Getting medical treatment at home can be a great option for families facing long-term care, but it comes with some risks. Getting treatment at home means that patients and caregivers often have to learn how to use complicated and sensitive equipment, and mistakes or equipment malfunctions can be fatal. Recently, a home dialysis machine was recalled after it filled a man’s abdominal cavity with fluid, killing him.
As a result of this and other faulty or confusing medical devices used at home, heath regulators are becoming painfully aware of the need for adequate education and checks to make sure equipment is safe and performing properly.
Out of the Hospital
About 7 million Americans receive some sort of health care at home, according to the National Association for Home Care & Hospice. And much of the longer-term at-home recuperation occurs after a hospital stay and requires the use of sophisticated medical equipment.
But without proper checks and precautions, and simply because of faulty products, home medical devices can fail, so proper use, instruction and follow-up checks should be conducted, according to the FDA.
And even if a caretaker is shown how to use the device properly, safety checks and reminders may still be necessary.
Ventilators, intravenous therapy devices, hemodialysis equipment used for kidney failure patients, as well as devices that aid in wound care have all moved into the home as more patients have chosen to conduct long-term treatments in a more familiar environment, according to the FDA. But as treatment responsibilities transfer to family members and home health aids, the devices could stand to be optimized for home use by non-health professionals.
Next month, the FDA will be gathering health care providers, health experts, device makers, patients and patient advocates to discuss concerns and challenges surrounding the use of medical devices at home as well as concerns about potentially faulty devices.
The FDA plans to discuss specific risks that could be present in the home, how a device is incorporated into the home environment, and monitoring the devices for safety.
Medical devices can have software defects, tricky interfaces and instructions, mechanical and battery failures and even fires during regular use, the FDA says.
To make sure home medical devices are being used safely, the FDA plans to conduct post-market surveillance, or checks on the products that have already been sold and are in use.
To accomplish the post-market checks, the agency expects to use HomeNet, part of the FDA’s Medical Device Surveillance Network that collects data on devices used by more than 350 health care providers in the U.S.
The FDA is partnering with the Community Health Accreditation Program and the Joint Commission, which evaluates and accredits 17,000 U.S. health care organizations and programs, to strengthen home health agency accreditation criteria that relate to medical device safe-use practices.