In 2001, Patty and David Skolnik spent nearly three years watching their only child, Michael, play victim to a broken system as a result of unnecessary brain surgery. Due to medical error caused by negligence and incompetence, routine expectations of our healthcare system proved ineffective in providing quality medical care and patient safety for 22 year old Michael Skolnik.
This geographic signifier gathers content together on our site which is regarded as having national significance. That includes items at the federal level.
State Disclosure Reports
- Healthcare Associated Infection (HAI) in Massachusetts Acute Care Hospitals
- Model Hospital Infections Disclosure Act
Consumers Union Documents
- Video: Testimony of Consumers Union at Senate hearing on medical errors
Watch Lisa McGiffert (Consumers Union Safe Patient Project Director) testify at a Senate hearing on medical errors, the third leading cause of death in the U.S.
- Consumers Union’s Testimony at Senate Hearing: More Than 1,000 Preventable Deaths a Day Is Too Many
Lisa McGiffert, Campaign Director for Consumers Union’s Safe Patient Project, testified at a Senate HELP subcommittee hearing on medical errors, July 17, 2014.
- Patient Safety Advocates Urge the Creation of a National Patient Safety Board to Fight Medical Errors
A network of patient safety advocates is urging Congress to take steps to improve patient safety by preventing hospital acquired infections and other preventable medical errors.
- CU urges Congress to support Senate-passed medical device reforms in final FDA User Fee bill
Letter from Consumers Union highlighting important patient safety reforms from the Senate-passed version of the bill that should be included in the final version of the legislation.
- 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)
- Consumers Union Calls on HHS To Restore Online Access To National Practitioners Data Bank’s Public File
Consumers Union (September 15, 2011)
- CDC releases infection prevention guide for outpatient clinics
Research shows that infection risks can be just as serious in outpatient surgery centers as they are in hospitals.
- Testimony of Elizabeth M. Imholz, Consumers Union Special Projects Director before CA Senate Health Committee
Stopping the occurrence of medical harm
- 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.
- Testimony of advocate Carole Moss before CA Senate Health Committee
Testimony of Carole Moss to the Oversight Hearing on October 20, 2010 to California Department of Public Health concerning Implementation of Hospital Patient Safety Legislation.
Consumers Union News Releases
- Consumers Union News Release on CDC National Report on 2013 Hospital-Acquired Infections
Atlanta, GA – A national report issued today by the Centers for Disease Control and Prevention (CDC) shows a continued decline in most of the types of hospital-acquired infections that are publicly reported. However, the 2013 data reveals that there is still much work to be done to reach the long-term goal of eliminating hospital-acquired infections, as set out by the U.S. Department of Health and Human Services (HHS). And, nationally, hospitals have failed to meet the 5-year goals set by HHS.
- 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
- Central Line Bloodstream Infections Disclosed at Hospitals Nationwide
Infection Disclosure Is A Milestone Following A Multi-Year Campaign By Consumer Advocates to Make Information Public
- Medicare Study Shows Most Medical Errors Go Unreported
WASHINGTON, D.C. — A new study released today by the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) found that hospital employees are only reporting fourteen percent of all medical errors and usually don’t change their practices to prevent future harm to patients.
- 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: Public Should Have Full Access to Doctor Database, Including Names of Problem Physicians
Consumer Reports Poll: Almost 9 in 10 Americans Say Public Should Have Access to Information Collected by Feds on Doctors
- CU urges HHS to restore online doctor database
HHS decision to remove online access runs counter to Administration pledge to promote transparency
- 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.
- HHS Announces National Campaign to Improve Patient Safety
CONSUMERS UNION SAFE PATIENT PROJECT — NEWS RELEASE Please Note: Consumers Union can connect reporters with patients who have suffered from hospital infections and other medical harm. To find out more, contact Michael McCauley at email@example.com For Immediate Release: Tuesday, April 12, 2011 Contact: Michael McCauley (firstname.lastname@example.org), 415-902-9537 (cell), 415-431-6747,
- Consumer Reports Poll Finds High Levels of Concern About Medical Harm & Support For Public Ratings on Hospital Safety
A new poll released today by the Consumer Reports National Research Center found high levels of public concern about hospital-acquired infections and other forms of medical harm.
