Hospitals and health systems looking for a blueprint for fighting the deadly disease should look to Ohio, where an aggressive campaign is being waged and mortality rates are falling.
The fight against sepsis is back in the news, but for those clinicians who spend their days combatting the deadly epidemic, the story never went away.
Health systems across the nation wrestle with a problem that the Centers for Disease Control and Prevention says is responsible for $24 billion in hospital costs each year.
Sepsis kills 258,000 people each year in the United States and costs more than $24 billion. It represents 6.2% of all hospital costs across the nation, which makes it the most expensive condition in the nation's healthcare system, according to the federal government's Healthcare Cost and Utilization Project.
HCUP analysis showed that while total hospital care expenditures have remained fairly stable, spending for sepsis rose 19% from 2011 to 2013, more than double the rate for all hospitalizations.
The study revealed that the mean expense per stay associated with those hospitalizations was over $18,000 in 2013, making hospitalizations from sepsis 70% more expensive than the average stay.
Sepsis resulted in nearly 1.3 million discharges that year from U.S. hospitals, an increase of 19% from 2011. Sepsis was also the most expensive hospital condition billed to Medicare, accounting for 8.2% of all Medicare costs incurred in 2013.
Hospitals and health systems that are looking for a blueprint for fighting the deadly disease should look to Ohio, where an aggressive campaign is being waged.
In 2015, Ohio's hospitals began a campaign to reduce sepsis encounters and related deaths by 30% by 2018. Less than one year after the initiative began, the Ohio Hospital Association reported an 8% reduction in mortality.
In 2012, the Buckeye State's 220 hospitals reported 26,299 encounters with severe sepsis and septic shock, resulting in 6,250 deaths. In 2015, those numbers had ballooned to 38,487 reported encounters and 7,478 deaths.
Of course, the reason why sepsis numbers are rapidly rising is because reporting systems such as ICD-10 have improved the ability to accurately report the infections, especially upon admission, which is where 80% of sepsis cases are traced.
But even with the proper context, the numbers are alarming and demand a response.
"Because we are encouraging people to identify it, we are not surprised that we have a more honest assessment of the problem in our state," says OHA President and CEO Mike Abrams.
"If we could go back and apply today's identification standards to the previous years, those numbers would be higher as well. The fact that we are better at identifying it is not the same as saying the problem is worsening."
Abrams says Ohio's hospitals in 2015 decided to "confront the brutal truths" and begin a campaign to reduce sepsis encounters and related deaths by 30% by 2018. Nine months into the initiative, OHA is reporting an 8% reduction in mortality. That's 353 lives saved.
"At every level of healthcare in our state, from CEOs to EMTs, ambulance workers and everything in between, we are trying to make sure that everyone in the system is more capable of identifying sepsis," Abrams says.
"We want to make sure they are curious about whether a patient is septic or becoming septic, and once that status is ascertained that they know what to do. It is a condition that we know how to treat, but it is time-sensitive."
Ohio's Two-pronged Approach
In 2015, the OHA board adopted two sets of interventions for sepsis; one for leadership commitment, the other for organizational strategies.
Among the recommendations, hospital leaders are asked to provide the resources and visible, vocal promotion of an accountable culture of safety in support of sepsis reduction.
Organizationally, hospitals are asked to develop early identification and intervention processes for sepsis, and coordinate sepsis prevention across the care continuum.
"A lot of it is just a conscientiousness about the process. It is identifying these patients earlier," Abrams says. "This is not like we don't know what to do. This is a condition that lends itself to certain interventions that work. Get the proper antibiotics to these patients in a timely way."
Abrams says hospital leaders respond more assertively when they're shown how their sepsis numbers compare with competitor and peer hospitals.
"Just that act alone raises awareness and identifies it as something that merits leadership level attention," he says.
"Once they understand that 'this is a problem in our facility' and there are interventions that work, that clinical science tells us the three-hour bundle is an actual intervention that clinicians have identified, the hospitals can learn for themselves where things break down."
