The mission of Washington Advocates for Patient Safety (WAPS) is to promote accountability, quality, safety, and responsibility in patient care. As the voice of patients, their goals are to eliminate medical errors and harm and to save more lives.
Hip and Knee Replacement
More and more people are getting hip and knee replacements to feel better, play longer. And if the hip or knee implant fails, it likely will require revision surgery, which is both painful and costly. Implants don’t come with a warranty. Consumers Union is calling on the top manufacturers of hip and knee implants to begin offering warranties for their products and take responsibility for the associated costs if they fail due to a product defective.
Consumers Union Documents
- Group sign on letter: UDIs in hospital claims Source: Consumers Union (Friday March 28, 2014)
Consumer and public health groups (including Consumers Union) express strong support for updated standards that will enable the capture and transmission of the FDA’s new unique device identifier (UDI) system in the claims transaction.
- Consumers Union Ad for USA Today on hip and knee warranties Source: Consumers Union (Monday March 10, 2014)
Consumers Union ad for USA Today on our campaign to get manufacturer warranties for hip and knee implants.
- Background: Warranties for Hip and Knee Implants Source: Consumers Union (Wednesday February 26, 2014)
Background paper on Consumers Union’s call to medical device makers to provide a warranty for hip and knee replacements
- Answers to Your Questions about Warranties for Hip and Knee Replacements Source: Consumers Union (Wednesday February 26, 2014)
Answers and recommendations for hip and knee implant warranties
- What To Ask Your Surgeon Before Getting Hip or Knee Replacement Surgery Source: Consumers Union (Thursday February 6, 2014)
13 Things to Ask Your Surgeon Before Getting Hip or Knee Replacement Surgery (by Consumers Union’s Safe Patient Project)
Consumers Union News Releases
- Consumers Union Takes Push for Hip and Knee Implant Warranties To Orthopaedic Surgeons Conference in New Orleans
Consumers Union, the policy and advocacy division of Consumer Reports, is taking its campaign to convince medical device companies to provide warranties for hip and knee implants directly to the doctors who perform hundreds of thousands of these operations each year. The campaign has launched an ad campaign and will be conducting outreach activities this week during the American Association of Orthopaedic Surgeons (AAOS) conference in New Orleans.
- Consumers Union calls on medical device makers to provide warranties for hip & knee implants
Consumers Union, the policy arm of Consumer Reports, is calling on the top manufacturers of hip and knee implants to provide warranties that would entitle patients to have defective devices replaced at no cost.
- Johnson & Johnson Settlement Resolves Metal Hip Lawsuits But Weak Oversight Of Medical Device Industry Leaves Patients Vulnerable
Consumers Union Calls for Stricter Safety Testing & Warranties for Implants.
- Consumers Union To Hold “Ending Medical Harm” Conference at Columbia University On November 6th
CONSUMERS UNION NEWS RELEASE For Immediate Release: Tuesday, October 29, 2013 Contact: Michael McCauley, firstname.lastname@example.org or 415-902-9537 (cell) or Ross Moonie, email@example.com or 917-690-5713 or Joe Duraes, firstname.lastname@example.org or 914-293-0100 Consumers Union To Hold “Ending Medical Harm” Conference at Columbia University On November 6 Conference To Focus on Tackling The 3rd Leading Cause of Death Continue Reading
- 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.
- Q & A for Surgeons on Warranties for Hip and Knee Replacements
Consumers Union’s Safe Patient Project will be talking to surgeons attending the AAOS 2014 Annual Meeting in New Orleans and hope to get their feedback on our warranty campaign. Here’s our answers to frequently asked questions on our campaign for hip and knee warranties.
- Docs for Hip and Knee Warranties?
We’ve started asking orthopedic surgeons who implant hip and knee devices what they think about our warranty idea. Next month, we’re going to New Orleans to talk with surgeons attending an annual orthopedic surgeons meeting.
- [Guest post] Does Your Joint Replacement Have a Warranty? By Brian Hatten, M.D.
Dr. Brian Hatten, an orthopedic surgeon, shares his perspective on warranties for hip and knee implants.
- Go Team! Advocates Deliver Patient Safety Message in Washington State
Last week, the Safe Patient Project traveled to Washington State to team up with Washington Advocates for Patient Safety to give a voice to the health care crisis of preventable medical harm
- NPR features CU’s Safe Patient Project and story sharer harmed by hip implant
Our Safe Patient Project Director, Lisa McGiffert, was on NPR’s Morning Edition yesterday about a story on the Johnson and Johnson metal hip settlement.
- FDA Warns Against Hysterectomy Technique That May Spread Cancer Source: ABC News (Thursday April 17, 2014)
A Boston couple behind a campaign to stop doctors from performing a risky surgical procedure is applauding a new U.S. Food and Drug Administration warning against doctors performing the procedure called laparoscopic power morcellation. The FDA warned doctors that this procedure to uterus or uterine fibroids poses a risk of spreading unsuspected cancerous tissue beyond the uterus.
- USDOJ: Astellas Pharma US Inc. to Pay $7.3 Million to Resolve False Claims Act Allegations Relating to Marketing of Drug Mycamine Source: Department of Justice (Wednesday April 16, 2014)
DOJ: “Pharmaceutical company Astellas Pharma US Inc. will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use, the Justice Department announced today. Astellas Pharma US Inc., located in Northbrook, Ill., manufactures and sells pharmaceutical drugs, including Mycamine.”
