FDA Seeks Greater Oversight Of Medical Devices For Home Use

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FDA Seeks Greater Oversight Of Medical Devices For Home Use 

   By Jennifer Corbett Dooren
   Of DOW JONES NEWSWIRES
 

WASHINGTON (Dow Jones)--The Food and Drug Administration is calling for greater oversight of medical devices for home use, as hospitals discharge patients after ever-shorter stays and more people continue post-operative care or treat chronic conditions with sophisticated medical equipment at home.

On Tuesday the agency plans to announce an initiative aimed at increasing safety for home users of medical devices. Some of these devices, including certain kidney dialysis machines, have FDA approval specifically for home use. But most others, such as infusion pumps that deliver medication intravenously, were approved for use by medical personnel in hospitals--not by an average person in an environment where factors ranging from children to humidity to pet fur to noise can compromise a device's effectiveness.

From 1997 through 2009, the FDA says it received more than 19,000 reports of adverse events involving medical devices used in homes, including fatalities in children on ventilators where tubings became disconnected at home.

Jeffrey Shuren, head of FDA's devices division, said the new initiative aims to facilitate the development of devices designed specifically for home use.

"What we are seeing is an explosion in home care" often with the use of devices designed for hospital use, Shuren said.

During the next year the agency will develop guidelines to help manufacturers design simplified versions of hospital devices for home use and spell out tests and other requirements for new devices seeking FDA approval. Devices approved for home use would have to be tested using patients rather than medical professionals.

Shuren also said the agency wants to establish on its Web site a library of labels and instruction manuals written for non-medical caregivers.

Many caregivers like Jolanda Graham, a former accountant, learned to use complex medical devices with just a few training sessions from a nurse. Graham, who now lives in Lithia, Fla., has been caring for her daughter Kaelyn since she was diagnosed with a heart defect soon after her birth in 2004.

At two months old, Kaelyn was discharged after her first open heart surgery at UCLA Mattel Children's Hospital and sent home with a feeding tube going in her nose and down her esophagus. Each time Jolanda fed Kaelyn, she had to check that the tube was properly placed by attaching a syringe to the end of the feeding tube and seeing if it could draw up stomach acid. Sometimes she would have to reposition the tube--waiting for Kaelyn to swallow, between cries, so the tube can be moved. If placed incorrectly, the tube would send food into the lungs instead of the stomach.

"When I looked back I was sort of alarmed that I was doing it," Graham says. "But when you've been at the hospital for two months, you'll do anything to go home."

Another time Graham had to administer antibiotics. The daily routine of disconnecting, cleaning and reconnecting the tube delivering medication from the infusion pump to the catheter in her daughter's chest was "truly scary," she recalls. She had to hold the then two-year-old still while cleaning the surrounding area with alcohol wipes, then flush the tube with a drug, check to make sure there were no air bubbles, reconnect it and tape it down to her daughter's chest.

Each year, an estimated 7.6 million patients receive home health-care from one of 17,000 agencies; an unpaid family caregiver is present in approximately 36 million households. While there are no hard figures on how many rely on medical devices, FDA officials say a majority use some type of device--whether it's an infusion pump to deliver antibiotics or chemotherapy, a kidney dialysis machine or a ventilator or other respiratory-support device.

When these devices fail or are used improperly, the results range from frustrating to tragic. The FDA cites a report of a patient who forgot to remove a cap from the line on a drug infusion pump; the medication flow was blocked and the patient was hospitalized. In another case, cat fur in a patient's kidney dialysis tubing entered the patient's body and caused peritonitis, a potentially life-threatening infection of the membrane that lines the organs inside the abdomen.

Shuren said he hopes such problems can be reduced or eliminated as manufacturers design new products to be used in the home setting.

 

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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