VA Wasted $3 Billion In Medical Implant Device Purchases, Will Now Track Medical Implant Devices With New Database
In response to a GAO report showing VA wasted $3 billion on medical implant devices, the agency plans to now track these implants to avoid waste and to notify patients about bad implants begging the questing, “How much will this cost taxpayers and will it work?”
In 2014, a GAO audit revealed the agency wasted $3 billion in the previous ten years on medical implant devices enabled by a lack of tracking. The audit also found VA failed to create a medical implant device registry to help it locate and notify veterans about bad implants that may put their health at risk.
To date, implanted devices in veterans have not been tracked. Meaning, if FDA learns that a certain device is faulty or dangerous, VA apparently lacked a national registry to facilitate locating impacted veterans.
Awesomesauce (yeah, that is a word).
Since VA is one of the largest purchasers of surgical implants, it is no wonder the agency was able to waste so much money until now with its program since there was no accountability. But that same lack of accountability put veterans lives at risk.
Finally, four years after GAO put American on notice of the failure and its potential health consequences, VA is finally taking heed.
RELATED: Advice For New Acting VA Secretary
“A medical device registry will allow VA to notify patients about safety recalls, identify devices when patients show up for medical emergencies with complications, and track and compare outcomes of implants,” states the agency’s announcement. “The most common medical devices in the veteran population may include cardiac implants (valves, pacemakers and stents), orthopedic implants (hip and knee) and neurosurgical implants.”
But who will create the database… and will it work?
RELATED: New Electronic Health Records System Given 6.4% Odds Of Working
Presently, there is no software solution in existence that supposedly tracks the location of the devices in the body on a national scale.
RELATED: VA Pays $500,000 For Deadly Allergic Reaction Induced By VA Doctors
With this new initiative, VA plans to provide short- and long-term surveillance of the devices. It also plans to track comparative safety and effectiveness assessments by leveraging its huge database of veterans.
How much value is present in keeping all veterans inside the VA health care system to further the aims of growing the agency’s data analytics capabilities?
Source: https://www.healthdatamanagement.com/news/va-to-launch-national-registry-for-medical-implant-devices
Hey Elf,
Did you catch the following article.
“Report: Andrew McCabe Seeks Immunity Deal for Testimony”
By Joshua Caplan, Breitbart News, June 5th, 2018
“Former FBI Deputy Director Andrew McCabe is reportedly in negotiations with Senate Judiciary Committee Chairman Chuck Grassley to be granted immunity in exchange for his testimony on the upcoming Justice Department Inspector General report on the FBI’s handling of the Clinton email probe.”
““Under the terms of such a grant of use immunity, no testimony or other information provided by Mr. McCabe could be used against him in a criminal case,” Michael Bromwich, an attorney for the former FBI official, told Grassley.
“Mr. McCabe is willing to testify, but because of the criminal referral, he must be afforded suitable legal protection,” Bromwich added.”
“https://www.breitbart.com/big-government/2018/06/05/andrew-mccabe-immunity-ig-report/”
Rat trying to escape justice for his actions.
Rats will devour their own then shit them out to be run over by the bus the rats are running from; regardless of political markings on the congress critter’s hind-quarters. 😀
I am sure it is one of those immunity deals where he agrees to testify and they only cover what is already known. He just admits his part and isn’t prosecuted for the crimes he committed and a year from now he gets his retirement package back.
Louie Greco a decorated World War II veteran who died in 1995 after serving 28 years in prison for a crime he did not commit. Three other men were also wrongly convicted of the crime.
Greco was convicted in Boston while Robert Mueller was an Assistant U.S. Attorney in the U.S. Attorney’s Office and then became the Acting U.S. Attorney from 1986 through 1987.
It was Mueller’s actions during that time that raised questions about his role in one of the FBI’s most controversial cases involving the FBI’s use of a confidential informant that led to the convictions of four innocent men, who were sentenced to death for murders they did not commit.
Local law enforcement officials, the media, and some colleagues criticized Mueller and the FBI for what they believed was the bureau’s role in covering up for the FBI’s longtime dealings with mobster and informant James “Whitey” Bulger.
Within days of the murder, Boston FBI agents knew the identities of the actual murderers, and reported the information to J. Edgar Hoover in Washington. But they allowed a Mob hitman they had flipped, Joseph Barboza, to settle some old scores by falsely testifying that the four men had taken part in the gangland murder he had helped arrange with others.
In 2002, lawyers for one of the innocent men, Louie Greco, were seeking a posthumous pardon for him from the state of Massachusetts. Greco, a decorated World War II veteran, had been living in Florida at the time of the murder, but was nevertheless convicted on Barboza’s perjured testimony.
