The United States Department of Food and Drug Administration (FDA) is pushing for doctors and manufacturers of medical staples to reconsider their use during surgical procedures. In some cases, a review of patient records found the staples to lead to serious injury and death.
How is the FDA trying to change things? The agency recently released a proposed order to reclassify staples used during internal procedures as class II, special controls. The agency currently classifies these medical tools as a class I device, requiring general controls. The change would result in additional premarket review.
Why the proposal? The FDA was likely motivated by a review that found the device was potentially connected to 366 deaths.
Of these deaths, the report found 159 were connected to an opening of the stapled area or failure of the staple to retain its shape, 53 to bleeding during surgery, 47 reports of sepsis, 5 of peritonitis, 5 of necrosis and 4 of air embolism. Reasons for these problems included mechanical issues and surgical error. The release further states that the proposal would allow for reasonable assurance the staples are safe and effective.
Will the FDA succeed in its attempt to change the classification of these medical staples? It is very early in the process. The FDA released the proposal April 24, 2019 and has requested comments.
The agency has also scheduled a meeting through the General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee. The agency's goal is to discuss whether it needs to review the device manufacturer's marketing strategies. The agency has stated misuse of the device is a problem. It is possible the manufacturer is inappropriately marketing the device.