Dirty, missing instruments plague DMC surgeries
The Midtown hospitals of the Detroit Medical Center have struggled for years
to properly clean surgical instruments, stoking doctorsâ€™ fears about patient
safety, a Detroit News investigation has found.
The Detroit News has obtained more than 200 pages of internal emails
and reports indicating that surgeons and staffers have complained for at
least 11 years about improperly cleaned, broken and missing instruments. The
complaints have continued under the tenure of the for-profit Tenet
Healthcare of Dallas, TX, which acquired the DMC in 2013, the documents
The records show improperly sterilized tools complicated operations from
appendectomies and brain surgeries to cleft palate repair and spinal
fusions. Patients were kept under anesthesia for up to an hour as staffers
replaced instruments. Dozens of operations were canceled at the last minute,
some after anesthesia was administered.
At least twice a childâ€™s chest or skull was open for surgery when doctors
discovered dirty instruments. In January 2015, open-heart surgery for a
7-month-old girl was interrupted at Childrenâ€™s Hospital of Michigan because
a tube leading to a bypass machine was clogged with blood from a previous
â€śWe are putting patients at risk frequently and now canceling up to 10 cases
this week ... promises just arenâ€™t cutting it,â€ť Joseph Lelli, chief surgeon
at Childrenâ€™s Hospital, wrote in an email to top administrators on June 29,
2015, at least his third warning in six months.
The emails offer a rare glimpse into an issue that experts such as
Chicago-based surgical instrument designer Jim Schneiter say is growing at
hospitals nationwide as the number and complexity of surgical tools have
And while the issue of improperly cleaned instruments at some hospitals has
garnered recent publicity, four DMC surgeons and four former administrators
told The News the duration and severity of problems at the system is
The DMCâ€™s chief administration officer, Conrad Mallett, acknowledged
challenges sterilizing equipment have frustrated doctors and canceled
surgeries. Mallett said the situation stems from a Central Sterile
Processing Department in the basement of Receiving Hospital. The department
cleans instruments for all five hospitals at the DMC center campus â€”
Childrenâ€™s, Detroit Receiving, Harper University, Hutzel Womenâ€™s and DMC
Heart hospitals. Mallett said the issues have equally affected all five
hospitals, which perform more than 37,000 operations per year.
Four surgeons at the DMC said they encounter improperly cleaned, missing or
incomplete sets of instruments about once a month or more. At other
hospitals, the problems are less common, occurring less than once a year,
said the doctors, who spoke on the condition of anonymity, fearing job
One longtime surgeon said heâ€™s discovered old tissue and blood on surgical
equipment that he regularly uses, and has used duct tape on occasion to
repair broken instruments during surgeries. He said he quit filing
complaints more than a year ago because the situation has not improved.
Without such documentation, the situations are not addressed and the
employees involved cannot be disciplined.
Another doctor said heâ€™s canceled 30-40 operations in the past two years
because of instrument problems.
In many cases, hospitals nationwide have moved quickly to correct problems
with dirty instruments or have been forced to by public health officials.
Last fall, the Veterans Administration Ann Arbor Healthcare System
voluntarily shut its operating room, brought in national experts and
transferred heart surgeries to the University of Michigan Health System
after finding particles on instrument trays. The contamination arose after
repairs to a nearby water main. VA officials voluntarily disclosed the issue
to the public.
At the DMC, the systemâ€™s â€śhuge challengesâ€ť have persisted for years â€” and
thereâ€™s been no â€śprolonged effortâ€ť to fix them, contended Laura Cortner, a
former director the DMCâ€™s Central Sterilization Department.
The departmentâ€™s 71 technicians make about $18 an hour and are responsible
for cleaning several thousand instruments per day to exacting
specifications, assembling them into sterile â€ścase cartsâ€ť and delivering
them to operating rooms in a few hours.
Cortner wrote the DMCâ€™s approach to problems was to â€śfire someone ...
replace ... run them in to the ground, blame them, repeat.â€ť
Mallett said managers are to blame and the DMC has made numerous efforts at
Hospital sterilization accuracy rates arenâ€™t public. DMC emails indicate 95
percent of instruments were delivered without problems in the month of June
2014. That was touted as an improvement in the emails. That works out to a
rate of 50,000 errors per million instruments.
Most sterile processing managers strive for no more than 3.4 errors per
million, according to the ECRI Institute, a Philadelphia-area nonprofit that
researches best practices in medical procedures and devices. That would be
nearly 15,000 times better than the DMC rate reported in the email.
Cortner, a former sterilization manager, wrote to administrators in 2013
that unions are so powerful she was reluctant to discipline workers for
dirty or missing equipment unless physicians took photos of the problems.
â€śWe have stopped formally disciplining staff, when we are lacking the
substantiating items listed above, because it ends up getting reversed at
third steps (or grievance hearings),â€ť Cortner wrote in an email.
One of her successors, Lukeysih Hall, wrote a long memo on April 2, 2015, to
a Tenet human resources official expressing similar frustrations.
The month before, internal reports show that eye surgeries on infants were
canceled because of missing and dirty equipment; broken scopes were found
during operations and an internal audit found that 100 percent of durable
medical equipment â€” intravenous machines and feeding pumps â€” at Childrenâ€™s
were incorrectly labeled as clean.
Hall wrote that her efforts at discipline were not supported by upper
Visit the Detroit News for the story.
Zika stays in women, baby's bloodstream longer than previously thought
More surprises from the world of Zika research this week: The virus can hide
in vaginal tissue and the bloodstream of infected infants much longer than
anyone expected, with dangerous consequences.
In most people, Zika lives in the blood for about seven days and then
resolves. It can last a bit longer in urine and saliva, but even that goes
away after a couple of weeks, leaving antibody testing of the blood as the
only way to determine whether you've had the virus.
But a letter published Wednesday in the New England Journal of Medicine
tells the story of a Brazilian baby who continued to have Zika in his blood
for more than two months after his birth. He wasn't diagnosed with
microcephaly when he was born, nor did he have any obvious developmental
issues at his two-month checkup, even though his mother had symptoms of the
virus during the third trimester of pregnancy.
But the baby's blood tested positive for Zika 54 days after birth and then
again at day 67, and by the time he turned 6 months of age, he had severe
muscle contractions and other signs of neurological decay.
So when was the baby's brain damaged, before or after birth? No one knows.
The case also raises questions about how long the virus can hide within the
body and where.
Researchers have known for some time that Zika can be transmitted via semen
from men to women, hiding in the testes, where it can avoid the immune
system; in fact, there is mounting evidence that it can continue to
replicate in the testes -- and even increase the viral load -- for months
after infection. That's why the Centers for Disease Control has issued
strict safe-sex precautions for pregnant women and their partners, which
also apply to anyone trying to conceive.
"All pregnant women with sex partners who live in or traveled to an area
with Zika use barrier methods during sex or abstain from sex for the
remainder of their pregnancy," the CDC said, adding that men should wait at
least six months after infection to attempt to conceive.
Then, in July, scientists found evidence that Zika can hide in a woman's
cervical mucus, quickly followed by the first report of a woman giving Zika
to her male partner during sex. There were only two cases, but the CDC
quickly responded, revising its safe-sex guidelines to include
female-to-male and female-to-female sexual transmission.
To determine whether vaginal transmission might be more common than
previously thought, a team of researchers at Yale University began vaginally
infecting virgin and pregnant mice with Zika. The results, published in the
scientific journal Cell, are alarming: Zika could hide and reproduce
in vaginal tissue of mice for up to seven days, with an average of four to
"The finding may be important for women, not only pregnant women," said
co-author Akiko Iwasaki, professor of immunobiology at Yale. "The vagina is
a site where the virus can replicate and possibly transmit to partners. And
for pregnant women, vaginal transmission of Zika virus may have a
significant impact on the developing fetus."
Visit CNN for the story.
Zika virusâ€™s spread pushes testing labs to expand capacity
survey of state and local laboratories found enough capacity to perform
3,500 to 5,000 tests a week for the Zika virus. But that wouldnâ€™t be enough
to meet demand under the Centers for Disease Control and Preventionâ€™s
worst-case scenario for a domestic Zika outbreak.