For 35 years, the FBI refused to release the evidence exonerating the wrongfully imprisoned men on the grounds of “national security.” It was finally released in 2000 as part of an investigation into corruption in the Boston office of the FBI.
After the state pardons board asked Mueller for the Bureau’s version of its actions, a Boston FBI agent, Charles Prouty, wrote back on May 9, 2002 that “FBI Headquarters in Washington, D.C. has directed the office to respond.”
While conceding that the damning FBI reports contained “impeachment material,” Mueller’s FBI still contended that the innocent men might in fact be guilty, despite the FBI’s own reports to the contrary.
“This does not necessarily mean, however, that Limone or any of the other defendants is innocent – it merely means that they are entitled to a new trial.”
Deegan was murdered on March 12, and the FBI office sent memos to Bureau headquarters in Washington on March 15 and March 19 identifying the real killers – and with no mention of the four men who later won the $102 million judgment.
Mueller, however, tried to convince the Massachusetts authorities that his own Bureau’s documents did not mean that the four men had been railroaded.
“Much of the FBI confidential source information relates to the individuals who were involved in the Deegan murder as principals,” Mueller’s deputy said, underlining the word. “This information is not necessarily inconsistent with the crimes for which the defendants were convicted.”
Michael Albano, a former member of the MA parole board and one-time mayor of Springfield, worked for years to free the innocent men.
“Even after the facts of the FBI cover up were revealed,” he said last week on “The Howie Carr Show” after reading the letter, “the FBI continued the cover up with the approval and authorization of Director Robert Mueller III.”
This newly rediscovered letter is the latest indication of Mueller’s role in what may have been the FBI’s greatest scandal ever, at least until the current Spygate controversy which has led to Mueller’s ongoing “investigation” of President Trump.
John Cavicchi, the Greco attorney who found Mueller’s FBI letter in his case files last week, said it had “outraged” him all over again.
Read the full story about Robert Mueller at:
“Not So Honorable: Docs Show Mueller’s FBI Denied Justice To Four Innocent Men
4:18 AM 06/05/2018
Howie Carr | Host, ‘The Howie Carr Show’
“https://dailycaller.com/2018/06/05/mueller-fbi-wrongful-conviction-case/”
Questions Still Surround Robert Mueller’s Boston Past
Mueller’s involvement in one of the FBI’s most embarrassing cases
Sara Carter Sara Carter March 22, 2018
“https://saraacarter.com/questions-still-surround-robert-muellers-boston-past/”
And your point is……….?
Got to say it T, with the Bloomberg article you pointed out. The Fake News article that Ben reviewed today. The two GAO reports from 1984 and the one released in 2014 at the same time the article you mentioned was published. The VAIG reports from 1981, 2012 and 2013. The prior reporting here on Ben’s site regarding how dead Veterans bodies are used.
Oh, and lets not forget the congressional investigation that turned up the fact that the people selling the body parts to the VA preforming transplants were also actually employed as surgeons by the VA. So not only were they selling the body parts as a vendor to the VA. They were the surgeons that were preforming the the transplant surgeries that used the body parts they had sold to the VA.
Their is something way wrong with what they are doing.
Also the research that Ben has reported on where they were storing living bodies the VA had classified as brain dead in a prolonged hypothermia state prior to transplanting the kidneys. Which they called non-human subject research because the donor had been called brain dead by the VA.
Is there any hospital or competent surgeon in the nation that does NOT track implants…outside of the VA?
Goes a lot toward the conversation of standard of care issues.
Amazing Seymore, it’s like peeling back an onion, each layer more rotten than the one before it.
Shut the damn VA down.
I wonder how many, congressman, and senators, have their hands in the VA cookie jar, and how big their greedy mitts are. I know it has already been shown, that money stolen from Veterans compensation checks, has found its way into political campaign funds. The first person to find this out was Edwin Crosby III. There has to be a way to follow those cookie crumbs.
The VA is the new post office scandal, only this time, since its only Veterans, nobody gives a shit.
“cj”,
I’m wondering how many elected and appointed officials have “stocks and bonds” in “Pig Pharma”!
The ASSHOLES have already made it legal for them to get away with “insider trading”!
Had one of those “not born yesterday”, or one of those “I was born at night but it wasn’t last night” moments when I first read Ben’s article. I did a little research and this is what I found:
1. The 2014 GAO report largely dealt with skin grafts which are considered medical device implants and as everybody who reads Ben’s Blog on a regular basis knows skin grafts have been reported on here lately. Three employees at the Department of Veterans Affairs were indicted on charges they accepted bribes from the pharmaceutical firm MiMedx which supplies the skin for skin grafts. The timing of the bribes started before the 2014 GAO report. Also, Congressional investigations following the GAO report found that at some VA Medical Centers the doctors preforming the skin grafts were also employed as the Vendors who were selling and suppling the skin graft material.
Considering the word Graft has multiple meanings and they both fit in this case. Graft, as understood in American English, is a form of political corruption, being the unscrupulous use of a politician’s authority for personal gain. The term has its origins in the medical procedure whereby tissue is removed from one location and attached to another for which it was not originally intended.
Pete Petit is the owner of MiMedx. MiMedx is the firm that paid the bribes to purchasing personal and hired the VA Doctors to act as Vendors to sell his skin graft products. He is also very well known for his ability to shed quite a few bucks during an election season and hanging out with former Health and Human Services Secretary Tom Price.
See: “VA doesn’t track tissue used in surgeries, GAO says”, By Leo Shane, Air Force Times, April 8th, 2014.
At: “https://coffman.house.gov/news/documentsingle.aspx?DocumentID=1434”
Most of my links used or kept over the years is history and can’t seem to find more info about this stuff or other good finds on the censored net today.
“https://www.bloomberg.com/news/articles/2014-01-24/u-s-vets-exposed-to-contaminated-cadaver-parts-from-labs”
Many years back there was questions about a New Jersey town mayor somewhere hooked up with a Rabbi selling and obtaining organs illegally. Comments and questions from vets, along with complaints, were shut down about that too.
In the old Yahoo chat vets started asking questions if this was being used at the Va’s and for those elite in government. Soon after the old chats and links were history. Along with reports being shared on the old Geocities chat arena or web site, now gone too a long time ago. To the more recent about how Cheney (?) I think in the Bush regime got to get hearts so easy not having to wait for years like others on a list.
Around here there was some chatter about cadaver knee replacements and joints having to be re-done for myriads of reason. That was shut down and went un-reported too. You have to encounter people that has gone through that to get a real story from the ‘horse’s mouth’ about their experiences. Or nicked arteries with such procedures.
All this freaking censoring and phony media needs to be shut down fast. Anymore all we get is propaganda, screened news, and crap news.
“https://www.activistpost.com/2018/06/council-on-foreign-relations-tells-govt-they-have-to-use-propaganda-on-americans.html?utm_source=Activist+Post+Subscribers&utm_medium=email&utm_campaign=764b2159b8-RSS_EMAIL_CAMPAIGN&utm_content=Yahoo%21+Mail&utm_term=0_b0c7fb76bd-764b2159b8-387865725”
Forgot to mention. Don’t expect to be able to read that article at Bloomberg. It has been blocked too from general readers.
T,
Want to see the censors in action mode.
Pulled up the Bloomberg article on the internet archives. Check it out and watch what happens.
“https://web.archive.org/web/20150322163740/https://www.bloomberg.com/news/articles/2014-01-24/u-s-vets-exposed-to-contaminated-cadaver-parts-from-labs”
That is what happed on the date it was first recorded on the internet. First the page comes up with the full article then it pulls up some censorship block from Bloomberg claiming the page doesnot exist after you just saw it.
T,
Is this the article T ?
“U.S. Vets Exposed to Cadaver Parts From Contaminated Lab”
Kathleen Miller
January 24, 2014 8:07 AM
“The U.S. Department of Veterans Affairs ordered $241 million of cadaver tissue and other material derived from human and animal bodies in the last three years, some of it from vendors warned by federal regulators about contamination in their supply chain.
About $4.7 million of the VA purchases came from Alachua, Florida-based RTI Surgical Inc. and the nonprofit Musculoskeletal Transplant Foundation, of Edison, New Jersey, according to data obtained by Bloomberg News under a Freedom of Information Act request.
The VA ordered human tissue from the two suppliers after they were warned by the U.S. Food and Drug Administration for safety deficiencies — RTI for contaminated products and processing facilities, and Musculoskeletal Transplant for distributing tissue from tainted donor bodies, according to federal contracting data compiled by Bloomberg.
The suppliers said they have addressed the problems, which weren’t tied to human harms.
The disclosures come as Congress and veterans’ advocates are pressing the VA about whether it tracks body parts and other implants used to treat veterans well enough to warn patients of potential dangers. In September 2012, the VA shelved a system it was building to help alert patients when the parts are recalled. Some of the VA’s buying was made outside standardized purchasing contracts without required justifications, the Government Accountability Office said earlier this month.”
Awaiting Disaster
“It’s a big accident waiting to happen,” said Rick Weidman, executive director for government affairs with the Silver Spring, Maryland-based Vietnam Veterans of America.
RTI received a warning letter from the FDA in October 2012, and Musculoskeletal Transplant received one six months later, following agency inspections.
The congressional scrutiny of the VA’s medical purchasing follows a surge in patients treated in its hospitals, where grafts from cadavers are used to replace burned skin, restore broken bones, or treat other wounds.
The VA has added more than 2 million veterans to its health-care system since 2009. The number receiving biological implants rose 22 percent to 19,350 in the two years ended in September 2013, according to the agency.
Tracking System
A year earlier, the department suspended a computer project known as the Veterans Implant Tracking and Alert System — which “was developed to address shortcomings” in its ability to track surgical implants, including biologically derived ones, and help find their recipients during recalls, according to a Jan. 13 report from the GAO, Congress’s investigative arm.
The project’s future is being evaluated, the VA said in a statement. The agency’s safety office tracks recalls for biological products and notifies its hospitals when necessary, Thomas Lynch, the VA’s assistant deputy undersecretary for health clinical operations, said in a congressional hearing last week. The VA said its safety office hasn’t received any reports from its hospitals about contaminated implants.
Reports of tainted tissue in the industry are especially troubling because oversight the suppliers isn’t strong, said Chris Truitt, a former tissue procurement technician who left the industry in 2005. One body can provide tissue for as many as 100 patients, according to the FDA.
Knee Bone
A Minnesota man died in 2001 after a knee surgery in which he was given contaminated cadaver bone, according to written testimony his parents gave the U.S. Senate Committee on Governmental Affairs in 2003.
In another case, a cadaver was the probable source of hepatitis C infection in at least eight people who had received organs or tissue from the donor, an official with the U.S. Centers for Disease Control and Prevention said in written remarks to the same committee.
“There is no way to track tissue,” Truitt, who wrote a book called “The Dark Side of Tissue Donation,” said in a phone interview. “So a recall may not reach everyone it needs to reach. There may be best practices, things that most people are doing, but if you don’t have 100 percent participation, it’s really no good.”
RTI and Musculoskeletal Transplant, which received the warnings from the FDA, are among hundreds of vendors providing biological products to the department, according to the VA data reviewed by Bloomberg News, which details spending commitments made from October 1, 2010 through September 30, 2013.
Warnings Intent
Drew Brookie, the VA’s press secretary, declined to say whether the department altered its spending with RTI and Musculoskeletal Transplant after the suppliers received FDA warnings. Such warnings aren’t designed to cause hospital systems to cut off suppliers, the VA said in a statement.
The department “is committed to providing the high quality, safe, effective and timely health care veterans have earned and deserve,” Brookie said in an e-mail. “VA has established a record of safe, exceptional health care that is consistently validated by independent reviews and organizations.”
VA contracting processes must give “physicians the flexibility to make the best decision for each individual patient,” Brookie said. The agency is making changes in its procurement process to allow it to make better purchases, he said.
VA Orders
Some of the VA orders were made outside agreements known as federal-supply schedule contracts, according to the House veterans committee and a report from the GAO last week.
The department officials didn’t file waivers or clinical justifications about why existing biologics contracts weren’t used, in violation of VA requirements, the GAO said.
If officials don’t use such contracts, purchases may cost taxpayers more and not include assurances about the country of origin for the tissue, said Representative Jeff Miller, a Florida Republican and the House veterans committee chairman.
“Veterans and the government are at an increased risk for problems associated with product efficacy and quality” when the buying takes place outside contracts that follow purchasing regulations, Miller said in an e-mail.
Academy Medical LLC, a supplier that has contracts with the Veterans Administration, finds it “inexplicable that so many vendors are able to participate in the VA market in violation of the procurement rules and sell their products through unauthorized means at prices that they set rather than prices set through competition,” said Daniel Shaw, managing partner of the West Palm Beach, Florida-based company.
Legs, Ribs
The data obtained by Bloomberg shows a wide range of costs and diversity in the VA buying: $3,555 for eye tissue from Johnson & Johnson, more than $27,000 on leg bones from Medtronic Inc. and $282 on “demineralized” rib bone from Zimmer Holdings Inc. No issues have been raised with these purchases.
Grisly stories, such as a man sentenced in 2008 for running a now-defunct company that conspired to steal tissue from more than 1,000 corpses, have intensified calls for increased industry oversight.
In 2006, Senator Chuck Schumer, a New York Democrat, proposed legislation requiring the FDA to conduct annual, surprise inspections of tissue banks in the wake of the investigation into Biomedical Tissue Services Inc., the defunct company linked to the stolen-tissue crimes. The measure failed.
