Healthcare Environmental Solutions Summer 2019 by Downing and Associates

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

VOL. XII XV NO. NO. 42 VOL.

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summer 2019 WINTER 2016

Baltimore Oversteps Authority to Regulate Incinerators out of Business, Suit Says

n early April, Maryland’s General Assembly passed the Clean Energy Jobs Act, which mandates that half of the state’s power come from renewable sources by 2030. Over the objections of some environmental activists and others, the act, which became law without the governor’s signature in May, retained trash incineration as an eligible “Tier 1” source of renewable power. Meanwhile, a month before the Clean Energy Jobs Act passed the General Assembly, then Baltimore Mayor Catherine Pugh signed the Baltimore Clean Air Act, which, according to a subsequent lawsuit, threatens to regulate the city’s two incinerators – including a medical waste facility - out of business. “When the (Clean Energy Jobs Act) was written, we didn’t know Baltimore was going to do what they did,” said Frederica Struse, spokesperson for State Sen. Brian Feldman (D-Montgomery), sponsor of Maryland’s Clean Energy Jobs Act. “It became a moot point, didn’t it?” Curtis Bay Energy LP, which operates the largest dedicated Hospital/Medical/Infectious Waste Incineration (HMIWI) facility in the U.S., is among the plaintiffs in the lawsuit that seeks to invalidate the Baltimore Clean Air Act. Wheelabrator Baltimore LP, a waste to energy plant that processes much of the city’s municipal solid waste, is the other lead plaintiff.

By Ken McEntee

Both facilities stand to be shut down by the “imposing extraordinarily low emission limits and other mandates that the city has no authority to require,” according to the suit, which was filed on April 30 in U.S. District Court for the District of Maryland. “The act – supported by no legislative factfinding and the thinnest of records – targets Wheelabrator Baltimore and Curtis Bay with the intent of driving them from business in an arbitrary and capricious manner and in a remarkable display of legislative hubris,” the lawsuit says. The suit charges that the city doesn’t have the authority to regulate air emissions, which are

regulated by state governments by authority of the federal Clean Air Act. It further suggests that that the city’s real aim is not to clean the air, but rather to pursue an “agenda to close the (incineration) facilities regardless of consequence to residents and businesses in Baltimore City and beyond.” “The (Baltimore Clean Air Act) is not a good faith effort to regulate air emissions,” the lawsuit says. “Rather it is a targeted attempt to shut down two specific facilities, ignoring all other stationary and mobile sources of air emissions in the city.” According to the suit, Wheelabrator - not Curtis Bay - is the primary target. “Baltimore City Councilman Edward Reisinger, who sponsored the (Baltimore Clean Air Act), stated that it is specifically intended to ‘shut down Wheelabrator’ and declared that ‘(Wheelabrator’s) got to be closed,” the suit says. However, should Curtis Bay be shut down, it would restrict the options for processing about 25,000 annual tons of medical waste the amount processed by the facility last year. “There are not a lot of medical waste incinerators in the country,” said Anne Germain, of the National Waste & Recycling Association (NWRA), a Washington, D.C.based trade association that has joined the lawsuit as a plaintiff. “That’s part of the reason

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Baltimore Oversteps Authority to Regulate Incinerators out of Business, Suit Says

Continued from page 1

why we were concerned about the actions being taken in Baltimore.” However, Germain acknowledges, most medical waste can be autoclaved, rather than incinerated. “It is just a very small subset that needs to be incinerated, and that would have to be done a far distance away (if Curtis Bay closed down),” she said. Bob Spurgin, of Irvine, Calif.-based Spurgin & Associates, a medical waste consulting firm, said the three constituents within medical waste that require destruction by combustion or pyrolysis are trace chemotherapy items, pathological tissue and non-hazardous pharmaceuticals. Additionally, he said, the U.S. Drug Enforcement Administration (DEA) specifies that the only method of rendering controlled substances, such as opiates and narcotics, is incineration. Such pharmaceuticals are regulated as hazardous waste. Germain said hazardous waste pharmaceuticals must be burned at a hazardous waste incinerator, not at a medical waste incinerator.

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

PUBLICATION STAFF Publisher / Editor Rick Downing Contributing Editors / Writers Ken McEntee Sandy Woodthorpe Production & Layout Barb Fontanelle • Christine Mantush 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. Healthcare Environmental Solutions news (ISSN #1557‑6388) is published quarterly by Downing & Associates. Reproductions or transmission in whole or in part, without written permission of the publisher, is prohibited. Annual subscription rate U.S. is $19.95. Outside of the U.S. add $10.00 ($29.95). Contact our main office, or mail-in the subscription form with payment. ©

Still, Spurgin said, “There are alternative treatment methods for medical waste but none that completely supplant incineration or pyrolysis.” He said about 10 percent of the regulated medical waste stream needs to be incinerated. About 90 percent can be autoclaved. “It is clear that incinerators are a necessary part of the disposal process,” he said. In a letter to current Baltimore Mayor Bernard C. Young, who then was president of City Council, Darrel K. Smith, president and CEO of NWRA, asked that the city reconsider its Clean Air Act. Smith argued that combustion has been determined to be the best management practice for a variety of waste streams - such as certain pharmaceuticals. The letter, written before Baltimore passed its Clean Air Act, and before the U.S. EPA published its newly revised Management Standards for Hazardous Waste Pharmaceuticals, said, “U.S. EPA’s forthcoming hazardous waste pharmaceuticals regulations will mandate the combustion of some pharmaceuticals. In addition, the rule will require cessation of sewering of some pharmaceuticals due to concerns about environmental impacts from wastewater discharge. This is why it is not always best to autoclave wastes from healthcare setting. Hazardous materials could be discharged to the sewer system leading to waterbodies.” Smith wrote that the disposal of controlled substances and medications disposed of through take-back events and kiosk programs would suffer from the shutdown of facilities like Curtis Bay. “Incineration is currently the only acceptable form of destruction for these materials, according to the Drug Enforcement Administration (DEA) and the U.S. EPA per new regulations. Such programs which are already costly, could incur increased cost if incineration capacity is further limited,” Smith wrote. An EPA spokesperson, however, said there is ample incineration capacity to burn pharmaceuticals. “Pharmaceuticals constitute a small fraction of the waste that is combusted,” she wrote in an email. “The Regulatory Impact Analysis for the hazardous waste pharmaceuticals final rule estimates that 16,000 to 21,000 tons of hazardous waste pharmaceuticals are disposed of annually by healthcare facilities and reverse distributors. These data only include pharmaceuticals that are regulated as RCRA (Resource Conservation and Recovery Act) hazardous waste. Therefore, the data do not include pharmaceuticals that are not regulated as RCRA hazardous waste, such as household pharmaceuticals.” Another EPA spokesperson said the new “pharmaceuticals rule,” which is scheduled to summer 2019

take effect on August 21, 2019, applies to a relatively small amount of medications. “ T h e r u l e t h at h a z a r d o u s w a s t e pharmaceuticals have to be treated before they can be land-disposed has been around for years and in almost all cases, treatment for hazardous waste pharmaceuticals is incineration,” she said. “That’s for hazardous waste pharmaceuticals that are from a health care facility. The new rule is specifically for take-back pharmaceuticals, such as community take-back events where law enforcement is present, or the take-back bins at places like Walgreen’s.” She said the new disposal rules specify that the recovered pharmaceuticals have to be “treated,” but not “incinerated.” However, she said, incineration is the only treatment currently approved by the DEA. The Curtis Bay facility, which opened in 1991, accepts medical waste generated by hospitals, doctors and dentists, nursing homes, emergency responders, medical research facilities, veterinarians and pharmaceutical manufacturers within Baltimore and the surrounding region. Medical waste generators within the city alone produce almost 11,000 tons of medical waste annually, most of which is disposed of at Curtis Bay. The facility is permitted to incinerate a maximum of 150 tons of medical waste per day in its two incinerator units. The processed medical waste is rendered safe for disposal at a sanitary landfill as ash. The lawsuit claims that the city of Baltimore, through its Clean Air Act, intentionally set air emission regulations so stringent that that Wheelabrator and Curtis Bay would be unlikely to meet them - at least without a a prohibitive cost to comply. Further, the suit says, the city does not have legal authority to regulate air emissions. Curtis Bay’s emission are regulated by the Clean Air Act, through EPA emission guidelines for HMIWI facilities, which were last revised in 1997 and formally adopted in May 2013. The suit cites EPA sources that say 2,400 HMIWI facilities operated in the U.S. prior to the guideline revision. Following the revisions, by 2008, that number dropped 98 percent, to 57 facilities. The Clean Air Act requires EPA to establish health based National Ambient Air Quality Standards, which individuals states then regulate through State Implementation Plans (SIPs). The lawsuit notes that EPA most recently approved Maryland’s SIP in 2017 following a public rule making process that sought input from local governments, including the city of Baltimore. The city didn’t participate in meetings, nor did it offer written comments relating to the proposed SIP.

Continued on page 4

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Baltimore Oversteps Authority to Regulate Incinerators out of Business, Suit Says Continued from page 3 Further, the lawsuit says, the city also did not request that the state adopt stricter emission guidelines for regulated HMIWI facilities specifically Curtis Bay - which operated within city limits “as it is permitted to do” under state law. Ironically, Curtis Bay’s most recent five-year Title V operating permit under the federal Clean Air Act went into effect on May 1, 2019 - less that two months after Pugh signed the local legislation that could close the facility down. The permit sets emissions limits for particulate matter, opacity, carbon monoxide, dioxins and furans, hydrogen chloride, sulfer dioxides, nitrogen oxides, lead, cadmium and mercury. Curtis Bay, the lawsuit says, meets federal guidelines and state limits for all of those. “These are the emissions limits that EPA and the Maryland Department of the Environment (MDE) have independently determined, after rigorous scrutiny, are the best achievable protective of human health and the environment,” the suit says. The Baltimore Clean Air Act sets limits that are, in some cases, significantly lower. For example, federal and state limits and Curtis Bay’s Title V permit limitations for nitrogen oxides is 140 ppmvd (parts per million volumetric dry). The Baltimore Clean Air Act places a limit of 45 ppmvd. In January 2018, after Curtis Bay applied to MDE for the permit that went into effect in May, nobody, including the city of Baltimore, provided a comment during the public notice period, the lawsuit says. When the permit was released in April, the city could have made a request for stricter emissions limits but didn’t. “The city made no such effort to shape emission limits under the new Title V permit, an issue it now claims is a priority that requires action by and through the (Baltimore Clean Air Act),” the lawsuit says. “This failure by the mayor and the city to use these well-established opportunities to effect a present reduction in emissions from the Curtis Bay Facility demonstrates that the city’s intent and goal with the act was not to reduce emissions from the Curtis Bay Facility to levels less than currently permitted, but instead an attempt to utilize the legislative process to force the facility to close.” In addition to NWRA, TMS Hauling LLC, a Baltimore hauler that delivers municipal solid waste to Wheelabrator, and the Arlington, Va.based Energy Recovery Council, also have joined the lawsuit as plaintiffs. The court in May granted the city an extended deadline of July 22, 2019 to respond to the lawsuit. Neither the city’s Law Department nor Councilman Reisinger responded to calls to discuss the suit. 4

