May 11, 2010

FDA Pushes Oversight of Devices

Filed under: Uncategorized — ktetaichinh @ 4:10 pm

With hospitals discharging patients after ever-shorter stays, more people are recovering and continuing post-operative care, or treating chronic conditions, with sophisticated medical equipment at home.

The Food and Drug Administration is raising a red flag, calling for greater oversight of devices such as dialysis machines, ventilators, infusion pumps and IV machines—which are increasingly operated by patients, family members and other minimally trained caregivers.

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Graham family photo

Five-year-old Kaelyn Graham has used feeding tubes, catheters and other medical devices since birth.

Complex and often confusing, the devices can represent a serious health risk for patients at home. From 1997 through 2009, the FDA says it has received more than 19,000 reports of adverse events involving medical devices used in homes, including fatalities in children on ventilators where tubing became disconnected 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.
Safety Steps

To heighten the safety of patients who rely on at-home medical devices, the Food and Drug Administration says it plans to:

* create guidelines for manufacturers
* develop an online library of device instructions, written for family members and other lay caregivers
* work with associations and accrediting bodies on training workers in how to teach patients and family members to use medical devices

* consider labeling and testing standards to address home use of medical devices

Source: the FDA

Jolanda Graham has cared for her daughter, Kaelyn, since her birth with a heart defect in 2004 and has learned to manage several challenging medical devices at home. She brought her two-month-old baby home from the hospital with a feeding tube going in her nose and down her esophagus. Each time she 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’d have to reposition the tube—waiting for Kaelyn to swallow, between cries, so the tube could 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,” Mrs. Graham says. “But when you’ve been at the hospital for two months, you’ll do anything to go home.”

A home nurse visited once to show Mrs. Graham how 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 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. The nurse didn’t leave written instructions.

In the years since, Mrs. Graham has mastered a variety of feeding tubes, nutrition-delivery devices and even, at times, oxygen tubes. (Kaelyn has undergone 17 surgeries for her heart defect and gastrointestinal problems, but her heart is still failing. On April 28, she will start the process of becoming wait-listed for a heart transplant.)

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 antiotics 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. Another patient who had incorrectly connected lines for overnight dialysis was discovered by her husband in the morning to be unresponsive and died of blood loss.

The FDA’s planned guidelines will help manufacturers design simplified versions of hospital devices for home use and spell out tests and other requirements for new devices seeking FDA approval. The agency also wants to establish on its Web site a library of labels and instruction manuals written for non-medical caregivers.Jeffrey Shuren, head of the FDA’s devices division, says these devices would have to be tested with patient-users. “What we are seeing is an explosion in home health care,” he says. “We want to facilitate the development of devices in the home.”The shift to health-care at home is expected to accelerate as the population ages and the system is pressured to save money. For example, the cost of delivering antibiotics intravenously at home can be nearly $8,000 less per patient per month compared with doing so in a hospital, according to 2008 data from the National Association for Home Care & Hospice cited by the FDA.

Write to Jennifer Corbett Dooren at


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