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:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
(Date:6/24/2016)... ... 2016 , ... Comfort Keepers® of San Diego, CA is excited to announce ... program to drive cancer patients to and from their cancer treatments. Comfort Keepers ... of life and ongoing independence. Getting to and from medical treatments is one ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... is actively feeding the Frederick area economy by obtaining investment capital for emerging ... the past 2½ years that have already resulted in more than a million ...
(Date:6/24/2016)... ... June 24, 2016 , ... Today, MTI-GlobalStem, a provider of ... other difficult to transfect cells, announces its launch of the PluriQ™ G9™ Gene ... System is a complete system for culturing and transfecting human pluripotent stem ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016 Research and ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" report ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, ... Structural electronics involves electronic and/or electrical components ... replacing dumb structures such as vehicle bodies or ...
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
(Date:6/23/2016)... , June 23, 2016 Research ... Devices Global Market - Forecast to 2022" report to ... the treatment method for the patients with kidney failure, it ... excess fluid from the patient,s blood and thus the treatment ... potassium and chloride in balance. Increasing number ...
Breaking Medicine Technology: