Tracking medical devices to ensure patient safety.
Registered nurses in perioperative settings and managers of perioperative departments must work together to implement policies and procedures to ensure compliance with these very important federal regulations. If the information is not recorded in the proper manner and shared with the manufacturer, patients' safety is at risk. Without the ability to contact physicians and patients, manufacturers cannot alert individuals appropriately if problems arise with a certain device. Tracking devices in the correct manner ensures that patients can be notified expediently. Nurses and managers should examine their current practices to ensure that they are consistent with federal regulations. A regular assessment should be conducted to ensure that tracking forms are completed in an accurate, timely manner, that permission to release a patient's social security number is obtained, and that the hospital is compliant with the FDA's most up-to-date list of devices that must be tracked. All perioperative staff members must receive education about the tracking process in their particular institution and receive updates when the process or FDA regulations change. Maintain patient safety by ensuring that the medical device tracking process is followed accurately and meets federal regulations.
Beyea
Suzanne C
SC
D004868:Equipment Failure; D004864:Equipment and Supplies; D033161:Government Regulation; D006801:Humans; D013527:Perioperative Nursing; D011358:Product Surveillance, Postmarketing; D017751:Safety Management; D014481:United States; D014486:United States Food and Drug Administration