The gap was â€śconsiderable,â€ť said Kelly Wroblewski, director of infectious
diseases for the Association of Public Health Laboratories, which conducted
the April survey.
The finding set off a rush to expand lab capacity that continues as Zikaâ€™s
foothold in the U.S. expands. In recent months, dozens of public health
laboratoriesâ€”which work with the government to monitor public health and
screen for diseaseâ€”bought equipment, stockpiled supplies and trained
employees needed to start Zika testing, said state and local health
The push has lowered some wait times for results to between one and four
weeks and the CDC estimates the nationâ€™s network of public health labs now
has â€śsufficient capacityâ€ť to screen pregnant women in multiple areas at high
risk for Zika transmission.
Heavy demand for testing is coming in Florida, where health officials
identified the first mosquito-transmitted outbreaks of Zika in the
continental U.S. starting in late July, centered around two zones in the
Miami area. As of Wednesday, 43 people had likely been infected by
mosquitoes in Florida, including at least one pregnant woman. The state is
also investigating possible cases in the Tampa Bay area.
Florida Health Department spokeswoman said the stateâ€™s three labs will rely
on commercial labs to boost capacity. Florida said it would cover the cost
for all pregnant women screened through public labs, including tests
performed by commercial labs, when necessary.
Major insurers and Medicaid in Florida, California and Texas cover the cost
of tests for those eligible under CDC guidelines. States largely regulate
access to laboratory tests, said Marcia Eisenberg, chief scientific officer
for diagnostics for Laboratory Corp. of America Holdings, which charges $150
to $780 for Zika screening, depending on the type of test. Patients will
need a physicianâ€™s order for Zika testing, according to LabCorp.
Zika infections can be detected with three different types of tests. A
molecular test can detect the virusâ€™s genetic material in urine and blood
samples and must be performed within 14 days after possible exposure or
onset of symptoms, which include a rash, fever, joint pain and red eyes.
Negative results for symptomatic patients and asymptomatic pregnant women
should be followed with a second type of test, which can detect infection
between two and 12 weeks from exposure, by screening for immune cells, or
antibodies, that fight the virus, said Dr. Villanueva.
positive antibody test result should be confirmed by a third test because
other mosquito-borne viruses, such as dengue and chikungunya, can trigger a
similar immune response. A limited number of labs perform the third
verification test, known as the plaque reduction neutralization test.
None of the tests are yet approved by the FDA, but the agency has allowed
emergency use of seven molecular tests and two antibody tests as of
Visit the Wall Street Journal for the article.
initiatives put patients at the center of their care while generating more
than $1.29 billion in total Medicare savings since 2012
The Centers for Medicare & Medicaid Services (CMS) announced the 2015
performance year results for the Medicare Shared Savings Program and the
Pioneer Accountable Care Organization (ACO) Model that show physicians,
hospitals, and healthcare providers participating in ACOs continue to make
significant improvements in the quality of care for Medicare beneficiaries,
while achieving cost savings. Collectively, Medicare ACOs have generated
more than $1.29 billion in total Medicare savings since 2012.
In 2015, Medicare ACOs had combined total program savings of $466 million,
which includes all ACOsâ€™ experiences, for 392 Medicare Shared Savings
Program participants and 12 Pioneer ACO Model participants. The results show
that more ACOs shared savings in 2015 compared to 2014 and those with more
experience tend to perform better over time.
The results from the Medicare Shared Savings Program and the Pioneer ACO
Model show significant improvements in the quality of care providers are
offering to an increasing number of Medicare beneficiaries. They are judged
on their performance, as well as their improvement, on an array of
meaningful metrics that assess the care they deliver. Those metrics include
how highly patients rated their doctor, how well clinicians communicated,
whether patients are screened for high blood pressure, and their use of
Electronic Health Records.
