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:6/24/2017)... ... June 24, 2017 , ... Dr. ... 217 Portion Road in Lake Ronkonkoma, Dental365 offers patients high-quality and affordable routine ... visits to the dentist fit into their patients’ busy lifestyles. Dental365 also gladly ...
(Date:6/23/2017)... ... 2017 , ... "The Better Care Reconciliation Act (BCRA) falls ... people with all chronic conditions, including mental illnesses, while increasing the cost of ... Care Act (ACA) requirement that insurers cover pre-existing conditions, it does not require ...
(Date:6/23/2017)... ... 2017 , ... The Military Officers Association of America (MOAA) announced its support ... retired Marine Col. Thomas G. Bowman. , Bowman currently serves as the staff director ... with the issues and challenges veterans face with the VA. Following a 30-year career ...
(Date:6/23/2017)... ... June 23, 2017 , ... Goodcents Deli Fresh Subs today announced the opening ... 4210 SW 21st St. Topeka, Kan. 66604 (near 21st and Gage). It is owned ... owns three other locations in the Topeka and Bonner Springs, Kan. area. , ...
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and South ... selected 21 leaders from government, business and civil society in 11 countries across the ... this fall, engaging in a transformative exchange of knowledge and ideas with the leading ...
Breaking Medicine News(10 mins):
(Date:6/7/2017)...  Diplomat Specialty Infusion Group, a brand of Diplomat Pharmacy, Inc. ... Iowa location. The Iowa ... an ISO 7 cleanroom—the standard needed to compound intravenous (IV) nutrition ... of pollutants. "Our new cleanroom ... serve our Iowa patients," said Phil ...
(Date:6/1/2017)... 2017 Nutriceutical Holdings (NH), parent company of ... and KD Pharma Group have decided to join forces ... Pharma Group. KD Pharma Group will become the largest ... the entire company. "We believe we have ... to growing the NH companies by providing us with ...
(Date:5/26/2017)... 2017  Endo International plc (NASDAQ: ENDP ) ... will represent the Company in a fireside chat at Goldman ... June 13, 2017 at 10:40 a.m. PT / 1:40 p.m. ... Rancho Palos Verdes, CA. ... be available on the Company,s website at http://www.endo.com/investors/overview . ...
Breaking Medicine Technology: