According to an article from USA Today, more than a dozen times a day, doctors mistakenly leave sponges and other surgical equipment inside the patient. These mistakes often cause permanent damage or death. To alleviate the devastating consequences of these medical mistakes, the FDA has implemented requirements for surgical equipment tracking.
Beginning on September 24, 2018, FDA § 801.45 requires all surgical equipment to be labeled with a UDI (Unique Device Identification) and must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
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1. Eisler, Peter. “What Surgeons Leave behind Costs Some Patients Dearly.” USA Today. Gannett, 08 Mar. 2013. Web. 6 July 2016. http://www.usatoday.com/story/news/nation/2013/03/08/surgery-sponges-lost-supplies-patients-fatal-risk/1969603/.
2. Compliance Dates for UDIRequirements".