Surprising Facts About Medical Device Labels

SURPRISING FACTS ABOUT MEDICAL DEVICE LABELS The rules pertaining to how medical devices and packaging labels are made, stored, and printed at an operational level has evolved. Today labeling is viewed from a strategic standpoint. Medical device manufacturers see labeling as a crucial element for maintaining compliance and high safety and quality standards, enhancing operational efficiency, ensuring brand consistency, and supporting company growth. New medical device regulations have paved a way for a handful of surprising facts about medical device labels across different parts of the world. Here are a few of these surprising facts: In Europe, medical device labels utilized for advertising need not to be identical to SMPC. The SMPC (Summary of Product Characteristics) is a legal document approved as part of the marketing authorization of each medicine. FACT: It is a healthcare professional's basis of information on how to safely use any medical product. In terms of advertising for medical devices, the rule does not require that advertising information given be identical to that of SmPC, so long as the details presented on the medical device label is not misleading. It must be presented objectively and should encourage its rational use without exaggeration. Moreover, the advertising information must be up-to-date, verifiable, accurate, and sufficiently complete so that healthcare professionals may form their own opinion of the device's therapeutic value. FACT: The FDA does not review promotional materials for medical device labeling Marketing and advertising paraphernalia for medical devices are not reviewed and cleared by the FDA. However, the regulatory body does make certain that the label and instructions of the product are accurate. They also assure that the information on the labels allow for safe use and does not include unsupported claims. Anyone who violates the FDA regulations is dealt with by the Office of Compliance, an FDA enforcement arm. FACT: Every medical device label must include a unique device identifier (UDI) 123 The FDA has released a final rule mandating that medical devices distributed in the country carry a UDI or unique device identifier. 31 The compliance dates medical device manufacturers must consider varies depending on the classification of the device. For class III devices, the UDI requirements have already been submitted to the Global Unique Device Identification Database (GUDID) on September 24, 2014. Meanwhile, labels on all life supporting, life sustaining, and implantable medical devices must carry a UDI by September 24, 2015, and must bear permanent markings if the device is re-purposed. By September 24, 2015, labels on class II medical devices must have permanent markings of UDI and be submitted to the GUDID. 00324 FACT: Medical devices with "single use" labels may not be unsafe for more than one use. The single use label is not an FDA requirement. Therefore, medical device manufacturers have the right to label a device for single use if they choose to. In the US, Europe and Canada, when a manufacturer develops a new product, it is the corporation's prerogative to determine how the device is going to be labeled. Product Record If a manufacturer intends to market the device as “reusable“, they must have data and resources that demonstrate that the product can be sterilized, cleaned, and reprocessed without impairing its use. Otherwise, the device is labeled as single use. ! However, the term "single use", as seen on many medical device labels, does not necessarily mean that the device cannot be reused safely under certain circumstances. It simply means that the medical device manufacturer opted not to conduct the required studies to show that the product can be reused. FACT: Microchip implants will make use of fluorescent labeling. Wireless microchip trackers for livestock, pets, and the elderly are widely available. Aside from acting as a tracking device, these microchips are being used to monitor the patient's vital signs and medicine dosages. Currently, scientists are developing a next level microchip implant that is a fraction of the size of a penny. The device promises to provide improved drug delivery and medical monitoring. $4 According to Ray Kurzweil, director of engineering, the microchip will involve medical nanobots. With the use of fluorescent labeling, these nanobots will be able to deliver drugs, as well as identify selected genetic markers. THE FUTURE OF MEDICAL DEVICE LABELING: XYZ ? MED FDA's intentions are to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United States." XYZ Implantable Device TM Item: 1234667891011 Lot: 19871027 STERILE CE OJe tv 2020-10-06 200 s The test will consist of 38 respondents (including 8 at participating hospitals and 30 at FDA headquarters) that will compare the possible standardized labeling format of the future against existing device labeling. The study will compare both forms of labeling related to 6 different devices. More interesting facts are yet to come. NTI DATA PRODUCTS INC. PROUDLY CREATED BY: ADVANCED LABELING SOLUTIONS www.ntidata.com REFERENCES: http://medicaldeviceslegal.com/2011/06/13/more-on-advertising-of-medical-devices-much-more/ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceldentification/ http://www.gao.gov/new.items/he00123.pdf#search=%22GAO%20single%20use%20devices%22 http://www.activistpost.com/2013/08/the-dna-nanobots-have-arrived.html#more http://fortune.com/2012/09/18/bad-to-the-bone-a-medical-horror-story/ http://hosp.gcnpublishing.com/fileadmin/qhi_archive/ArticlePDF/AJO/036080407.pdf http://www.fiercemedicaldevices.com/story/fda-takes-step-toward-standardized-medical-device-labeling/2014-09-16