All 12 participants in the Pioneer Accountable Care Organization Model
improved their quality scores from 2012 to 2015 by more than 21 percentage
points. Overall quality scores for nine out of 12 Pioneer participants were
more than 90 percent in 2015.
Visit CMS for the report.
CDC: U.S. deaths from heart disease, cancer on the rise
Heart disease is the No. 1 cause of death in the United States. But after
nearly three decades in decline, the number of deaths from heart disease has
increased in recent years, a new federal report shows. Meanwhile, the number
of cancer deaths have been climbing for decades, bringing the nationâ€™s top
two killers closer than ever in the rankings for leading cause of death.
The report, released by the Centers for Disease Control and Prevention,
showed that heart disease deaths increased by 3 percent between 2011 and
2014, and that cancer deaths rose by 2.6 percent during that time. This is
the first time the CDC has published a report looking specifically at the
number of deaths from heart disease and cancer.
Statisticians at the CDCâ€™s National Center for Health Statistics had
expected cancer to surpass heart disease as the top killer a few years ago
and planned to release the report then, said Robert Anderson, Ph.D., chief
of the CDCâ€™s mortality statistics branch and coauthor of the report.
The number of cancer deaths is going up because the population is getting
older, Anderson said. That makes the decline in heart disease deaths in the
1990s and 2000s â€śall that much more remarkable,â€ť he said. But the recent
rise in deaths from both diseases caught the CDCâ€™s attention, Anderson said.
The new findings might offer public health officials and others useful
insights about where to focus their efforts. The CDC report showed that
although heart disease continues to take the most American lives in the
South and many other states, cancer is now the leading cause of death in 22
states, including Arizona, California, Maine and West Virginia. By
comparison, in 2000, cancer was the No. 1 cause of death in only two states:
Alaska and Minnesota.
The burden of each disease also appears to differ by race and ethnicity.
While heart disease remains the leading cause of death for white and black
Americans, cancer tops the list for Hispanics and Asians or Pacific
Rather, he said, death rates reflect the true risk by giving the number of
people who die for every 100,000 people in the U.S. population. Based on a
separate CDC report issued last December, heart disease was responsible for
167 deaths per 100,000 Americans in 2014. Cancer was a close second at 161.2
Visit the American Heart Association for the report.
Jump starting the brain: Experimental device suggests new path to rousing
team of physicians and neuroscientists reported the successful use of
ultrasound waves to â€śjump startâ€ť the brain of a 25-year-old man recovering
from coma â€” and plan to launch a much broader test of the technique, in
hopes of finding a way to help at least some of the tens of thousands of
patients in vegetative states.
The team, based at the University of California, Los Angeles, cautions that
the evidence so far is thin: They have no way to know for sure whether the
ultrasound stimulation made the difference for their young patient, or
whether he spontaneously recovered by coincidence shortly after the therapy.
But the region of the brain they targeted with the ultrasound â€” the thalamus
â€” has previously been shown to be important in restoring consciousness. In
2007, a 38-year-old man who had been minimally conscious for six years
regained some functions after electrodes were implanted in his brain to
stimulate the thalamus.
The UCLA procedure used an experimental device, about the size of a teacup
saucer, to focus ultrasonic waves on the thalamus, two walnut-sized bulbs in
the center of the brain that serve as a critical hub for information flow
and help regulate consciousness and sleep.
â€śWe found a way to jump start these circuits back into service,â€ť said the
studyâ€™s lead author, Martin M. Monti, a UCLA psychologist and neuroscientist
who studies cognition and consciousness. He wrote up a case study, which was
published online in the Journal of Brain Stimulation as a letter to
Visit Stat News for the story.
