launched to safeguard patients from counterfeit medical implants and
improved recall accuracy
At the head of the controversy is a Wisconsin neurosurgeon and a California
implant company alleged to have produced knockoff spinal screws and rods out
of a non-medical grade machine shop.
The counterfeit parts were manufactured by a California machine and tool
shop and sold by Spinal Solutions LLC, the suit charges. Findings of the
Counterfeit Spinal Implants included:
The implants were made of low-grade material and were not made with the
original high-grade titanium materials
Counterfeit screws had uneven threads and a much higher risk of backing out
Some doctors who used the fake hardware took kickbacks including cash and
private plane rides
Middlemen profited by wildly inflating the cost of the screws, according to
one suit filed in Sacramento, CA.
A hospital executive pleaded guilty in April to paying doctors to bring in
patients as part of a $500 million insurance scam.
Spinal Solutions executive admitted to bribing a former California State
Senator to keep huge insurance payments flowing.
Counterfeit medical devices and recalled medical implants pose a real threat
to patient health and are emerging more and more in the $110 billion per
year market. Counterfeit and recalled implants may cause infection, injury,
produce fallacious test results, and possibly death.
The World Health Organization (WHO) warns that 8% of the medical devices in
use are counterfeit, creating a branch to protect the public from such
devices called the International Medical Products Anti-Counterfeiting
Recalls cost the medical device industry on average $2.5 â€“ $5 billion per
year according to a McKinsey & Company study.
Thousands of patients, many of which may never be identified due to human
data entry and retrieval errors, have defective devices implanted. Many of
these devices cause pain and medical complications, with their recipients
unaware their medical implant is fake or has been recalled.
Because there is no fool-proof way to track an implantâ€™s pedigree today,
itâ€™s relatively easy for a device to be counterfeited and enter into a
hospitalâ€™s inventory. Unscrupulous acts like those alleged by Spinal
Solutions may simply switch the FDA approved implant with the counterfeit
Others sell replica parts, often made in China, to unknowing hospitals that
end up in hot water when revealed. An internet search for Chinese implants
yields thousands of results â€“ from dental implants to pacemakers. They even
list the original manufacturer product and trade name such as â€śHoffmann
External Fixation Small Fragment Set Stryker Surgical Instruments Orthopedic
Traumaâ€ť on their products. This makes it virtually impossible for a hospital
to know with absolute certainty that the device is the FDA approved version
rather than a fake. When it all unravels, often, the hospital is dragged
Surgical devices are implanted in a sterile environment. In certain cases,
hundreds of implants are brought into the operating room in countless set
configurations. Keeping track of which devices were implanted and which were
not with absolute accuracy has been impossible to accomplish. Many of these
devices are small and identical in shape. They are typically brought in by
outside manufacturer representatives or are re-sterilized from another case,
if previously unused.
Nurses use several methods to try to keep precise implant records, including
clip boards, stickers, calling out numbers, relying upon a manufacturerâ€™s
representative to provide accurate information and other manual methods,
such as trying to piece it all together after the surgery. All of these
methods, however, are highly inaccurate. At the end of the surgery, chances
are that at least some of the implants have been misidentified.
Hospitals may be paying as much as 30% or more, because of inaccurate
implant counts, unnecessary upcharges by reps, who charge hospitals; the
hospitals in turn, unknowingly charge patients and insurance companies for
these devices. A recent example of overbilling involves former regional
manager and a former sales representative who admitted to rigging more than
$800,000 in overcharges to hospitals and surgery centers by misrepresenting
their use of the company's orthopedic products, U.S. Attorney Paul Fishman
In another example, a sales representative with the publicly traded medical
device company overcharged medical facilities by billing them for a greater
number of products than they actually used or for more expensive products,
which would bump up his own compensation, prosecutors said.
The American Legion believes that VA still has a problem tracking surgical
implants, and until it is fixed veterans remain at risk. An audit made by
VAâ€™s Office of Inspector general two years ago identified expired surgical
devices on VA supply shelves. The Government Accountability Office has also
indicated that VA has an inaccurate tracking capability in recording the
serial numbers of implant surgical devices.
A January 13th, 2015 GAO report found that the VHA was limited in its
ability to identify and locate patients who had received surgical implants,
which, according to the GAO, "has potentially significant patient safety and
cost implications." The report also found VA surgical implant vendors are
getting involved in patient care, which goes against industry practices,
according to medical experts.
In an effort to combat counterfeit medical implants and improve recall
efficiencies, the FDA is now implementing regulations that would place
requirements on manufacturers so that legitimate products may be traced by
marking unique device identifiers (UDI) on each of the products.
Technology has emerged that takes the guesswork out of implant tracking.
Matrix IT Medical Tracking Systems, Inc., based out of Wisconsin, has
created TRACTUS, a high speed scanner that is used in the sterile field to
track the implantâ€™s unique device identifier (UDI) information, including:
Manufacturer, device, lot, serial and expiration. The scanner works real
time during surgery and accurately identifies each implant as well as
placement of the implant in the patient.
The surgeon scans the implant, and then identifies the implantâ€™s placement
inside of the patient. Because the sterile-covered scanner is placed next to
the patient during surgery, each implant is identified on an â€śas you goâ€ť
Surgery time is reduced because hospital staff donâ€™t need to pause during
surgery to record implant information, which saves money and is safer for
After surgery, hospital departments such as central supply, sterile
processing, patient financial services and medical records must each
manually input this information into their computers. With TRACTUS, the data
is electronically sent to the corresponding departments, saving the hospital
Coupled with UDI tracking software that documents every implant from the
manufacturer to the hospital, TRACTUS verifies that each device is FDA
approved before it is implanted and provides the hospital with instant
results of the implanted devices. In the event of a recall, the hospital may
instantly alert affected patients.
TRACTUS also provides accurate implant utilization information so that the
hospital may accurately charge for their services as well as verify
manufacturer charges for implants used during surgery. TRACTUS offers
utilization data that may be parsed such as a comparison of surgeons and how
long a particular device takes to be implanted, cost by surgeon or
procedure, as well as many other capabilities.
Future capabilities will allow the study of long term patient outcomes,
providing important information on how each device and surgeon performs in
multiple categories, including age groups, gender or diagnosis.
Inventor of the sterile field tracking technology, spine surgeon Branko Prpa,
M.D. said â€śbecause Tractus is the final portion of the implant chain of
custody, healthcare organizations may guard against counterfeit implants and
quickly alert patients with recalled implanted devices.â€ť
For more information on TRACTUS and Matrix Medical, their website is
faces sentencing today for massive fraud scheme
Prosecutors seek 12 1/2 years in prison in fraud case; ex-hospital CEO hopes
for probation, community service.
As the leader of a hospital in one of Chicago's most impoverished
neighborhoods, Edward Novak often championed himself as a down-to-earth
businessman who brought access to health care to those otherwise ignored.
But federal prosecutors say Novak, the fabulously wealthy owner and CEO of
Sacred Heart Hospital, in reality had a very different view of the residents
of the Garfield Park area he supposedly served.
Novak, 60, was convicted in March with two of his top executives of charges
of paying hundreds of thousands of dollars in kickbacks to doctors for
referring patients on Medicare or Medicaid to the struggling hospital.
Novak, the son of a pharmacist who grew up sweeping the floors at his
father's shop, is seeking a sentence of probation and community service. His
lawyers argued in a recent court filing that Novak rescued Sacred Heart from
closure when he took over the failing hospital at 33 and built it into a
119-bed, acute care facility through hard work and dedication.
But in seeking more than 12 1/2 years in prison for Novak, prosecutors
ridiculed his claims he was guided by charity and concern for the blighted
neighborhood, saying the hospital reaped nearly $35 million from the
improper medical referrals over the dozen years of the scheme.
Many of the patients were taken to Sacred Heart from distant locations,
admitted to the hospital for dubious medical reasons and given care that was
substandard at best, prosecutors said. Records show Sacred Heart was
consistently rated as one of the worst hospitals in the country and was
beset by problems ranging from improperly trained nurses to a maggot
infestation in the intensive care unit that had to be quelled by dousing
patients with bug spray.
