Navigation Links
Consumers Union to Testify for Stronger Medical Device Safety Oversight at House Hearing Today

WASHINGTON, Feb. 15, 2012 /PRNewswire-USNewswire/ -- Lisa Swirsky, senior health policy analyst for Consumers Union, will urge Congress today to strengthen medical device safety oversight in testimony before the House Energy & Commerce Health Subcommittee.  The subcommittee will hold a hearing on the reauthorization of the Medical Device User Fee Act beginning at 10:15 AM in Room 2322 of the Rayburn House Office Building. 

Recent safety problems with metal hip implants and surgical mesh have underscored how lax federal oversight of medical devices fails to protect patients.  Consumers Union has called on Congress to require more rigorous testing before medical implants are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems come to light.

"Congress has the opportunity to fix a flawed system that allows too many unsafe medical devices to enter the market," said Lisa Swirsky, senior health policy analyst for Consumers Union, the nonprofit advocacy arm of Consumer Reports.    "But so far, the debate in Washington has been all about how to make it easier for industry to rush new devices to the market without addressing the need to protect patients from potential safety hazards.  Americans are counting on lawmakers to strengthen the law to ensure timely access to new medical devices without sacrificing patient safety."

In her testimony before the subcommittee, Swirsky notes that the recent user fee agreement negotiated by the U.S. Food and Drug Administration (FDA) and the medical device industry, fails to make any patient safety improvements and falls short of providing the resources needed to meet the increasing demands on the agency.  The FDA had previously indicated that it needed between $770 million and 1.15 billion to implement the performance goals pushed by industry.  Instead, the medical device industry has agreed to $595 million in user fees.   

Swirsky's testimony highlights additional concerns about the agreement, including new performance goals for the FDA that may inhibit the agency's ability to get the information it needs to properly evaluate medical device applications.  Her testimony also raises concerns about potential conflicts of interests involving industry-funded patient groups that could be involved in evaluating new devices.  

In addition, Jim Shull of Browns Mills, New Jersey, will testify at the hearing about his experience as a patient harmed by synthetic mesh used for a hernia operation.  Six years after his operation, Shull is living with daily pain from the mesh that has caused severe nerve damage and other debilitating complications.   

"The mesh that was put inside of me has caused so much damage that none of the nerves can ever be repaired," said Shull.  "Now I face a lifetime of pain and struggle because of it.  Surgical mesh and other medical devices should be tested for safety before they are allowed to be implanted into people like myself."   

For more details on the reforms Consumers Union is urging Congress to adopt, see the Safe Patient Project's Improve the Safety of Medical Devices fact sheet.

SOURCE Consumers Union
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Medco, Castlight Health Integrate Web Tools For Drug And Medical Costs To Empower Consumers and Improve Care
2. AIM Honored for Innovative Program That Helps Consumers Make Better Choices About Their Care
3. PCMA: Governor Cuomos Call to Amend Anti-Mail-Service Pharmacy Law Protects Employers and Consumers
4. Consumers Union Urges Congress to Strengthen Medical Device Oversight
5. FTC Study Finds that in FY 2011, Pharmaceutical Industry Continued to Make Numerous Business Deals that Delay Consumers Access to Lower-Cost Generic Drugs
6. Savvy Medicare Consumers Can Save Hundreds During Medicare Open Enrollment
7. FDA Participates in Global Efforts to Protect Consumers and Patients from Unsafe Drugs on the Internet
8. Healthy Advice® Networks Partners With MediaForce PR to Deliver Public Service Announcements to Educate Consumers About Appropriate Use of Prescription Medications
9. Unrestricted Access to Advanced Imaging a Top Priority for Consumers
10. Win for Consumers and Payers: Maine Repeals Costly PBM Fiduciary-Disclosure Law
11. CVS/pharmacy Encourages Consumers to Consult With Pharmacists
Post Your Comments:
(Date:6/23/2016)... June 23, 2016 Capricor ... ), a biotechnology company focused on the discovery, ... that patient enrollment in its ongoing randomized HOPE-Duchenne ... exceeded 50% of its 24-patient target. Capricor expects ... third quarter of 2016, and to report top ...
(Date:6/23/2016)... NORTHBROOK, Ill. and BOGOTA, Colombia , June 23, 2016  Astellas today announced the ... joins Astellas Farma Brasil as the company,s second affiliate in Latin America . ... ... appointed General Manager of Astellas Farma Colombia ... ...
(Date:6/23/2016)... , June 23, 2016  Experian Health, ... and transforming the patient payment and care ... innovative new products and services that will ... revenue cycle offerings. These award-winning solutions will ... workflows, remain compliant in an ever-changing environment ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal ... personalized through a fitness app. The fitness app plans to fix the two major problems ... offer a one size fits all type program , They don’t eliminate all ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to a ... new, often overlooked aspect of head lice: the parasite’s ability to live away from a ... occurrence, but a necessary one in the event that lice have simply gotten out of ...
(Date:6/25/2016)... ... 2016 , ... First Choice Emergency Room , the largest network of ... Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased to ... said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
Breaking Medicine News(10 mins):