- FDA alerted healthcare providers Friday to an increasing number of medical device reports associated with use of surgical staplers and made recommendations to help reduce risks associated with the devices.
- The agency said in a press release that between Jan. 1, 2011, and March 31, 2018, it received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.
- FDA said it plans to issue draft guidance with labeling recommendations for manufacturers and will hold a yet-to-be-scheduled public advisory meeting to discuss whether the current pathway for marketing the devices is appropriate and whether to reclassify surgical staplers from Class I to Class II.
FDA's steps follow a report Thursday by Kaiser Health News that examined the problem of stapler malfunctions. The investigative story also cast light on a little-known database at the agency, separate from the public Manufacturer and User Facility Device Experience (MAUDE) database, where reports of incidents with surgical staplers and other medical devices are collected out of the public eye.
Kaiser Health News found that at least 1.1 million reports of injuries and malfunctions involving about 100 medical devices have been filed since 2016 alone in the alternative database through FDA's voluntary summary reporting program. Manufacturers can request an exemption that allows them to submit reports of device malfunctions in the alternative database, though deaths must still be reported in MAUDE, Kaiser Health News reported.
The story singled out surgical staplers as an example of the disparity between the small number of incident reports included in MAUDE compared to those in the alternative database. Medtronic, a leading maker of surgical staplers, told the news service it used reporting exemptions to file stapler-related reports through July 2017. Johnson & Johnson's Ethicon unit, the other top stapler manufacturer, said it had not.
A Medtronic spokesman, in an email to MedTech Dive, confirmed that the company stopped using the alternative summary reporting process in July 2017, and noted that FDA has been phasing out the program. An increase in device-related adverse event reports related to surgical staplers in the MAUDE database from 2016 through 2018 is attributable to the reporting change and not related to any quality or safety issue with the company's stapling products, the spokesman said.
Staplers are used in many types of surgeries, including gastrointestinal, gynecologic and thoracic cases, and can shorten procedure times compared to manual suturing.
FDA said the most common problems identified in adverse event reports include opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples in which the wrong size is used for the tissue.
Improving the safety of surgical staplers and implantable staples is a top priority of the agency, FDA said, and it is conducting an ongoing assessment of medical device reports on file. The purpose of its letter to healthcare providers is to remind them of the importance of appropriate selection and use of surgical staplers and staples to reduce risk, FDA said.
FDA also reminded providers to review instructions and indications for use for surgical staplers and implantable staples, such as choosing the right staple size for the patient's tissue type and thickness. The letter suggests considering alternative options if the patient's tissues are swollen, prone to bleeding or necrotic. FDA also discusses how to recognize and manage device malfunction.
When used correctly, the devices can be beneficial surgical tools, allowing surgeons to perform less invasive operations, which may reduce postoperative pain and shorten recovery time, FDA said.
The agency said it will issue draft guidance for public comment this year with recommendations on information to include on product labels to help healthcare providers better understand the appropriate use and risks of the devices.
FDA will at a later date announce details of a public meeting of the General and Plastic Surgery Devices Panel to be held this year for discussion of the current pathway to market for surgical staplers, wherein the agency said it will present an analysis of all medical device reports received for surgical staplers and staples for internal use.
The agency intends to seek input from the panel on whether reclassifying surgical staplers is appropriate. Reclassifying surgical staplers for internal use from Class I to Class II would allow FDA to establish special controls, such as mandatory performance testing of mechanical features, demonstration of usability and label comprehension, and specific labeling elements to support safe use of the device, FDA said.