In January 2007 I underwent cabx5, an aneurysm repair in left ventricle of my heart, where a bi-ventricular pacemaker was inserted. According to my medical records, my doctor found the aneurysm in the left ventricle in 2004, and in 2005 in the stress test, and never told me about it. I am permanently disabled.
Medical Device Safety
Some medical devices are simple, basic items like tongue depressors and alcohol swabs, while others, like hip replacements and heart valves, are permanently implanted or life-sustaining. Consumers Union supports a strong FDA oversight system that ensures that medical devices are safe and effective before they are sold and monitors devices to make sure they are not harming patients.
Consumers Union Documents
- Consumers Union’s comments of FDA Reclassification of Metal on Metal Hip Implants
- Real People, Real Stories: Diane’s knee replacement story
Diane of Longmont, CO shared her knee replacement story with Consumers Union. Diane had a terrible experience with her initial knee replacement and is worried about what the future holds.
- Consumer Reports: FDA cracks down on all-metal hip replacements
Manufacturers who want to keep selling all-metal hips will have to prove that they’re safe and effective, according to proposed new rules from the Food and Drug Administration.
- Consumers Union Comments on the Proposed Rule, “Unique Device Identification System”
CU strongly supports the implementation of the unique identifier for medical devices. The adoption of a Unique Device Identification (UDI) System has the potential to improve the safety of devices used by consumers as well as to promote many significant public health objectives. A well-implemented UDI system will help consumers to more easily find information about their implant/device’s safety record and to more precisely report problems that they are experiencing.
- Consumer Reports: What to do after a hurricane if you use a home medical device
If you rely on electricity for home medical equipment like an oxygen tank, ventilator, medical bed, wheel chair, or blood glucose monitor, losing power can be much more than an inconvenience.
Consumers Union News Releases
- Consumers Union Urges FDA To Require Safety Testing of Metal on Metal Hips and Other High Risk Implants
Consumers Union urged the U.S. Food and Drug Administration today to adopt a proposed rule requiring metal hip implants to be reviewed through the agency’s premarket approval (PMA) process to prove that the devices are safe and effective.
- FDA Proposes Unique Device Identification Regulations for Medical Device
New system could help consumers of implantable life-sustaining devices access recall and other safety information about their specific device with a unique identifier system.
- Senate to Vote on Final FDA User Fee Bill As Early As Today
Bill Makes Some Improvements To Medical Device Oversight But Falls Short of Giving The FDA The Tools It Needs to Protect Patients
- House and Senate Leaders Announce FDA User Fee Act Compromise Bill
Bill Includes Patient Safety Provisions From Senate-Passed Version And Some Measures Opposed By Consumer Groups; House Vote On FDA User Fee Bill On Wednesday, June 20
- CU pushes medical device reforms in final FDA bill
Consumers Union urges lawmakers to adopt stronger patient safety provisions from Senate version of the FDA User Fee Act
- We’re live blogging at Selling Sickness!
Consumers Union’s Safe Patient Project is here in DC at the Selling Sickness conference, and we’ll be live blogging speaker panels while we’re here. Just come back to this page to see our live updates.
- Heartbreaking news: Child discovers 2nd recall connected to her defibrillator
9-year-old child, Avery de Groh, faces a scary situation: having a recalled defibrillator which the family found out by accident. This is the second time that Avery’s family has been affected by a recalled defibrillator. Last year, Avery’s mother, Molly, shared her daughter’s story about how she was shocked by a defective defibrillator at age three and thought monsters were attacking her. Her device was later recalled by the manufacturer.
- Advocates share medical device dangers in presentation at University of Texas
Medical device safety advocates, Lana Keeton and Joleen Chambers, share their personal stories of medical device harm and the need to be informed, in a presentation at the University of Texas in Austin.
- Update: 2012 Medical devices safety law pros and cons
Many of us like to think we could live forever. And with today’s technology, a medical device – hip replacement, heart valve, artificial knee – seems to put ‘forever’ a lot closer within reach.
- Consumers Union Comments to FDA Advisory Panel on Metal-on-Metal Hip Implants
Lisa McGiffert, Director of Consumers Union’s Safe Patient Project comments to the FDA advisory panel on metal-on-metal hips, June 28, 2012.
- J&J Will Stop Sales of Metal-on-Metal Hip Replacements Source: Bloomberg (Friday May 17, 2013)
Bloomberg reports: “Johnson & Johnson (JNJ), the world’s biggest maker of health-care products, said it will stop selling metal-on-metal and ceramic-on-metal hip replacements as demand wanes for the devices and U.S. regulators seek new rules.”
- J.&J. Unit Phasing Out All-Metal Hip Devices Source: New York Times (Thursday May 16, 2013)
NY Times: “The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industrywide trend to abandon the once widely used implants because of high early failure rates.”
- J&J will abandon metal hip replacement sales Source: Fierce Medical Devices (Thursday May 16, 2013)
J&J announced it will discontinue selling its metal-on-metal and ceramic-on-metal hips by the end of 2014. Consumers Union has voiced major patient safety concerns with metal-on-metal hip implants after hearing from many patients with metal-on-metal hips who faced problems and/or became disabled.
- Strengthening our National System for Medical Device Postmarket Surveillance Source: FDA (Monday April 1, 2013)
Update and next steps.
- Strengthening Our National System for Medical Device Postmarket Surveillance Source: FDA (Saturday September 1, 2012)
The report includes plans for establishing a unique device identifier and promotion of registries for tracking devices.
Research and Reports
- Patient Safety America Newsletter (March 2013) Source: Patient Safety America (Monday March 4, 2013)
John James, Ph.D., Patient Safety America: “This month I’ve tried to put some important things in perspective for you. Ben Goldacre’s book called “Bad Pharma,” which I reviewed, is a worth-while read. Gun violence is compared with “medical violence” as far as they affect our children’s lives. The cheap, effective medical care received in Cuba is summarized as a lesson for us, and then I pound on the dangers of drugs and the unstoppable overpricing of medical care in our country. Finally, you’ll learn what post-hospital syndrome is and how to manage it to remain out of the hospital.”
- FDA Safety Communication: Metal-on-Metal Hip Implants Source: FDA (Thursday January 17, 2013)
Today the U.S. Food and Drug Administration (FDA) issued a Safety Communication on metal-on-metal hip implants which includes recommendations on imaging a patient with a metal-on-metal hip implant.
- NEJM Perspective: The 510(k) Ancestry of a Metal-on-Metal Hip Implant Source: New England Journal of Medicine (Thursday January 10, 2013)
Using FDA documents obtained from the agency’s database and Freedom of Information Office, authors traced the ancestry of the ASR XL back more than five decades, through a total of 95 different devices (including femoral stems), including 15 different femoral heads and sleeves and 52 different acetabular components (see figure, and the interactive graphic, available with the full text of this article at NEJM.org).
- Top 10 Health Technology Hazards For 2013 Source: ECRI Institute (Thursday November 1, 2012)
ECRI lists the top 10 health technologies that may potentially harm patients.
- Editor's Choice: The scandal of medical device regulation Source: BMJ (Wednesday October 24, 2012)
“Try describing Europe’s system for regulating medical devices and, as Peter McCulloch says in his editorial this week, the response from your audience will be incredulous.”