- NerdWallet Findings on Orthopedic Surgeons from Medicare Physician Data Source: NerdWallet (Tuesday April 15, 2014)
NerdWallet cost and quality findings on orthopedic surgeons based on newly released Medicare physician data.
- Medical devices for kids are often only tested on adults Source: Reuters (Monday April 14, 2014)
“Most medical devices that have been recently approved for use in pediatrics weren’t actually tested on kids first, according to a new study.”
- Campaigners renew calls for end to mesh implant operations after US court says device is defective Source: Daily Record (Sunday April 13, 2014)
The Daily Record covers a mesh case in TX court that could impact other mesh lawsuits against Johnson & Johnson for its pelvic mesh implants.
Research and Reports
- Patient Safety America Newsletter (November 2013) Source: Patient Safety America (Thursday October 31, 2013)
Summary from John James: “The devastation wrought by hurricane Sandy leaves us full of empathy for those who lost loved ones and homes. When disaster unfolds suddenly, we notice it as the news media graphically magnifies the events on our TVs. The disaster that comprises much our medical industry quietly unfolds as medical errors occur in hospitals spread across the nation, and no one is there to produce graphic images of the death and suffering. In an attempt to display some of the suffering, my November newsletter begins with a review of the book “Unaccountable” by Marty Makary, MD. I was not fully aware of the endemic nature of the dangers lurking in hospitals.
The first two articles deal with medical errors – the first on diagnostic errors and the second on errors of omission. On page 3 I take a look at recent misdeeds of big Pharma, and then deal with ethical issues associated post-marketing drug testing on patients. A business model suggests that providers should start giving us what we really want – health – not medical care. Finally, we have a look at why hospital prices continue to escalate. I hope you find these stories informative.”
- Patient Safety America Newsletter (October 2013) Source: Patient Safety America (Wednesday October 2, 2013)
Summary from John James: “These are frustrating days in our country because it seems that anyone left in the middle ground on major political issues is rare, or at least they dare not speak. As we chide Congress for its ineptness, we must acknowledge that we put those people there, and in most cases they reflect what we want.
This month I was honored to have my new estimate of harm to hospitalized patients, which was published in the September issue of the Journal of Patient Safety (http://journals.lww.com/journalpatientsafety/pages/articleviewer.aspx?year=2013&issue=09000&article=00002&type=abstract), picked up Marshall Allen of Pro Publica (http://www.propublica.org/article/how-many-die-from-medical-mistakes-in-us-hospitals). He brought validity to my estimate by asking MDs in the patient safety community what they thought of my work. I have marked his and other sources that wrote about the new estimate with an asterisk in my “SitesLinks” collection this month. There are many examples of medical care gone bad.
October’s newsletter deals with 1) over-diagnosis of mental illness, 2) the secrets of the medical industry, 3) how unintended consequences can occur when physician performance is measured, 4) the death toll on women from painkillers, 5) the need to stop calling so many things cancer, and 6) the issues associated with high blood pressure and too much sodium.”
- Patient Safety America Newsletter (September 2013) Source: Patient Safety America (Wednesday August 28, 2013)
John James’ summary: “Young children often grow up in a world where everything is about their needs, both perceived and real. Wise parents work against this self-centered worldview so that by the time children become adults, they understand that they are not the center of the universe. There is one circumstance where this view must be discouraged – medical care. When receiving medical care you should be the center of all that can be reasonably done for your wellbeing – with you giving informed permission for anything invasive.
In reality, medical care, although headed in the direction of patient-centered care, has a long way to go. My newsletter’s first article demonstrates this reality. The second suggests that intense care is not usually patient-centered for critically ill patients; furthermore, the money we spend on medical care can be misspent, in part due to the fee-for-service scheme that doctors prefer. The third article describes how stress from medical bills can become pervasive, especially for the uninsured.
The fourth article slams the FDA for not enforcing a law that requires drug makers to do additional testing of their drugs, and a fifth criticizes Congress for not requiring stronger control of compounding companies. The newsletter ends with an article on regulating those who could misinterpret images, and with another article on cancer-drug makers who downplay the side effects of their potent products.”
- 2014-2015 Targeted Medication Safety Best Practices for Hospitals Source: ISMP (Thursday December 12, 2013)
Institute for Safe Medication Practices report on medication safety best practices for hospitals.
- Patient Safety America Newsletter (April 2013) Source: Patient Safety America (Sunday March 31, 2013)
Summary by John James: “Changes are long overdue in American healthcare as pointed out by the Institute of Medicine and National Research Council in their new book “The US health Disadvantage Relative to Other High-income Countries.” My first newsletter article attempts to summarize this report. In the second article I discuss the risks associated with sleeping pills. The third article considers legislation that often has collateral damage. The fourth involves one doctor’s view of how he was led into care that was not patient centered. My next two articles deal with mental health: 1) As we age, we all fear the loss of mental capabilities, but a new study has linked mid-life fitness with a reduction in the risks of dementia. 2) Young people often do not have access to mental health facilities as pointed out by experts writing in the JAMA. The next articles deal with unintended death from pharmaceuticals and with loss of confidence in drug companies. The newsletter concludes with a short piece on the vanishingly small value of robotic surgery for those who might need a hysterectomy.”