‘Completely Unregulated’
“People who sell you homes are regulated. People who sell you food are regulated,” Michel Anteby, an associate professor at Harvard Business School who has studied the supply channels, said in a phone interview. “Yet the people who operate in this tissue donation world collected from human cadavers are almost completely unregulated.”
Ukrainian authorities investigated allegations that some morgues were supplying body parts obtained through forged documents or pressuring relatives of the deceased to sign consent paperwork, according to a July 2012 report”” by the International Consortium of Investigative Journalists.
RTI, mentioned as an importer from the country in the report, said in a statement that it decided that year “to voluntarily cease receipt of tissue from the Ukraine due to sensitivities and political disruptions” affecting suppliers there. The decision “did not impact tissue safety in any way,” RTI said.
FDA Letters
Firms should take FDA warning letters like those sent to RTI and Musculoskeletal “very seriously,” said Steven Niedelman, a former FDA deputy associate commissioner for regulatory affairs, who worked for the agency for 34 years.
“They are basically the free pass before the agency considers injunction, seizure or some other action through the Department of Justice,” said Niedelman, a health-law compliance consultant at the law firm of King & Spalding in Washington.
“It is not common for a tissue establishment to be sent a warning letter by FDA,” said Sarah Gray, director of public affairs for the American Association of Tissue Banks, a non-profit group based in McLean, Virginia, that provides accreditation to tissue banks.
Second part of article–
“FDA Letters
Firms should take FDA warning letters like those sent to RTI and Musculoskeletal “very seriously,” said Steven Niedelman, a former FDA deputy associate commissioner for regulatory affairs, who worked for the agency for 34 years.
“They are basically the free pass before the agency considers injunction, seizure or some other action through the Department of Justice,” said Niedelman, a health-law compliance consultant at the law firm of King & Spalding in Washington.
“It is not common for a tissue establishment to be sent a warning letter by FDA,” said Sarah Gray, director of public affairs for the American Association of Tissue Banks, a non-profit group based in McLean, Virginia, that provides accreditation to tissue banks.
Bacteria, including one strain that can infect humans, were found on 70 separate occasions in RTI’s finished sports-medicine goods, the FDA said in an October 2012 letter “” . The products were made from human tissue and weren’t distributed, Jenny Highlander, an RTI spokeswoman, said in an e-mail.
Purchases Continue
The VA continued to purchase from RTI after the FDA warning letter, according to online federal contracting data. The post-warning orders included a $3,375 Achilles-tendon order in April 2013 and a $3,355 skin-graft order in September 2013, according to the data.
The agency’s letter told RTI that it found fungus in tissue-processing and packaging areas, bacteria in its water systems, and had failed to recognize environmental-monitoring data “indicative of contamination throughout your facility.”
Some RTI relationships with customers suffered as a result of the warning, Brian Hutchison, the company’s chief executive officer, said in an August 2013 call with analysts.
“There are certain accounts only in certain pockets of the country where we are blocked based on that letter,” Hutchison said. “So we just have to put those customers aside for now and go focus where we can and grow business where we can and go back and address them once we have the clearance letter that we need or that they say we need.”
The VA ordered $260,679 in human tissue and other surgical implants from RTI during the fiscal year ended September 30, 2013, and almost $1 million from the company in the three years to that date, according to the data obtained by Bloomberg.
Suspicious Bodies
FDA investigators conducted a re-inspection in September, after RTI took corrective action, Wendy Crites Wacker, a spokeswoman for the company, said in an e-mail. The FDA told the company in an October 2013 letter that “it appears that you have addressed the violation(s).” Some customers came back to RTI after the re-inspection and the company was confident it would “gain back our market share,” Hutchison said that month.
The veterans department also ordered more than $3.7 million in biologics over the three years from Musculoskeletal Transplant, according to the data obtained by Bloomberg.
Food Poisoning
The supplier was cited by the FDA in an April 2013 warning letter “” for distributing tissues that came from donors whose bones tested positive for bacteria that can cause pneumonia, food poisoning or other illness. VA orders from the supplier made after the letter included $11,827 for “graft” products and $12,704 for “acellular human dermis,” or skin, in September 2013, online federal data show.
The tissues referenced in the warning letter came from parts of the tainted donors’ bodies that weren’t contaminated and didn’t contain the bacteria, said Gordon, of Issues Management/Insight Communication in Princeton, New Jersey, who is designated to speak for Musculoskeletal Transplant.
The body parts were processed and distributed, which “was against our protocols,” Gordon said in an e-mail. The company voluntarily recalled the products, she said.
Musculoskeletal Transplant has “taken steps to fully address all of the observations noted in the inspection and in the warning letter,” she said. It is waiting for the agency to conduct a re-inspection”.
