The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
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 Safe Patient Project Recommendations for Strengthening Medical Device Safety Oversight
Improve review of devices before they enter the market.
- Consumers Union Testimony on Medical Device Safety Before U.S. House Committee on Energy and Commerce/Health Subcommittee
Consumers Union Testimony on Medical Device Safety before U.S. House Committee on Energy and Commerce/Health Subcommittee
- Improve the Safety of Medical Devices
An overview of Consumers Union’s Safe Patient Project Initiative
- Two pathways for approval of devices
Consumers Union background on device approval and recommendations to make it safer
- FDA Advisory Committee Members Should be Free of Conflicts-of-Interest
Several congressional bills have introduced bills that would relax conflict of interest rules for the Food and Drug Administration (FDA) advisory committee members.
- Consumers Union Letter to Congress Concerning the Medical Device User Fee Act (MDUFA)
Consumers Union Letter to Congress Concerning the Medical Device User Fee Act (MDUFA)
- Letter to FDA from consumer groups with recommendations for medical device
Consumer Groups preliminary MDUFA suggestions to improve the agency’s performance in terms of ensuring that consumers have access to safe and effective medical devices, and to guarantee the scientific integrity of the safety review process.
Consumers Union News Releases
- CU testifies for stronger medical device oversight at House Hearing Today
Congress Shouldn’t Sacrifice Patient Safety In The Drive to Speed Up Medical Device Approvals, CU Says
- Consumers Union steps up campaign to improve medical device safety
Consumers Union’s Safe Patient Project teams up with eight patient safety activists from around the country to Washington, D.C. to meet with lawmakers in Congress and press for improvements in the Medical Device User Fee Act (MDUFA).
- Lax oversight of medical devices puts patients at risk, Consumers Union says
Consumers Union, the advocacy arm of Consumer Reports, urged Congress to strengthen the law governing approval of medical devices.
- Consumers Union Urges Congress to Strengthen Medical Device Oversight
Consumers Union urged Congress today to strengthen the law that governs the approval of medical devices to ensure
- Consumers Union Statement on IOM Medical Device Study
The medical device industry lobby has criticized a report on medical device regulation before it was published.
- Consumers Union: IOM Report Urges More Consumer Protection for Medical Devices
The report that found thousands of medical devices are allowed to go on the market without proper testing for safety.
Blog Posts
- Institute of Medicine report scrutinizes medical device approval process
The IOM released a report last week reviewing the 510(k) medical device approval process. The report finds that the current FDA process “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of devices.
News Articles
- Consumer Advocates Push House Panel For Stronger Oversight of Device Approvals Source: Bloomberg (Wednesday February 22, 2012)
Consumer advocates told a House panel Feb. 15 that stronger medical device safety oversight is needed, especially now that the Food and Drug Administration has a potential new user fee agreement with industry. Includes quotes by Lisa Swirsky, senior health policy analyst for Consumers Union.
- Hip Maker Discussed Failures Source: New York Times (Tuesday February 21, 2012)
Flawed Depuy hip implant had early FDA notice
- How dirty medical devices expose patients to infection Source: iWatch News (Wednesday February 22, 2012)
An outbreak of infections at a Texas hospital prompted an investigation of the surgical tools used and raised concerns about dirty devices, including possible design flaws that make them difficult to clean.
- Consumer group clashes with medical device industry on Capitol Hill Source: Cardiovascular Business (Tuesday February 21, 2012)
Some coverage of the medical device U.S. House hearing. Features quotes by Consumers Union and Jim Shull, who told about his experience as a patient harmed by synthetic mesh used for a hernia operation.
- Controversy over medical device safety Source: WOAI (Wednesday February 15, 2012)
San Antonio’s WOAI reports on the medical device debate in Congress, including the story of Mike McReynolds who can barely walk these days, because the hip implants he received in 2009 are causing excruciating pain. He recently learned those implants, made by a company called DePuy, were never subjected to clinical trials to prove their safety.
- Consumer Groups: Medical Devices Need More Oversight Source: Fowler Tribune (Monday February 20, 2012)
Colorado publication: Patient safety advocates are asking Congress to step up the regulation of such medical devices as hip replacements and heart stents. Comments by Lisa McGiffert, Director of Consumers Union’s Safe Patient Project.
- St. Jude Device Exposes Safety Monitoring Failures, Doctor Says Source: Bloomberg Businessweek (Thursday February 16, 2012)
Bloomberg story on a defective cable used in heart defibrillators. It is based on an article in the New England Journal of Medicine, which says that the cable is the latest example of a defective medical device that wasn’t spotted quickly enough because U.S. surveillance systems are lacking.
