Can you say Dr. D’s favorite, ugly, six-letter word, RECALL? As the late Mr. Rogers would say, “I know you could.” In a perfect world, there are no taxes, Cuban cigars are legal, good bourbon is always free, and the San Jose Sharks finally win Lord Stanley’s Cup. Unfortunately, this world is far from perfect and the medical device industry even more so. Eventually, all medical device manufacturers will have to deal with at least one product recall. The more products being introduced into the U.S. marketplace and the chances for a recall begin to increase significantly. One of the underlying reasons recalls occur is because good-ole Mr. Murphy is alive and well in the device industry. In fact, Mr. Murphy continues to actively breed.

That being said, FDA has very clear and concise policies pertaining to “removals and corrections” delineated within 21 CFR, Part 806. The doctor strongly suggests that for those readers not familiar with Part 806, there is no time like the present to start reading it. Part 806 can often be viewed by many as an “inscrutable” (look-it-up) piece of regulatory text than is often misconstrued. However, FDA will use every tool at their disposal to force the removal of medical devices that are not safe and effective from the US market. Enjoy!  

Recall

For those regulatory purists out there, Dr. D has a simple question for you. Do you know how many times the word RECALL is mentioned in Part 806? If you answered zero, the big goose egg, you would be correct. Although industry frequently employs the term recall, Part 806 provides definitions for four basic terms associated with getting bad devices or devices violative of the Act out of the US market: (a) correction; (b) market withdraw; (c) removal; and (d) stock recovery. Regardless of the term, the agency’s message is loud and clear; “keep bad medical devices out of the American marketplace.

Part 806

Dr. D is not going to dive into Part 806 and give the readers a blow-by-blow take on the actual requirements. Since Part 806 is a relatively brief document, the doctor will allow the readers to scan Part 806 on their own time. However, Dr. D will provide some insight into the salient points associated with executing an effective recall.

For starters, you just might want to consider beginning with the scripting of a well-written procedure defining your organization’s approach to recall management. The procedure should incorporate all of the little nuances associated with the FDA-mandated requirements delineated within Part 806. Make sure you focus on the customer notification process, the product recovery process, good-faith effort process, effectiveness checks, the reporting process to FDA, and the certified destruction process. If your company is in the infant stages of your organizational development, then the doctor strongly suggest investing in an ERP/MRP system that will allow for superb product traceability, including product shipments. Why? Because when Mr. Murphy comes knocking, it will just be a matter of time before the word RECALL will raise its ugly little head. Executing a successful recall will be driven by knowing where all of the suspect medical devices reside: (a) with a healthcare organization; (b) on a consignment shelf, (c) sitting on a shelf in a distribution center; (d) in transit; or (e) in the infamous trunk stock location, a.k.a., in the back of a sales rep’s car or in the rep’s garage.

Recall classes

FDA has identified three categories of recalls, each premised on risk to public health and safety. The recall class will drive the level of attention to detail and FDA involvement with the recall process. These guidelines categorize all recalls into one of three classes, according to the level of hazard and risk involved:

Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food. 

The classification of a particular recall will define the boundaries for executing the recovery process. For the most part, product recalls are voluntary; however, FDA giveth and the FDA taketh away. If a medical device poses an imminent threat to public health and safety, the agency can order a Class I recall. Even for a device manufacturer-sponsored recall, FDA notification is required. Through the concept of “First Alert,” FDA becomes aware of a product issue and the clock starts ticking. 

Executing the Class I recall

Right after the call is made to FDA for the initial consultation, the device manufacturer begins the arduous task of identifying where the medical devices requiring to be recalled are located within the United States. Written notification will be required. In fact, ensure evidence of notification is collected, e.g., use FedEx, UPS or USPS to ship the recall packets and collect evidence of receipt. Just in case you are wondering, evidence of receipt equates to a signature acknowledging receipt of the recall package.

In the eyes Dr. D and FDA, the magic number is three, which equates to three attempts to collect product being recalled. Collecting the suspect devices will require significant vigilance and a recall manager with the persistence and tenacity of a pit bill, ruff, ruff! As product is returned and collected, it is imperative that the product be placed into a quarantine location and meticulous records associated with the recall maintained. Once the device manufacturer is in a position to accurately determine that no more devices are going to be returned, hopefully an effectiveness rate of greater than 90.0 percent, then FDA can be contacted and plans for the certified destruction of the devices executed. Once upon a time, in a distant land called California, Dr. D watched in amazement as a forklift was driven back and forth over a couple of hundred catheters in an effort to destroy them. Was it effective, heck yes; however, it was also quite messy. The doctor recommends contacting a firm specializing in the certified destruction of medical devices. Make sure the certificate of destruction is included in the recall documentation.

Dr. D strongly recommends pursuing the same rigor when executing a Class II or Class III device recall. Remember, FDA will want to look at all of the documentation associated with a recall as part of one of their friendly visits, a.k.a., facility inspection. The agency is always interested in the effectiveness of a device manufacturer’s recall efforts, regardless of the classification.

Takeaways

For this week’s guidance, the doctor will leave the readers with two takeaways. One – It is inevitable a device manufacturer will eventually have to execute a product recall. The best policy is to always be prepared. In preparation, begin with scripting a procedure that fully embraces 21 CFR, Part 806. Two – It is imperative that FDA be kept in the loop for product recalls. Always, contact your local FDA office prior to commencing with a recall. The discussion with FDA will ensure that correct classification of recall is selected.

In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success. 

References: 

1. Code of Federal Regulation. (2013, April) Title 21 Part 806: Medical devices: reports of corrections and removals. Washington, D.C.: U.S. Government Printing Office.
2. Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.