Full article at: “????????????????”
Seymore. Yeah that is one of them I think and close enough. There were many reports coming out years back about anything connected to this topic and stretching out to how far and wide the taking of organs illegally was. Kinda like sex trafficking but not much on MSM reports about it. Some articles leading to others and some like reading a damn book they were so long and including many personal stories over it all. Then trying to use old links or sites from memory the Bloomberg article was the only one that popped up on Duck Go searching.
It just caught my attention because of so many vets coming up here like from Florida for knee surgeries or implants instead of having them at home. One guy told me he came up due to the many problems they were having with those surgeries at his VA and town. Don’t remember the town.
Plus civilians having the same issues to multiple implants or surgeries to problems with skin grafts and such not working or creating more issues. Causing loss of legs over knee issues and on it went. Then on top of that the severe spreading of diseases, staph, then MERSA, washing of hand issues, MD’s dirty hands from patient to patient, to the Hep C complaints then trying to tell some they were druggies and not about the surgeries that made some look totally uncaring and stupid. The buck passing defenses. Or the disease came from other lifestyles we aren’t supposed to discuss.
Then later YouTube came on the scene with documentaries about how the international organ trade was booming and how in some Asian country doping and stealing others organ or kidney was done by medical mafia types. That info now gone too.
The VA’s history on following recalls on medical devices historically has been very poor at best. Recent recalls of Cardiac Care devise have been sizable and leaves Veterans at serious risk. Not to mention the sizable risk the VA is taking by not following those recalls they then become liable for any harm to the Veteran caused by their failure to follow the recalls.
Last fall 465,000 Pacemakers were recalled due to Hacking Fears. January 2018 due to defects in the manufacturing process the FDA issued recall notices on numerous Cardiac Care devices requiring surgical replacement of those devices made by Medtronic. Which is a major contractor suppling the VA with Cardiac Care devices such as the recalled Resynchronization Therapy and Implantable Cardioverter Defibrillators. Since 1972 the FDA has required the maintenance of a listing of all Cardiac Care devises a medical care provider installs in patients.
In a 1984 GAO report titled “VA Central Office Needs to Exercise Better Oversight of Cardiac Pacemaker Recalls” dated Apr 16, 1984. The 1984 report was written following an investigation into how the Veterans Administration had performed during a series of Class 1 recalls requiring the mandatory replacement of the defective pacemakers ordered by the FDA which started in 1981.
The FDA ordered the recall for pacemaker affecting 19 models manufactured by ARCO Medical Products Company and Synthemed Corporation that were subject to unpredictable failure. The GAO identified 44 patients who, according to the VA’s pacemaker registry, may have been using one of the three pacemakers that had been recalled. The VA’s Automated Pacemaker Registry was completed by the VA in 1979. The 44 Veterans who had received the defective pacemakers had implanted at one of 15 VA medical centers.
The GAO investigation of the VA’s compliance with the FDA’s Pacemaker recall was implemented following a then recent court case involving a birth control device, in which a California court of appeals found a doctor liable for a patient’s injuries because he had failed to notify the patient that the device had been recalled. (86 Cal. App. 3d 656 (1978), 150 Cal. Rptr. 384).
At the GAO’s request, the Program Chief, Cardiovascular Diseases, contacted the 15 medical centers in April of 1983 to determine the status of the 44 patients. He told them GAO of the 44 patients;
28 — were still using the recalled pacemakers
6 — had had their pacemakers replaced
4 — had died
6 – could not be located
__
The recall required three things to occur.
1. All inventories of the defective pacemakers were to be removed from the shelves and their use discontinued.
2. All patients who had the defective pacemakers installed were to be notified and the pacemakers were to be replaced. Also required were entering of the date the patient was notified was required to be entered into the patient’s medical Records.
3. In all cases where the patient had not been notified or the pacemaker had not been replaced the medical facility was required to note the reason in the patient’s Medical records.
From the list the GAO chose the 4 VAMCs that had installed the highest number of surgeries connected to the defective pacemakers being recalled to visit and use their patient records to see how well the VA had complied with the recall.
In all cases reviewed the GAO found that “NO Veterans were notified that their pacemakers had been recalled by FDA” as Required by the FDA’s mandatory recall order on the defective pacemakers installed in the Veterans.
Regarding the requirements to record in the Veterans medical records, why the Veteran was not told about the Mandatory Recall order, or the pacemaker was not replaced. None of the Veterans Medical records where updated with the required entry.
