Traceability is important to containing the costs of a recall because it allows manufacturers to precisely identify the affected lots and thus keep the volume of recalled product as limited as possible, thus avoiding the time and expense of recalling unaffected products. In addition to the cost-savings benefits of product traceability, it is also mandated by the FDA quality system regulations for medical device tracking.
There are two general means of establishing traceability—lot tracking and individual serial tracking. If the medical device is a product produced in high volumes and made in daily batches identical in design, materials, and specifications, then lot tracking—or a system for tracing them as a “lot”—may be the best option. If instead the device is more complex such that each device may not be identical, individual serialization is likely more appropriate. When the devices are shipped to a distributor or end-user, the manufacturer must record the serial number or lot number and quantity of the products shipped. If the company uses a distributor to get the products to the end-user, the distributor must either provide that information to the manufacturer or retain that information for the manufacturer’s access in case of a recall. This requirement to retain the product and end-user information Retention of this information should be a requirement included in the contractual agreement between the manufacturer and distributor, and should include the required duration of retention (which should be longer than the useful life of the product).
Many manufacturers opt to use a database to record traceability information, but it is important to remember that in order to use a database, it must first be validated. Once in use, the database should be backed up periodically to ensure the availability of the information despite a hardware or software problem affecting the database.
In addition to the current quality system regulations that require medical device tracking, medical device manufacturers will soon have to comply with the FDA’s Unique Device Identifier (UDI) program, likely to be deployed beginning in 2013. The UDI program will require medical devices—including implantable devices—and device packages to be labeled with two identifying codes. The first of these would be a combination of letters and numbers specific to the device model, and the other a “production identifier” that will convey, among other data, the lot or batch number and expiration date. The Agency speculated that the UDI could be fully implemented by May of 2014. The wide-spread system would have exceptions for over-the-counter devices and those of the lowest risk.
Prior to a recall, companies should draft recall SOPs that enumerate the step-by-step procedures to regain control of affected products and identify the persons or positions associated with each responsibility.
If a manufacturer finds that it must issue a recall, it is important to rapidly develop and deploy the recall strategy. This foremost part of the strategy is identifying the depth of the recall—the manufacturer must decide if the recall should be at the wholesale, retail, or end-user level. The manufacturer must also immediately submit a recall notice to the FDA, including, among other things, vital product information, the reason for the recall, and an assessment of the health hazard posed by the deficiency in the outstanding product. The full requirements for information included in the recall submission can be found in 21 CFR Part 7 and the FDA Industry Guidance “Product Recalls, Including Removals and Corrections.”
The manufacturer's next step is to prepare and release its public communications. In most cases, a press release is appropriate. The FDA suggests issuance of the release through the Associated Press (AP) in order to assure the broadest coverage. In its recall guidance, the agency has also outlined the required information to be included in such a press release. Along with meeting FDA requirements for these communications, it is also very important to craft each message carefully and perhaps with the advice of counsel, being mindful that recalls are often signals to plaintiffs’ lawyers of potential products liability suits.
It is critical to obtain control of all recalled product and then isolate it from outgoing product. If products are to be tested or destroyed, they should be immediately designated as such in a way that makes them immediately visibly distinct from defect-free products. Sample products from the recalled lots should be retained in case of litigation.
The worst time to develop a recall plan is after the recall has been initiated. Manufacturers must implement a reliable system for ensuring the traceability of their devices and develop recall SOPs to minimize the time and expense of a recall.
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