Ultimately, Abrams says OHA "wants to do for sepsis what we did for ventilator-associated pneumonia: Make them rare."
"Raise everyone's awareness that this is a condition that you need to be intellectually curious about. Once you have identified it, here is a known intervention that works," he says.
"There are all kinds of reasons why you should be curious about sepsis. One is the number of lives you are saving, but the other is the true economic cost to our system that this condition presents. We all need to be interested in this."
The hospital sector offers unanimous thumbs down to the Senate’s proposal to repeal and replace the Affordable Care Act.
The nation’s largest hospital associations united in rejecting the Senate’s proposal to repeal and replace the Affordable Care Act, and urged lawmakers to “hit reset” and “go back to the drawing board.”
The response to the Senate plan released Thursday was virtually identical to the unanimous disdain shown this spring for the House Republicans' American Health Care Act.
That is not surprising because the two bills are fundamentally the same on key points. They both eliminate the individual mandate, slash Medicaid, and eliminate a 3.8% tax on investment income above $200,000 that is a key funding source for Obamacare.
Moody’s Investors Service said Thursday the Senate bill would hurt hospitals.
“Under the proposed Senate bill, both for-profit and not-for-profit hospitals would face weaker demand for services and higher rates of uncompensated care expense, with the most significant impact on the sector occurring after 2020 when the changes to federal Medicaid funding are phased in,” said Daniel Steingart, a vice president at Moody’s.
“Transitioning federal Medicaid payments to a per-capita, or block grant system, and freezing Medicaid expansion would reduce the number of people with insurance and increase hospitals’ exposure to bad debt and uncompensated care costs.”
The nonpartisan Congressional Budget Office has yet score the bill, but by some estimates as many as 11 million people who gained coverage under the Medicaid expansion would be booted from the rolls under the Senate plan.
Hospitals Say ‘Hit Reset’
Rick Pollack, president and CEO of the American Hospital Association, said the Senate Better Care Reconciliation Act “moves in the opposite direction” from “key principles” the AHA had set down to protect health insurance coverage, particularly for vulnerable patients.
“The Senate proposal would likely trigger deep cuts to the Medicaid program that covers millions of Americans with chronic conditions such as cancer, along with the elderly and individuals with disabilities who need long-term services and support,” Pollack said in a statement issued shortly after the Republican plan was made public.
“Medicaid cuts of this magnitude are unsustainable and will increase costs to individuals with private insurance. We urge the Senate to go back to the drawing board and develop legislation that continues to provide coverage to all Americans who currently have it.”
Those sentiments were echoed in a statement by Sister Carol Keehan, DC, president and CEO of the Catholic Health Association, who said the Senate proposal “will have a devastating impact on our nation's most vulnerable populations.”
“After weeks of working behind closed doors, and despite claims that the Senate would start over and develop its own legislation, there is very little that differs from the House bill,” Keehan said.
“The small tweaks made in the newly released Senate bill do not change the fact that millions will lose their health care especially through a complete restructuring and deep federal funding reduction to the Medicaid program.”
Bruce Siegel, MD, president and CEO of America’s Essential Hospitals, accused Senate Republicans of putting “ideology ahead of lives with a plan that puts health and home at risk for millions of working Americans and that would badly weaken essential services for everyone in communities across the country.”
“For the hospitals that protect millions of Americans and their communities — our essential hospitals — this bill might even accelerate decisions by some to reduce services or close their doors,” Siegel said.
“Particularly troubling is the opaque process senators have followed to reach this point. Legislation of this scope and with such potential for harm demands a fair and public hearing, but Senate leaders so far have rejected that. This is a slap in the face to the democratic process and bad policymaking for the country.”
Federation of American Hospitals President Chip Kahn said the Senate still has time “to hit reset” and make critical revisions in the bill.