CVMC invests in UV disinfection systems for additional protection from HAIs
Valley Medical Center (CVMC) has become one of the first hospitals in North
Carolina to adopt the Clorox Healthcare Optimum-UV
System, adding an extra innovative precaution to its existing infection
control processes. Funded through a generous grant from the Catawba Medical
Foundation, the systems utilize ultraviolet-C (UV-C) light, the
highest-energy form of ultraviolet light, to kill germs that pose a threat
to the healthcare environment.
light inactivates the germs' DNA, rendering them harmless and unable to
replicate. The system is effective against a range of dangerous germs,
including methicillin-resistant staphylococcus aureus (MRSA)
and clostridium difficile (C. diff) spores, in just five
minutes. Multi-drug resistant organisms that can cause healthcare-associated
infections continue to be a problem among the nationâ€™s healthcare
decision to purchase the two Clorox Healthcare Optimum-UV Systems was based
on the devicesâ€™ ability to kill key organisms associated with increased
hospital-acquired infections, ease of use and cost effectiveness. The device
is effective against a range of dangerous pathogens, including MRSA and
C. difficile spores, in just five minutes at a distance of eight feet.
implemented use of the systems to clean all operating rooms and patient
isolation rooms between patients and other patient rooms and public areas on
a rotating basis in early August. The devices run after the environmental
services team thoroughly cleans and disinfects each room with a chemical
surface disinfectant product and the UV device is then used to supplement
these efforts. In a typical patient room, the device is placed on both sides
of the patient bed and turned on for five minutes in each position. Itâ€™s
also placed in the patient bathroom for another five-minute cycle. A similar
process is followed for the ICU.
Visit Clorox for more information.
Health companies label thousands of patient deaths as 'injuries'
How could a patient's death be correctly classified as an injury? It is a
question perplexing to family of Oklahoma's Shelly Wilhite. She was an
epilepsy patient who died in 2010 after being implanted with the Vagus Nerve
Stimulator (VNS), a device that emits small shocks intended to block
seizures. Less than 48 hours after complaining of abnormally painful shocks,
Wilhite's family says she collapsed and died on the bathroom floor.
Since then, her loved ones have come to learn Cyberonics, the manufacturer
of the nerve stimulator, has classified dozens of patient deaths as less
serious injuries and malfunctions.
In 2001 and 2004, the FDA sent Cyberonics warning letters, accusing the
manufacturer of failing to investigate and report patient deaths in a timely
manner. The company said all the issues in those letters were corrected.
But after NBC New York and CNBC asked Cyberonics about a number of more
recent patient deaths that were classified as injuries and malfunctions, the
company did an internal review, finding a total of 108 misclassified deaths.
Karen King, a spokeswoman for Cyberonics parent company LivaNova, said in an
email the misclassifications were a mix of unintentional human and
procedural errors. Cyberonics said the errors are being fixed and noted they
make up less than 1 percent of the 34,728 safety reports filed for alleged
problems with the VNS.
Madris Tomes, a former consultant to the FDA, said the labels "death,"
"injury" and "malfunction" matter a great deal, because public health
analysts must prioritize their work. "The way that the FDA reviews the
[safety] reports is in order of importance by the classification that is
checked on the form," Tomes said. "So if it is an injury or malfunction, it
could take them weeks to months to get to reading them."
The FDA said analysts do often prioritize death reports, but they also use
other criteria to review safety data and identify patient fatalities.
In 2009, an investigation by the Office of Inspector General of the
Department of Health and Human Services, found the vast majority of unread
safety reports were events classified as
"malfunctions" and the FDA's software only assigned about 10 percent of
malfunction reports to analysts for review.
Since the inspector general report, the FDA has made investments to better
track safety problems with medical devices. The agency is currently
upgrading its software platform for reporting problems. The new system would
link data on health risks from several different sources including clinical
registries, electronic health records, medical billing claims and data
transmitted from devices themselves.
Typically the FDA allows manufacturers the discretion to decide when and if
their product is related to the death.
For example, in five separate cases, VNS patients were found to have died of
pneumonia. Although the VNS instruction manual warns the nerve stimulator
could cause patients to aspirate liquid into their lungs â€” a known pneumonia
risk â€” Cyberonics reasoned three of the patient deaths were properly
classified as "injuries" or "malfunctions" because medical professionals
attested the device was not related to the pneumonia.
In the other two fatal pneumonia cases, Cyberonics said human errors
resulted in reporting mistakes.
The FDA said when it comes to balancing the interests of the medical device
industry and consumers, regulators favor the public.
Visit CNBC for the article.