form is filed in a central location.
- Any necessary credits are processed in accordance with the manufacturer’s or vendor’s recommendations.
- All shipping records are retained for recalled products.
Recall Classifications
The U.S. Food and Drug Administration has assigned the following recall classifications to reflect the relative degree of the health hazard presented by the recalled product:
- Class 1: A situation in which there is a reasonable probability that the use of or exposure to a recalled product will cause serious adverse health consequences or death.
- Class 2: A situation in which use of or exposure to a recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
- Class 3: A situation in which use of or exposure to a recalled product is not likely to cause adverse health consequences.
See the Sample Product Recall Form in Appendix 1 -- Samples of Commonly Used Forms, Statements and Procedures.
insert here sky medical Product Recall Form