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 31, 2017

If Cars Were Sold Like Healthcare . . .

In all reproductions and shares of this piece, please attribute it to the author,  Patient Advocate & harmed patient, Kerry O'Connell.  

If cars were sold like Healthcare.

  1. They would never disclose the price
  2. There would be no finance packages
  3. Months after you drove off you would get a very big bill from the dealer
  4. Then you would get a separate bill for the salesmen’s time talking you into it
  5. Six months later you would start getting separate bills from every supplier who provided parts
  6. You would get bills for the gas, and the oil, and the air in the tires
  7. There would be absolutely no owner’s manual of any kind
  8. There would be absolutely no warranty of any kind

When you brought it in for service

  1. They would give you no cost estimate or repair time
  2. You would sign a release stating that they might fix your car, they might not be able to fix your car, in the process of trying to fix your car it might burn to the ground and in any of these cases you are still responsible  for every cost that they incurred while your car was there.
  3. If they happened to leave any tools in your car  you would be charged extra
  4. If any work performed caused rust, smells, or cosmetic concerns you should be happy  it runs.
  5. If the problem  reoccurs you get to come back and pay again

No matter what you felt about the above experiences you would be prohibited from telling anyone under threat of lawsuit.

Tuesday, October 24, 2017

Catastrophic FAIL: Easier to Recall Spinach Than Medical Implants

By Joe Carlson OCTOBER 21, 2017 — 2:00PM
Fictitious medical device label is shown for unique device identifier information.

In March 2015, Target Corp. alerted customers to throw out certain 10-ounce bags of organic chopped spinach because they were potentially contaminated with listeria bacteria, which can cause serious health problems.
The recall notice, filed with the U.S. Food and Drug Administration, urged people who bought the spinach to check UPC codes and a special nine-digit tracking code called the DPCI that Target includes on its sales receipts. The recall was routine, and no illnesses were publicly linked to the incident.
No such system exists for medical device consumers, however.
In fact, proposals to give insurers and patients access to the serial numbers on their implanted medical devices remain controversial.
Manufacturers say it would cost additional time and money with no guarantee of benefit to put the device serial numbers into insurance claim forms. Consumer safety officials and auditors argue the move would improve patient safety and enhance accountability.
To patient advocates like Lisa McGiffert, director of the Consumers Union's Safe Patient Project, omitting device serial numbers from an insurance claim would be like buying a car without getting its VIN number.


