Adverse events involving staples for internal use, as well as external surgical staplers, have been increasing by significant numbers. This situation has the U.S. Food and Drug Administration (FDA) concerned. The organization wants health care providers to help reduce the risk of adverse events occurring and help improve patient safety with these devices. It is announcing new actions they intend to take so the safety of such devices is improved.
Medical Device Report
Surgical staples are a system designed for internal use. Medical device reports received by the FDA for both implantable staples and surgical staplers have been carefully reviewed by the organization. This was done so the FDA would have a comprehensive overview and safety profile for these devices. The review by the FDA is still ongoing. The report covered a period from 2011 to 2018 and involved more than 40,500 individual medical reports. These reports included staples for internal use and staplers. They showed more than 365 deaths, over 8,900 serious injuries as well as more than 31,000 malfunctions.
The reports that showed problems to the FDA identified surgical staplers for internal use as the main source of the problems. It is believed this is occurring because the use and function of the stapler are what determines proper staple formation. There were some common problems identified:
- Elevated recurrence risk of cancer
- Malformation of staples as well as an opening of the staple line
- Internal organ and tissue tearing
- The failure of the staple to fire
- Difficulty firing
- Fistula Formation
- User applying staples to the wrong size of tissue or applying staples to wrong tissue.
The FDA has provided recommendations for health care providers who provide medical treatment involving these types of devices:
- While a stapler is closed on tissue, a blood vessel should be ligated or clamped prior to releasing the stapler.
- The instructions provided by the stapler manufacturer should be carefully read and closely followed.
- Since clamping can cause injury without staples being fired, clamping a stapler to delicate tissue should be avoided.
- A different size staple may necessary if there is difficulty involved with squeezing the stapler handle.
- The aorta and other large blood vessels should not be used.
- Any tissue too thin or too thick should only have the appropriate staple size used on them.
- Any unintended structures like a foreign object need to be identified, so they are not in the staple line.
- It is important to know the structure around the site where staples are intended to be placed.
- All possible options for any patient swollen with fluid should be considered. This is also the case with tissue that easily bleeds, or tears when manipulated or palpated, as well as any dead tissue. The staples have a good chance of not securing to the tissue.
- Different companies utilize different color schemes on their cartridges. This is done to identify different sizes of staples.
In 2019, the FDA is committed to drafting guidance for public comment. This guidance is intended to promote efficiency as well as safe utilization of staples for internal use and staplers. This guidance will have suggested recommendations to manufacturers concerning the labeling of their product.
Open Public Meeting
The FDA is also planning in 2019 to have open public meetings. These meetings will involve the Committee of General and Plastic Surgery Devices Panel of the Medical Devices Advisory. This is going to be done to discuss if surgical staples for internal use should be reclassified as a Class II medical device. These devices are currently identified as Class I. This does not require manufacturers to make an FDA premarket submission. A Class II device would be subject to the premarket submission to the FDA. This could create special controls that could mitigate known dangers associated with the device. The FDA will announce the details of the meeting 15 days before it takes place.
The FDA will continue its position of working with professional societies as well as hospitals to encourage the latest training and education concerning the proper utilization of these devices. Postmarket performance of all marketed devices is regularly done by the FDA. It will still collect and analyze all data available concerning the utilization of these devices. When any new information becomes available, the FDA will inform the public.
The FDA has a goal of quickly identifying and obtaining a better understanding concerning problems associated with these products. This can be achieved with prompt reporting. If anyone believes they are experiencing a problem with an implantable staple or surgical staple, they are encouraged to file a report with the FDA through MedWatch.
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