Navigation Links
Scrutiny Sought For Reused Devices in U.S.

A key member of the U.S. Congress called on Monday for more rigorous federal monitoring of reuse of single-use instruments.//

The Food and Drug Administration (FDA) has been monitoring the industry -- called reprocessing -- but significant gaps remain, according to Rep. Rosa L. DeLauro (D-Conn.), the ranking Democrat on the House Appropriations subcommittee that oversees the FDA.

Reprocessing is a growing industry believed to serve hospitals in all 50 states and at least eight medical facilities in the Washington area.

Device manufacturers refuse to guarantee the safety of their reconditioned single-use devices, but reprocessors deny any credible evidence that use of their refurbished devices carry a higher risk than new ones. They also say no surgery is without risk.

Many hospitals which reuse processed equipment cite the practice's safety and cost savings.

DeLauro, however, expressed concerns about the FDA's role. She wants the FDA to increase the number of inspectors assigned to reprocessors; now, there is no set number. She also said she plans to address the issue in an appropriations bill next year and possibly call for a hearing on the matter.

FDA relies on doctors to voluntarily report problems with faulty medical devices, and medical facilities are required to report to the FDA deaths, but not device malfunctions.

Naomi Halpern, an attorney for the Association of Medical Device Reprocessors, said the group "looks forward to working with Congresswoman DeLauro as she develops legislation affecting the regulation of the medical device industry."

The FDA said that prior to 2000 it did little to oversee reprocessors other than inspect their facilities and require them to follow good manufacturing practices.

Now, it requires reprocessors to submit data to validate that their work produces safe devices. In a statement, the FDA said it "provides stringent regulatory oversight" and "wi ll act swiftly" if reprocessors do not comply with its requirements.
'"/>




Related medicine news :

1. Fentanyl Narcotic Pain Patch under Scrutiny
2. Bausch & Lomb Facility under Scrutiny
3. Use of Nanoparticles in Sunscreen under Scrutiny
4. Solutions Being Sought For Prevention Of Rickets
5. Dosage Of Tamiflu Sought To Be Increased
6. Muslim Leaders’ Help Sought To Discourage Smokin
7. Health Service Reform Planned To Cut Bureaucracy: Public Opinion Sought
8. PMs Intervention Sought To Implement Ban On Smoking In Films
9. Speedier Access To Advances In Breast Cancer Sought For Patients
10. Nurses Help Sought To Check Teenage Pregnancies In English Schools
11. Psychiatrists Help Sought to Counsel Children Making Hoax Calls
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... 2017 , ... Apple Rehab Shelton Lakes , which specializes in the ... facility as part of a disaster drill on October 3rd. , Apple Rehab participated ... Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid Plan ...
(Date:10/13/2017)... ... 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out ... free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting ... children of all ages; it is a non-competitive, non-timed event, which is all about ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... 12, 2017 , ... Planet Fitness, one of the largest and fastest growing ... open a flagship location in Covington, LA at 401 N. U.S. Highway 190, in ... to Office Depot in the Holiday Square shopping center. Its location allows it to ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized ... have expanded their existing home health joint venture through an agreement, effective October ... a joint venture home health company with Asante, delivering clinically integrated care, for ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global digital ... its MyDario product is expected to appear on The Dr. Oz Show ... Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz Show kicked off ... The segment features ...
(Date:9/23/2017)... -- Janssen Biotech, Inc. (Janssen) announced today that it ... Food and Drug Administration (FDA) for the Biologics License ... of moderately to severely active rheumatoid arthritis (RA). The ... to further evaluate the safety of sirukumab in the ... "We are disappointed by ...
(Date:9/19/2017)... , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company developing a ... targeted tissues, announced three leadership team developments today:   ... ... ... Veteran medical device executive Josh Stopek , ...
Breaking Medicine Technology: