Hes summer '17 final

healthcare

Environmental solutionsnews Covering infection prevention, medical waste management & sustainable practices

VOL. NO. 42 VOL. XIII XII NO.

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Industry-Funded Research for Antibacterial Products: Boon or Bane?

Medical Waste Management Assoc (MWMA) – pg 15

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Summer 2017 WINTER 2016

By P.J. Heller

A

s hospitals struggle to reduce drugresistant bacterial infections among patients, one of the tools they have turned to is germ-killing chemical chlorhexidine.

But a recent Reuters news report raises serious questions about studies conducted by medical researchers promoting the use of the powerful antiseptic – studies paid for by companies that manufacture and market the antibacterial products.

“Makers of products using chlorhexidine to fight bacteria in hospitals provide support for scientists who repeatedly find those products to be very effective – even as concerns about safety have mounted,” the special report by Reuters said. “. . . as use of chlorhexidine products has grown, so have concerns about their effectiveness and safety ­– and about the role of industrybacked research in promoting them. The industry money funding chlorhexidine research muddies the message of the results, in the view of many health experts,” the report said.

The news agency cited funding for a patient study on chlorhexidine wipes provided by manufacturer Sage Products, at Rush University Medical Center in Chicago. The findings, published in 2006, reported that the wipes were highly effective at preventing vancomycin-

resistant enterococci (VRE), an antimicrobialresistant bacteria which most often occurs in hospitals. VRE outbreaks, which have occurred worldwide, can be fatal.

Following publication of its study, Rush University Medical Center received a $1 million donation from a family foundation of Sage’s founder. According to Reuters, the money was to go to Dr. Robert A. Weinstein, the senior scientist who conducted the chlorhexidine study. The foundation said the money was to be used for research and that there were no strings attached to the funds.

“Since then, Sage has provided funding and millions of dollars in wipes for studies by Weinstein and his colleagues,” Reuters reported, noting that during that time “ . . . Weinstein and his colleagues have published 11 articles on six trials that endorse daily washing of patients with Sage’s patented wipes – an ‘off-label’ use, as the U.S. Food and Drug Administration (FDA) has approved the wipes only for cleaning patients before surgery.”

Those findings, as well as others that were published following industry-backed funding and support, raise questions about their validity and about whether results may have been skewed, according to health experts.

Such concern is nothing new, having

Continued on page 3

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Healthcare Environmental Solutions news

Industry-Funded Research for Antibacterial Products: Boon or Bane?

Continued from page 1

been raised in other industry-backed research projects, such as for infant formula, tobacco and alcohol.

“Opinions are divided on whether research and educational material funded by the tobacco, alcohol, or infant formula industries can be scientifically sound or whether it is inevitably tainted,” the National Institutes of Health Opinions noted nearly a decade ago.

For his part, Weinstein, an infectiousdisease specialist at Rush, told Reuters that Sage did not meddle in his research or have any input into his findings. He also said he published a brief negative reviews of Sage’s products in a European journal in 2010, according to Reuters.

Many of his studies were co-sponsored by the Centers for Disease Control, which was “looking over my shoulder.” he told the news agency.

Nevertheless, the World Health Organization suggests that “pharmaceutical company funded research is more likely to show results favorable to the product being studied than research funded from other sources.

“There is an association between the

healthcare

Environmental solutionsnews Covering Infection prevention, medical waste management & sustainable practices

PUBLICATION STAFF Publisher / Editor Rick Downing Contributing Editors / Writers P.J. Heller Sandy Woodthorpe Production & Layout Barb Fontanelle • Christine Pavelka Advertising Sales Rick Downing Subscription / Circulation Donna Downing Editorial, Circulation & Advertising Office 6075 Hopkins Road, Mentor, OH 44060 Ph: 440-257-6453 • Fax: 440-257-6459 Email: downassoc2@oh.rr.com Subscription information, call 440-257-6453.

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In its most recent warning, the FDA said opinions of investigators about products and that “rare but serious allergic reactions have been their source of funding but causality has not reported with the widely used skin antiseptic been established,” WHO said. products containing chlorhexidine gluconate.

Questions about industry-funded medical Although rare, the number of reports of research were also raised in a 2012 article serious allergic reactions to these in Scientific American. products has increased over the “Many clinical research last several years.” studies are funded by T h e F DA a s ke d “Kickback pharmaceutical companies manufacturers of overand there is a general schemes undermine the-counter antiseptic perception that such products containing industry-based funding the integrity of medical chlorhexidine to add a could potentially skew the decisions, subvert the warning label to their results in favor of a new products about the risk. medication or device,” health marketplace Reuters reported it said. “Pharmaceutical that the number of adverse c o m p a n i e s o r d ev i c e and waste taxpayer events reported to the manufacturers need to dollars.”

FDA with possible links to increase the sales of newly chlorhexidine nearly tripled developed drugs or devices in between 2007 and 2016 from an order to generate adequate profits. average of 85 per year to 226; the It would be in their best interest to number stayed fairly even for the first seven support research that favors their corporate years but then jumped in both 2015 and 2016. goals. Even though this rationale makes intuitive It noted, however, that a “reported event” may sense, it does not necessarily prove that industrynot be caused by the product and that not every funding does influence the results of trials. adverse event is reported.

However, there is also data to support the fact Among adverse events cited included that the funding source does seem to correlate anaphylaxis shock (120 reports), skin irritation, with the outcomes of clinical trials.” rashes and burns (325 mentions) and lifeThe Reuters article pointed out that threatening events (48 reports). Seven deaths declining government funding for medical were reported. research made industry support even more The chlorhexidine product ChloraPrep was necessary. Nearly 75 percent of all funding for cited for about one-third of the allergic reactions, clinical trials in the United States currently Reuters said. The product was originally sold comes from corporate sponsors, according to

by CareFusion; the California company was health experts. acquired in 2015 by Becton, Dickinson for There is also a lot of money is at stake $12.2 billion. for companies that market antiseptics and CareFusion in 2014 agreed to pay the U.S. disinfectants such as chlorhexidine wipes. BCC government $40.1 million to settle allegations in Research estimates that the global market for a whistleblower suit that it paid kickbacks and those products will increase to $7.9 billion in promoted its products for uses that were not 2020, up from $5.6 billion in 2015, a compound approved by the FDA. annual growth rate of 7 percent during those The allegations centered on CareFusion’s five years. payment of $11.6 million in kickbacks to Dr. Of particular concern with the studies, Charles Denham to get him to “recommend, according to Reuters, was that while industrypromote and arrange for the purchase of funded research has found chlorhexidine ChloraPrep by healthcare providers,” according products to be extremely effective, questions to the Justice Department. At the time, have been raised about effectiveness and safety.