“FAH has been explicit about our health reform core principles: maintain coverage levels, reasonable Medicaid structural reforms, sustain affordable, high quality individual coverage, protect employer-sponsored insurance and roll back untenable cuts to hospital reimbursement,” Kahn said.
“At this time, the BCRA draft does not sufficiently meet those principles which are so important to those Americans our community hospitals serve and our employees who care for those patients every day. Now is the time for the Senate to hit reset and make key improvements to this legislation.”
Association of American Medical Colleges President and CEO Darrell G. Kirch, MD, said his members “are extremely disappointed by the Senate bill released today.”
“Despite promises to the contrary, it will leave millions of people without health coverage, and others with only bare bones plans that will be insufficient to properly address their needs,” he said.
“As the nation’s medical schools and teaching hospitals see every day, people without sufficient coverage often delay getting the care they need. This can turn a manageable condition into a life-threatening and expensive emergency. Rather than stabilizing the healthcare marketplace, this legislation will upend it by crippling the Medicaid program while also placing untenable strain on states and providers.”
Payers Peeved
Compared to the hospital lobby, the health insurance industry was restrained in its criticism of the Senate plan. America’s Health Insurance Plans spokeswoman Kristine Grow said it would “continue to analyze the bill, consistent with our previous positions.”
In May, AHIP CEO Marilyn Tavenner urged the Senate “to ensure the continued strength of the Medicaid program, which delivers real value to more than 70 million Americans.”
After weeks of secret meetings, Senate Republicans have released a ‘discussion draft’ of their proposal to repeal and replace the Affordable Care Act, and hope to rush the sweeping legislation to a Senate floor vote before the July 4 recess.
Senate Republicans today released their version of a bill to repeal and replace the Affordable Care Act.
On key points the Senate bill essentially copies the American Health Care Act, which was passed by House Republicans last month on a strict, party line vote.
The Senate bill:
Eliminates the individual mandate.
Eliminates Obamacare’s 3.8% tax on investment income on income above $200,000.
Phases out Medicaid expansion by 2023, potentially putting at risk health insurance coverage for more than 10 million Americans.
Adopts the House plan for a per capita cap on Medicaid spending, and in 2025 shifts the growth in spending away from the consumer price index for medical care to the lower CPI for all goods, which could result in significantly smaller annual federal funding increases to account for inflation.
Maintains Obamacare subsidies to help pay for individual coverage.
Provides $2 billion to help states deal with the opioids abuse crisis.
The nonpartisan Congressional Budget Office has yet to score the bill.
Republican Senate leaders have come under intense criticism, even from within their own party, for drafting the legislation in secret. Senate Majority Leader Mitch McConnell, R-KY, has said he hopes to have the bill up for a floor vote before the Senate’s July 4 recess.
President Donald Trump has pushed hard for the repeal of Obamacare, a pledge that was a centerpiece of his campaign. He initially praised the House AHCA when it passed this spring, but later called the legislation “mean.”
Last night, Trump told supporters in Cedar Rapids, IA that the Senate plan would have “heart.”
"I think and I hope, I can't guarantee anything, but I hope we're gonna surprise you with a really good plan," Trump told the crowd.
"I've been talking about a plan with heart," Trump said. "I said, 'Add some money to it!' A plan with heart."
Early reaction from within the healthcare sector to the Senate draft was fiercely negative.
“Senate leaders today have put ideology ahead of lives with a plan that puts health and home at risk for millions of working Americans and that would badly weaken essential services for everyone in communities across the country,” Bruce Siegel, MD, president and CEO of America’s Essential Hospitals, said in a media release.
“Today’s Senate bill makes few material improvements to the deeply damaging House legislation, and might be worse overall. For the hospitals that protect millions of Americans and their communities—our essential hospitals—this bill might even accelerate decisions by some to reduce services or close their doors,” he said.
Teledoc CEO Jason Gorevic says the acquisition of Best Doctors will create a combined company that can offer a range of virtual care options for markets that include employers, health plans and health systems. The deal also allows Teledoc to develop global expansion plans.
In an interview with HealthLeaders Media, Teledoc CEO Jason Gorevic detailed the Purchase, NY-based telehealth company’s $440 million acquisition of Best Doctors. The following is a lightly edited transcript.
HLM:Why did you make this acquisition?
Gorevic: The combination opens up a tremendous set of possibilities for the healthcare consumer, ultimately providing a comprehensive platform of virtual healthcare delivery services. Teledoc came at the telehealth market at the low end of the acuity spectrum, focusing on high-frequency, low-severity conditions. Best Doctors came at it from the top of the pyramid, focusing on the most-costly and complex issues. Together we can provide a single, centralized resource for the consumer, regardless of what their healthcare issue is.
HLM: Who can access Teledoc? Is it open to the general public?
Gorevic: Most of our businesses are distributed through sponsoring organizations; employer health plans, health systems, insurance companies, financial service companies. Together we have millions of members around the world.
HLM: How will Teledoc be different after the acquisition is finalized.
Gorevic: Historically, our business has been focused on providing care for consumers across the country who are experiencing episodic conditions such as flu symptoms, allergies, pink eye, urinary tract infections, things like that. This year, we will do that almost 1.5 million times for our 20 million members. Over the last 18 months, we added additional clinical specialties, such as behavioral health, dermatology, a sexual health program, a tobacco cessation program, the ability for our consumers to get on a three-way interaction with a doctor for an aging family member who they are providing care for, and themselves, and help to facilitate the delivery of care. We’ve been consistently expanding the scope of our clinical services.
Once the Best Doctors transaction closes we will be able to direct consumers to their network of more than 50,000 Best Doctors around the world, provide a specialist who can answer detailed medical questions, and be able to provide an in-depth expert second opinion for someone who’s been diagnosed with a musculoskeletal issue, and maybe surgery has been recommended, or has a heart condition, maybe was diagnosed with cancer and is being recommended for chemotherapy. By leveraging Best Doctors in more than 450 specialties we will be able to collect the medical records, assemble a summary of the case, and provide for an expert opinion.
HLM: What are the limitations of tele-medicine?
Gorevic: Obviously, we are not setting broken bones or suturing lacerations. There are certain things that need to be seen in person. Both organizations share a focus on quality and so Teledoc is able to send the consumer for a lab test if it is necessary and similarly Best Doctors will retake pathology or testing if necessary to get a clear view and ensure the accuracy of their second opinion.
HLM: Will the consumers do this out of their homes, or will they do it in a physician’s office?
Gorevic: The consumer should be able to access the highest quality care from wherever they are. They don’t have to be in a facility or a physician’s office. The Best Doctors expert opinion report is delivered to both the consumer and the treating physician. It’s complementary to the local delivery system, regardless of where the patient is.
HLM: Provide an example of how this might work.
Gorevic: Let’s take the example of a shoulder injury. The patient has gone to see an orthopedic surgeon who is recommending surgery. In that case, it would be common for the patient to come to Best Doctors and ask ‘I’d like a second opinion so I know whether surgery is the best course of treatment.’ The member will work with the Best Doctors case manager, who is usually a nurse, and the specialist, who will first interview the patient, then go through an extensive medical records collection process, including collecting the actual films from an MRI, or something like that. If the films are inconclusive, they will order a new set of films to be taken so that they can ensure that they have all the information they need.
That information will be put into a summary report that is sent to a subspecialist, who in this case would be not just an orthopedic surgeon, but an orthopedic surgeon who specializes in shoulders. That specialist will review the record and either confirm or refute the diagnosis, and either confirm or recommend a modification to the treatment plan. Once that report is completed, it is delivered to both the patient and the original treating orthopedic surgeon, who will get continuing medical education credits for reviewing that information.
HLM: How are Best Doctors compensated?
Gorevic: They are paid on a case-by-case basis. They are consultants to Best Doctors. It’s important to understand that Best Doctors assembles this network of experts by going out to the physicians in the community and asking them to nominate and vote on the best physicians in their peer groups. Again, the advantage here is bringing together two organizations with a common focus on ensuring that consumers can access the highest quality care from wherever they are in a virtual environment that will be able to delivery across the healthcare spectrum.
HLM: Are there regulatory issues related to using international doctors, or specialists from other states?
Gorevic: This is an expert consultation that is being provided to local treating physicians. The Best Doctors expert isn’t treating the patient. They are acting as a consultant to the treating physician.
HLM: Are you developing a global network of physicians?
Gorevic: We talk about global because 40% of Best Doctors business comes from outside the United States. About half of that comes from Canada. They have members around the world in more than 100 countries.
HLM: What percentage of Best Doctors physicians are US-based?
Gorevic: About 80%.
HLM: What is your outlook for the telemedicine industry?
Gorevic: We’ve seen our utilization increase significantly year-over-year. Our first quarter utilization was up 127 basis points over the same time last year. And, while I wouldn’t say that we’ve yet achieved the ultimate potential, we’ve certainly hit the inflection point of adoption for telemedicine.
Awareness among consumers continues to be the biggest obstacle to expansion. This combination of the two companies who are both leaders, both have market leading brands, with complementary attributes, I believe will help to increase awareness and increase adoption.
The combined company will offer a range of virtual care options for markets that include employers, health plans and health systems. The deal also allows Teladoc to develop global expansion plans.
Telehealth platform Teladoc, Inc. will purchase medical consultation company Best Doctors in a deal valued at $440 million, the two companies announced this week.
In a joint media release, the two companies said the deal marries Teladoc’s technology, engagement capabilities, and scalable platform with Best Doctors’ network of medical experts, analytics, patient decision-support, and regional expertise. The combined company will offer virtual care services for markets that include employers, health plans, and health systems. The deal also allows Teladoc to develop global expansion plans.
The purchase price includes $375 million cash and $65 million of Teladoc common stock, and the deal is expected to close in July, subject to regulatory approvals and routine closing conditions.
“When you think about what these two industry leaders have been able to do independently, it’s clear that the potential impact that we can make together is truly inspiring,” said Jason Gorevic, CEO of Purchase, NY-based Teledoc. “What you can expect to see with these two companies coming together is a comprehensive, virtual healthcare environment that will help consumers find resolution across a wide spectrum of healthcare needs.”
Privately held Best Doctors was founded in 1989 by Harvard Medical School professors and now claims more than 40 million members globally. In 2014, Best Doctors acquired Rise Health to expand of its digital health services. Best Doctors generated $92.2 million in 2016, $23.7 million in the first quarter of 2017, and is expected to generate more than $100 million this year.
“By combining data and analytics with a focus on nothing but the highest standard for care, we’ve successfully created a better way for patients and their families across the globe to get resolution to the most life-changing medical conditions,” said Best Doctors CEO Peter McClennen, who will be president of the Best Doctors division under Teladoc. “Now aligned as one greater organization under Teladoc, the impact we can make together is tremendous, delivering a paradigm shift in care access that comes with a phenomenal patient experience, unprecedented outcomes and cost savings.”
Findings in 25-state study challenge the notion that the expansion of health insurance coverage under the Affordable Care Act would reduce emergency department visits, but that’s not necessarily bad.
States that expanded Medicaid coverage under the Affordable Care Act saw 2.5 emergency department visits more per 1,000 people after 2014, while the share of ED visits by the uninsured decreased by 5.3%, according to a study this week in Annals of Emergency Medicine.
“Medicaid expansion had a larger impact on the healthcare system in places where more people were expected to gain coverage,” study lead author Sayeh Nikpay, PhD, of Vanderbilt University, said in remarks accompanying the study. “The change in total visits was twice as large in a state like Kentucky, where most childless adults were ineligible for Medicaid at any income level before 2014, as in states like Hawaii, where childless adults were already eligible for Medicaid above the poverty line.”
