- Surgical staplers for internal use are almost certainly headed for Class II regulation after an advisory panel Thursday endorsed FDA's proposal to add premarket review and special controls to the category of devices.
- The panel said Class II regulation would offer a reasonable assurance of safety and effectiveness, and recommended simplifying proposed labeling and increasing surgeon training with the devices to improve outcomes.
- Medtronic, the only manufacturer in attendance, voiced support for the formal up-classing, as did the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).
FDA said it identified 412 reports of death and about 110,000 reports of malfunction related to surgical staplers and staples for internal use from both its MAUDE (Manufacturer and User Facility Device Experience) database and alternative summary reporting system between Jan. 1, 2011 and Dec. 31, 2018.
The agency has repeatedly noted the imperfect nature of adverse event reporting in its reliance on manufacturers, physicians and other voluntary reporters to diligently register malfunctions.
Panelist Alexander Krupnick, surgical director of lung transplant at the University of Virginia, said that in some personal cases of stapler malfunction, he has chosen to "chew out" the manufacturer sales rep rather than flag the incident to the agency directly.
Recent FDA policing has only addressed a small fraction of the malfunctions, according to one analysis.
A recall of certain Ethicon stapler models initiated in April only covered about 4% of the total stapler-related adverse event reports identified by Madris Tomes, a former FDA manager and current head of independent data analysis firm Device Events.
Those devices don't belong in the same Class I category as cotton swabs and crutches, said Jack Mitchell, director of health policy at the National Center for Health Research, who testified at the hearing.
Neither the panel nor industry stakeholders needed much convincing to support reclassification.
Implantable surgical staples are already regulated in Class II, and representatives from Medtronic's Minimally Invasive Therapies Group, which markets 23 models of stapler, said they have long treated staplers as Class II devices too.
But specific special controls and labeling recommendations remain up for discussion. Medtronic said it wants to work with FDA and other companies to ensure labeling does not restrict clinical decision-making. Its main market counterpart, Johnson & Johnson's Ethicon, did not participate in the meeting but told MedTech Dive it similarly treats its staplers as Class II devices.
Medtronic voiced opposition to much of the retroactive product testing proposed by FDA, arguing the safety profile for most manual staplers has been established during their many years on the market. However, the company told FDA additional testing of newer, powered staplers would be warranted.
Scott Lucas, director of accident and forensic investigation at the ECRI Institute, said his organization has scrutinized a number of stapler-related adverse event cases over the last decade and concluded that emphasis on user-friendly stapler design and instructions for use, more robust training, and ensuring surgeons have a back-up plan in the event of stapler failure are among key safety measures FDA can consider.
FDA could also require manufacturers to uniformly "color code" staplers by size of staple, to help surgeons easily identify and confirm correct stapler type in an operating room, regardless of stapler maker, Krupnick recommended.
Other ideas floated by panelists included creating some sort of training certification label recognizing proper instruction and demonstration of competency for graduating residents going forward. One panelist pitched a registry, but others said such an undertaking could be burdensome to physicians and results may be difficult to interpret.
"It's easy to have a registry — it's hard to have people put data into it, we're already going nuts over what we have to put into EHR," said panelist William Meurer, emergency medicine clinician and researcher at the University of Michigan. "A registry would be subject to much of the underreporting we’re seeing here."
Ultimately, the panel agreed with FDA's evaluation of most of the risks associated with the devices: infection, adverse tissue reaction and complications tied to device malfunction and user error.
Panelists disagreed, however, with FDA's contention that malfunction can cause increased risk of cancer recurrence, as well as the risk that non-biocompatible staplers can cause local tissue irritation upon contact.
The panel recommended FDA trim down the specificity of labeling, and test the usability of those instructions for use on doctors in an organization like SAGES.
The comment period for FDA's proposed reclassification closes June 24.