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.
"The publication of IEC 60601-1-11, ‘Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment,' and the FDA's Medical Device Home Initiative are evidence that significant changes are coming in the home healthcare equipment industry and it's important that manufacturers are fully aware of what's taking place," said Anil Patel, General Manager UL Health Sciences Industry. "This represents a unique change for manufacturers, as most medical devices are intended for use by trained caregivers. This standard addresses the increased use of medical devices in the home, representing a change in the way future health care is delivered. As a leader in home safety, UL is dedicated to helping manufacturers, regulators and users prepare to comply with the evolving industry and continuing to fulfill our mission of protecting people and property."