UNITED STATES – As reported online by www.physiciansweekly.com, the United States Food and Drug Administration (FDA) announced new steps to help reduce the risk of patient injury and death associated with surgical staplers.
In March of 2019, the FDA sent a letter to healthcare providers notifying them of an increasing number of medical device adverse event reports involving the use of surgical staplers. Between January 1, 2011, and March 31, 2018, the FDA received more than 41,000 individual adverse event reports related to surgical staplers. Of these reports, more than 32,000 involved malfunctions, more than 9,000 involved serious injuries and 366 involved deaths. A majority of the adverse event reports involved the following:
- An opening of the staple line;
- Malformation of staples;
- Misfiring of staples;
- Firing difficulty of staples;
- Failure of the staples to fire; and
- Misapplied staples.
FDA Announces New Steps to Protect Patients
To reduce the substantial number of adverse events related to the use of surgical staplers, the FDA proposed reclassification of surgical staplers from being Class I medical devices to Class II medical devices. Currently, Class II medical devices must undergo a review and clearance process by submitting a premarket notification to the FDA before marketing a product.
The FDA also prepared a draft guidance for medical device manufacturers to assist them in ensuring stapler labeling provides sufficient information on potential hazards, contraindications for use, along with other safety information for healthcare providers to use the device.
On May 30, 2019, the FDA will hold a public meeting of the “FDA General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee” to discuss all potential adverse events related to the use of surgical staplers that have been reported to the FDA so far. Additionally, the panel will hear from experts on the FDA’s proposed reclassification of the surgical staplers from Class I to Class II as well as on the FDA’s draft guidance.
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