Unique device identifier for device manufacturers
Overview: Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.
The reports further indicated that many issues have to be addressed prior to successful implementation of UDI for devices, including determining the technology needed to utilise UDI effectively, identifying the data needed for patient safety; development, maintenance, and validation of a central data repository; and harmonising UDIs for the international marketplace. FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely into two categories: labeling and tracking. How does UDI fall into this category?
Why should you attend:
Understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting. Understand some of the issues associated with the use of various automatic identification technologies (e.g., bar code, radiofrequency identification). On February 26, 2004, FDA published a final rule (the ``bar code rule'') (69 FR 9120 ) requiring bar codes on certain human drug and biological products to help reduce medication errors in hospitals and other health care settings. The bar code is intended to enable health care professionals to use bar code scanning equipment in conjunction with computerized medication administration systems to verify that the right drug, in the right dose, is being given to the right patient at the right time. This rule (now codified at 21 CFR 201.25 and 610.67) requires that manufacturers encode the unique National Drug Code (NDC) number in a linear bar code on the product's label. The bar code rule, however, does not apply to medical devices. In the bar code rule, FDA stated that, unlike drugs, medical devices do not have a standardized, unique identifying system comparable to the NDC number, and that the absence of such a system complicates efforts to put bar codes on medical devices for purposes of preventing medical errors. Since the issuance of the final bar code rule, various entities, including members of Congress and a consortium of hospital groups and manufacturers, have asked that the Agency revisit the issue of bar coding medical devices to improve patient safety; improve quality of care; and encourage cost effectiveness, e.g., of health care by improving delivery and supply chain efficiency.
Areas covered in the session:
Understand how to implement the unique device identification
Identify the uses and benefits of UDIs
Understand the challenges, recommendations and proposed conclusions from multiple groups
Review examples of device Identification management scenarios reflecting the benefits
Learn where the use of medical device identification encompasses four current main elements
Who will benefit: This webinar will provide a general overview and update to companies who need to better understand industry's and FDA's current overview of unique device identification. The employees who will benefit include:
All end-users from appropriate departments who desire or require a better understanding and overview of unique device identification and current update.
QA and compliance
Regulatory affairs and RA specialists
Marketing
Consultants
Technical Writers and employees who review labeling/tracking info
David R. Dills, an independent Regulatory and Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, GxP compliance, auditing, interfacing with the regulatory agencies, managing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR's and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a well-known CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background.
Date: 20 September 2012Time: 09:00 - 11:30
Venue: Online Training, Wilmington
Cost: $245.00
More info:
Online Training