13 of the pacemakers had been implanted at Buffalo VAMC. Two of the pacemakers had been replaced after they had failed years after the recall. They were replaced with the same defective pacemaker. One of the patients who had transferred to the Bay Pines VAMC contained a copy of a letter from the Buffalo VAMC’s chief of staff advising Bay Pines VAMC that the patient had a potentially defective pacemaker. The letter stated that the manufacturer could not predict the ultimate failure rate or average service life of the pacemaker but advised that
“Since we have had no problem with these units and since all patients are satisfactorily pacemade, I intend to leave these units in place functioning until end-of-life indicators indicate the need for replacement.”
“. . . For the present I intend to follow the patients at three-month intervals. There is always the chance of random failure, of course.”
The letter did not mention the FDA recall of the pacemaker issued 3 months earlier. None of the other medical records contained mention of the pacemaker defect. None of the 13 records reviewed form VAMC Buffalo indicated that the patients were notified of the recall.
When questioned the Buffalo Chief of Staff said That almost all pacemaker patients, even those with complete heart block, have their own heartbeat that would “kick in” if their pacemaker failed.
When the GAO discussed the statements of the VAMC Buffalo’s Chief of Staff’s actions and statements with the VA’s Program Chief of Cardiovascular Diseases. He stated with emphasis that it is VA policy that critically unreliable pacemakers be replaced in pacemaker-dependent patients. He said although most pacemaker-dependent patients, as the Buffalo chief of staff stated, have an underlying heartbeat, they still risk severe physical damage (such as kidney or brain damage) if their pacemakers fail. He said that even a day without a pacemaker could cause serious damage in a pacemaker-dependent patient and that such damage might kill the patient.
__
The GAO noted in the report that on 08/28/1981 shortly before the recalls began in November of 1981. The VA inspector General issued a report stating that the pacemaker registry did not accurately reflect the VA pacemaker patient population because;
13% of the “events” (implantations, replacements, repairs, and adjustments) that should have been recorded in the registry were not and
28% of the records in the registry contained significant inaccuracies, including incorrect pacemaker model and serial numbers, incorrect implant dates, unreported deaths, and unrecorded replacement pacemaker implants.
An interview with the GAO at that time with the VA’s Medical Records Information staff said that the registry could give VA an effective way to handle pacemaker recalls. She said that VA’s Data Processing Center at the St. Paul, Mn could generate a report identifying patients who have a recalled pacemaker within about 2 weeks After receiving notification of the recall.
The GAO also Noted that somehow “miraculously” before the problem was being looked at. The VA’s program chief had proposed that a new and improved clinical pacemaker registry be established which could be used to ensure that medical enters respond appropriately to the pacemaker recalls. It could even employ all kinds of new bells and whistles for researchers.
The program chief said that the clinical registry would be used to identify all pacemaker-dependent patients with recalled pacemakers and that their doctors would be alerted to replace the recalled pacemakers. He said that a circular establishing the new clinical registry will soon be finalized. The Director, Medical Service, had advised him and his team on February 24th, 1984 that the new clinical registry is being delayed by funding problems.
So, this is the point that we say, “hey wait a minute isn’t that pretty much the same thing Ben’s article is covering today in 2018” 33 years later. How is this possible?????
It is part of the VA’s play book to get major bucks from the taxpayers to fund new projects that would not be approved otherwise. Simply create a crisis and claim the new project will cover the crisis and wal-aa congress approves the funding.
The real goal of the new Fake News on the need for the new database is to sell funding the dam thing and implementing a number of changes in how all Veterans health care records are collected and managed by the VA. What they are moving toward is changes in Hipaa were the VA is able to access all Veterans medical records even those from Veterans who have never applied for VA health care and have never used any VA medical facility.
Source: (GAO / HRD – 84-33) — “VA Central Office Needs to Exercise Better Oversight of Cardiac Pacemaker Recalls”
At: “https://www.gao.gov/assets/210/207173.pdf”
_________________
Also a notice for all Veterans who have any implanted Cardiac care devises implanted I highly recommend that you obtain the model and serial number of the devise and check them against the FDA current recall list. Even if it was implanted without any VA involvement.
For anyone who finds that they have a defective implant I highly recommend seeing an attorney and then seek care outside of the VA.
Wow! It just boggles the mind that so much has happened, is exposed, happening, and the masses out there just don’t seem to care or try to justify. Hope DC critters and the elite are making enough money to make them smile over all this and much more. While we are attacked and claimed to be the ‘crazy ones’ or domestic terrorist? Crazy crazy crazy.
.
VA, new metallic cock replacement surgical implant, corkscrew type 1-b
Vet meets woman with new metallic corkscrewed vagina type 2-c
In the morning they found them dead, wouldn’t you know it she had a left hand thread.
😀 😀 Then there’s the entire metric domain to explore 😀 😀
“The inmates are definitely, and still, running the nut house!”