- The Low-Down Dozen: Consumer Reports flags twelve hospitals for low infection prevention ratings
Today Consumers Union, the policy in action arm of Consumer Reports, is launching “The Low-Down Dozen,” a social media project to call attention to twelve hospitals that earned low scores for avoiding five infections in our latest ratings.
- Congress puts pharma before patient safety with 21st Century Cures
A bill in Congress has several key provisions that would significantly weaken consumer protections and lead to patients being exposed to potentially unsafe or ineffective drugs and medical devices. Tell your Senators you support safe, effective, and affordable cures.
- Safe Patient Project Director Makes Modern Healthcare’s “100 Most Influential People in Healthcare”
Lisa McGiffert, Director of Consumers Union’s Safe Patient Project, was recognized in Modern Healthcare’s “100 Most Influential People in Healthcare” list. We couldn’t be more proud.
- Consumer Reports Survey Shows Americans Affected by Drug Price Increases
One third of Americans in a recent Consumer Reports poll are facing higher prices for their medications. Our advice can help you avoid sticker shock.
- National Practitioner Data Bank “Public” Use Data File Should Actually Be Public
A Consumer Reports national poll found that almost 9 in 10 Americans (88%) said the public should have access to federally collected information about problems with doctors.
- Cancer patient asks hospitals for their infection rates
Seeking safe healthcare for her cancer treatment, patient safety advocate–Kathy Day of Maine–recalls the transparency hurdles she faced when she asked a hospital for its infection rates.
- Consumer voices to be heard at national hospital infection meeting
Meet the eleven consumer advocates who will be attending a U.S. Department of Health & Human Services (HHS)hospital infection meeting this week.
- “Please, don’t infect me”
Hospital infection survivor and “numerator,” Kerry O’Connell describes the emotional and physical impact of hospital infection on patients and calls for more empathy and honesty from our health care providers.
- If you’re in the San Diego area tomorrow, meet us at the Empowered Patient training
On Saturday, October 9, the Empowered Patient Coalition along with Consumers Union’s Safe Patient Project and AARP California will be holding a special training in San Diego for patients and caregivers on how to stay safe in the hospital.
- MRSA Study Indicates Good News But Far Too Many Patients Suffering
Last week’s good news of a decline in serious MRSA health care-acquired infections, is a victory for patient safety, but we still have a long way to go to eliminate this very preventable crisis.
- GAO: Medical Devices Vulnerable to Hacking, Oversight Needed Source: iHealthBeat (Friday September 28, 2012)
GAO report warns of dangers of medical devices that rely on software to operate such as pacemakers and insulin pumps could be vulnerable to hacking.
- Could The Supreme Court’s Health Care Ruling Kill Patient Safety Reforms? Source: ProPublica (Friday June 15, 2012)
ProPublica asks experts to weigh in on an often overlooked question on the Supreme Court’s health reform decision: What might happen to the many patient safety and quality of care provisions sprinkled through the Affordable Care Act?
- Markey, Waxman, Schakowsky, DeLauro Introduce Legislation To Close Loophole In Flawed Medical Device Approval Process Source: Congressman Ed Markey (Wednesday February 1, 2012)
To protect patients from defective devices, Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill closes a major loophole in the device approval process known as the 510(k) by ensuring that a new device is not cleared by the FDA if it is based on an earlier product that was pulled from the market for causing serious harm to patients.
- Merkley Backs Bill to Make Medical Devices Safer Source: KTVZ (Thursday March 15, 2012)
U.S. Senators introduce a bipartisan bill that would give the FDA more tools to improve oversight of medical devices. The bill has been endorsed by a number of organizations, including Consumers Union.
