FDA eyes home-based medical equipment for regulation

"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 Wall Street Journal reports. "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." Because of the complexity involved in using these devices at home, they can become a serious health risk. "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." The agency will announce an initiative Tuesday to step up safety for these devices (Dooren, 4/20).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.