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Unique device identification (UDI) is a system used to identify medical devices entering the healthcare supply chain. Each device (and version or model thereof) will have a designated number assigned by the manufacturer or labeller which must be added in both machine- (Auto ID) and human-readable form to both the packaging and, in some cases, the device itself, provided doing so is required under the regulation. The rule also necessitates dates on medical device labels to conform to a standard format: day-month-year (eg, 30-09-2013) to ensure dates are unambiguous and clearly understood by device users. Standards have been developed by regulators, such as the FDA, to increase patient safety via the ability to effectively track devices through their distribution and use. In Europe, the European Commission has introduced the European Medical Devices Directive to ensure the health and safety of EU citizens is protected in this area (1).
As a globally recognised standard, every medical device manufacturer will be required to comply with the regulations, which state that a UDI must be included on device labels and packages, unless an exception or alternative is stated within the rules.
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