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
- Petition to the FTC: Include warranties in the Zimmer-Biomet merger Source: Consumers Union (Monday August 11, 2014)
Over 12,000 consumers signed this petition to the FTC asking that Zimmer keep Biomet’s knee warranty and offer warranties for all hip and knee products.
- Consumers Union Comments to FDA on Reclassification of Surgical Mesh Source: Consumers Union (Wednesday July 30, 2014)
Consumers Union strongly supports the FDA’s proposed order to change the classification for surgical mesh used to repair transvaginal Pelvic Organ Prolapse (POP) from Class II to Class III. This change will require any future mesh product for POP to provide much needed clinical evidence demonstrating it is a safe and effective device before it is marketed for use in patients.
- Consumers Union letter to FTC regarding the proposed Zimmer-Biomet merger Source: Consumers Union (Wednesday July 9, 2014)
Consumers Union letter to FTC regarding the proposed Zimmer-Biomet merger
- Consumer Reports: What can I do if the pharmacy gives me the wrong drug? Source: Consumer Reports (Thursday May 8, 2014)
Tips from Consumer Reports on avoiding medication errors at the pharmacy.
- Consumers Union comments to FDA regarding direct to consumer TV ads Source: Consumers Union (Monday April 21, 2014)
Consumers Union’s Safe Patient Project submitted comments to FDA about a proposed rule to study limiting the list of drug side effects in a TV drug ad. We have concerns about the possibility of limiting major drug side effects in drug ads, and believe the FDA proposed study has design flaws.
Consumers Union News Releases
- Consumers Union sends petition to FTC on hip and knee replacement warranties
More than 12,000 people urge FTC to consider importance of warranties as it evaluates Zimmer-Biomet merger.
- Consumers Union Urges FTC to Consider Importance of Hip and Knee Replacement Warranties
As the FTC evaluates the proposed merger of manufacturers Zimmer and Biomet, the group sent a letter to regulators urging the preservation of existing warranties.
- 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.
- Rethinking the use of Morcellators on Women
A morcellator is a medical device that seems like it was developed in medieval times as an instrument of torture. But it is actually marketed and used to grind up tissue during laparoscopic hysterectomies and uterine fibroid removal. It becomes problematic if the tissue being shredded is cancerous. The FDA recently issued a safety alert stating, “Morcellating these tumors can spread cancerous tissue internally and significantly worsen the odds of long-term survival.
- Patient safety activists react to USA Today story on seniors and Rx drugs
This week’s USA Today story about the problem of overprescribing serious narcotics and pain killers to seniors touched a nerve with Consumers Union’s Safe Patient Project activists. According to the story, “hundreds of thousands of the nation’s seniors are misusing prescription drugs, including narcotic painkillers, anxiety medications and other pharmaceuticals, for everything from joint pain Continue Reading
- 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.
- No Evidence Supporting Newer Joint Replacement Devices Source: Medscape (Thursday September 11, 2014)
Medscape: “Recent improvements in joint replacement devices may not be worth the risk, according to a systematic review published online September 9 in the BMJ.”
- That new knee will come with a guarantee: Virginia Mason to offer warranties on joint replacement surgeries Source: Puget Sound Business Journal (Thursday September 4, 2014)
Puget Sound Business Journal coverage of Virginia Mason’s surgical warranty for hip and knee replacement. Mentions Consumers Union’s campaign for hip and knee warranties.
- Cars, TVs come with warranties: Why not hips and knees? Source: Seattle Times (Wednesday September 3, 2014)
Seattle Times coverage of Virginia Mason’s surgical warranty for hip and knee replacement. Mentions Consumers Union’s campaign for hip and knee device warranties.
- Virginia Mason Warranty for Hip and Knee Replacement Surgery Source: Virginia Mason (Thursday September 18, 2014)
Here’s what Virginia Mason’s surgical warranty for hip and knee replacement covers. Note: Virginia Mason’s surgical warranty does not cover complications due to failure of the surgical implant device.
- Virginia Mason to offer warranties on hip, knee replacements Source: Modern Healthcare (Friday September 5, 2014)
Modern Healthcare coverage of Virginia Mason’s surgical warranty for hip and knee replacements; mentions Consumers Union’s campaign for hip and knee warranties.
Research and Reports
- Health Watch USA Newsletter (March 2014) Source: Health Watch USA (Tuesday May 6, 2014)
Patient safety news collected by KY-based Health Watch USA. Features Dr Steven Tower on metal-on-metal hip implants.
- 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.