Basically,
1.) The VA doesn’t have any way of knowing who has had “devices put in their bodies”?
Because,
2.) VA has no one to track down the veterans?
Because,
3.) Because there’s no computer company with the proper functioning,
Which means,
4.) VA will have to go in front of Congress (again) to ask for more taxpayers monies!
Which could lead to,
5.) More corruption, waste, fraud and abuse by many top people in VA.
Thereby,
6.) In about 10 years or more, we’ll be hearing how some contractor pleads guilty to many fraud indictments!
Is it just me, or does anyone else see a similar and continuous pattern of behavior within the 2nd largest and most corrupt government agency?
Yep, it’s like that disturbing pile of looping dog poo you see when out on a walk in middle of sidewalk. One continuous loop of poo.
Just one more effort to duplicate our nations healthcare services already in place not in the name of segregation but rather in the name of avoiding the cost of war. However, segregation is the tool used to try to avoid the pot of gold at the end of the rainbow: low cost war.
And we wonder why the Leprechauns are wearing green?
That woulda retired three thousand veterans. At least paid for REAL lifetime health care for five thousand. So sad.
Of all those $3 BILLION worth of surgical implants, not one brain. So…
“If I Only Had A Brain”, by ‘The Flaming Lips’
“I would while away the hours
Conferin’ with the flowers
Consultin’ with the rain
And my head I’d be scratchin’
While my thoughts were busy hatchin’
If I only had a brain.
I’d unravel every riddle,
For every individle,
In trouble or in pain.
With the thoughts you could be thinkin’,
You could be another lincoln,
If you only had a brain.
Oh I, could tell you why,
The ocean’s near the shore.
I could think of things I never thought before,
Then I’d sit, and think some more.
I would not be just a nothin’,
My head all full of stuffin’,
My heart all full of pain.
I would dance and by merry,
Life would be a dingle derry,
If I only had a brain.
Oh I could tell you why
The ocean’s near the shore.
I could think of things I never thought before
And then I’d sit, and think some more.
I would not be just a nothin’,
My head all full of stuffin’,
My heart all full of pain.
I would dance and by merry,
Life would be a dingle derry,
If I only had a brain.”– ‘The Flaming Lips’
Yep, not one brain, hope the VA gets to oz soon, so they can get in to see the wizard before all is lost.
How about all those hernia surgeries when using mesh to repair have ripped apart, or failed? Heard and seen plenty of that while at the VA. Some being told more surgery would be too difficult, too much scar tissue to do whatever, some vets said they’d just live with it. Should have scanners today that would pick that issue up going down the highway at 70MPH.
Pity with all the secrecy, censoring, in-house cover-ups we will never know what is going on or how well any bright ideas coming from all that research, testing, is coming along. We can hear out in public about the re-dos and failures of all kinds of implants, like mine, but never reported on unless some hip recall happens or see ads on TV by lawyers filing suits about it, and the like.
Reading this article an old movie popped into my mind. Future world criminals or non-conformist had explosive neck rings put on them and nearly impossible to remove. Step out of boundary lines or do wrong in the tyrants minds. Boom. It would be more humane than what some VA retaliation and networking has done to some of us, and made global lefty communities hell on Earth to live in.
Oh oh. Hope I didn’t give the gov, “the top” or VA any ideas. Naw, they’ve all probably thought about all that stuff. Me, they just tried to burn out to try to keep me quiet. Catching some in retaliation network in lie after lie. What a wicked web the VA and corrupt officials and others can weave for the outspoken. Oh, I am to be more concerned about puppy dog stories and to hell with my own issues. Riiiiight.
No worries, All they have to do is leave you in the body bag until you liquify and then strain the faulty devices out to be, maybe, sterilized and, definitely re-used. Afterall, we can’t have our facility directors driving around in last years mercedes-benz.
Oh and FIRST!!!!
😀 😀 😀 😀 The VA body bags may even have that straining mechanism built-into the exploding body bags and reason they now call them self-straining meat sacks. 😀 😀 😀 😀
For the really pesky ones the VA finally fires-up that MRI Machine and that will reclaim all metallic devices in no time. m:D
Yeah, and don’t forget they have to get a new pair of low quarter loafers every month too, some of those loafers cost more than you or I could make in a couple of months. Anyway, you gave me an idea, I think I’m going to get liquefied and condensed so I can be put into an old mason jar, and sat on the fireplace mantel piece, at the local Lebanon cracker barrel, underneath the Kentucky long rifle, and in between the portraits of Ma and Pa Cracker. But anyways, I think I understand what you were saying the other day and it was AWESOMESAUCE
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