By William A. Hyman, ScD
Manufacturers—which are supposed to report their actions to the U.S. FDA—initiate the overwhelming majority of medical device recalls. The FDA subsequently analyzes the product recall and assigns one of the following recall classifications:
- Class I: in which there is a reasonable chance that the product will cause serious health problems or death
- Class II: in which a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death
- Class III: in which a product is unlikely to cause any health problem or injury, but the product still violates FDA law
Note: Recall classification should not be confused with device classification.
Medical Device Recall Database
The FDA enters recalls in the Medical Device Recall database and also generates public notices—primarily of Class I recalls—in several formats, each with slightly different information. These notice formats include recall and MedWatch notices.
Even so, there is often a considerable delay between the manufacturer’s action and the FDA’s postings. This delay may be due to the manufacturer not providing timely communication to the FDA or not calling their action a “recall.” Or perhaps the FDA is just slow in moving through its own process.
Because of the delay between manufacturer action and FDA action, the FDA has not been a good primary source for recall information. (A separate issue is how long it takes manufacturers to launch a recall after they receive credible information about a problem with their product.)
Further, the FDA’s listing of 2017 recalls—most of which are Class II—can be accessed at goo.gl/JUkSdo. For January 2017, there were 178 recalls. In the first Class I recall, which was posted on January 3, the manufacturer notified customers of the problem on Oct. 5, 2016—three months earlier—and asked customers to immediately discontinue product use. (Note: A stop-use recall is clearly one in which delays can be critical.)
The FDA posted the last recall of 2016 on December 16. In this case, the manufacturer had notified customers on July 29, 2016, five months before the FDA’s post. Similarly, the FDA’s December 9 recall listing was for a manufacturer’s notice of October 21.
In order to reduce the lag time between manufacturer action and FDA posting, the FDA announced in January that it would begin posting recalls in the database before the agency’s own classification procedure ran its course.
The new FDA language states: “When a company initiates a correction or removal action, the FDA posts information about the action in the Medical Device Recall database. The FDA updates the Medical Device Recall database after it classifies the recall and again after it terminates the recall.” However, the FDA notes that a recall won’t appear in the Enforcement Report or any other posting until after classification.
Communication Is Key
Monitoring the recall database for newly listed recalls will apparently require searching date ranges on a regular basis—something that’s certainly possible, but not very convenient. Therefore, whether the FDA’s new policy proves to be helpful in the field remains to be seen. However, early appearance in the database does presents challenges that might result from having an injury occur after the device has been recalled. And early posting does take away—at least in part—the criticism that the FDA moves too slowly in this arena.
Nevertheless, direct communication from the manufacturer to the customer continues to be the timeliest means of learning of a recall (or other urgent matters)—but receiving, identifying, and tracking such notifications is not a simple task. Problems include how a recall is addressed, whether or not the word “recall” is actually used, and recognizing and processing the notice within the hospital.
Some third parties also provide recall notices, but these also lag the manufacturer’s action by varying degrees, depending on the source of their information and their processing time. The FDA’s MedSun newsletter also list recalls, but with another built-in delay.
Ideally, manufacturers would electronically send recall notices to entities based on hospital inventory and purchase records, and maybe even patient records. While we are well entrenched in the Information Age, this technology has yet to be applied to recall notification and processing.
Further, the use of unique device identification (UDI) could theoretically facilitate this process by, according to the FDA, “providing a standardized identifier that will allow manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls.” Still, I haven’t seen a recall that provided UDI information.
William A Hyman, ScD, is professor emeritus, biomedical engineering, at Texas A&M University in College Station, and adjunct professor of biomedical engineering at The Cooper Union, New York.