Navigation Links
FDA Tightens Oversight of Home Medical Devices
Date:4/20/2010

As more patients use portable ventilators, dialysis machines, agency says safety an issue,,

TUESDAY, April 20 (HealthDay News) -- As the population ages and medical technology improves, more people are using complex medical devices such as dialysis machines and ventilators at home, adding to the need for better-educated patients.

To meet this growing need, the U.S. Food and Drug Administration announced Tuesday that it has started a new program to ensure that patients and their caregivers use these devices safely and effectively.

"Medical device home use is becoming an increasingly important public health issue," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health said during an afternoon news conference.

The U.S. population is aging, and more people are living longer with chronic diseases that require home care, he added. "In addition, more patients of all ages are being discharged from the hospital to continue their care at home," Shuren noted.

Meanwhile, medical devices have become more portable and sophisticated, making it possible to treat and monitor chronic conditions outside the hospital. "A significant number of devices including infusion pumps, ventilators and wound care therapies are now being used for home care," he said.

Given the growing number of home medical devices, the agency plans on developing procedures for makers of home-care equipment. Procedures will include post-marketing follow-up, and other things that will encourage the safe use of these devices.

The FDA is also developing educational materials on the safe use of these devices, the agency said.

According to Shuren, there are no clear regulations for complex medical devices used in the home.

Devices not made specifically for the home can pose a safety problem, he noted. "There may be environmental or safety hazards that can affect a device's performance, including the presence of pets, sanitation issues and electromagnetic interference from home wireless networks or even video games that can disrupt the function of a medical device," Shuren explained.

The agency has already received reports of medical device-linked adverse events that have occurred in the home. "And due to widespread underreporting, it is likely just the tip of the iceberg," Shuren said.

For example, a dialysis machine became blocked by cat dander and would not function, he said. In another case, a ventilator whose alarm could not be heard in the home caused the ventilator to fail, resulting in injury and death. "We do have such examples," he said.

To deal with these problems the agency plans to:

  • Develop recommendations for approval of these devices, including testing with home caregivers and patients.
  • Develop FDA's authority to require that certain devices are labeled as cleared for home use.
  • Develop post-market procedures to track and address adverse events in the home.

In addition, the agency is launching a 10-month pilot program this summer to get manufacturers to voluntarily submit their labeling to the agency for posting on a central Web site, Shuren noted.

This could help patients and caregivers to quickly find important safety information about their devices, he added.

The FDA is already citing manufacturers on potential trouble from at-home devices. On Monday, the agency sent letters to makers of negative-pressure wound therapy devices indicating that they will have to start including testing their devices specifically for home use and labeling them accordingly or stating that the device is not for home use, Shuren said.

"By providing greater assurance of the safety and safe use of medical devices in the home, FDA hopes to support the tremendous promise of home health care to provide patients with more comfort, convenience and independence in their medical care," Shuren said.

More information

For more information on home medical devices, visit the U.S. Food and Drug Administration.



SOURCES: April 20, 2010, teleconference with: Jeffrey Shuren, M.D., J.D., director, Center for Devices and Radiological Health, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA Tightens Controls on Anemia Drugs
2. Americas Prostate Cancer Organizations Offer Pointers to House Committee on Oversight and Government Reform
3. Actuaries Say Base Health Insurance Oversight on Actuarial Principles
4. Airway Obstructions Have High Death Rate for Young Children, According to New Research from Children's National Medical Center
5. ELLKAY Launches Electronic Medical Records (EMR) Conversion Division to Healthcare Industry
6. Mount Sinai School of Medicine Ranked in the Top 20 Best Medical Schools by US News & World Report
7. Respiratory Therapist School, Pima Medical Institute, Donates Time, Money to American Lung Association
8. First Retail Branded Edible Medical Marijuana Product Line Introduced at San Francisco Trade Show
9. Gurnick Academy of Medical Arts, Radiologic Technology Program Earns JRCERT Accreditation
10. Allegheny Medical's Occupational Health Services Helps Employers Build a Healthier Workforce
11. Exclusive Medical Organization, The Leading Physicians of the World Negotiates Equipment Contracts on Their Members Behalf
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... ... March 24, 2017 , ... Empower Brokerage, ... their training and leads programs. , In February, 2017, Empower Brokerage introduced their ... Performance Partners is designed to teach how to maximize their sales efforts, as ...
(Date:3/24/2017)... ... March 24, 2017 , ... “Finding Christ Through Social Media: ... journal chronicling the writer’s path toward true communion with God. “Finding Christ Through ... is the creation of published author Lea Michelle Johnson, a follower of Christ, ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... “Vintage and ... a retired minister and college Bible teacher residing in North Carolina with his wife, ... who have blessed them with six grandchildren. David is also the author of “Shadow ...
(Date:3/24/2017)... ... ... “The Adventures of Joey, The Dog Who Barks at Puddles”: a boisterous story ... fullest, as God intended. “The Adventures of Joey, The Dog Who Barks at Puddles” ... passion for writing, especially about truth and human behavior. , Published by Christian Faith ...
(Date:3/23/2017)... ... ... A recent report from the National Council on Teacher Quality (NCTQ) advocates for ... on a review of GPA and SAT/ACT requirements at 221 institutions in 25 states, ... that this higher bar should be set by states, by the Council for the ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... , Mar 23, 2017 Research and ... Analysis & Trends - Industry Forecast to 2025" report to ... ... of around 6.9% over the next decade to reach approximately $3.5 ... estimates and forecasts for all the given segments on global as ...
(Date:3/23/2017)... , March 23, 2017 The ... ageing population, increasing diabetic population, accelerating economic growth and increasing ... this industry are higher life expectancy of ESRD patients, rising ... emerging markets. However, the expansion of the market is hindered ... ...
(Date:3/23/2017)... , March 23, 2017  Transportation Insight, a multi-modal ... end-to-end supply chain management firm with expertise serving clients ... Solutions Rick Zaffarano was named a 2017 ... Supply Chain by the only publication exclusively dedicated to ... supply chain. "Rick has brought to Transportation ...
Breaking Medicine Technology: