FDA Proposes Reclassifying Surgical Staplers

Regulatory NewsRegulatory News | 23 April 2019 |  By 

Tens of thousands of surgical staplers for internal use have been associated with serious adverse events, prompting a new proposal from the US Food and Drug Administration (FDA) to reclassify the devices.

The reclassification would mean manufacturers of surgical staplers for internal use would face increased requirements as part of the FDA’s Center for Devices and Radiological Health’s (CDRH) new steps to help reduce risks. The agency also issued draft guidance to propose new labeling recommendations for surgical staplers.

The proposed reclassification—from class I (general controls) into class II (special controls) and subject to premarket review—and draft guidance come in response to an analysis of more than 41,000 individual medical device reports (MDR)—otherwise known as adverse events reports—FDA received between 1 January 2011 to 31 March 2018.

Surgical staplers for internal use can provide certain benefits compared to manual suturing, including a reduction in procedure times and in surgical contamination. A single surgical stapler for internal use may be indicated for a range of applications, such as gastrointestinal, gynecologic and thoracic surgery, to deliver staples to tissues.

But the numerous adverse events that have been associated with the prescription devices since their initial assignment into class I under a 1988 rule signal the need to move surgical staplers for internal use up to a higher-risk classification category to require 510(k) clearance and new special controls. The proposed order seeks not only to reclassify internal use surgical staplers into class II with the identified special controls, but also to distinguish these from surgical staplers for external use.

The agency said it “has tentatively determined that special controls, in addition to general controls, are necessary to provide a reasonable assurance of safety and effectiveness for surgical staplers for internal use,” based on its review of MDRs, recall databases and the published literature. The available information does not currently suggest that reclassifying surgical staplers for external use is necessary, FDA says.

As part of the reclassification proposed order, surgical staplers for external use would remain exempt from premarket review, while those for internal use would be subject to 510(k)s if the new order is finalized.

The proposed order also identifies a set of special controls to serve as mitigation measures for the evaluated risks to health. Special controls on device performance, usability, sterility and shelf-life testing as well as biocompatibility evaluation seek to mitigate the risks of complications associated with device failures or malfunctions, adverse tissue reactions to patient-contacting materials and infections.

Most MDRs reported complications related to use error. These include 11 reports out of 366 deaths in which use error was a contributing factor and 159 that associated cause of death with an opening of the staple line or staple malformation. The most common malfunctions in about 32,000 reported failures of the stapler to fire the staple and failure to form staples, among others, which is consistent with the 167 class II recalls of the devices from November 2002 to 30 December 2018.

“Both device misuse and device malfunctions are root causes of the adverse events associated with use of surgical staplers for internal use,” CDRH says. “Device misuse may be exacerbated by inadequate instructions for use and insufficient warnings or precautions in the device labeling.” Considering this new information, special controls are largely focused on risk mitigation via adequate device labeling.

Draft Guidance

The 11-page draft guidance proposes several labeling recommendations for contraindications, warnings, directions for use, technical characteristics and performance parameters.

“Helping manufacturers identify appropriate information to include in their product labeling will ultimately help better protect patients by helping health care professionals better understand the appropriate use and the risks of these devices,” says CDRH Director Jeff Shuren. He points to the Medical Device Safety Action Plan and the work to develop registries as examples of broader efforts.

CDRH scheduled an advisory committee meeting on 30 May to obtain expert input on the appropriate regulatory pathway for manufacturers of surgical staplers for internal use, the proposed classification order and the draft guidance.

“We believe these steps will help better protect patients by ensuring that these devices are safe and effective for their intended use in surgeries,” Shuren adds. The agency remains “dedicated to closely monitoring reports of adverse events associated with surgical staplers for internal use and implanted staples and will take additional action, as needed, to protect patients.”

Proposed rule, Draft guidance


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