- Hip Implant U.S. Rejected Was Sold Overseas Source: New York Times (Tuesday February 14, 2012)
Background info on the Johnson & Johnson ASR metal hip implant. In March 2010, The Times disclosed that F.D.A. records showed that the agency had received 300 complaints about the ASR, virtually all of them involving patients who had to undergo replacement operation just a few years after getting the device. That number has since reached into the thousands.
- Faulty hip implants may cause long-term health, joint damage Source: USA TODAY (Wednesday February 8, 2012)
Faulty hip joints implanted in tens of thousands of Americans pose adverse health effects in some patients even after removal, according to new research.
- Austin woman, injured by device, lobbying Congress on law Source: Austin American-Statesman (Tuesday February 7, 2012)
Lana Keeton, an Austin woman injured by a medical device, went to Washington DC to meet with her Congress members asking for safety improvements for medical devices. Lana had a synthetic mesh bladder sling implanted in 2001 and has had 17 surgeries and procedures to remove the mesh and has had ongoing medical problems,
Research and Reports
- NEJM: Regulation of Medical Devices in the United States and European Union Source: New England Journal of Medicine (Tuesday February 14, 2012)
“In our view, the greatest challenge facing U.S. device regulation is the evaluation of high-risk devices through pathways intended for lower-risk devices, such as the 510(k) process.”
- NEJM: Postmarketing Surveillance of Medical Devices — Filling in the Gaps Source: New England Journal of Medicine (Tuesday February 14, 2012)
- Substantially Unsafe: Medical Devices Pose Great Threat to Patients
Public Citizen report on dangers of poorly regulated medical devices.
- Testimony of James Shull Before U.S. House Committee on Energy and Commerce/Subcommittee on Health
James Shull of Brown Mills, NJ testifies before U.S. House Energy and Commerce Committee, Health Subcommittee on medical devices
- FDA Should Enhance Its Oversight of Recalls Source: GAO (Tuesday June 21, 2011)
GAO report on medical device recalls
- FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process Source: GAO (Thursday January 1, 2009)
GAO report on Class III medical devices and the 510(k) process.
- Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments Source: GAO (Wednesday February 18, 2009)
GAO found that FDA does not review all class III devices through its most stringent premarket review process.
- FDA's Premarket Review and Postmarket Safety Efforts Source: GAO (Wednesday April 13, 2011)
Government Accountability office report
- Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years
IOM report: Thousands of medical devices are allowed to go on the market without proper testing for safety. FDA should develop a new framework for ensuring the safety and effectiveness of these devices.
- Pharmaceutical and Medical Device Manufacturer Code of Conduct
This page provides information relating to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) regulation. Reports on drug and medical device industry gifts to physicians.
Stories about Medical Device Safety
My mother had hip surgery during which the doctor, unbeknownst to my mother or her rehab crew, severed a nerve. After several months of my mother not getting the mobility or correct walking gait back, the doctor insisted it would only take more rehab.
Gary of Reno, Nevada
My mother had hip surgery during which the doctor, unbeknownst to my mother or her rehab crew, severed a nerve. After several months of my mother not getting the mobility or correct walking gait back, the doctor insisted it would only take more rehab.
Gary of Reno, Nevada
My family experienced a surgical error in 2007. We filed a complaint with the state department of public health over this incident. In the single issue of exposing an IgE latex allergic patient to a medical device containing latex, it should have been very easy for DPH to find that the surgeon and hospital provided our daughter with negligent care. The device was clearly labeled as containing latex, the hospital and surgeon identified our daughter, Kelly, as a latex allergic patient before surgery, standard of care at the hospital was the strict avoidance of all latex products in an surgical/medical procedure for an identified latex allergic patient, and the Informed Consent for this procedure does not give the hospital or surgeon permission to treat our daughter with a medical device containing latex.
Lesley of Stamford, Connecticut
My defibrillator fired fifteen times until I finally told them to turn it off. I said my goodbyes to my wife and told her I loved her, thinking it was over for me. The shocks stopped and nothing happened, much to my surprise, as I thought I would die. I later found that nine of the fifteen shocks were not programmed.
Jerome of DeBary, Florida
To Delay is Deadly
98,000 people die each year needlessly because of preventable medical harm. Efforts to reduce this are few and fragmented. With little transparency and no public reporting (except where hard fought state laws now require it), scarce data does not paint a picture of real progress.
In this report (PDF) we give the country a failing grade on progress on select recommendations we believe necessary to create a health-care system free of preventable medical harm.