The implementation of Unique Device Identification (UDI) will have a profound effect on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient. UDI is poised to fundamentally change the way constituents in the Med-Tech ecosystem manage information about Medical Devices that will directly impact the end user – the patient.
The value of UDI goes well beyond the requirement to include a unique ID number; it is more than another Track & Trace metric; it is a plan calling for optimizing meaningful data collection and analysis. Like a car’s Vehicle Identification number (VIN) that can enable an automobile manufacturer to identify owners of cars with faulty parts for recall, UDI will allow a patient to be notified when a Medical Device issue needs to be addressed and so much more.
The FDA’s UDI initiative truly focuses on the patient as the primary beneficiary.However, the advantages of implementing such a system have benefits to all healthcare constituents.
“UDI may be an acronym for unique device identification, but what it really stands for is better information, better access to safe and effective medical devices, and ultimately, better patient health,” commented Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health[i].
Major constituencies affected by the new UDI rule include:the Medical Device industry, the FDA, the healthcare providers and the patients.Each constituent has a different stake in this new initiative.
Axendia’s recent whitepaper highlights the benefits UDI is expected to provide to the major constituencies of the rule, including:
1. Medical Device Manufacturers – the ability to uniquely identify devices would:
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Enable more efficient and effective device recalls
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Enhance the ability to identify devices throughout product life cycle
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Improve patient safety
2. The FDA – the requirement to uniquely identify devices would:
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Strengthen the FDA’s ability to query data systems for relevant device information
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Assist in more efficient and effective device recalls
- Support the development of a harmonized medical device identification system that can be recognized around the world
3. HealthCare Providers – the ability to uniquely identify devices would:
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Support the reduction of medical errors by enabling healthcare providers and patients to more rapidly and precisely identify a device
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Enable healthcare providers to auto-capture information about a device accurately and consistently throughout their systems including electronic Medical Device Reporting (eMDR)
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Aid in disaster preparedness and shortages/substitutions
4. Patients – the value of UDI to the ultimate consumer includes:
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Improved patient engagement
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More effective and timely patient notification of device issues & rapid product replacements (if needed) to avoid potential life-threatening complications
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Reduce billing errors through proper device identification
To learn about these and other benefits of UDI, read Axendia’s whitepaper “Beyond the ID, the Value of UDI; Championing the Patient.” The whitepaper highlights several areas where the effective execution of the UDI program could realize the greatest benefits. It also discusses global implications for UDI. To request your copy, visit: http://emailing.3ds.com/dsx/lp.jssp?template=LDP19868
About Axendia:
Axendia, Inc. is a leading trusted advisor to the Life-Science and Healthcare industries. The firm provides trusted counsel to industry stakeholders on Business, Regulatory and Technology issues.
For more information, visit www.axendia.com or contact us at info@axendia.com. Read Axendia’s blog: Life-Science Panorama at http://LSP.axendia.com. Follow us on Twitter at twitter.com/axendia and LinkedIn at linkedin.com/company/axendia-inc
[i]Identifying Medical Devices Will Strengthen Safety , FDA Voice, September 20, 2013http://blogs.fda.gov/fdavoice/index.php/2013/09/identifying-medical-devices-will-strengthen-safety/#sthash.amP6IAx9.dpuf
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