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:6/26/2016)... N.J. (PRWEB) , ... June 27, 2016 , ... Quality ... sources, yet in many ways they remain in the eye of the beholder, according ... (EBO), a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
(Date:6/23/2016)... 2016 Any dentist who has made an implant ... process. Many of them do not even offer this as ... high laboratory costs involved. And those who ARE able to ... a high cost that the majority of today,s patients would ... Parsa Zadeh , founder of Dental Evolutions Inc. and inventor ...
(Date:6/23/2016)... Ill. , June 23, 2016  In a startling report ... are failing their residents by lacking a comprehensive, proven plan to ... a definitive ranking of how states are tackling the worst ... to only four states – Kentucky , ... Vermont . Of the 28 failing states, three ...
Breaking Medicine Technology: