Support to Reclassify Surgical Staplers

Stakeholders say they support an FDA proposal to reclassify internal surgical staplers as Class 2 devices and to implement uniform special controls as part of the reclassification. In a letter commenting on an agency draft guidance, Medtronic says that conducting additional bench and animal testing on devices that have been in clinical use for many years and have an established safety profile “is unlikely to provide clinically meaningful information and, in fact, may adversely affect patient access.” The company also notes that some of the agency’s proposed labeling updates cross into the realm of surgical practice and potentially may interfere with a surgeon’s decisions in the operating room.

In its comment, ECRI Institute, an independent applied research organization, says data from its safety surveillance program indicate that surgical staplers for internal use should be Class 2 devices. “Patient risk can be high in certain procedures,” it says, “and more emphasis in the form of special controls should be placed on usability, the stapler/tissue interface, instructions for use, and training.” The institute says there are recurring contributing factors associated with device use, including unfamiliarity with the device, clamping on surgical instruments prior to firing, and clamping on tissue that is too thick for the chosen cartridge. “Additional emphasis on these areas, particularly with regard to high-risk procedures, will improve outcomes,” it says.

A Johnson & Johnson response says its Ethicon unit supports reclassification from Class 1 to Class 2.

Finally, Applied Medical Resources says it supports the agency objective to promote the safe and effective use of surgical staplers and staples for internal use. “We appreciate the agency’s willingness to collaborate with industry and relevant stakeholders to promote patient safety and favorable clinical outcomes,” it says.