UL White Paper Examines Key Implications of Growing Home Healthcare Industry

NORTHBROOK, Ill., January 10, 2011 - Underwriters Laboratories (UL), a world leader in safety testing and certification, announced today the release of a white paper that addresses the current and anticipated regulatory landscape for manufacturers of home healthcare equipment. The white paper, "Home Healthcare Equipment: An Overview," examines the new IEC 60601-1-11 standard, and highlights the unique challenges for manufacturers with the U.S. Food and Drug Administration's (FDA) recently announced Medical Device Home Initiative.

The U.S. FDA has forecasted that the home healthcare equipment market, which includes a wide scope of medical electric equipment intended for use in a non-medical setting, will grow by 7.4 percent each year through 2016. As manufacturers face this above average growth, UL is positioned to help them address a special set of safety issues and challenges related to the use of products in homes, including operating environment, caregiver technical knowledge and ability, and device usability. The introduction of recent regulations will help manufacturers mitigate these challenges while raising the bar for the creation of safe, high-performing home healthcare products. 

The new IEC 60601-1-11 requires manufacturers to define specific product safety risks associated with the use of their equipment in uncontrolled environments by untrained users. Additionally, the FDA's new initiatives will increase the collection of data regarding unsafe products, while enhancing safe-use education for patients and caregivers.

To download a copy of "Home Healthcare Equipment: An Overview," visit www.uluniversity.com/thoughtleadership or www.ul.com/medical.

To find out more about UL's services for medical devices intended for home use, visit

http://www.ul.com/global/eng/pages/offerings/industries/healthsciences/medicaldevices/homehealth/