Doesn’t Add up: The medical industry is divided over adding a unique device identifier (UDI) to devices, which would make it easier to locate a device but at a higher cost for companies.
"We don't even have the make and the model" in insurance claims, McGiffert said. "We can put it on a car — why shouldn't we have it on a hip that you're putting in my body?"
Thousands of medical devices are recalled each year, but it can be hard to track them. In 2005, former Minnesota device maker Guidant Corp., now part of Boston Scientific, urgently recalled thousands of pacemakers because excess moisture could seep inside the life-preserving devices and ruin them.
A handful of patients with the devices went into cardiac arrest or experienced heart failure, and one death may have been linked to a pacemaker failure. Yet the Government Accountability Office (GAO) reported in 2011 that 1,732 of these recalled pacemakers were never recovered because there was "no implant record available."
Medicare, which pays hospitals to implant such devices in patients aged 65 and older, had no direct way of tracking down which of its patients may have gotten those 1,732 leaky Guidant pacemakers — nor, for that matter, any of the hundreds of thousands of other heart devices that have been recalled by the medical device industry in the years since then, critics inside and outside the government say.
Congress mandated a system of serial numbers to track medical devices known as UDIs, or unique device identifiers, back in 2007, and the Food and Drug Administration has been rolling out rules for how and when to use them ever since.
The med-tech industry and some doctors have fought hard to keep them out of Medicare claims and private insurance bills.
A two-year investigation by Medicare's inspector general office recently concluded that the publicly funded health insurer spent an estimated $1.5 billion over 10 years on surgeries and follow-up care for patients who had one of seven specific heart devices made by Minnesota manufacturers. The review did not include the Guidant pacemakers mentioned by the GAO and didn't examine other widely recalled types of devices, like metal-on-metal hip implants.
John Boujoulian, senior auditor on the Medicare inspector general investigation, said the lack of UDI numbers in Medicare claims makes it harder to locate patients affected by medical device recalls. But as it stands, Medicare would have to do a detailed review of medical records to find the UDIs to track down devices that it pays to have implanted or replaced.
"We had to go through all the medical records to find out," Boujoulian said in an interview about the audit. Using subpoenas to the device makers, "we had lists of all the people who had the medical devices implanted and the specific models, and we had to go through them all to see which ones had issues."
But going through the detailed medical records of patients is exactly what the medical device industry advocates.
"We support the collection of the UDI in the electronic health record, where it can actually be used to really help track patient outcomes and be used in a more proactive way around postmarket surveillance," said Don May, executive vice president for the Washington-based medical device manufacturer trade group AdvaMed. "If we are really concerned about patient safety, then let's go to the tool that makes the most sense."
Industry officials say the codes are too long and varied to put into insurance claims. AdvaMed says hospitals would have to invest in new bar code scanners and come up with ways to accurately transmit the data to payers. The American Medical Association says reporting UDIs in insurance claims would be cost prohibitive and insufficient for detecting widespread problems.
Organizations including Centers for Medicare and Medicaid Services and the Medicare Payment Advisory Commission have supported adding a short section of the UDI known as the "device identifier," or DI, to Medicare claims forms.
The full UDI, however, can run to 75 characters and comes in three different formats used by three different standards organizations. The full code contains not just model numbers, but batch and lot numbers, dates of manufacture and other information that would identify which specific devices are affected by problems.
AdvaMed Associate Vice President Zach Rothstein, who advocates on medical device regulation involving the FDA, said researchers who use just snippets of the UDI codes may draw inaccurate conclusions about devices that could negatively affect both medical device makers and patients.
"Think about all the food recalls where you go to your freezer and say, 'Well, was this done in that time frame and in that plant?' And the news gives you the code. It's not just this was Tyson chicken," he said. "Without [the full serial number], you just don't know."
Advocates say patient safety would benefit from the added transparency, dismissing arguments that it's too difficult or expensive. Ben Moscovitch, manager, health information technology at Pew Charitable Trusts, noted that the FDA's Sentinel program to root out problems with prescription drugs is based largely on claims data, which incorporates 10-digit National Drug Codes.
"Many of the safety challenges that occur with devices occur across the entire product line," Moscovitch said, "and to evaluate the safety of products in that capacity requires only the brand and model of the device, and not the production information that is included in the [full UDI]."
The three companies that made the recalled or defective heart devices that led to $1.5 billion in Medicare spending documented in the inspector general's report — Boston Scientific, Medtronic and St. Jude Medical owner Abbott Laboratories — all declined to comment for this story.
Asked whether the medical device companies' opposition to including UDIs in Medicare-claims forms was related to financial concerns like lost sales or increased litigation, May noted that product recalls are already costly.
"From a litigation perspective, I think malpractice attorneys are very aggressive in a lot of ways, and this just becomes one additional data source," May said. "But if you've got a product that is recalled, my guess is the company is already feeling a financial impact because it's a product that they've had to recall."

Tuesday, October 3, 2017

Could One Company Be . . . Medtronic? St. Jude?

By FRED SCHULTE and CHRISTINA JEWETT   OCT. 2, 2017  The New York Times
WASHINGTON — Medicare paid at least $1.5 billion over a decade to replace seven types of defective heart devices, a government watchdog says. The devices apparently failed for thousands of patients.
A report released on Monday by the inspector general’s office for Health and Human Services said officials needed to do a better job tracking these costly product failures to protect patients from harm. More detailed reporting could lead to earlier recognition of serious problems with medical devices and faster recalls of all types of “poorly performing” ones, the inspector general’s office said.
The report marks the first effort by anyone in government to assess the losses to taxpayers and patients 65 and older from medical gear that proves faulty.
Officials said the $1.5 billion lost from the seven devices from 2005 through 2014 was a “conservative estimate.” Patients also paid $140 million in out-of-pocket costs for this care, the report noted.
The report found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections. It did not outline specific injuries that patients suffered as a result.

The inspector general did not identify the manufacturers of the seven devices, but officials said they included implanted cardio defibrillators and a pacemaker that had either been recalled because of flaws or had “prematurely failed.” Pacemakers and implantable defibrillators are small devices placed under the skin to help treat irregular heartbeats.
How best to identify these defects and cut Medicare spending associated with fixing them has been under consideration at various times since 2007, according to the report. But it remains a contentious issue.
The inspector general recommended that hospitals and doctors be required to submit detailed information identifying failed devices, like serial and batch numbers, during the billing process.
“This could help reduce Medicare costs by identifying poorly performing devices more quickly, which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly,” the report said.
David Lamir, an official in the inspector general’s Boston office, said the $1.5 billion figure represented a “drop in the bucket” of the true costs to Medicare from medical products that malfunction. He said device failures not only waste money, but also can expose patients to a “high risk of illness,” including needless surgeries.

The report said that medical device recalls nearly doubled from 2003 through 2012 and noted that they have probably cost Medicare billions of dollars. In the past five to six years, more than 200 cardiac devices have been recalled, according to the inspector general’s office. In most cases, manufacturers withdrew their products voluntarily after reports surfaced of injuries or malfunctions. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration.
Diana Zuckerman, president of the National Center for Health Research who has testified before Congress on device safety, said her organization supports making hospitals report malfunctioning devices when they seek Medicare payments to cover an implant surgery. She said the change would help officials pinpoint faulty devices before issuing a recall for tens of thousands of products in patients.
“It would be much more obvious much more quickly which implanted devices were causing problems,” she said.
Ms. Zuckerman noted that the report did not touch on other high-profile device failures, like metal-on-metal hip implants or vaginal mesh.
Medical device companies and some doctors have opposed tighter reporting, arguing that it would be costly and difficult to integrate with existing payment claim forms and might not yield useful information.
“It is abundantly clear that data collected in electronic health records is a far superior and more cost-effective method for monitoring the performance of medical devices,” said Mark Leahey, who heads the Medical Device Manufacturers Association. The trade group represents nearly 300 device companies.
Mr. Leahey said that the electronic health record “captures the full clinical history of the patient, their changing health status and detailed information on their medical treatments,” including any surgically implanted devices.
A spokesman for the Centers for Medicare and Medicaid Services said the agency had not seen the report and would have no comment.
But in written remarks included in the report, Seema Verma, the agency’s administrator, said the tighter reporting requirement was “under consideration” and that the agency would “carefully evaluate the potential that this policy would impose a burden on physicians unnecessarily.”
This article was produced in collaboration with Kaiser Health News, an editorially independent program of the Kaiser Family Foundation. 

Sunday, October 1, 2017

Surgical Mesh Scandal: Worse Than Thalidomide. Truth.

Compensation could "run into the billions of pounds" according to a lawyer, making it one of the largest medical cases in history.
16:40, UK,
Saturday 30 September 2017

The vaginal mesh that was fitted to tens of thousands of women, leading some to suffer pain
By Charlotte Lomas, Sky News Correspondent and Aubrey Allegretti, News Reporter

An operation to treat incontinence performed on tens of thousands of women across the UK could be hiding a scandal worse than Thalidomide, a leading expert has warned.
Professor Carl Heneghan, who specialises in evidence-based medicine, said some of the devices used in vaginal mesh implants had not been clinically tested and, "unlike in the Thalidomide scandal, you are unable to see the extent of the women's injuries".
Speaking about the scale of the scandal, he said: "I think this is the worst one that we'll ever see in my lifetime because of the scale of the number of women affected."
More than 75,000 women in England had the procedure - known as TVT - between 2006 and 2016, according to NHS data.
One in 15 have had the implant removed.
The 20-minute operation is used to treat stress incontinence and also prolapse, mainly caused after childbirth, by inserting a plastic mesh, made out of polypropylene, into the vagina to support the bladder.

While for many the procedure can be quick and successful, for others it can have dire consequences, leaving patients in chronic pain and unable to walk, work and have sex.
The mesh is supposed to be flexible, but when inside the body can stiffen, erode and slice through organs, including the bladder.
Lesley Elder, 49, had the mesh fitted in 2010 after having two children, and has had 13 subsequent operations to repair the catastrophic damage.
She is now registered disabled, is in chronic pain and survives on benefits.

Lesley Elder has had 13 operations to repair damage caused by the fitting of the mesh
"I'm not the woman I used to be," she told Sky News. "I feel like a helpless no-hoper. I think I'd be better off dead; I don't want to live like this. I want my old life back."
Professor Heneghan, from the University of Oxford, said Lesley's case is not unique, and warned that the UK is heading for a "major disaster".
"Every young woman I have talked to has not been told about the adverse consequences," he told Sky News.
Professor Heneghan said the NHS was not offering the operation to patients based on "need" but on what manufacturers with a commercial interest wanted.
The mentality, he said, was: "Get people through the system - in and out."

Ms Elder says she has to take a cocktail of drugs after having the procedure
One manufacturer of TVT is Ethicon, a subsidiary of Johnson & Johnson.
Up to 300 women in the UK are taking part in legal action against Johnson & Johnson, claiming the implants they were fitted with are not fit for purpose.
David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, said it was a "significant" medical case.
Total compensation, he claimed, could "run into the billions of pounds, which would make it the largest medical case in UK history".
A spokesperson for Johnson & Johnson told Sky News implantable mesh was "backed by years of clinical research" and that "Ethicon is confident in its products".
They said the use of pelvic mesh devices is "supported by medical experts around the world".
The spokesperson added: "Ethicon is defending lawsuits concerning the use of our pelvic mesh products.

"We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."

Mission Accomplished!