Nikpay analyzed patient visits in 14 states that expanded Medicaid coverage and 11 that did not and found that the share of visits covered by private insurance remained constant for expansion states and increased by several percentage points for non-expansion states. Gains in insurance coverage in non-expansion states were almost entirely in the form of private coverage, not Medicaid.
Increases in ED visits were largest for injury-related visits. There was also a large change in payer mix for dental visits, because dental ED visits are most prevalent among low-income, non-elderly adults on Medicaid. Out-of-pocket dental costs were reported as one of the more unaffordable types of care among the target population for Medicaid expansion under the ACA.
Ari Friedman, MD, of Boston’s Beth Israel Deaconess Medical Center, wrote an accompanying editorial and said that the increased ED visits in the expansion states “runs contrary to the prediction by many policymakers that by providing greater access to primary care, insurance expansion would break the decades-long trend of increasing ED volume.”
Friedman said there was scant evidence to support that prediction, but plenty of actual experience from states such as Oregon, which demonstrated that decreasing the cost of healthcare by providing for health insurance leads to an increase in care use of all kinds, be it in the ED or the primary care setting.
“More emergency department visits by Medicaid beneficiaries is neither clearly bad nor clearly good,” Friedman said. “Insurance increases access to care, including emergency department care. We need to move beyond the value judgments that have dominated so much study of emergency department utilization towards a more rational basis for how we structure unscheduled visits in the health system. If we want to meet patients' care needs as patients themselves define them, the emergency department has a key role to play in a flexible system."
People with the lowest education level had higher lifetime risks of cardiovascular disease than those with the highest education level, research shows.
Educational attainment is one of the biggest socioeconomic factors contributing to cardiovascular disease, according to a study this week in JAMA Internal Medicine.
Researchers led by Yasuhiko Kubota, MD, of the University of Minnesota, Minneapolis, examined the linkage between educational attainment and CVD risk by estimating lifetime risks of coronary heart disease, heart failure and stroke in a large biracial study. The authors also looked at how income, occupation and parental education were associated with educational attainment and lifetime CVD risk.
The study included 13,948 whites and African-Americans, ages 45-64, who were tracked from 1987 through 2013, who were free of CVD. The subjects lived in Washington County, MD; Forsyth County, NC; Jackson, MS; and the suburbs of Minneapolis, MN. The authors documented 4,512 CVD events and 2,401 non-CVD deaths.
In men, lifetime CVD risks from ages 45-85 ranged 59% for those with a grade school education to 42% for those with a graduate school education. In women, lifetime CVD risks ranged from 51% for those with a grade school education to 28% for those with graduate school degrees, the study found. In general, the more educated the person, the lower the risk of CVD, regardless of other socioeconomic factors including family income, occupation or parental education level.
Kubota’s team caution that lifetime risks of CVD should be interpreted carefully because they could be influenced by other CVD risk factors. “Even with such a proviso, our estimates of lifetime risk can help in elucidating the association between education and CVD risk,” the researchers said.
“More than 1 in 2 individuals with less than a high school education had a CVD event during his or her lifetime. Educational attainment was inversely associated with the lifetime risk of CVD, regardless of other important socioeconomic characteristics. Our findings emphasize the need for further efforts to reduce CVD inequalities related to educational disparities,” the researchers said.
“Both organizations are committed to ensuring our community members receive the healthcare they need, regardless of their ability to pay,” Palmetto Health CEO Charles D. Beaman Jr. said in a media release.
“Our integration to become a new health company continues our commitment to serving our patients. We will create a culture that attracts, retains and develops the highest quality and diversity of team members, and continue to teach the next generation of physicians and other caregivers,” he said.
If the deal clears regulatory review, it would create the largest health system in South Carolina, and one of the 50 largest health systems in the nation, with 13 hospitals and hundreds of physician practices and ambulatory centers. Nearly half of South Carolinians would be within 15 minutes of a facility operated by the merged system, which would be the largest private employer in South Carolina, with more than 28,000 employees and 2,800 physicians, the two systems said.
