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August 26, 2016   Download print version

Dirty, missing instruments plague DMC surgeries

Zika stays in women, baby's bloodstream longer than previously thought

Zika virus’s spread pushes testing labs to expand capacity

ACO initiatives put patients at the center of their care while generating more than $1.29 billion in total Medicare savings since 2012

CDC: U.S. deaths from heart disease, cancer on the rise

Jump starting the brain: Experimental device suggests new path to rousing coma patients

CVMC invests in UV disinfection systems for additional protection from HAIs

Health companies label thousands of patient deaths as 'injuries'


Daily Update Archives


Self Study Series:
September 2016

The Surgical Instrument Protection Team
by Sandra Beauclair, BSN, RN, CNOR

Sponsored by

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Self-Study Series

Self-Study Series

Dirty, missing instruments plague DMC surgeries

The Midtown hospitals of the Detroit Medical Center have struggled for years to properly clean surgical instruments, stoking doctors’ 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 show.

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 child’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 Children’s Hospital of Michigan because a tube leading to a bypass machine was clogged with blood from a previous operation.

“We are putting patients at risk frequently and now canceling up to 10 cases this week ... promises just aren’t cutting it,” Joseph Lelli, chief surgeon at Children’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 increased.

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 unusual.

The DMC’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 — Children’s, Detroit Receiving, Harper University, Hutzel Women’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 reprisals.

One longtime surgeon said he’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 he’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 system’s “huge challenges” have persisted for years — and there’s been no “prolonged effort” to fix them, contended Laura Cortner, a former director the DMC’s Central Sterilization Department.

The department’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 “case carts” and delivering them to operating rooms in a few hours.

Cortner wrote the DMC’s approach to problems was to “fire someone ... replace ... run them in to the ground, blame them, repeat.”

Mallett said managers are to blame and the DMC has made numerous efforts at reform.

Hospital sterilization accuracy rates aren’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.

“We 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),” 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 — intravenous machines and feeding pumps — at Children’s were incorrectly labeled as clean.

Hall wrote that her efforts at discipline were not supported by upper management.

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 five days.

"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 virus’s spread pushes testing labs to expand capacity

A 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 wouldn’t be enough to meet demand under the Centers for Disease Control and Prevention’s worst-case scenario for a domestic Zika outbreak.

The gap was “considerable,” 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 Zika’s foothold in the U.S. expands. In recent months, dozens of public health laboratories—which work with the government to monitor public health and screen for disease—bought equipment, stockpiled supplies and trained employees needed to start Zika testing, said state and local health officials.

The push has lowered some wait times for results to between one and four weeks and the CDC estimates the nation’s network of public health labs now has “sufficient capacity” 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.

A Florida Health Department spokeswoman said the state’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 physician’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 virus’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.

A 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 Thursday.

Visit the Wall Street Journal for the article.


ACO 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 ACOs’ 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 nation’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 CDC’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 CDC’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 “all that much more remarkable,” he said. But the recent rise in deaths from both diseases caught the CDC’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 Islanders.

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 deaths.

Visit the American Heart Association for the report.


Jump starting the brain: Experimental device suggests new path to rousing coma patients

A team of physicians and neuroscientists reported the successful use of ultrasound waves to “jump start” the brain of a 25-year-old man recovering from coma — 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 — the thalamus — 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.

“We found a way to jump start these circuits back into service,” said the study’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 the editor.   

Visit Stat News for the story.


CVMC invests in UV disinfection systems for additional protection from HAIs

Catawba 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.

The UV 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 nation’s healthcare facilities.

CVMC decision to purchase the two Clorox Healthcare Optimum-UV Systems was based on the devices’ 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.

CVMC 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. It’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 — a known pneumonia risk — 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.