Denham was the co-chair of the safe practices “Despite all the promising study results, committee at the National Quality Forum, a the number of hospital-acquired drug-resistant non-profit organization that reviews, endorses infections has remained stubbornly high,” and recommends standardized healthcare Reuters noted. performance measures and practices.

In February, the FDA issued a warning In 2015, the Justice Department announced about possible allergic reactions to products that Denham had agreed to pay $1 million containing chlorhexidine. Some deaths were “to settle allegations that he violated the reported, according to Reuters.

False Claims Acts by soliciting and accepting The FDA had issued a warning in 1998 kickbacks.” to healthcare professionals about the risk of “Kickback schemes under mine the serious allergic reactions with products, such integrity of medical decisions, subvert the as dressings and intravenous lines, that contain chlorhexidine gluconate.

Continued on page 4 summer 2017

HEALTHCARE ENVIRONMENTAL SOLUTIONS news

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News Briefs

Practice Greenhealth Announces Winners of Top 25 Environmental Excellence Awards

Most prestigious environmental achievement award recognizing sector’s top hospitals

R

eston, VA – Practice Greenhealth, a nonprofit membership and networking organization for sustainable health care, has announced the winners of its annual Top 25 Environmental Excellence Awards.

The award recognizes 25 health care facilities that exemplify the best in environmental excellence, and the highest standards for environmental practices in health care.

“Each year, we see more health care facilities recognizing the link between environmental responsibility and health–and these 25 hospitals are setting the bar for environmental performance in health care,” said Paul Bogart, Executive Director for Practice Greenhealth.

“These leading hospitals continue to innovate on ways to protect and promote health through more environmentally responsible practices—and we’re excited to recognize their efforts as models for the sector.”

Award winners are chosen among hospital applicants that have the highest scores on the Greenhealth Partner for Change application. Each year, the competition for these top spots increases, as a growing number of facilities are implementing creative, sustainable and implementable practices.

The Top 25 winners this year include: • Advocate Good Samaritan Hospital (Downers Grove, IL) • Advocate Good Shepherd Hospital (Barrington, IL) • Aleda E. Lutz VA Medical Center (Saginaw, MI) • Boston Medical Center (Boston, MA) • Cheyenne VA Medical Center (Cheyenne, WY) • Cleveland Clinic (Cleveland, OH) • Erie Veterans Affairs Medical Center (Erie, PA) • Gundersen Health System (La Crosse, WI) • HackensackUMC of Hackensack Meridian Health (Hackensack, NJ) • Harborview Medical Center (Seattle, WA) • Hudson Hospital & Clinic (Hudson, WI) • Iowa City VA Health Care System (Iowa City, IA) • James E. Van Zandt VA Medical Center (Altoona, PA) • Kaiser Permanente Vacaville Medical Center (Vacaville, CA) • Memorial Sloan Kettering Cancer Center (New York, NY) • Minneapolis VA Healthcare System (Minneapolis, MN) • Park Nicollet Methodist Hospital (St. Louis Park, MN) • Ralph H. Johnson VA Medical Center (Charleston, SC) • Regions Hospital (St. Paul, MN) • Seattle Children’s (Seattle, WA) • Southern Arizona VA Health Care System (Tucson, AZ) • St. Cloud VA Health Care System (St. Cloud, MN) • The University of Vermont Medical Center (Burlington, VT) • The University of Washington Medical Center (Seattle, WA) • Virginia Mason Hospital & Seattle Medical Center (Seattle, WA) The 25 hospitals presented with Practice Greenhealth’s highest honors range in size from large, urban, academic medical centers to critical access hospitals—but are all leading the country in recognizing and addressing the links between the environment and human health—and have the programs, data and documentation to demonstrate their successes.

These facilities have committed, engaged staff supporting these programs, and also show leadership in their local communities and across the health care sector.

Practice Greenhealth will celebrate the Top 25 Environmental Excellence Award Winners on May 18 at the Environmental Excellence Awards Gala in Minneapolis, MN, which will bring the CleanMed 2017 Conference and Exhibition to a close.

Practice Greenhealth will also celebrate additional winners of its Environmental Excellence Awards program at the gala, including: the Visionary Leader Award; the Circles of Excellence, the Greening the OR Leadership Award; the Greenhealth Emerald, Partner for Change and Partner Recognition Awards; the Making Medicine Mercury-Free and Greening the OR Recognition Awards; and the System for Change Award—recognizing the top health systems who are leading by example.

Learn more about the Top 25 Environmental Excellence Award Winners: https:// practicegreenhealth.org/awards.

Industry-Funded Research for Antibacterial Products: Boon or Bane?

Continued from page 3

health marketplace and waste taxpayer dollars,” said then-Acting Assistant Attorney General Benjamin C. Mizer. “Doctors and other healthcare professionals who accept illegal inducements undermine the public’s trust in federal healthcare programs . . .”

There was no determination of liability in either settlement, Justice Department officials said.

In 2008 – and again last year – Sage issued a recall of its chlorhexidine wipes because the chemical could be contaminated, Reuters reported.

The recall was sparked after the wipes were linked to infections by Burkholderia cepacia, a known cause of infections in hospitalized patients and which are often resistant to common antibiotics.

Six patients involved in a study funded by Sage were among those infected due to the contamination.

That 2008 recall prompted a temporary halt in the Sage study, according to Reuters. Weinstein described the recall as a “treatment interruption” in a 2013 article in the New England Journal of Medicine and said the wipes “were safe and effective.” He made no reference to the six B. cepacia infections, Reuters said.

Dr Michael W. Climo, lead author of the study and a professor at Virginia Commonwealth University, told Reuters the infection references were deleted from the manuscript “for brevity” and “because they didn’t directly relate to the wipes’ effectiveness in reducing drug-resistant infections.”

Sage, founded in 1971, was acquired for $1 billion in 2012 by Madison Dearborn Partners, a private equity investment firm. Four years later, in 2016, Sage was acquired by the Stryker Corp., a medical technology company based in Kalamazoo, Mich., for $2.7 billion. Sage is a business within the Stryker Medical Division.

That same year, Sage expanded its voluntary worldwide recall of its chlorhexidine wipes due to potential product contamination with the bacteria B. cepacia.

“Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups,” the company said. “These infections could be lifethreatening.”

The U.S. is not alone in having concerns about chlorhexidine. In 2012, the British government warned of the risk of anaphylactic reaction due to chlorhexidine allergy. According to Reuters, the number of adverse events jumped from 14 in 2007 to 117 in 2016.

“The MHRA (Medicines and Healthcare products Regulatory Agency) has received a number of reports of anaphylactic reactions following the use of products containing chlorhexidine,” it reported.

In March, a month after the latest FDA warning, Ireland’s Health Products Regulatory Authority (HPRA) also issued a warning about the risks associated with medical devices containing

Continued on next page

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HEALTHCARE ENVIRONMENTAL SOLUTIONS news

summer 2017

News Briefs Continued from previous page chlorhexidine. The HPRA said the antiseptic agent had recently been associated with “serious but rare anaphylactic reactions due to chlorhexidine allergy” as well as “severe chemical injury and burns in premature infants.”

Meantime, Reuters reports that debate continues over the benefits of bathing patients with chlorhexidine wipes. Studies cowritten by Weinstein of Rush University Medical Center endorsed that practice, saying that adult patients bathed with Sage’s wipes showed a decrease in drug-resistant cultures and that the wipes reduced MRSA (Methicillin-resistant Staphylococcus aureus) cultures in intensive-care units. MRSA infection is caused by a type of staph bacteria that’s become resistant to many of the antibiotics used to treat ordinary staph infections.

According to the study, “Daily bathing with chlorhexidineimpregnated washcloths significantly reduced the risks of acquisition of MDROs (multidrug-resistant organisms) and development of hospital-acquired bloodstream infections.”

Others have questioned the way the study was conducted and the possible risks of using chlorhexidine every day. Among concerns was whether antibiotic-resistant bacteria could also develop a resistance to chlorhexidine.

Reuters said the Sage wipes are approved by the FDA for cleaning skin before surgery but not for universal daily bathing.

However, it said the company can advise medical practitioners about such an off-label use, leaving it up to them to decide whether to use the wipes for off-label purposes.

A federal lawsuit in 2014 against Sage, by a fired employee, alleged the company was involved in off-label marketing by attempting to get researchers and others to promote daily bathing of patients. The suit was settled last year but terms weren’t disclosed, Reuters said. It said Stryker issued a written statement saying “Sage denied and continues to deny the allegations brought forth in the suit.”

Leapfrog Group Issues Spring Hospital Safety Grades

W

ashington, D.C. – The Spring 2017 Leapfrog Group Hospital Safety Grades rankings show that national hospital acquired infection rates have been declining steadily, according to a CaliforniaHealthline.org article.

The Leapfrog Group, an employer-backed nonprofit, collects and ranks U.S. hospitals on patient safety measures such as medical errors and hospital acquired infections. The school report card-style rankings (A, B, C, D or F) are based on tabulations performed by top patient safety experts. The information is peer reviewed, fully transparent and free to the public. Erica Mobley, a Leapfrog spokeswoman, said the group’s methodology compares all hospitals to each other on a national scale, so a mix of factors may be responsible for lower scores statewide.

In the past five years, the Leapfrog rankings have shown that U.S. hospitals have made strides in improving patient safety, including: a 21 percent decline in hospital acquired conditions, increased adoption and improved functionality of computerized physician order entry systems, and millions of averted patient harms.

Of more than 2600 U.S. hospitals participating, 63 have achieved an “A” in every scoring update of the Leapfrog Hospital Safety Grade since its inception.

Significant data in the most recent report published this April: •

823 scored an “A,” 706 scored a “B,” 933 scored a “C,” 167 scored a “D” and 10 scored an “F”

•

the highest percentage of “A” hospitals this spring are Maine, Hawaii, Oregon, Wisconsin and Idaho

•

Maine is the only state to sustain its ranking as one of the top five states in percentage of “A” graded hospitals since the Safety Grade began in 2012

Some performance measures are risk-adjusted for patient severity and income so hospitals aren’t penalized for admitting sicker, poorer patients.

Medicare posts star ratings for hospitals nationwide, another resource for patients and policymakers.

www.a-solutionsinc.com summer 2017

HEALTHCARE ENVIRONMENTAL SOLUTIONS news

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Copper-infused Sheets – Cutting Edge Infection Control

C

harlottesville, VA – After participating in several studies using copper-infused linens, textiles and other products at its CarePlex, Lehigh and Norfolk General hospitals, Virginia’s Sentara Healthcare system has committed to placing the antimicrobial sheets on most of the beds at Martha Jefferson facility starting in April.

According to a Pilotonline.com article, study findings presented last fall at a conference of the Infectious Disease Society of America showed an 83 percent decrease in Clostridium difficile with use of the copperinfused countertops and bed linens. Also, there was a 78 percent decrease in drug-resistant infections, such as methicillin-resistant Staphylococcus aureus, or MRSA, when compared to a control group.

Sentara Healthcare became an early adopter of the innovative products when the institution was approached by two Virginia companies: Norfolk-based EOS Surfaces LLC and Richmond-based Cupron Inc. EOS makes countertops, bathroom sinks, bedside tables and bed rails with a copper product that’s been certified as antimicrobial by the Environmental Protection Agency. Cupron, Inc. produces copper-infused bed linens, thermal blankets, patient gowns, towels and washcloths.

When Sentara Lehigh built its new West Tower in 2015, EOS and Cupron supplied copper-infused countertops, over-the-bed tables, bed rails, and textiles ranging from bed linens to patients gowns. All 250 of the hospital’s patient rooms in the new tower became part of a 10-month trial.

The trial was a retrospective study and did have certain limitations, according to Sentara. Different types of patients in the comparison groups and the tower with the copper products was newer with larger rooms than the control wing in a 1970s-era section of the hospital. According to an outside validator, however, the data derived from the trial was significant and it built on smaller studies showing the same positive impact of copper-infused products.

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News Briefs

Georgia Company Denied Permits for Medical Waste Facility

M

acon-Bibb County, GA – Plans to build a medical waste facility here were nixed by the County Planning & Zoning Commission, according to a Macon.com article.

Medsafe, a locally owned company, applied for a conditional use permit to construct the 10,000-square-foot facility that would use autoclave sterilization. Plans also included a 10,000-square-foot addition.

Despite Medsafe’s plans for fencing and continuous staffing and assurances of safe operation, the Macon-Bibb zoning commission delayed a final decision. In their review, members of the commission questioned plans for on-site storage of medical waste in truck trailers and ultimately sided with local residents who opposed the project.

At a public hearing in March, neighboring property owners voiced concerns and opposition to the proposed facility, citing a negative impact on real estate values and increased truck traffic, which would have numbered up to eight tractor-trailers a day, according to Medsafe’s permit application.

The medical waste facility would have employed a staff of five.

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Joint Commission Hospital Inspections Spark Model Behavior, Researchers Say

S

tudy findings published in the Journal of American Medical Association draw a correlation between lower 30-day patient mortality rates and surprise quality inspections conducted by The Joint Commission(TJC).

A team of researchers from Harvard Medical School, Partners Healthcare and the National Bureau of Economic Research used Medicare Provider Analysis and Review (MedPAR) data from 2008 to 2012 to see if there was any correlation between hospital caregiver behavior during TJC visits and patient mortality rates. During TJC visits, nurses, doctors, students and other staff are observed by inspectors, and they are most likely to follow best practices for patient safety and care quality.

To increase accuracy and avoid inputs skewed by national holiday timeframes and fluctuating staff, the team ran their calculations using randomization and replication methodologies. They crunched statistics for more than 244,000 admissions during 3417 TJC survey weeks and over 1.4 million admissions in the three weeks before and after a TJC inspection.

The results revealed a “significant reversible decrease in 30-day mortality” for admissions during an inspection compared to non-survey time periods, with large teaching hospitals showing the widest difference between survey weeks and non-survey weeks. At the teaching hospitals, patient deaths within 30 days of discharge declined from an average of 7.21 percent to 7.03 percent, the study authors noted.

During a normal week, unadjusted 30-day mortality averaged 6.41 percent. When the inspectors were onsite, the rate dipped to 5.93 percent.

“At major teaching hospitals, which had the largest relative mortality reduction, given an annual average of more than 900,000 Medicare admissions as defined in this study from 2008 to 2012, an absolute reduction of 0.39 percent in 30-day mortality would translate to more than 3600 fewer mortality events for Medicare patients annually,” they said.

In addition to the mortality rates, the researchers looked at incidences of pressure ulcers, central line associated bloodstream infections, Clostridium difficile infections, post-surgical complications, and in-hospital mortality from cardiac arrest.

The team believes the phenomenon closely resembles the Hawthorne effect, a common observation in the social sciences that research participants change their behavior because of the awareness of being monitored. The team suggested that the findings could help hospitals consider new strategies for improving patient safety.

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HEALTHCARE ENVIRONMENTAL SOLUTIONS news

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News Briefs

Infant MRSA Outbreak in California Prompts Investigation

O

range, CA – The California State Department of Health has wrapped up an investigation into an outbreak of methicillin-resistant Staphylococcus aureus, (MRSA), that had occurred at University of Irvine Medical Center, according to TheState.com and Los Angeles Times articles.

As of early April, the source of the disease had not been established. A Los Angeles Times article first reported the MRSA outbreak, which affected a total of ten infants between December 2016 and March 2017. The infants had been patients in one of the hospital’s two neonatal intensive care units. The infants were isolated and treated in the neonatal intensive care unit (NICU) where the outbreak began last December, while new patients were accepted into the other unit. Five more babies in the same NICU tested positive in January, two in February and one in March. All of the cases were documented and all of the infants survived.

Orange County health officials learned of the infections in the middle of December.

The Times reported that county officials did not make a public announcement because the UCI cases were not considered to be a statistically higher risk than infants admitted to other hospitals. UCI said it notified the state about the infections by letter in early January, but state officials said they never received the letter.

The hospital immediately notified the parents of the babies that had tested positive for MRSA, but also disclosed the MRSA infections to parents of all 2017 News babieshEs in the intensive care units. Meanwhile, the hospital’s infection control director instructed staff to use antiseptic soap and ointment to eliminate bacteria on their skin and in their noses. In January, four hospital employees who tested positive for the same strain of MRSA have since tested negative after using the antiseptic soap, UCI spokesman John Murray told media.

A state inspection report released in April found that the hospital had not violated any federal or state laws.

Daniels Sharpsmart Invokes U.S. Commerce Clause Against State of California

F

resno, CA – Daniels Sharpsmart is suing the state of California in Federal Court over requirements that allegedly restrict the medical waste company’s business, according to a CourthouseNews.com story.

The suit comes after Sharpsmart received letters from California Department of Public Health (CDPH) regarding disposing of medical waste that originated in California but was transported to other states for incineration. Charging that CDPH Medical Waste Management Act requirements are unconstitutional, the company is seeking damages for the increased costs of hauling medical waste outside of California.

According to the CourtNews.com article, California requires biohazardous medical waste to be incinerated at a permitted waste treatment facility, or disposed of through another method approved by the Department of Public Health. Because California did not have an incineration facility capable of treating Sharpsmart’s medical wastes, the company trucked the waste to facilities in other states that did not require incineration, according to the complaint.

Those facilities disposed of the wastes according to the laws of their states.

When Sharpsmart objected to CDPH’s requirements, the state informed the company that California law governs the treatment of medical wastes in Kentucky, Maryland, North Dakota, Alabama, and Indiana, where Sharpsmart had transported the medical waste for disposal. CDPH also fined Sharpsmart $567,000.

To avoid more fines or legal action from California, Sharpsmart says it is taking its medical wastes to incinerators in other states despite the added costs.

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News Briefs

Disinfection Strategies – How Much Difference Can They Make?

C

leveland, OH – A year-long experiment conducted to assess the correlation between thorough cleaning of high-touch surfaces and reduced hospital acquired infections may lead preventionists to reevaluate infection control strategies.

Findings presented at The Society for Healthcare Epidemiology of America (SHEA) spring conference compared disinfection methods used to kill vancomycin-resistant Enterococcus (VRE) and/or MRSA and Clostridium difficile (C. diff.). Where all three bacteria were present, the tested methods had no significant impact on C. diff. The study was led by Curtis J. Donskey, MD, professor of medicine at Case Western Reserve University School of Medicine, and hospital epidemiologist at the Louis Stokes Veterans Affairs Medical Center in Cleveland, Ohio.

While other investigators have linked cleaning techniques with reduced C. difficile cases, the Donskey study showed strikingly different results. The 12-month randomized trial compared two cleaning methods – enhanced and standard – at seven acute-care hospitals vs. standard cleaning in eight control hospitals.

In the enhanced method, an intervention strategy used fluorescent markers in CDI and non-CDI rooms to monitor thoroughness of the environmental services staff. Feedback was provided to both the environmental services and infection control staffs. Based on the removal of the fluorescent markers, researchers were able to observe that the intervention method significantly increased cleaning thoroughness. The intervention strategy also improved the effectiveness of disinfection based on reduced recovery of C. diff. and vancomycin-resistant Enterococcus (VRE) and/or MRSA from high-touch surfaces in the CDI rooms.

However, no impact on the incidence of health care-acquired CDI was seen.

Donskey and his colleagues noted that their results were consistent with another recent randomized trial conducted by Duke University researchers, where the added use of ultraviolet disinfection devices in CDI rooms was not associated with a reduction in CDI in comparison to the use of bleach alone.

Skyrocketing Hospital Costs Consider What is Thrown Away

A

s politicians argue about health insurance and the rising costs of health care in the United States, a 2012 National Academy of Medicine (NAM) study estimated the U.S. health care system literally was tossing away $765 billion a year, a ProPublica article reports.

The annual waste, according to the NAM study, could have paid for the insurance coverage of 150 million American workers. The amount includes both the employer and employee contributions.

The ProPublica article highlights a 15,000-square-foot warehouse outside of Portland Maine run by the nonprofit, Partners for Health.

The building is filled with hospital cast-offs: surplus supplies such as catheters and feeding bags in unexpired sealed packages, as well as perfectly functional medical devices and equipment.

The warehouse has, for example, an ultrasound machine ($25,000), Infant Warmer ($3,995), Miltex Hegar Uterine Dilators ($40 each), AirFlow Manual Resuscitator/Ventilator (about $26), Covidien HET Bipolar Forceps (about $299) and more equipment totaling about $20,000 in value.

Last year, Partners sent seven containers overseas with an estimated value of $250,000. According to a U.S. News article, a similar nonprofit based in Georgia, MedShare, “sent 156 containers, each amounting to as much as $175,000 of cast-off medical goods to hospitals in developing countries.”

For hospitals, equipment and brand new packages of gauze, tubing, needles, sterile saline, diapers and other supplies are part of the cost of doing business. The expenses are charged off to insurance companies, and ultimately, patients.

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BD to Acquire Bard for $24 Billion

F

ranklin Lakes/Murray Hill, NJ – BD (Becton, Dickinson and Company), will acquire C. R. Bard, Inc. under an agreement that specifies $317.00 per Bard common share in cash and stock, for a total consideration of $24 billion in a sale that will be finalized next fall pending shareholder and regulatory approvals. Boards of directors of both medical technology companies voted unanimously in favor of the transaction.

According to a BD press release, the combination will create a highly differentiated medical technology company uniquely positioned to improve both the process of care and the treatment of disease for patients and healthcare providers. The transaction will build on BD’s leadership position in medication management and infection prevention.

Bard’s vascular access segments, PICCs (peripherally inserted central catheters), midlines and drug delivery ports, will complement BD’s leadership and innovation in IV drug preparation, dispensing, delivery and administration.

Other advantages include expansion of BD’s leadership in infection prevention, and enhanced capability to address 75 percent of the most costly and frequent healthcare associated infections (HAIs). The new company is expected to offer more comprehensive, clinically relevant solutions to address Surgical Site Infections (SSIs) and catheter-related bloodstream infections (CRBSIs), as well.

The addition of Bard’s R&D capabilities is expected to increase BD’s opportunities in fast growing clinical areas, including peripheral vascular therapy, oncology and bio-surgery while Bard’s portfolio of clinical offerings will create more meaningful scale and relevance for BD in high-growth categories of oncology and surgery. Additionally, Bard will expand BD’s focus on the treatment of disease states beyond diabetes to include peripheral vascular disease, urology, hernia and cancer.

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summer 2017

News Briefs

Hospital Floors Recognized as Infection Risk

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A

rlington, VA – Hospital room floors may be an overlooked source of infection, according to a study published in the March issue of the American Journal of Infection Control, the official journal of the Association for Professionals in Infection Control and Epidemiology (APIC). Because items in the patient’s room may touch the floor, pathogens on hospital floors can rapidly move to the hands and high-touch surfaces throughout a hospital room.

“Understanding gaps in infection prevention is critically important for institutions seeking to improve the quality of care offered to patients,” said 2017 APIC president Linda Greene, RN, MPS, CIC, FAPIC. “Even though most facilities believe they are taking the proper precautions, this study points out the importance of ensuring cleanliness of the hospital environment and the need for education of both staff and patients on this issue.”

In the study by Abhishek Deshpande, MD, PhD and colleagues, researchers cultured 318 floor sites from 159 patient rooms (two sites per room) in five Cleveland-area hospitals. The hospital rooms included both C. difficile infection (CDI) isolation rooms and non-CDI rooms. Researchers also cultured hands (gloved and bare) as well as other high-touch surfaces such as clothing, call buttons, medical devices, linens, and medical supplies.

The researchers found that floors in patients’ rooms were often contaminated with Methicillin-resistant Staphylococcus aureus (MRSA), VRE, and C. difficile, with C. difficile being the most frequently recovered pathogen found in both CDI isolation rooms and non-CDI rooms.

Of 100 occupied rooms surveyed, 41 percent had one or more hightouch objects in contact with the floor. These included personal items, medical devices, and supplies. MRSA, VRE, and C. difficile were recovered from 6 (18 percent), 2 (6 percent), and 1 (3 percent), respectively of bare or gloved hands that handled the items.

“Efforts to improve disinfection in the hospital environment usually focus on surfaces that are frequently touched by the hands of healthcare workers or patients,” said Deshpande, et al in the study findings.

“Although healthcare facility floors are often heavily contaminated, limited attention has been paid to disinfection of floors because they are not frequently touched. The results of our study suggest that floors in hospital rooms could be an underappreciated source for dissemination of pathogens and are an important area for additional research.”

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Mixed Reactions to Proposed Medical Waste Transfer Station

W

ebster, MA – A family-run waste management company wants to locate a 49-tons-per-day transfer station for medical waste in Webster, but some residents and city officials are uncertain about the idea, according to a Telegram.com report.

United Medical Waste Management of Sutton would accept 9,800 tons per year (up to 49 tons per day) at the proposed site that is located near two commercial businesses. Last fall, the company’s plans received a nod from the state Department of Environmental Protection.

Concerns by residents and some town officials, however, surfaced on social media and at a public hearing in March. The medical waste, which is to include sharps and garbage from dentists, vets and doctor offices, would arrive in vans, and stored for later pick up by semi-trucks. It would be stored in plastic bags and boxes.

The company, which operates five route trucks and three 50-foot trailers handles more than 50 percent of the nursing home volume for New England, according to the owners. Waste generators are trained to properly package and manage the waste until the company picks it up and takes it to a transfer station in Haverhill. It is then transported to the mid-Atlantic. By building the transfer station in Webster, the company would no longer have to use the Haverhill station. summer 2017

HEALTHCARE ENVIRONMENTAL SOLUTIONS news

11

News Briefs

Hospitals Save Millions by Going Green

C

leveland, OH – Sustainable initiatives, such as those at the Cleveland Clinic, are helping U.S. hospitals reduce their environmental footprints – and save money, according to a HealthCareFinanceNews.com article.

The Cleveland Clinic shifted to a zero waste contract with their office equipment supplier.

For one thing, the Clinic has been saving on ink costs by switching printer/scanner/copier settings to double-sided. So far, according to Jon Utech, director of the Clinic’s Office for a Healthy Environment, the move has saved $250,000.

The big news is the $6 million a year the Clinic has saved in energy costs, Utech says.

As the hospital converts to energy-efficient, LED lighting, lighting costs are expected be reduced by about $3 million a year. Utech says the the Clinic has committed to a 20 percent reduction in energy usage per square foot for their buildings and has achieved 12 percent so far.

The Clinic has saved millions in waste reduction initiatives, as well.

Data from the U.S. Energy Information Administration illustrates that buildings are responsible for almost half of the energy consumed and 38 percent of all greenhouse gas emissions in the United States. According to the advocacy group Practice Greenhealth, hospitals are the second greatest commercial energy user behind commercial food services, emitting roughly 8 percent of the country’s greenhouse gas emissions. The group says hospitals produce more than 4.67 million tons of waste every year and use 7 percent of the country’s commercial water supply.

Operating rooms consume 30 percent of the supplies for the entire hospital. Practice Greenhealth says hospitals can save $25,000 per room by reformulating kits and unused tools, medical device reprocessing, adjusting temperature and light controls and other energy-efficient practices.

By partnering with its utility company, Minnesota-based HealthPartners has received more than $460,000 in rebates over the last five years and has saved about $1.3 million through energy-efficient equipment installed over the same period.

HealthPartners saved another $1 million last year with operating room initiatives, such as single-use device reprocessing, reusable containers, reusable fluid management systems and recycling “hard-to-recycle” plastics.

Town Discovers a Ton of Medical Waste in Sewer System

M

ahoning, PA – According to TheDailyItem.com, Water and Sewer Department employees discovered medical waste in Mahoning Township’s wet well this spring.

Needles, catheters, rubber gloves and paper towels – estimated to be nearly a ton – floated to the top of the holding tank that holds untreated sewage before it flows out to the area’s waste treatment plant.

Wet wells are the holding sump for gravity flow sewer systems. As sewage enters the well, the water level rises and pumps are engaged to pump out the sewage to a forced main. In some systems, sewage is lifted to a higher grade to continue the gravity flow to the outlet point.

Town officials told reporters the origin of the waste was unknown, but they would be sending out letters to healthcare facilities to inquire. One guess is that the waste was coming from a private residence where someone is undergoing medical care at home.

The township’s wet well, about 8 feet in diameter, is cleaned out about every five years. The waste was vacuum removed and sent to a medical waste facility.

Read more online at www.HealthcareEnvironmentalSolutions.com

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HEALTHCARE ENVIRONMENTAL SOLUTIONS news

summer 2017

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News Briefs

G

rayson, KY – According to Journal-Times.com, a suit brought by a concerned resident to halt construction of a medical waste facility in northeastern Kentucky has employed a unique tactic – citing the county’s landfill ordinance rule against hazardous waste.

Plaintiff, Scott Stewart, filed the temporary injunction suit in Carter Circuit Court, along with an affidavit from the county’s former coroner. The affidavit describes possible health and environmental safety dangers that could result from the facility’s operations including: “release of odorous emissions, improper handling, storage, disposal or transportation and treatment of the waste.”

Medical Waste Services, Inc., submitted applications for zoning permits at two locations. The first site selection met with opposition. In February, Carter Fiscal Court voted 3-2 to allow a site permit for the company to operate at another site. The company has repeatedly denied that harmful or odorous emissions would be released as a result of its sanitation procedures.

St. Louis University Researchers Predict Zika on the Mississippi Delta

S

t. Louis, MO – Researchers at the Saint Louis University (SLU) say the Zika virus may be prevalent on the Mississippi delta this year, according to an slu.edu article.

In an SLU American Journal of Public Health article, the scientists also listed the City of St. Louis and St. Clair County, Illinois, as high risk areas for transmission of Zika infection.

“The purpose of this study was not to create unwarranted alarm, but rather to enhance Zika prevention methods such as mosquito control, effective prevention message dissemination, and treatment and care preparation, in advance of a Zika epidemic in the contiguous U.S.,” said Enbal Shacham, Ph.D., M.Ed., associate professor of behavioral science and health education at Saint Louis University and the lead author of the study.

Zika poses the most serious threat to unborn babies who may die or develop devastating birth defects, such as brain damage, after their mothers contract Zika during pregnancy.

Shacham and her collaborators studied 3,108 counties in the U.S. They determined 507 “high risk” areas for Zika transmission based on several factors: the presence of Aedes aegypti mosquitoes; high rates of sexually transmitted infections (STI), which is an established surrogate marker for unprotected sex that leads to Zika virus spread; number of women of child-bearing age; and an estimate of birth rates for each county.

It is unclear if sexual transmission of Zika occurs 100 percent of the time; therefore, the researchers projected three different models of transmission risk: 70, 85, and 100 percent risk based on the data-driven model.

Assuming that Zika is transmitted in 70 percent of the cases of STIs, the researchers estimate between 300,000 to 41.7 million people from highrisk counties could be more likely to contract Zika than individuals who live in other counties in the U.S. Of those at potential higher risk, between 3,700 and 632,000 may be pregnant women, the highest at-risk group.

“Our results also show that complications from the Zika virus are likely to overlap with impoverished counties with large minority populations where resources are more likely to be scarce to combat a large-scale Zika virus outbreak,” Shacham said.

Shacham suggested developing intensive interventions to prevent infection as well as treatment and care plans for families with affected newborns in higher risk areas.

“Enhanced vector control, Zika surveillance, and clinical management in these higher-risk areas will be critical for reducing the impact of a sustained Zika virus outbreak that may potentially occur particularly among economically challenged populations and communities that are least equipped to handle an outbreak,” Shacham added.

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News Briefs

Scientists Demonstrate How Technology Can Help Stop Deadly Virus Outbreaks

Biofilm Disruption Study Reveals New Way to Treat Bacterial Infections

S

F

eattle, WA – An international team of 96 scientists from 60 institutions in 18 countries contributed to a new study that shows how real-time genome sequencing and data-sharing can be effective in containing outbreaks of deadly viral disease. The findings were published in the journal Nature.

By reviewing the entire database of the West African Ebola virus genomes, the team gained valuable insight into the epidemic that affected more than 28,000 people, killing more than 11,000 of them. The data allowed the scientists to spot factors, such as mobility between cities – and the distances between those cities – that sped or slowed the disease between 2013-2016. Other variables, such as shared languages, economic output and climate were not found to have significant impacts on transmission of the disease.

“We calculated that 3.6 percent of cases traveled, basically meaning that if you were able to focus on those mobile cases and reduce their mobility, you might have had a disproportionate effect on the epidemic,” said computational biologist Dr. Gytis Dudas, a Mahan Postdoctoral Fellow at Fred Hutchinson Cancer Research Center in Seattle, Washington. Dudas is the paper’s lead author.

Using genome sequencing for synthesizing that information with data on population size, travel distances, geography, language and other factors can effectively pinpoint which factors influence an epidemic’s spread and duration — and where to target treatment and interventions, the team found. Cutting edge sequencing equipment and methodologies have contributed to time and cost efficiencies that were impossible in the past. Basically, it is much easier to sequence an entire viral genome today and get the word out.

The 1,610 Ebola virus genomes analyzed by the researchers represented more than 5 percent of the known cases, the largest sample analyzed for a single human epidemic. The analysis is the first to look at how Ebola spread, proliferated and declined across all three countries most affected: Guinea, Sierra Leone and Liberia. Previous analyses focused primarily on either a single country, a limited time frame or used fewer sequences.

Many of the scientists involved with the project had worked on earlier papers as clinicians gathering blood samples, researchers doing genome sequencing or analysts drawing on portions of the dataset. Dudas and senior author Dr. Andrew Rambaut of the Institute of Evolutionary Biology at Scotland’s University of Edinburgh were involved in the analyses for many of those efforts.

Border closure dates correlated with reducing the spread of the virus between regions, containing it within some of the countries, analysis showed. But by the time Sierra Leone, Liberia and Guinea closed their borders, cross-border travel had already seeded outbreaks in each country, the researchers found. Though international traffic of viruses was reduced after the closures, it didn’t stop completely.

Previous genome analyses traced the epidemic’s origin to December 2013, when a two-year-old who had been playing near a bat-filled tree died in a small village in the southeastern part of Guinea. It took until March 2014 for hospital workers to detect and report the spread of a disease with an unusually high death rate. By later that month it was identified as Ebola.

Getting scientists to share data remains a challenge. Despite the precedent set by the response to the Ebola epidemic, Bedford and Dudas point out that fewer researchers have shared Zika virus genomes from the more recent crisis in Brazil, Central America and the Caribbean. In part, they said, that may be because the Zika virus is more difficult to sequence than Ebola, making researchers more prone to guard their rare sequences for publication.

14

HEALTHCARE ENVIRONMENTAL SOLUTIONS news

ort Lauderdale/Davie, FL – Seeking new ways to combat antibiotic-resistant infections, a team of researchers at Florida’s Nova Southeastern University (NSU) literally has been shaking up bacteria, according to a NSUNews. edu article.

The NSU team, along with researchers from Duke University and the University of Minnesota, have been looking at how bacteria – in this case, a strain of Escherichia coli – better known as E. coli – lives and behaves. Observing the biofilm in which the bacteria live is providing new insights on ways to halt the proliferation that causes infections.

Led by NSU graduate Cortney Wilson, Smith’s lab recently discovered that “shaking the house that the bacteria have built,” affects the ability of the bacteria to talk to one another.

“We found that shaking the bacteria forced them to face a decision; do they want to grow, or do they want to cooperate,” Smith said. “And if we shook them at just the right frequency, we created enough confusion that the bacteria could do neither effectively.”

Smith notes that this strategy of preventing bacteria from talking to one another has promise in reducing the need for antibiotics. The team of scientists hope to begin testing their theory in more species of bacteria, and eventually in mice.

Study Finds Fault with Methodology Used for Hospital Safety Grades

A

nn Arbor, MI – According to a ScienceDaily.com article, findings published in the journal Medical Care show that surveys and report card-type grading systems used to rank hospitals on patient safety measures have some drawbacks.

University of Michigan researchers reviewed the Hospital Safety Grade system, run by The Leapfrog Group and found that the surveys differ from independent reviews. For one thing, the rankings do not take into account sanctions for high infection or readmission rates. What’s more, the surveys may not reflect normal, day-to-day practice in the hospitals.

“The Safe Practices part of the Hospital Safety Grade is based on whether a hospital self-reports that it has adopted certain protocols, and not whether those protocols are actually followed,” says Jennifer Meddings, M.D., M.Sc., the study’s senior author and an assistant professor of internal medicine at the U-M Medical School.

The researchers noted that the Leapfrog organization has implemented some improvements to its survey methodology. A new formula will be used for the Fall 2017 hospital rankings.

The Hospital Safety Grades program combines survey response data from participating hospitals, as well as data sourced from the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention. For hospitals that do not participate in its hospital survey, Leapfrog calculates grades using publicly-available measures only.

Shawna Smith, Ph.D., the study’s lead author, explains, “Hospitals that have less-than-perfect performance on Leapfrog’s list of protocols get a big hit to their grade, but those with most or all protocols in place are rewarded very little. Our simulations show that some hospitals would have had better grades when they didn’t report than when they reported imperfect compliance.” Smith is a U-M Internal Medicine statistician and Institute for Social Research postdoctoral fellow.

This disincentive also creates a problem for moving hospitals forward on safe practices. “One of the principles of promoting safe practices is to ensure that hospitals are comfortable reporting that they still have work to do,” says Meddings, a member of U-M’s Institute for Healthcare Policy and Innovation who also holds a position at the VA Center for Clinical Management Research.

Meddings added, “The Leapfrog approach was really cutting edge when it first came out, and started an important movement, but Leapfrog relies in part on process measures which can ‘top out’ as a new process becomes widely adopted.

It’s time to have a new discussion about how to measure new metrics and use them in innovative ways to evaluate hospitals.”

summer 2017

News Briefs

Explosion of Virginia Medical Waste Facility Cleanup Continues

P

etersburg, VA – Cleanup has continued at a medical waste services building in Petersburg, following a March explosion that injured three when a building collapsed, according to a WTVR news report.

The cause of the explosion at Curtis Bay Medical Waste Services was unknown in April. Investigation by federal, state and local officials was stalled until a three-phase safety cleanup could be completed.

Petersburg Fire Chief Brian Sturdivant told media that the preliminary investigation indicated an explosion in the boiler room, but access to that area was delayed until cleanup crews could finish in that area.

More than 30 local, state and federal officials, including the Department of Environmental Quality, toured the inside of the facility as part of the investigation.

“Environmental Quality wants to ensure that whatever the contaminants may be, they are contained to the site and there’s no impact to local water ways or environmental issues,” said Sturdivant.

Sturivant explained to reporters that the entire building may have to be demolished and that Curtis Bay Medical Waste Services wants to re-build on the same site.

Veteran’s Administration Transparency Policy Reveals Hospital Infection Rates

C

hicago, IL – According to the numbers posted on the Veterans Administration’s newly launched patient access website, two Chicago-area V.A. hospitals compare poorly with a dozen private-sector facilities for catheter-associated urinary tract infections, ChicagoBusiness.com reports.

The posted rates for catheter-associated urinary tract infections at Edward Hines Jr. VA Hospital and Jesse Brown VA Medical Center are double the national average (0.86), and much higher (1.79) than all of the non-veterans hospitals in the area. Central Line Associated Bloodstream Infections were lower than the national average and higher (.65) than all but five of non-veterans hospitals.

Neither hospital reported rates of clostridium difficile (C. diff) or methicillin-resistant Staphylococcus aureus (MRSA), infections reported by most of their private peers.

The V.A. developed the Access to Care website to provide patients and caregivers more transparency and accountability. Centers for Medicare and Medicaid Services (CMS) Hospital Compare also provide patient care comparisons. Hospital Compare provides information on over 4,000 Medicare-certified hospitals across the country.

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VOL. XIII NO. 2

summer 2017

TOP STORIES Industry-Funded Research for Antibacterial Products: Boon or Bane?

PAGE 1

Copper-infused Sheets – Cutting Edge Infection Control

PAGE 6

Skyrocketing Hospital Costs Consider What is Thrown Away

PAGE 9

Hospital Floors Recognized as Infection Risk

PAGE 11

Hospitals Save Millions by Going Green

PAGE 12

Scientists Demonstrate How Technology Can Help Stop Deadly Virus Outbreaks

PAGE 14

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