“Greenville Health System and Palmetto Health are joining together from individual positions of strength,” Greenville Health System CEO Michael C. Riordan said. “We have a long history of successful collaboration, as well as a strong cultural fit and mutual commitment to make South Carolina healthier. Together we will continue to ensure our community members, including those in rural areas, have access to high-quality, locally based care.”
South Carolina has some of the nation’s highest rates of obesity, diabetes, stroke, and cardiovascular and pulmonary disease. The two health systems said the merged company will have the scale, scope and resources to address the health issues of the people it serves. It also will continue to be a not-for-profit, mission-driven organization committed to making healthcare more affordable and accessible.
Because of its scale, the new company will have the potential to invest up to an additional $1 billion over the next five years in programs, technology, facilities and employees. No layoffs are planned.
The merger received the unanimous approval of the boards of directors of both health systems, capping months of discussions and analysis by both organizations. A new board with equal representation from Palmetto and Greenville would oversee the new health company. Riordan and Beaman would be co-CEOs and share leadership responsibilities.
The process now enters a due diligence stage, which is expected to take several months. The merger must also clear state and federal regulatory hurdles. In the meantime, Palmetto Health and Greenville Health System will continue to offer care and services as two separate, independent organizations
Experts say alarming results support findings from earlier studies and underscore the importance of rigorous monitoring of device maintenance schedules to minimize the risk of patient harm.
More than one-in-three heater-cooler units inspected over 18-months tested positive for a bacterium linked to fatal infections in open-heart surgery patients, a new study found.
“Our results showed M. chimera (Mycobacterium chimaera) in 37% of units tested and is consistent with previous findings. The extent of contamination from such a rare organism in multiple units from all over the country was surprising,” said John Rihs, vice president of Laboratory Services at Special Pathogens Laboratory, which conducted the research.
“Some devices remained positive for M. chimera for months, indicating that disinfection can be difficult and routine testing is advisable. Beyond M. chimera, we found other NTM (Nontuberculous mycobacteria) species, Legionella, and fungi, indicating these units are capable of supporting a diverse microbial population,” Rihs said in remarks accompanying the study.
The research, presented at the 44th Annual Conference of the Association for Professionals in Infection Control and Epidemiology, examined 563 water samples from 89 heater-cooler units in use at 23 hospitals in 14 states, the District of Columbia and Canada between July 2015 and December 2016.
Thirty-three units tested positive for M. chimaera, and four units were colonized with Legionella. Rihs said researchers were surprised at how contaminated the units were, with 97 cultures deemed uninterpretable due to high levels of bacterial and fungal contamination. Multiple other strains of mycobacteria were also detected in many of the units.
HCUs control the temperature of a patient's blood and organs during heart bypass surgery. The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention already have issued safety warnings that the widely used LivaNova PLC Stӧckert 3T Heater-Cooler System might be contaminated during manufacturing, putting patients at risk for life-threatening infections. Approximately 60% of heart bypass procedures performed in the United States use the Stӧckert device.
HCUs have water tanks that provide temperature-controlled water during surgery through closed circuits. The water does not come into direct contact with the patient. However, the water can aerosolize and transmit bacteria through the air into the environment and to the patient.
APIC President Linda Greene, RN, said the findings “highlight the importance of monitoring the decontamination and maintenance schedules of these devices to minimize the risk of patient harm.”
“Hospitals must follow the cleaning and disinfection instructions provided in the manufacturer's device labeling, as well as updated communications from the FDA and CDC,” she said.
M. chimaera is often found in soil and water but is rarely associated with infections. However, patients exposed to the bacteria through open-heart surgery can develop symptoms that can often take months to emerge. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat.