"For Edward Novak, buying patients was not an issue of ethics or morality,
let alone legality," prosecutors said in their sentencing memo. "The only
calculus was the bottom line."
Indeed, a hospital executive convicted with Novak said the hospital should
have been called "Our Lady of the Bottom Line," prosecutors said.
The government is seeking more than $10.6 million in restitution from Novak,
whose personal wealth has been estimated in court papers at $30 million.
He's been free on a $10 million cash bond since his arrest.
More than two years after the hospital abruptly shut down in the wake of a
dramatic FBI raid, the boxy, four-story brick building on West Franklin
Boulevard remains vacant, its front doors boarded up after a recent break-in
attempt. On the building's facade, a faded vertical banner featuring smiling
patients and the words "Healing body and spirit!" still hangs.
Records show the building, along with two nearby parking lots and an
adjacent warehouse, was scooped up in late 2013 for just $250,000 by a
Chicago-based for-profit group run by two doctors who have said they want to
transform it into an outpatient clinic and a free-standing emergency room.
When authorities raided the hospital in 2013, a criminal complaint filed
against Novak and his team of administrators made bombshell allegations that
doctors were performing medically unnecessary tracheotomies and giving heavy
sedation to patients in a process called "snowing."
At least five deaths at the hospital had been under scrutiny at one time,
authorities said. But when the indictment came six months later, none of the
ghoulish allegations involving patient deaths or over sedation was leveled
against any of the defendants.
Still, the duration and brazenness of the fraud scheme â€” coupled with the
unusual step of effectively shutting down a working hospital â€” kept the
Sacred Heart case in the headlines.
The federal jury deliberated over parts of three days before convicting
Novak on all but one of the 28 counts against him, including conspiracy and
paying direct kickbacks to physicians. The jury found Clarence Nagelvoort,
60, the former chief operating officer, guilty on 11 of 12 counts, while Roy
Payawal, 66, the former chief financial officer, was convicted on 17 of 27
Nagelvoort and Payawal are scheduled to be sentenced. Four defendants have
been convicted in the case, including executives Anthony Puorro, 57, and
Noemi Velgara, 66, who cooperated with the investigation. Last month, U.S.
District Judge Matthew Kennelly acquitted a doctor of charges of accepting
kickbacks in the scheme â€” the lone setback for prosecutors so far. Another
doctor, Venkateswara Kuchipudi, known as the "King of Nursing Homes," is
scheduled for trial in the fall.
Visit the Chicago Tribune for the story.
disease kills two, sickens 31 in New York City
A deadly outbreak of Legionnaires' disease that killed two people and
sickened 31 is under investigation in the South Bronx section of New York
City, health officials said on Wednesday.
The new wave of Legionnaires', a type of pneumonia caused by bacteria, has
been recorded since July 10, the city's health department said in a
It was double the number of cases recorded in the last outbreak, in which 12
people in the Bronx fell ill in December 2014. The cause was traced to
contamination in cooling towers at Co-op City, the world's largest
cooperative housing development, according to the health department.
The disease is caused by Legionella, a bacteria found in certain plumbing
systems, including hot tubs, humidifiers, cooling towers and hot water
tanks. It is spread by breathing in mist from water, and can't be spread
from person to person.
The health department said it was testing water in the area to determine the
cause of the outbreak. Symptoms for Legionnaires' include fever, cough,
chills and muscle aches.
Read the news story at MSN for the story.
depression could be predicted by marker found in blood of pregnant mothers
It is now possible to identify women who are at a particular risk for
depression following the birth of their child. The study carried out by an
international team of scientists has found a marker in the blood of pregnant
women which can be used to detect postpartum depression.
The scientists have identified the role of the gene oxytocin receptor may
play in instances where women become increasingly vulnerable to depression.
Oxytocin is a hormone which is known to play a positive role in women who
are about to undergo child birth. Oxytocin is also known to play a positive
role in maternal bonding and lowers stress levels in mothers.
"We can greatly improve the outcome of this disorder with the identification
of markers, biological or otherwise, that can identify women who may be at
risk for its development," said senior author of the study Jessica Connelly,
assistant professor of psychology at University of Virginia.
Visit News Everyday for the study.
Growing support for making information governance a priority in healthcare
As healthcare professionals work to advance information governance (IG),
there is growing support among leaders to make IG a priority, according to
an American Health Information Management Association survey on IG conducted
with Cohasset Associates, Inc.
In this second AHIMA survey to examine IG practices and readiness in
healthcare, more than 40 percent of the over 1,260 respondents reported
advancements in IG at their organizations in the last year. In the first
survey on IG by AHIMA and Cohasset Associates released in June 2014,
two-thirds of the responding healthcare professionals said their
organizations did not have a comprehensive IG strategy.
A new white paper, based on the survey, examines the readiness of healthcare
professionals to address the technical and strategic demands they face in an
evolving IG environment, as well as the career opportunities from the
advancement of IG in organizations. Complete results and analysis can be
found in the Cohasset Associates | AHIMA 2015
Information Governance in Healthcare: Professional Readiness and Opportunity
The results indicate that 76 percent of survey participants said their
overall body of knowledge and skills will support their organizationâ€™s
transition to IG, illustrating that professionals involved in healthcare IG
disciplines are positioned to lead IG efforts. The findings also underscore
that moving IG forward requires the work of multiple disciplines including
health information privacy, information integrity, data quality and the
management of health records.
Additional findings of the survey include:
36 percent of survey respondents indicate that their organizations have
designated a senior executive to sponsor IG
23 percent of respondents identify themselves as the chair or participant
of their organizationâ€™s IG oversight body
Respondents strongly agree that communication is among the most compelling
of their skills, enabling them to foster IG advancement support with
leadership and staff within their organization
43 percent of respondents believe their IG role gives them the opportunity
to be more visible and valuable to other departments in their organizations
Through their work to advance IG, healthcare professionals experience job
satisfaction; however, opportunities exist to bolster the satisfaction level
To continue prioritizing IG in healthcare and growing the right skills for
implementation, AHIMA recommends healthcare professionals: Press for the
formation of an IG oversight body such as an IG council, committee or
working group within their organizations; Illustrate how IG supports a
healthcare organizationâ€™s strategic goals by linking the investments
necessary for IG advancement to improved clinical and business performance;
Establish or participate in online IG communities to learn more and share IG
knowledge; Take advantage of the growing knowledge of IG; Illustrate
expertise in IG by becoming involved in an organizationâ€™s IG oversight body
as a demonstration of IG credibility; and Communicate regularly IG-related
achievements and needs that demonstrate benefits to the organization.
Visit AHIMA for the survey report.
Omnilab, a provider of IT and middleware solutions for laboratories
Abbott announced that it has acquired Omnilab, a leading provider of
software solutions for clinical diagnostics and blood transfusion
laboratories. Omnilabâ€™s software solutions, known as middleware, connect
laboratory information systems (LIS) to analyzers, automation systems,
point-of-care or other diagnostic devices within the laboratory.
Designed by laboratory experts to meet the unique needs of the lab, Omnilab
IT and middleware solutions include a complete suite of applications with a
range of advanced features, such as test ordering and result management,
sample management, quality control and workflow management, and clinical
decision support. These IT solutions play an increasingly important role in
helping laboratories standardize processes and improve decision making,
interfacing with thousands of instruments and different LIS systems.
â€¨Middleware solutions are
a critical component of Abbottâ€™s total laboratory solution for customers and
were previously available to Abbott customers through a partnership
agreement, primarily in Europe, Middle East, Australia and New Zealand.
Abbott will expand availability of the Omnilab LabOnline IT solutions to
additional markets outside of the United States globally.
Visit Select Science for the release.
revolution in American healthcare
Despite significant efforts by numerous organizations, medical error still
exists in the laboratory and hospitals in general. In Tuesdayâ€™s plenary
session, Martin Makary, MD, professor of surgery and health policy at Johns
Hopkins University, described how increasing transparency in hospitals can
significantly reduce medical error. â€śThere is an incredible movement towards
transparency in America today, emphasizing civility, teamwork, and
Makary, who is also author of the best-selling book, Unaccountable: What
Hospitals Wonâ€™t Tell You and How Transparency Can Revolutionize Health Care,
named two major barriers to revolutionizing healthcare: access to data and
variability in practice. He believes that these are man-made barriers and
points to transparency as the answer. For example, a 2013 study determined
that there are about 210,000 unintentional hospital deaths in the U.S. per
year. Yet, these are not listed among the leading causes of death by CDC. He
estimates that it is the third leading cause of death in America and
suggests that we need to change the way we collect and publish vital
Further, despite billions of dollars spent to identify the latest diagnostic
and treatment tools, we rarely track patient outcomes once these tools are
implemented, Makary noted. Either the data does not exist or the public does
not have access to it. Among over 150 government-funded registries tracking
patient outcomes in the US, only 3% is available to the public. The goal of
Makaryâ€™s research is to develop simple ways to make this critical
information accessible to the public, ultimately increasing transparency in
When he began writing his book, Unaccountable more than 3 years ago,
transparency in healthcare was a controversial topic. But the climate around
this issue has started to change, he said. Transparency is no longer a dirty
word. In fact, there are now numerous examples demonstrating that it works,
noted Makary. â€śHealthcare is on the brink of a revolution,â€ť and transparency
is a major reason for this change, he said.
Makary and colleagues have looked at the effects of numerous tools aimed at
increasing transparency and reducing medical error, including publishing
patient and healthcare worker satisfaction surveys, checklists, and public
reporting of medical quality indicators. He cited the examples at the
Cleveland Clinic and the University of Utah where patient satisfaction
surveys were made available to the public. Making this data available
resulted in steadily improved satisfaction ratings along with increased
In the field of laboratory medicine, Makary suggested that collaboration
across specialties will become increasingly important. Academia is uniquely
suited for such a transition, as it is an optimal place for partnerships
between clinicians, laboratorians, and basic researchers, he said. Such a
partnership emphasizing quality, invention, and transparencyâ€”focused on
improving patient outcomesâ€”will continue to revolutionize healthcare.
Visit AACC for the report.
Medicare deaths, hospitalizations and costs reduced
The U.S. healthcare system has scored a medical hat trick, reducing deaths,
hospitalizations and costs, a new study shows. Mortality rates among
Medicare patients fell 16% from 1999 to 2013. Thatâ€™s equal to more than
300,000 fewer deaths a year in 2013 than in 1999, said cardiologist Harlan
Krumholz, lead author of a new study in the Journal of the American
Medical Association (JAMA) and a professor at the Yale School of
Researchers based the study on records from more than 68 million patients in
Medicare, the federal health insurance program for people age 65 and older.
Researchers were able to find additional information about hospitalization
rates and costs among Medicareâ€™s traditional â€śfee-for-serviceâ€ť program, in
which doctors and hospitals are paid for each procedure or visit. This
information wasnâ€™t available for people in the managed-care portion of
Medicare, which had about 29% of patients in the overall Medicare program in
Among fee-for-service patients, hospitalization rates fell 24%, with more
than 3 million fewer hospitalizations in 2013 than 1999, Krumholz said. When
patients were admitted to the hospitals, they were 45% less likely to die
during their stay; 24% less likely to die within a month of admission; and
22% less likely to die within a year, the study found.
Costs for hospitalized patients also fell by 15% among fee-for-service
A 1999 report from the Institute of Medicine, which found that hospital
errors killed up to 98,000 people a year, jump-started a movement to improve
healthcare, said P.J. Brennan, chief medical officer at the University of
Pennsylvania Health System. â€śThat was one of the first shots fired in the
patient safety movement,â€ť said Brennan, who was not involved in the new
Public health improvements also likely played a part in cutting death rates,
Krumholz said. While more Americans today are obese than in the 1990s, the
air is generally cleaner and fewer people smoke. New drugs for common
conditions such as cancer and heart disease also may have kept people alive
â€śWhatâ€™s gratifying is the cost savings donâ€™t appear to have come at the
expense of quality,â€ť said Helen Burstin, chief scientific officer at the
National Quality Forum, a non-partisan group that aims to improve the
quality of healthcare.
Burstin said she hopes the country will expand its efforts to improve
healthcare quality by focusing on outpatient care, such as that given in
nursing homes or by home health aides.
Visit USA Today for the report.