- Safe To Be Sick Source: National Journal (Thursday January 19, 2012)
Susan Manganello, patient safety advocate in CT, interviewed about the hospital infections that took her 22-year-old daughter’s life in 2005. Public reporting efforts led by consumer advocates have motivated hospitals to reduce their infection rates. Said the CDC’s Denise Cardo: “If it weren’t for Consumers Union pushing for legislation, public reporting, we would not be here now,” she said at a forum sponsored by National Journal and the Association of Professionals in Infection Control and Epidemiology in October. “We have many states with public-reporting legislation. That’s the reason I can come and tell you what is going on in the nation.”
- An MS Patient Loses Trust When She Finds Out Her Doctor Is Paid By Drug Companies
As of 2013, a national physician payment database created under the Affordable Care Act will make such information available to all.
- Consumer Group Wants Full Access to National Practitioner Data Base Source: HealthLeaders Media (Wednesday November 16, 2011)
HealthLeaders Media reports on Consumers Union’s Safe Patient Project call to open the National Practitioner Data Bank to the public.
- Agency re-posts National Practitioner Data Bank file, but restrictions draw fire Source: Association of Health Care Journalists (Wednesday November 9, 2011)
The Obama administration has reposted the Public Use Data File but with new restrictions that ProPublica journalist Charles Ornstein says are “unworkable and amount to a prior restraint.”
- AHRQ Awards $34 Million To Expand Fight Against Healthcare-Associated Infections Source: AHRQ (Wednesday November 2, 2011)
The U.S. Department of Health and Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ) announced today that it has awarded $34 million in fiscal year 2011 for grants and contracts to hospitals, academic medical institutions, and health care research organizations to expand the fight against healthcare-associated infections (HAIs).
- Editorial: Obama shouldn't be hiding records on doctor errors Source: Sacramento Bee (Tuesday October 18, 2011)
The Obama administration should restore the Public Use File of the National Practitioner Data Bank for use by the public.
Research and Reports
- FDA Should Expand Its Consideration of Information Security for Certain Types of Devices Source: GAO (Friday September 28, 2012)
GAO report on the dangers of hacking into medical devices that require software with wireless connections. Hacking into a device could, for instance, stop a pacemaker from operating.
- GAO investigation on injection safety Source: GAO (Friday July 13, 2012)
The Government Accountability Office (the group that inspects activities happening within government agencies) has recently released a report on injection safety efforts currently underway at CDC and CMS. See page 26 of the report for a summary list of all of the outbreaks associated with unsafe injection practices.
- HHS Action Plan releases a section on preventing infections in nursing homes Source: HHS (Monday July 23, 2012)
The Department of Health and Human Services has recently released for public comment a draft action plan on preventing infections among nursing home residents.
- Support for the SOUND Act of 2012 Source: Congressman Ed Markey (Wednesday February 1, 2012)
Consumers Union signs on to legislation introduced in Congress that will protect the public from avoidable harms caused by unsafe devices that should never have been cleared for sale in the first place. It will also help to ensure that decisions on device safety are based on more reliable information.
- 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
- HRSA Response to Consumers Union Regarding National Practitioner Data Bank's Public Use Data File
Health and Human Services Administration (HRSA) letter responding to Lisa McGiffert, director of Consumers Union’s Safe Patient Project, regarding its decision to remove the National Practitioner Data Bank Public Use File on September 1, 2011. Consumers Union’s letter to HRSA can be read here.
- Sen. Chuck Grassley letter to Health Research and Services Administration concerning removal of National Practitioner Data Bank's Public Use File
Sen. Chuck Grassley of Iowa today asked the head of a federal agency to explain a decision to shut down public access to data on malpractice payouts, hospital discipline and regulatory sanctions against doctors and other health professionals
- Journalists' letter to Sebelius on the National Practitioner Data Bank file
Letter from six national journalism organizations to Health and Human Services Secretary Sebelius elevating their concerns about a decision by the Health Resources and Services Administration to remove the Public Use File of the National Practitioner Data Bank from the agency’s website.
- National Practitioner Data Bank Public Use File
Investigative Reporters and Editors post National Practitioner Data Bank public use file (available for download) on physicians that was removed by the federal government last week.