Hospitals were instructed by the CDC and FDA to notify patients who have had open-heart surgery within the last five years that they were potentially at risk for infection. Patients were notified to seek medical advice if they were showing any symptoms or signs of infection, which can be vague or inconspicuous.
LivaNova Responds
On Friday morning, LivaNova spokeswoman Deanna Wilke responded by email to a request for comment. Wilke wrote that the London-based medical device company has developed a three-part remediation plan to address the issue.
“The remediation plan developed by the company consists primarily of a modification of the 3T Heater-Cooler design to include internal sealing and a vacuum system to existing devices,” Wilke said.
"Another part of this plan we are implementing is a no-charge deep disinfection service for 3T Heater-Cooler users who have reported confirmed M. chimaera mycobacterium contamination,” Wilke said. “The deep disinfection service has been approved by numerous local regulatory authorities and is available in many countries around the world. We anticipate expanding the deep disinfection service globally as regulatory approvals are received.
"Finally, the company will continue its program to loan existing 3T Heater-Cooler users a new 3T Heater-Cooler device at no charge, pending regulatory approval and implementation of the vacuum system and deep disinfection service worldwide,” she said.
Study shows that response times plummeted when a drone carrying an automated external defibrillator was used for simulated out-of-hospital cardiac arrest episodes.
Someday soon, drones toting life-saving medical equipment and supplies may zip across the skies over the United States on missions of mercy.
A new study published this week in JAMA shows that a drone hauling an automated external defibrillator drastically reduced emergency response times by an average of 16 minutes for simulated out-of-hospital cardiac arrest cases.
Out-of-hospital cardiac arrest in the United States has a low survival rate of between 8% -10%, so reducing time to defibrillation is a critical factor for increasing survival. A 12 lbs. drone with a 1.7 lbs. AED attached was used in this study, which was conducted in Sweden.
The drone was activated by a dispatcher and sent to an address provided by a 911 caller so that bystanders could use the device, said study lead author Andreas Claesson, RN, of the Karolinska Institutet in Stockholm.
Claesson said it’s not clear if drones can reduce response times in real-life situations. To get a comparison with traditional emergency medical services response times, a drone was placed at a fire station in a rural setting outside of Stockholm.
The drone, which cost about $20,000, was equipped with a global positioning system, a high-definition camera and integrated with an autopilot software system. It was sent to locations where OHCAs had occurred between 2016-2014 and within a 6.2-mile radius from the fire station.
The drone used in the study has a range of more than nine miles, and is capable of speeds of up to 45 mph, Claesson said.
Eighteen remotely operated flights were performed with a median flight distance of about two miles. The median time from call to dispatch of EMS was three minutes. The median time from dispatch to drone launch was 3 seconds. The median time from dispatch to arrival of the drone was 5:21 minutes versus 22 minutes for EMS.
The drone arrived more quickly than EMS in all cases with a median reduction in response time of 16:39 minutes, the study found.
Claesson and his colleagues acknowledged that the study is limited because the drone flew less than 20 routes of short distances and in good weather. Still, they said the findings warrant further investigation.
“Saving 16 minutes is likely to be clinically important. Nonetheless, further test flights, technological development, and evaluation of integration with dispatch centers and aviation administrators are needed,” the study authors wrote. “The outcomes of OHCA using the drone-delivered AED by bystanders versus resuscitation by EMS should be studied.”
In an email exchange with HealthLeaders Media, Claesson said drones have the potential to provide many other emergency medical services.
“The technology is here,” he said. “The cardiac arrest case is easy to understand and a drone may transport anything. We have shown that in certain areas the timesaving of a drone system as compared to EMS. It’s rather the mindset that needs to change. Manned aircraft needs to adapt to unmanned not just the other way around.”
Claesson conceded that the flight proficiency and licensure for the drone’s operators “requires a lot of training” and that the drone pilots also spent a lot of time before the test preparing flight routes and identifying flight corridors. The use of drones also could be hindered by flight restrictions and local ordinances in some areas, he said.
