FDA Recommends New Testing Standards for Home Use Devices | RAPS

FDA Logo for the CDRH“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable.

Background

In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers.

The latter category, often referred to as “home use devices,” is associated with a unique set of concerns compared to its professional use counterparts. Because the devices are typically used frequently by those without medical training, FDA has taken an interest in making sure that they are designed appropriately for use within the home.”

Read the full article: via FDA Recommends New Testing Standards for Home Use Devices | RAPS.

Read the final FDA guidance:
Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF)


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Prolonged Power Outages Can Be Deadly for People Who Rely on Durable Medical Equipment | Huffington Post

English: Biloxi, Miss., September 4, 2005 -- T...

FEMA/Mark Wolfe (Photo credit: Wikipedia)

“Already this year, American communities have experienced floods, tornadoes and wildfires. Our country needs a better way to protect medically fragile people so natural disasters don’t become medical emergencies.

Thousands of people in the United States rely on electrically powered DME to meet their medical needs at home. While they can manage their medical conditions well on a day-to-day basis, in prolonged power outages, that’s when they need our help the most.

Each of us can make a difference during emergencies for people whose lives depend on electrical medical equipment. If you use electrically-powered medical equipment or care for someone who does, please take action today to be prepared for power outages.”

Read the full article: via Prolonged Power Outages Can Be Deadly for People Who Rely on Durable Medical Equipment | Nicole Lurie, M.D., M.S.P.H..


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