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Pharmaceutical & Medical Packaging News, September/October 2015

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Page 25 of 43 • Pharmaceutical & Medical Packaging News September/October 2015 26 Vision Inspection Implementing Vision for Medical Device UDI Regulations Solutions are underway to address challenges in code reading, substrates, lighting, validation, and more. By Rick Roszkowski, Senior Director of Marketing, Vision Products Business Unit, Cognex Corp. F DA's final rule establishing a Unique Device Identifica- tion (UDI) system requires the device labeler, in most cases the manufacturer, to include an automatic identification (AutoID) code on device labels and packages and, in the future in some cases, on the devices themselves. In most cases, complying with these regulations will require labeling packages and eventu- ally products with 1-D or 2-D codes as well as a human-readable code with batch-level identification. These codes nearly always need to be verified at the time they are marked or printed and at additional times downstream in the process. Code reading can be challenging because of the potential for code degradation and the wide range of potential surfaces that may need to be marked. Another potential chal- lenge is that vision systems need to be validated based on Good Automated Manufacturing Practice (GAMP) in order to provide documented assur- ance that they are appropriate for their intended use before going live. The machine vision industry is helping to address these challenges by developing software algorithms that are able to find and decode even dam- aged 1-D or 2-D codes and read low- contrast or damaged text. Another advancement involves application- specific solutions for vision systems that eliminate the need for programming and prebuilt documentation that sub- stantially reduces the time required for FDA validation. UDI BACKGROUND FDA issued the rule in 2013 requir- ing that the medical device industry must include the UDI as both a bar code and in human-readable text on device labels and packages. The UDI must include a device identifi- er (DI) that identifies the labeler and the specific version or model of device and a production identifier (PI) that includes or more of the following: lot or batch number, serial number of a specific device, expiration date of the device, and the date the device was manufactured. FDA categorizes medical devices into one of three classes—Class I, II, or III—based on their risks and the regulatory controls necessary to pro- vide a reasonable assurance of safe- ty and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk. Class III medical devices have been required to carry UDI labeling since September 2014. Implantable, life-saving, and life- sustaining Class I and II devices are required to carry UDI labeling as of September 2015. All Class II devices must carry UDI labeling and Class III Class III: implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defbrillators, and in-bone implants Class II: powered wheelchairs, infusion pumps, surgical drapes, and condoms Class I: elastic bandages, examination gloves, and hand-held surgical instruments Class III 5% of devices Class II 40% of devices Class I 55% of devices Examples of medical devices in Classes I, II, and III.

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