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, i
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved

Page: 1 2 3

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:4/23/2014)... University researchers have developed a way to detect and ... tiny gold particles with tails of synthetic DNA., A ... biological engineering, used gold nanoparticles to target and bind ... RNA splice variants, which can indicate the presence and ... splice variants in a cell can be determined by ...
(Date:4/23/2014)... area of the gastro-intestinal tract has long been considered ... at the Sahlgrenska Academy have used refined microscopic techniques ... inner surface of the gastro-intestinal tract is only as ... Fndriks. , The digestive tract, which passes from the ... has a length of about 5 meters in a ...
(Date:4/23/2014)... and accessible detection methods that can rapidly screen ... a single cell inside that population has been ... Lu. , In the Royal Society of Chemistry ... that he and his coworkers have developed a ... a protein ( Chem. Sci. , 2014, DOI: ...
(Date:4/23/2014)... vegetables are often displayed in the popular Swedish ... plenty of high-sugar foods. A new study from ... portrayed in children,s TV programmes as well as ... habits and weight status. , Steingerdur Olafsdottir,s doctoral ... the popular Swedish children,s TV show Bolibompa. Healthy ...
(Date:4/23/2014)... of scientists led by a researcher from the Cancer ... University of Singapore has identified the cancer specific stem ... the possibility of developing new drugs for the treatment ... The research group, led by Dr Chan Shing Leng, ... first time that a cancer-specific variant of a cell ...
Breaking Medicine News(10 mins):Health News:Gold nanoparticles help target, quantify breast cancer segments in a living cell 2Health News:The surface area of the digestive tract 'only' as large as a studio apartment 2Health News:Following a protein's travel inside cells is key to improving patient monitoring, drug development 2Health News:High-calorie and low-nutrient foods in kids' TV 2Health News:Scientists identify cancer specific cell for potential treatment of gastric cancer 2Health News:Scientists identify cancer specific cell for potential treatment of gastric cancer 3
... and emerging biomedical approaches to HIV/AIDS prevention will be ... sponsored by the UCSF-Gladstone Institute for Virology and Immunology ... for AIDS Prevention Studies. , "Defining new biomedical approaches ... high priority. This symposium will provide a timely ...
... Blue Shield of Michigan supports physical activity and nutrition ... More than 16,600 Michigan children and their local communities ... and other physical activities and to learn to eat ... of Michigan.They,ll join youngsters like those at Detroit,s Maybury ...
... 94 percent BENTONVILLE, Ark., Feb. 13 Wal-Mart Stores, Inc., ... of associates who have health care coverage through its benefits ... percent to 94.5 percent. Over 733,000 or 51.8 percent of ... total - were covered by Wal-Mart,s plans at the end ...
... says the dark kind protects against cancer, along with being ... chocolate to your Valentine might be more than sweet; it ... great news this Valentine,s Day is that in addition to ... play a role in cancer prevention," Sally Scroggs, a health ...
... (Nasdaq:, EMAG ), a leader in enterprise medical ... today that it has received the,$9 million that had ... York Mellon by,Health Systems Solutions, Inc. (OTC Bulletin Board: ... escrowed funds became payable to Emageon,when the merger was ...
... electronic medical records to be provided at locations ... has entered into a clinical collaboration with MinuteClinic, ... care in the United States, at several locations ... which provide a convenient, seven-day-a-week option for those ...
Cached Medicine News:Health News:UCSF symposium considers biomedical approaches to HIV/AIDS prevention 2Health News:Schools Receive Grants to Help Kids be Active, Eat Healthy 2Health News:Schools Receive Grants to Help Kids be Active, Eat Healthy 3Health News:Schools Receive Grants to Help Kids be Active, Eat Healthy 4Health News:Schools Receive Grants to Help Kids be Active, Eat Healthy 5Health News:Schools Receive Grants to Help Kids be Active, Eat Healthy 6Health News:Wal-Mart Health Care Benefits Enrollment Rises, Uninsured Rate Declines 2Health News:Wal-Mart Health Care Benefits Enrollment Rises, Uninsured Rate Declines 3Health News:Chocolate for Your Valentine a Healthy Idea 2Health News:Emageon Receives Escrowed Funds and Terminates Merger Agreement 2Health News:Emageon Receives Escrowed Funds and Terminates Merger Agreement 3Health News:Cleveland Clinic Enters into Agreement with MinuteClinic 2Health News:Cleveland Clinic Enters into Agreement with MinuteClinic 3Health News:Cleveland Clinic Enters into Agreement with MinuteClinic 4
(Date:1/15/2014)... Jan. 15, 2014  Research and Markets ( http://www.researchandmarkets.com/research/6k27gw/dental ) ... Market - Global Industry Analysis, Size, Share, Growth, Trends ... offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ... used on patients in order to treat dental impairments, ...
(Date:1/15/2014)... OAKS, Calif. , Jan. 15, 2014 ... Amgen (NASDAQ: AMGN ) announced today ... jointly discover and validate new therapeutic targets and ... a chronic disorder that affects millions worldwide. The ...
(Date:1/15/2014)... 15, 2014  In an unprecedented effort to curb the spread of ... other transport vehicles, an advanced and portable UV germicidal lamp manufactured ... first time. In order to prevent EMS paramedics ... West Palm Beach Fire Rescue is the ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 4Superbugs No Longer Ride In Rescue Vehicles 2
... Young Innovations, Inc. (NASDAQ: YDNT ) today announced ... 2012.  Sales for the first quarter of 2012 ... in the first quarter of 2011. Income from operations increased 5.3% ... million in the first quarter of 2011. Net income increased 5.6% ...
... April 23, 2012  This week COPAN launched videos ... The new videos were created for the Centers ... to be used in a web based course ... for healthcare providers.  The educational videos show proper ...
Cached Medicine Technology:Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012 2Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012 3Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012 4COPAN Produces CDC/Joint Commission Educational Specimen Collection Videos 2
Standard Deflectable Catheters...
... Quadripolar Multilumen Shaft Fixed ... The Medtronic CardioRhythm ... for use in diagnostic ... is designed for recording ...
... H Steerable Catheter. Steerable atrial ... of designs and a unique ... 10 to 24 electrodes, regular ... and active tip electrodes, and ...
The Polaris-DX steerable diagnostic catheter is designed for comfort and ergonomic handling during mapping procedures....
Medicine Products: