Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Tuesday, October 29, 2013

NYC November 6: Tackling Medical Harm-the 3rd leading cause of death in the U.S.

Posted 10/28/13 at 1:21 pm  FiDA highlight

Columbia School of Journalism Lecture Hall (2950 Broadway at 116th St.)
November 6, 2013, 10am – 3pm
10:00-10:15 am: Welcome - Chris Meyer, Consumer Reports, Vice President, External Affairs.
10:15-10:30 am: Introduction: The Overlooked Consumer Perspective
Lisa McGiffert, Campaign Manager, Safe Patient Project
10:30- 11:30 am Pulling Back the Curtain: Translating patient safety data into useable public information.
 The panel will discuss current and future ideas for turning data into information that can be used by consumers, patients and health care providers to improve medical care and save lives.
Charlie Ornstein – ProPublica
John Santa, MD, MPH – Consumer Reports’ Health Rating Center
Pete Eisler, Reporter, USA Today
Moderator: Marshall Allen – ProPublica
11:30 -12:00 pm Bill Baby Bill: Today’s health care mantra & what it means for consumers
Rosemary Gibson – Author and public interest advocate will discuss how overuse of medical care is unnecessary, expensive and can be dangerous.
12:00-1230 pm: Lunch
12:30-1:30 pm: Bad Bearings: The rise and fall of the metal-on-metal hip
Steven Tower, MD: An orthopedic surgeon who got a metal-on-metal hip implant will share his journey on becoming an “accidental authority on the health hazards of metal-on-metal hip implants.”
1:30-2:30 pm: Stories Matter: Publishing patient experiences to drive public policy change.
This panel will explore participants’ transformation after the pain of death and injury of a loved one to becoming expert patient safety advocates. Their work demonstrates the important role that patients and consumers are playing in the push to end medical harm.
John James, PhD- Patient safety advocate and author of “A New, Evidence-Based Estimate of Patient Harms Associated with Hospital Care,” published by The Journal of Patient Safety.

Pat Masters- Author of Design to Survive, 9 ways an IKEA Approach Can Fix Health Care and Save Lives.

Dan Walter- Author of Collateral Damage: A Patient, a New Procedure & the Learning Curve.
Suzanne Henry, Policy Analyst, Consumers Union Safe Patient Project
2:30-3:00 pm: A Consumer Movement 10 Years in the Making
Lisa McGiffert will cover a retrospective of accomplishments and work ahead for the Safe Patient Project Network.

Speaker Bios
Chris Meyer- Vice President of Consumers Union External Affairs and Information Services. He supervises CU’s multi-state advocacy campaign work and activist recruitment. Chris also supervises the Communications Division and Strategic Planning and Information Services. Chris came to CU in October 2004 after working for 20 years for the New York Public Interest Research Group, a student-directed research and advocacy group focused on consumer and environmental issues. He served as the group’s executive director from 1997-2004.
Lisa McGiffert- Manager of Consumers Union’s Safe Patient Project which works on state and national levels to make information available to consumers about medical harm, focusing on healthcare-acquired infections, medical device safety, medical errors, and physician accountability. Beginning in 2003, the campaign initiated state laws to publish hospital infection rates and raise public awareness about the problem; today more than half of the states and Medicare require such reporting. The campaign’s collaboration with individuals who have personal experiences with medical harm has developed into a national consumer activist network to make health care safer. McGiffert routinely lends the consumer voice on these issues at conferences, with the media and when serving on national and state-based patient safety advisory committees. From 1991-2003, McGiffert directed CU advocacy efforts on the full array of health issues in Texas including access to care, health insurance, physician and hospital regulation and quality of care. Prior that, she was the legislative director for the Texas Senate Committee on Health and Human Services and a juvenile probation/parole officer.
Charles Ornstein-Reporter for Propublica. Charles was a lead reporter on a series of articles in the Los Angeles Times in collaboration with Tracy Weber, titled “The Troubles at King/Drew” hospital that won the Pulitzer Prize for Public Service, the Robert F. Kennedy Journalism Award and the Sigma Delta Chi Award for public service in 2005. His ProPublica series, with Tracy Weber, “When Caregivers Harm: California’s Unwatched Nurses” was a finalist for a 2010 Pulitzer Prize for Public Service. Ornstein reported for the Times starting in 2001, in the last five years largely in partnership with Weber. Earlier, Ornstein spent five years as a reporter for the Dallas Morning News. He is president of the Association of Health Care Journalists and a former Kaiser Family Foundation media fellow.
John Santa- Director of the Consumer Reports Health Ratings Center. John has been Director of the Consumer Reports Health Ratings Center since 2008. Previously he practiced internal medicine in Oregon and served in administrative roles in hospitals, insurance companies, and medical groups that insure and care for commercial, Medicare and Medicaid patients. From 1999 to 2003 he was Administrator of the Oregon Office for Health Policy and Research, a state agency concerned with Medicaid and other areas of health policy.
Pete Eisler- Investigative reporter at USA TODAY, where he’s reported on everything from lax enforcement of U.S. safe drinking water laws to medial errors and superbugs in US hospitals, including the series “When Health care makes you sick.” In 2013, Eisler shared the Gerald Loeb Award for online journalism, the Hillman Prize for Web-based investigative reporting, and the duPont-Columbia Award for digital journalism. His work also has been honored in the Barlett and Steele Awards for Investigative Reporting, the National Headliner Awards, the National Press Club Awards and the Awards for Excellence in Health Care Journalism. He is a board member and treasurer at the Fund for Investigative Journalism, which provides reporting grants to independent journalists, and he volunteers as a high school teaching fellow for the News Literacy Project in Washington, DC.
Marshall Allen-Reporter for ProPublica. His “Do No Harm: Hospital Care in Las Vegas,” written in collaboration with Alex Richards for the Las Vegas Sun, was honored with several journalism awards, including the Harvard Kennedy School’s 2011 Goldsmith Prize for Investigative Reporting and a Pulitzer Prize finalist for local reporting. His health-care coverage was recognized as the best in the country in 2009 by the Association of Healthcare Journalists (AHCJ). In 2007, he won second place for his beat reporting for the Sun where he spent five years before coming to ProPublica in 2011. He has been instrumental in creating ProPublica’s Patient Harm Community on Facebook. Before he was in journalism, Allen spent five years in full-time ministry, including three years in Nairobi, Kenya. He has a Master’s degree in Theology.
Rosemary GibsonSenior Advisor to The Hastings Center; an editor for JAMA Internal Medicine “Less is More,” author of Wall of Silence: The Untold Story of the Medical Mistakes that Kill and Injure Millions of Americans, The Treatment Trap: How the Overuse of Medical Care is Wrecking Your Health and What You Can Do to Prevent It,  Medical Meltdown, and Battle Over Health Care.
Steven Tower, MD – Tower specializes in orthopedics in Anchorage Alaska and was featured in a 2012 Consumer Reports article about medical devices, which led to patients contacting him from all over the world. Dr. Tower, who was “captured by why hips fail” since his training in hip replacements, describes himself as an accidental authority on metal-metal complications following his own experience of being poisoned by a metal-on-metal hip implant. This experience launched him on a passionate quest to educate physicians and patients about the perils of this device. Along the way he ran into roadblocks from the FDA and his own profession.
John James-Patient safety advocate and author of “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care, published by The Journal of Patient Safety, Sept 2013. This estimate has been hailed as a much needed update on the death statistics published by the Institute of Medicine in 1999. John’s Patient Safety America monthly newsletter is dedicated to his 19-year old son, John Alexander James, who died as a result of uninformed, careless, and unethical care by cardiologists, and provides critical analysis of published studies and reports on medical harm. He serves on the Texas advisory committee overseeing implementation of laws requiring reporting of health care-acquired infections and medical errors. He is the author of A Sea of Broken Hearts: Patient Rights in a Dangerous, Profit-Driven Health Care System.
Pat Masters-Author of Design to Survive, 9 ways an IKEA approach can fix health care and save lives. Through colorful analogies, gripping stories from families and top doctors, and her quest to find out what happened to her own father, Pat has served up key strategies for patients, families and health care providers, with the conviction that we can do better. Pat is a veteran news and medical reporter at several New England television stations; the creator of the Patient Pod, a patient engagement & empowerment tool that brings patient autonomy and communication to the bedside, that is undergoing a clinical trial in a hospital system with “teachback” to reduce hospital re-admissions; and an active blogger. Her blog posts at Islands of Excellence have been cross-posted by the National Patient Safety Foundation, The HealthCare Blog, KevinMD and Reporting on Health. She worked to pass Rhode Island’s hospital infection reporting and serves on the state’s advisory committee to implement that law.
Dan Walter- Author of Collateral Damage: A Patient, a New Procedure, and the Learning Curve. “MY larger purpose in writing this book is to tell Pam that she does matter, and that her life is important — and her story is important – and it deserves to be honestly told…” What unfolds in Dan’s book is a compelling behind the scenes look at the corrupting corporate influence on American’s health care system. A review by David Mayer said “… this book should be required reading for all resident physicians and health science students entering the field.” Dan has served as a Communications Director of the American News Network and for US Senator Herb Kohl and as a political consultant with Joe Trippi. He was a technical writer for Oregon Gov. John Kitzhaber’s health care reform effort.

Saturday, October 26, 2013

Totally Fraudulent and Phony: Medical Device Industry demands for Tax Repeal

October 25, 2013 by Arezu Sarvestani     FiDA highlight
MASSDEVICE ON CALL — Medical device tax repeal efforts have made friends across party lines and in both houses of Congress, but Senate Health Committee chairman Tom Harkin isn't one of them.
In harsh comments made yesterday Harkin characterized the debate over the medical device tax as a fabricated controversy, saying that the industry can afford to pay its share to help fund healthcare reform, Minnesota Public Radio reported.
"That medical device tax issue is one of the phoniest issues I have seen in my years here," Harkin said. "It is absolutely, totally fraudulent and phony. That small amount of tax won't hurt them one bit, and they make a lot of money on medical devices."
Harkin promised to fight any efforts to repeal the tax, MPR wrote. The sentiment is one long shared by the White House.
The Obama administration has on several occasions said that medical device tax repeal is a non-starter, maintaining that the levy represents the medtech industry's fair burden in helping to fund healthcare reforms that will bring them more customers. The so-called "windfall" rhetoric has been a staple of the battle over the medical device tax, with proponents of the tax arguing that medtech companies will offset much of their costs through their new customers and the industry insisting that the newly insured aren't the kind that end up needing medical devices.
The White House said for the 1st time this month that it would consider repeal of the levy, as long as lawmakers could come to terms on some means of making up for the lost revenue. The issue of a so-called "pay-for" to make up for the lost revenue the medical device tax is projected to generate has been a sticking point for many Democrats.

Friday, October 25, 2013

Toxic medical device cartel penetrates government at the highest levels.

 May 13, 2013 by Brian Johnson

AdvaMed's government affairs guru J.C. Scott has been named a "top lobbyist" by CEO Update, a publication that covers the trade association industry.
Scott received praised by the publication for his work on efforts to repeal the medical device tax,. He was one of only two healthcare related lobbyists on the list.
"[Scott] built bipartisan support for repealing the medical device tax, resulting in a nonbinding 79-20 Senate vote,"the publication wrote. "Helped lead Hill efforts to reauthorize user fees, and then to allow FDA to spend the full amount collected."
AdvaMed hired Scott away from the American Council of Life Insurers 2 years ago. He is a Capitol Hill veteran, having cut his teeth on the Hill as deputy director for policy at the House Republican Conference and in a number of capacities for Rep. Deborah Pryce (R-Ohio) before spending seven years at ACLI.
His predecessor, Brett Loper, left Advamed in early 2011 to become the policy director for House Speaker John Boehner (R-Ohio).

Wednesday, October 23, 2013

Patient harm escalates: patient safety is elusive.

Washington Bureau
Published: 22 October 2013 08:14 PM
Updated: 23 October 2013 12:47 AM

Parkland Memorial Hospital, which has a new facility under construction, saw its grade drop in the most recent Leapfrog safety ratings from A to C.
                Editorial: What Parkland needs in a new CEO
WASHINGTON — Sixteen of 41 Dallas-area hospitals slipped in safety ratings issued Wednesday by the nation’s largest self-insured employers.
Parkland Memorial Hospital and Baylor Medical Center at Carrollton fell two marks from A to C grades, while Texas Regional Medical Center in Sunnyvale fell from a B to a D.
Medical Center of Plano, meanwhile, went from a C to an A.
The grades, compiled by the Washington-based Leapfrog Group, are summations of 28 safety indicators and correspond to the letter grades most kids get in school.
Nine hospitals including Medical Center of Plano improved their grades from May’s evaluation. Another 16 hospitals stayed the same.
The middling showing for Dallas-area hospitals was reflected nationwide among 2,539 hospitals that were judged on the incidence of medical and medication errors, infections and injuries.
Two new types of hospital-acquired infections — for colon surgeries and urinary-tract catheters — were added to the latest report card. But a review of the data did not show they were responsible for the lower scores at some hospitals.
John T. James, a Houston toxicologist and head of an advocacy group called Patient Safety America, estimates that as many as 440,000 Americans die each year as a result of preventable harm while hospitalized.
The Leapfrog Group is made up of hundreds of large companies and includes the Dallas-Fort Worth Business Group on Health. It cited James’ findings in its latest report.
“We are burying a population the size of Miami every year from medical errors that can be prevented. A number of hospitals have improved by one or even two grades, indicating hospitals are taking steps toward safer practices, but these efforts aren’t enough,” said Leah Binder, president and CEO of the Leapfrog Group.
Parkland’s slump was “a disappointment,” said interim senior vice president Mike Malaise. The hospital had pulled itself up from a C to an A in Leapfrog’s May evaluation.
“We remain focused on sustaining the many improvements we have recently made. There is no question that Parkland is a much better health care provider than it was two years ago, but we must remain focused on continual improvement,” Malaise said in a statement.
No surprise
Medical Center of Plano’s jump from a C to an A was no surprise, said chief nursing officer Sandy Haire.
“We embrace public reporting of quality and safety data, and we work hard every day to improve the care we deliver. We fully anticipated our most recent score would accurately reflect our ongoing commitment to provide the highest level of quality patient care,” she said.
Baylor Health Care System saw grades fall at five of its nine Dallas-area hospitals, while one — Baylor Medical Center at Irving — improved from a B to an A.
Baylor chief quality officer Dr. Donald Kennerly said the hospital group supports Leapfrog and other evaluators, but he said it has improved by its own measures.
“Since there is no nationally accepted yardstick to judge patient safety, we use a variety of measures to evaluate our performance monthly, many of which are not available to Leapfrog,” he said.
“By constantly measuring and working to improve patient safety at all of our facilities, we have seen a more than 40 percent reduction in preventable adverse events over the past five years,” Kennerly said.
Texas Regional Medical Center and Dallas Medical Center (formerly Texas Hospital for Advanced Medicine) were the only area hospitals to get a D grade.
Texas Regional argued it would do better once more recent results become available.
First few years
“Much of the data Leapfrog used for this year’s assessment is based on the hospital’s first few years of business. Since Texas Regional Medical Center at Sunnyvale opened in September 2009, we are always improving,” said Dani Morales, the hospital’s director of quality.
Even though this is the second report card issued in 2013, Leapfrog officials said they were basing their latest results largely on data submitted a year or two ago by the hospitals to the federal government.
Hospitals are required to report information on medication errors, surgical site infections, bedsores, falls and other maladies that occur while patients are hospitalized. The information is summarized for consumers at
Those results plus information on electronic health records, staffing and training are sifted by Leapfrog analysts and reviewed by a panel of hospital safety experts.
Leapfrog analysts say they work with the latest data and invite hospitals to update information as it becomes available.
The Leapfrog grades are available at
Follow Jim Landers on Twitter at @landersjim.

Monday, October 21, 2013

Medical device cartel would shut down the U.S. government over 2.3% tax? Yup!

The New York Times
By TOPHER SPIRO  FiDA highlights
Published: October 16, 2013
WASHINGTON — IN the last few days of negotiations in Congress, repeal of the Affordable Care Act’s tax on medical devices emerged as a key Republican demand. The medical-device industry waged an intense lobbying campaign — even garnering the support of many Democrats who favored the law — arguing that the tax would stifle innovation and increase health care costs.

This argument is doubly disingenuous. Not only can the medical-device industry easily afford the tax without compromising innovation, but the industry’s enormous profits are a result of anticompetitive practices that themselves drive up medical-device costs unnecessarily. The tax is a distraction from reforms to the industry that are urgently needed to lower health care costs.
The medical-device industry faces virtually no price competition. Because of confidentiality agreements that manufacturers require hospitals to sign, the prices of the devices are cloaked in secrecy. This lack of transparency impedes hospitals from sharing price information and thus knowing whether they are getting a good deal.
Even worse, manufacturers often maintain personal relationships (sometimes involving financial payments like consulting fees) with physicians who choose the medical devices that their hospitals purchase, creating a conflict of interest. Physicians often don’t even know the costs of the devices, and individual physicians often choose devices on their own, which weakens a hospital’s ability to bargain for volume discounts.
Such anticompetitive practices help generate a wide variation in the prices of medical devices — and contribute to higher prices in general. For example, the Government Accountability Office found that prices for cardiac implantable medical devices in the United States vary by several thousand dollars. And even the lowest-priced devices in the United States are expensive compared with those in other developed countries. According to the consulting firm McKinsey & Company, the United States spends about 50 percent more than expected on the top five medical devices, compared with Europe and Japan. McKinsey calculates that this amounts to $26 billion in excessive spending each year. Medicare, private health insurers and patients end up paying these inflated prices.
Excessive prices fuel enormous profits — profits that dwarf both the medical-device tax and the industry’s investments in research and development. Consider the device division of Johnson & Johnson, which in 2012 had an operating profit of $7.2 billion. By the company’s own estimate, the device tax would amount to at most $300 million, and its investment in research and development amounts to only $1.7 billion.
There are several ways policy makers could lower device costs. The first step would be to end the anticompetitive practices that prevent hospitals from getting the best deals. Senator Charles E. Grassley, Republican of Iowa, has sponsored legislation that would foster transparency by posting online price information for implantable medical devices.
In addition, instead of simply paying hospitals based in part on what they have spent on devices, Medicare should force manufacturers to compete for business based on a product’s price and quality.
Medicare should also pay hospitals a single lump sum for all of the associated costs of a given procedure (like a hip replacement). This approach, known as “bundling” the costs, would create incentives for hospitals to lower device costs. Savings should be shared with the physicians, so that their incentives are aligned with the hospital’s.
Bundling has been used successfully in pilot programs. Under Medicare’s Acute Care Episode Program — which bundled payments for cardiac and orthopedic procedures — physicians worked together to choose high-quality, cost-effective devices. Baptist Health System in Texas, which participated in the program, used clinical evidence to choose devices and negotiated lower prices for both Medicare and non-Medicare patients.
States could adopt similar payment reforms for private insurance and their Medicaid programs. In Arkansas, the Medicaid program and private payers — including Walmart — have collaborated to adopt bundled payments for several procedures, including hip and knee replacements.
To complement these efforts, the new Patient-Centered Outcomes Research Institute, a nongovernmental body created by the Affordable Care Act, should pay for research that compares the effectiveness of devices so physicians can make informed choices. (Three years into its existence, the institute has initiated few, if any, studies of medical devices.) Medicare or the Food and Drug Administration should also require the use of registries that track when devices fail.
Currently, medical-device manufacturers allocate only a sliver of profits to research and development and often focus on “tweaks” to existing devices, without providing any evidence that they are of better quality. Competitive pressures from public and private payers would provide incentives for the industry to become more innovative, producing technologies that actually lowered costs and offered truly advanced breakthroughs.
Instead of using its clout to lobby against the device tax — which helped foment opposition to the Affordable Care Act — the medical-device industry needs to share the responsibility of lowering costs for patients, businesses and taxpayers.
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Topher Spiro is the vice president for health policy at the Center for American Progress.

Sunday, October 20, 2013

Katie Couric: apply to talk about SUI and OAB treatments

FiDA highlight

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Implanted medical devices tracked by FDA: probably not!

 FiDA highlight
Manufacturers are required to track certain devices from their manufacture through the distribution chain when they receive an order from the agency to implement a tracking system for a certain type of device. The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial distribution. Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices.
                Devices Subject to Tracking
                Tracking Documents
                Other Helpful Links
Manufacturers must adopt a method of tracking devices whose failure would be reasonably likely to have serious, adverse health consequences; or which is intended to be implanted in the human body for more than one year; or are life-sustaining or life-supporting devices used outside of a device user facility. The regulations implementing the tracking requirements became effective on August 29, 1993 and can be found in 21 CFR Part 821.
Important Note: Effective, February 19, 1998, the tracking requirement has been changed to eliminate automatic mandatory tracking for certain devices. The Modernization Act gives FDA discretion to order manufacturers of certain types of Class II or Class III devices to initiate a program to track their medical devices down to the patient level.
Information on implementation of the Medical Device Tracking Regulation along with the current list of devices that FDA has ordered to be tracked can be found in the following guidance "Guidance on Medical Device Tracking". Please note that 21 CFR 821 does not contain the current list of devices to be tracked. The current list can be found in the guidance document referenced above and at the bottom of this page.
The tracking provision is intended to ensure that manufacturers can expeditiously remove potentially dangerous or defective devices from the market and/or notify patients of significant device problems.
Tracking augments FDA's authority to order mandatory recalls and require notification of health professionals and patients regarding unreasonable risk of substantial harm associated with a device.
Manufacturers of a tracked device must establish a written standard operating procedure (SOP) which includes a method for tracking the device throughout distribution and a quality assurance program including audit procedures. Final distributors of these devices will be required to provide manufacturers with patient information.
Device tracking is required for the useful life of the device.
The types of devices subject to a tracking order may include any Class II or Class III device:
                the failure of which would be reasonably likely to have serious adverse health consequences;
                which is intended to be implanted in the human body for more than one year; or
                which is intended to be a life sustaining or life supporting device used outside a device user facility.
The Modernization Act also allows patients receiving a tracked device to refuse to release, or refuse permission to release, their name, address, social security number, or other identifying information for the purpose of tracking.

The FDA plans to contact manufacturers of devices that have previously been identified as devices subject to tracking to indicate whether they should continue to track these devices or if tracking may be discontinued. Manufacturers currently required to track devices under Section 519(e) of the FFD&C Act should not discontinue tracking prior to communication from FDA.
Devices Subject to Tracking
FDA has issued orders to manufacturers who are required to track the following implantable devices:
                Glenoid Fossa prosthesis
                Mandibular condyle prosthesis
                Temporomandibular Joint (TMJ) prosthesis
                Abdominal Aortic Aneurysm Stent Grafts
                Automatic implantable cardioverter/defibrillator
                Cardiovascular permanent implantable pacemaker electrode
                Implantable pacemaker pulse generator
                Replacement heart valve (mechanical only)
                Implanted cerebellar stimulator
                Implanted diaphragmatic/phrenic nerve stimulator
                Implantable infusion pumps
                Silicone Gel-Filled Breast Implants
                Cultured Epidermal Autografts
FDA has issued orders to manufacturers who are required to track the following devices that are used outside a device user facility:
                Breathing frequency monitors
                Continuous Ventilators
                DC-defibrillators and paddles
                Ventricular Bypass (assist) Device
Tracking Documents
Other Helpful Links
                Postmarket Surveillance Studies
                MDR Home page