The US Food and Drug Administration (FDA) has taken measures to help reduce risks associated with surgical staplers and implantable staples.
The information was published on the official website of the US Food and Drug Administration on March 8th, 2019.
The U.S. Food and Drug Administration (FDA) has released a letter to the health care providers. In this letter, the agency has recommended decreasing the use of medical devices such as surgical staplers and implantable surgical staples. These are common devices that are used in the surgeries.
The letter to health care providers also suggests some alternative options and other recommendations regarding the recognition and management of the malfunctioned device. The step is taken to curb the risk associated with their use.
FDA has also planned to take additional actions to report the safety of the devices. These steps include the issue of guidance regarding labeling for manufacturers. A public advisory committee meeting will also be held to discuss the appropriate ways for manufacturers to market surgical staplers for internal use.
The agency has mentioned about the risks involved with the surgical staplers and implantable staples. They are conducting the analysis of medical device reports that are registered with the agencies.
The major problems that are reported in these reports include malformation of staples, failure of the stapler to fire the staple, and misapplied staples. Such malfunctions or misuse can be adverse and result in prolonged surgical procedures. It can lead to other problems such as bleeding, tearing of internal tissues and organs, increased risk of cancer recurrence, and even death.
William Maisel, a chief medical officer in the FDA's Center for Devices and Radiological Health said, "As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices."
Maisel further added, "As part of our Medical Device Safety Action Plan, we are committed to streamlining and modernizing how we implement post-market actions to address device safety issues to make our responses to risks more timely and effective."
The Surgical staplers and staples are used in many surgical applications, including gynecologic, gastrointestinal, and thoracic surgeries to eliminate a part of an organ. It is also used to cut organs and tissues so that a connection can be created between structures.
These devices proved to be really helpful in surgical procedures. These can shorten the surgical procedure time as compared to the manual stitching.
It is imperative for the patients as well to understand how surgical staplers and staples can be beneficial surgical tools. The devices are used in many surgical cases that help the surgeon to perform smooth operations. The use of these devices can reduce the postoperative pain and it can shorten the recovery time.
The FDA is intending to issue certain new guidance describing the proposed recommendations for manufacturers of surgical staplers and staples. This will further help the health care providers to understand the suitable use and the risks involved with these products.