White paper cites home healthcare device challenges
The market for home healthcare equipment is expected to grow exponentially in the coming years as the delivery of healthcare services shifts from clinical settings to the home. However, manufacturers face a series of unique challenges in supplying home healthcare equipment that is both effective and safe, according to a recently released white paper from Underwriters Laboratories (UL).
The paper seeks to address the current and anticipated regulatory landscape for manufacturers of home healthcare equipment by examining the new IEC 60601-1-11 standard (requirements for medical electrical equipment and medical electrical systems used in home care applications), and highlights the challenges for manufacturers.
The FDA has predicted that the home healthcare equipment market will grow by 7.4 percent each year through 2016. In April 2010, FDA announced its plan to provide closer oversight of home healthcare equipment in the United States, according to UL, of Northbrook, Ill.
According to UL, FDA’s Medical Device Home Use Initiative will:
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, UL stated. The FDA's new initiatives also will increase the collection of data regarding unsafe products, while enhancing safe-use education for patients and caregivers.
“While the use of medical equipment in clinical settings by trained professionals offers some degree of predictability, the operation of healthcare equipment in the home presents a special set of issues and challenges, including many with potential safety consequences to both patients and caregivers,” the report added.
According to the paper, the following will be challenge areas associated with the use of home healthcare equipment:
“Adapting to these changes will initially require additional work on the part of the manufacturers, and may introduce some short-term uncertainty as these changes fall into place," concluded the report. "However, manufacturers who are committed to producing safe and reliable home healthcare products have the potential for significant gains as better educated consumers take greater responsibility for their choices in home healthcare equipment.”
To view the report, click here.
The paper seeks to address the current and anticipated regulatory landscape for manufacturers of home healthcare equipment by examining the new IEC 60601-1-11 standard (requirements for medical electrical equipment and medical electrical systems used in home care applications), and highlights the challenges for manufacturers.
The FDA has predicted that the home healthcare equipment market will grow by 7.4 percent each year through 2016. In April 2010, FDA announced its plan to provide closer oversight of home healthcare equipment in the United States, according to UL, of Northbrook, Ill.
According to UL, FDA’s Medical Device Home Use Initiative will:
- Establish guidelines for manufacturers who seek FDA approval or clearance for devices intended for use in the home;
- Create a home use device labeling repository to provide consumers with direct access to information about marketed devices;
- Partner with home health accrediting bodies to strengthen accreditation criteria related to the use of medical devices in the home;
- Improve data collection and reporting to enhance post-market oversight; and
- Increase agency-sponsored education efforts to provide information about potential safety concerns.
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, UL stated. The FDA's new initiatives also will increase the collection of data regarding unsafe products, while enhancing safe-use education for patients and caregivers.
“While the use of medical equipment in clinical settings by trained professionals offers some degree of predictability, the operation of healthcare equipment in the home presents a special set of issues and challenges, including many with potential safety consequences to both patients and caregivers,” the report added.
According to the paper, the following will be challenge areas associated with the use of home healthcare equipment:
- Operating environment;
- Caregiver technical knowledge and ability; and
- Device usability.
“Adapting to these changes will initially require additional work on the part of the manufacturers, and may introduce some short-term uncertainty as these changes fall into place," concluded the report. "However, manufacturers who are committed to producing safe and reliable home healthcare products have the potential for significant gains as better educated consumers take greater responsibility for their choices in home healthcare equipment.”
To view the report, click here.