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
- Pennsylvania 2009 Report: Healthcare-Associated Infections
- Model Hospital Infections Disclosure Act
Consumers Union Documents
- 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.
- CU testifies at Senate hearing about California’s lax enforcement of patient safety laws
Testimony of Elizabeth M. Imholz, Special Projects Director; Consumers Union before California Senate Health Committee; October 20, 2010
- Ratings of Heart Surgeons
Consumer Reports has teamed with The Society of Thoracic Surgeons (STS) to rate heart-surgery groups based on their performance data for bypass surgery. For the first time, consumers can easily see how surgical groups compare with national benchmarks for survival, complications, and other measures.
- Consumer Reports AdWatch
Consumers are besieged daily by ads for prescription drugs, all beseeching you to “ask your doctor” for a given brand-name drug for an ailment that you might, or might not, actually have. Those ads don’t always tell the whole story. They might, for example, play down or omit information about nondrug options, or imply that a drug works wonders for everyone when in reality it works only marginally better than a placebo. That’s why we started the Consumer Reports AdWatch series. Check out our video commentaries on TV drug ads.
Consumers Union News Releases
- 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.
- CDC: 58% drop in central line infections in ICUs
Report Shows Infections Are Preventable But More Effort Is Needed To Protect Patients.
- 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.
- Victory for patients! Public reporting of certain infections will go nationwide
Soon it will be easier for you to find out how well your hospital prevents certain infections. As part of the new health care reform law, the Department of Health and Human Services will require hospitals to publicly disclose several types of dangerous hospital infections.
- Patient safety activists hold “conversation” with CDC
On June 16, Consumers Union’s Safe Patient Project and 11 patient safety advocates from 10 states attended the first “Consumer Conversation on Healthcare-Associated Infections” at the Centers for Disease Control and Prevention (CDC) in Atlanta.
- Let’s talk about labels
A bill in California (SB 1390) would create a minimum of 12-point font for the most crucial information on medication labels and would require translation of medication label information into commonly used non-English languages.
Guest blog post from Kerry O’Connell of Conifer, Colorado. Kerry is a member of the Colorado Health Facility Acquired Infections Advisory Committee. A committed patient safety advocate, he calls for restoring empathy and compassion in health care.
- 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.