FDA: Environment, user issues among risks in home medical devices
Home use medical devices are intended for patients to use in any environment, however, for that very reason they pose a number of risks and challenges which should be addressed by users and regulators, according to information provided in an FDA webinar July 28.
There are nearly 17,000 home care organizations, roughly 15,000 distributors of medical equipment and more than 7.6 million people in home care, explained Mary Weick-Brady, MSN, RN, senior policy analyst at the FDA's Center for Devices and Radiological Health (CDRH). That costs an average of $57 billion annually.
Of those receiving home care, 75 percent receive skilled nursing, in addition to self and caregiver care. Estimates figure that in 20 years, there will be close to 72 million people older than the age of 65 in the U.S. In addition to the elderly, newborns, people with chronic conditions and temporary medical users are included in the demographic of home medical care, Weick-Brady noted.
The FDA definition of a home medical device is one “that is intended for users in any environment, apart from the professional healthcare facility or emergency medical services, and may require training for the user by a qualified healthcare professional to assure safe and effective use.
"In a nutshell, a medical device is something used to diagnose, treat or prevent disease,” Weick-Brady said, noting examples such as over-the-counter diagnostic tests, computer systems and even implants. Not to be excluded, the FDA is also currently working to establish guidelines for the medical use of wireless technology as well.
Outside of a clinical setting, the use of medical devices is subject to risk factors not normally present. “There are a lot of risks in the home environment,” Weick-Brady said. “You could have children that can injure themselves with accessories such as needles; they could use devices as toys; or they could try to operate devices themselves, changing the settings along the way.”
Other home risk factors include: electromagnetic interference, remote locations, noise and pets.
“As a nurse, I’ve seen squirrels and other rodents chewing on tubing, roaches in equipment and pets sitting next to a patient [while] doing open wound care or dialysis,” she said. Other factors include sanitation, temperature, humidity, storage and water.
In addition to considering the home environment, Weick-Brady said device manufacturers and providers need to consider individual abilities when it come to the use of a device, including but not limited to educational level, emotional stability and physical capabilities.
In April 2010, the CDRH moved ahead with policy to address risks with medical devices used in the home. There are five initiatives, according to Weick-Brady:
There are nearly 17,000 home care organizations, roughly 15,000 distributors of medical equipment and more than 7.6 million people in home care, explained Mary Weick-Brady, MSN, RN, senior policy analyst at the FDA's Center for Devices and Radiological Health (CDRH). That costs an average of $57 billion annually.
Of those receiving home care, 75 percent receive skilled nursing, in addition to self and caregiver care. Estimates figure that in 20 years, there will be close to 72 million people older than the age of 65 in the U.S. In addition to the elderly, newborns, people with chronic conditions and temporary medical users are included in the demographic of home medical care, Weick-Brady noted.
The FDA definition of a home medical device is one “that is intended for users in any environment, apart from the professional healthcare facility or emergency medical services, and may require training for the user by a qualified healthcare professional to assure safe and effective use.
"In a nutshell, a medical device is something used to diagnose, treat or prevent disease,” Weick-Brady said, noting examples such as over-the-counter diagnostic tests, computer systems and even implants. Not to be excluded, the FDA is also currently working to establish guidelines for the medical use of wireless technology as well.
Outside of a clinical setting, the use of medical devices is subject to risk factors not normally present. “There are a lot of risks in the home environment,” Weick-Brady said. “You could have children that can injure themselves with accessories such as needles; they could use devices as toys; or they could try to operate devices themselves, changing the settings along the way.”
Other home risk factors include: electromagnetic interference, remote locations, noise and pets.
“As a nurse, I’ve seen squirrels and other rodents chewing on tubing, roaches in equipment and pets sitting next to a patient [while] doing open wound care or dialysis,” she said. Other factors include sanitation, temperature, humidity, storage and water.
In addition to considering the home environment, Weick-Brady said device manufacturers and providers need to consider individual abilities when it come to the use of a device, including but not limited to educational level, emotional stability and physical capabilities.
In April 2010, the CDRH moved ahead with policy to address risks with medical devices used in the home. There are five initiatives, according to Weick-Brady:
- Develop guidelines for manufacturers;
- Establish a home use labeling repository;
- Partner with home health accrediting agencies;
- Enhance post market oversight; and
- Increase public awareness and education.