Unique Device Identification Market Overview
Unique Device Identification intends to assign a unique identification to medical devices sold within the United States. It was signed into law on 27th September 2007 as a part of the Food And Drug Administration Amendments Act of 2007. It requires the label of each device to bear a unique identification unless another location is specified by the F.D.A or an exception is made for that particular device or its grouping. It should be able to identify the device through distribution and use and also include the serial number if specified.
The main motive of the Unique Device Identification market is to make a common vocabulary which will enhance tracking of medical devices electronically. When fully implemented, it will label most medical devices with a UDI readable by both people and machines. Some of the main advantages are improved patient safety by helping identify counterfeit products and improving the ability of medical staff to differentiate between devices that look similar but serve different functions. The Unique Device Identification market will better device post-market surveillance by helping streamline a recall process if required and also foster medical device innovation.
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Unique Device Identification Market Drivers
There are a few key drivers for the Unique Device Identification market one of which is the desire to adopt a single global standard. If all medical devices manufacturers conform to it, it makes life easier for both them and consumers. For UDI, the standard considered is GS1 which already has 110 member organisations. GS1 has been accredited by the U.S. FDA as an issuing agency for UDI’s. The unique device identification market also helps to reduce medical errors by allowing healthcare experts to rapidly identify a device & obtain important information about its characteristics. This is of particular relevance in the case of product recalls where a defective batch unit may need to be withdrawn from the market. The battle against counterfeit medicines is another factor ensuring the continued growth of the Unique Device Identification market. UDI’s can allow the foundation of a secure, global supply chain to be laid and also nip counterfeiting in the bud by instantaneously identifying them. The Unique Device Identification market is also driven by the rising importance of IT adoption in healthcare. It provides a clear, standardised way of documenting devices in electronic records, information systems, data sources & patient registries. A robust post-market surveillance system can quickly clear new medical devices or new uses of existing ones.
Unique Device Identification Market Restraints
There are some challenges in the Unique Device Identification market which are cost, the time required & effort. Some medical devices or medicines like those meant for treating different forms of cancer, for example, are already prohibitively expensive. If manufacturers are forced to add a UID to them, they will simply pass on the cost to the end consumer causing them more heartache. A second issue is a time & effort required. Several smaller organisations will have to invest in this expensive technology to comply with governmental norms, further hitting their bottom line. The Medical Device Manufacturers Association (MDMA) agrees with this and has lobbied the FDA to provide greater compliance flexibility. The transition to UID will require significant investment and with smaller medical companies facing a medical tax, increased user fees and reduced capital investment, greater flexibility will be required to comply.
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Regional analysis includes:
- North America (U.S., Canada)
- Latin America (Mexico. Brazil)
- Western Europe (Germany, Italy, France, U.K, Spain)
- Eastern Europe (Poland, Russia)
- Asia Pacific (China, India, ASEAN, Australia & New Zealand)
- Middle East and Africa (GCC, S. Africa, N. Africa)
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