The United States Food and Drug Administration recently sent a Letter to Health Care Providers outlining the dangers connected to use of surgical staplers. The letter focused on the use of internal staples and implantable surgical staples, devices commonly used in surgical procedures.
What led to the FDA's involvement?
A representative for the FDA stated the agency needed to communicate the threat of misuse of these types of medical devices. The agency has stated it recognizes the important benefits these devices provide during complicated surgical procedures. This includes the fact that using a staple can reduce the amount of time a patient is under anesthesia as staples are generally take less time compared to manual suturing techniques.
However, the agency also states improvements are necessary to address current safety concerns. Concerns that include a need to address reports to the agency of 366 deaths, over 9,000 serious injuries and 32,000 malfunctions of these medical devices. Reports include claims the device misfired, misapplied and failed to fire as needed.
These issues led to complications during surgical procedures such as tearing and bleeding. If the issues were not properly addressed by medical staff, the patient could suffer serious injury or death.
What did the government recommend?
Ultimately, the agency recommends the following:
- Review instructions. The FDA called on medical professionals to review labeling instructions and use the staples only as intended.
- Education. The agency also called on facilities to better ensure all those who use these devices are educated on proper use.
- Alternatives. In some cases, an alternative is best. The FDA specifically called on doctors to consider other options for patients with swollen tissue, those who are prone to bleeding or those who have necrosis in the area that requires attention.
The agency has also stated it will continue to monitor reports of adverse events involving surgical staples and encouraged medical professionals and patients to continue to report problems with these medical devices.