JayH
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Someone recently posted the following on the dental-lab mailing list. I didn't see it generate a lot of discussion but have been looking into it as of late.
In all of the regulatory and government language I have come across the dental lab industry seems to be more of an afterthought than a primary concern to the subject. Vague comments have been made to the (im)practicality of bar-coding crowns, etc but I have found nothing of significance to make me think we need to start making any changes, yet.... The bulk of the discussion centers around hospitals and their suppliers. Even the ERG final report makes only passing references to our industry.
Any thoughts or comments?
In all of the regulatory and government language I have come across the dental lab industry seems to be more of an afterthought than a primary concern to the subject. Vague comments have been made to the (im)practicality of bar-coding crowns, etc but I have found nothing of significance to make me think we need to start making any changes, yet.... The bulk of the discussion centers around hospitals and their suppliers. Even the ERG final report makes only passing references to our industry.
Any thoughts or comments?
Unique Device Identification (UDI) is Coming
FDA first steps to adopt a UDI system
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It's anticipated that in the first quarter of 2012 the Food and Drug Administration (FDA) will announce the first official steps to adopt a Unique Device Identification (UDI) system for the medical device industry. UDI will mandate that manufacturers and distributors assign bar codes to their products and equipment that identify the name of the manufacturer, manufacturer’s contact information, date of origin, lot number, date of shipment, the product’s class (I, II or III device, risk classification),any expiration dates and other pertinent information.
Due to DTA efforts, most dental devices will only be required to have their UDI numbers printed on the box or packaging and not on the actual device. The exception is some Class III devices such as defibrillators.
Most dental devices will be included in the final group of devices requiring UDI adoption in approximately three years from the official date of adoption. Class III devices, representing devices with the highest patient risk, will be required to adopt UDI procedures, most likely beginning in calendar year 2013.
All manufacturers will be required to pay a fee to have their products assigned UDI numbers. Those fees have not yet been determined. Manufacturers will also bear the cost of having to redesign their packaging to accommodate two UDI barcodes. Once FDA releases its final recommendations, DTA will provide its members with more specific details.
To learn more about this new system for identifying and monitoring devices manufactured and sold in the US, go to Workshops & Conferences (Medical Devices)