Pamela Gwynn, UL Principal Engineer for Medical and Home Healthcare Equipment, presented at the 2016 US-German Standards Panel on “Innovation in the Medical Device Sector”, co-hosted by the American National Standards Institute (ANSI) and the German Institute for Standardization (DIN) on April 12, in Washington, D.C. UL was asked to provide its perspective on electro-medical device standards and how we help clients navigate standards and regulations when bringing new products to market. The event brought together a range of public- and private-sector representatives from the United States and Germany – including leaders from the National Institute of Standards and Technology, Association for the Advancement of Medical Instrumentation, ASTM International, and the American National Standards Institute – to explore opportunities for the joint development of standards around medical devices and other innovative areas in healthcare. Speakers presented on a range of issues, including recent developments in electronic health records and the implications for standardization and public policy, including suggestions for bilateral U.S.-German standards development should TTIP negotiations falter.
In her presentation, Ms. Gwynn shared the process UL uses to address electromedical products with features not covered within the 60601 series of standards. She explained that often times, manufacturers are concerned that they will not be able to place products onto the market due to this issue and that UL can and does certify products with features not currently addressed by the standard. First, UL will partner with the electrical medical device manufacturer to understand the unique issue of the device. Once this understanding is reached, UL will work to address the hazard by again leveraging the expertise of our global staff to determine if published requirements exist in other standards, such as AAMI. IEC, ISO etc. When requirements exist in other standards, UL will look to use them. When requirements do not exist, UL will work to establish requirements, both construction and performance. These requirements are presented to the manufacturer for discussion. Once the additional requirements are finalized, the medical electrical equipment is evaluated to the 60601 series of standards and the additional requirements. After compliance with all applicable requirements are met, the product is certified to bear the UL mark. If new requirements are developed, UL will begin the process to have these requirements included in the suitable standards.Ms. Gwynn’s remarks were well received and helped balance panel discussions with the many practical challenges manufacturers face and how UL helps clients navigate global markets.