UK Study: Insects in Hospitals Identified as Vectors for HAI

ccording to study findings published in Journal of Medical Entomology, researchers who collected nearly 20,000 flies in seven British hospitals found a high percentage of the insects to be carrying Enterobacteriaceae, Bacillus spp., Staphylococcus spp. and other bacterial strains. The study, which was conducted by investigators from Aston University, in Birmingham, listed Diptera species as the most abundant (73.6 percent of the total), followed by Hemiptera or “true bugs,” such as aphids (13.9 percent). Much smaller numbers of Hymenoptera, which includes ants, wasps and bees (4.7 percent) and Lepidoptera or moths (2.9 percent). Coleoptera or beetles made up 2 percent of the catch. The insects were collected from patient rooms, cafeterias, wards, neonatal units, and maternity units. The researchers identified 82 bacterial strains present in Diptera, the majority of which belonged to the Enterobacteriaceae which includes E. coli and Salmonella (42 percent). Next most numerous was Bacillus spp. (24 percent) and Staphylococcus spp. (19 percent). Less abundant were bacteria of the genus Clostridium (6 percent), Streptococcus (5 percent), and Micrococcus (2 percent). A total of 68 bacterial strains were characterized for their antibiotic resistance profile; 52.9 percent demonstrated a resistant phenotype to at least one class of antibiotic. Staphylococcus spp. represented the highest proportion of resistant strains (83.3 percent), followed by Bacillus spp. (60 percent) and Enterobacteriaceae (31.3 percent). Diptera were the predominant flying insects present in the U.K. hospital environments sampled and found to harbor a variety of opportunistic human pathogens with associated antimicrobial resistance profiles. The scientists also found that 53 percent of the isolated strains had developed resistance to at least one class of antibiotics, the drugs most commonly used to fight infections. Of all the antibiotics, penicillin was the least effective against the harmful bacteria that the researchers had identified. Other antibiotics to which many flying insect-borne bacteria had developed resistance included vancomycin and levofloxacin. Given the ability of flies to act as mechanical vectors of bacteria, they present a potential to contribute to persistence and spread of antimicrobial-resistant pathogenic bacteria in the hospital environment, the study authors wrote. Although the risk of insect-carried bacteria spreading to patients is very low, it’s important to take steps to prevent bacteria being brought into hospitals by insects, a co-author said.

Increase in U.S. Hepatitis A Virus Infections

ccording to a Centers for Disease Control news release, reports of hepatitis A infections in the United States increased by 294 percent between 2016–2018, compared with 2013–2015 cases. Most of the cases related to the outbreaks have been associated with contaminated food items, men who have sex with men, and persons who report drug use or homelessness. Hepatitis A virus (HAV) is primarily transmitted fecal-orally after close contact with an infected person. It is the most common cause of viral hepatitis worldwide, typically causing acute and self-limited symptoms, although rarely liver failure and death can occur While the rates of hepatitis A had declined by approximately 95 percent during 1996–2011, CDC saw a spike in 2016–2018 (15,000 reports of HAV infections from U.S. states and territories). Eighteen states had lower case counts during 2016–2018 compared with 2013–2015. Nine states and Washington, DC had an increase of approximately 500 percent. The sharpest percent increases in cases between 2013-2015 and 2016-2018 have been in Arkansas, Hawaii, Indiana, Kentucky, Missouri, Ohio, Tennessee, Utah, West Virginia and the District of Columbia, the report showed. Since 2016, more than 15,000 people reportedly had been infected and 140 had died in connection with hepatitis A, according to the CDC. In the past, outbreaks of hepatitis A virus infections occurred every 10–15 years and were associated with asymptomatic children. With the widespread adoption of universal childhood vaccination recommendations, asymptomatic children are no longer the main drivers of hepatitis A outbreaks. Although the overall incidence rate of HAV infections has decreased within all age groups, a large population of susceptible, unvaccinated adults who were not infected by being exposed to the virus during childhood remain vulnerable to infection by contaminated foods (typically imported from countries with endemic HAV transmission) and recently, on a much larger scale, through behaviors that increase risk for infection in certain vulnerable populations, such as drug use. The CDC recommends vaccinating populations at risk to help control the current increases and prevent future outbreaks of hepatitis A in the United States.

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summer 2019

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New EPA Management Standards for Hazardous Waste Pharmaceuticals Take Effect August 21, 2019

ashington, D.C. – The federal ban on flushing pharmaceuticals down the toilet, rinsing them the sink or other “sewering” methods takes effect on August 21, 2019. The EPA Management Standards for Hazardous Waste Pharmaceuticals released in the Federal Register on Feb. 22, 2019 set sector-specific standards under the Resource Conservation and Recovery Act (RCRA). The final rule spells changes to the storage and disposal of pharmaceuticals by hospitals, pharmacies, dentists, nursing and long-term care (LTC) facilities and clinics. Pharmaceutical

UK Scientists Develop a New Drug Discovery Methodology for Antimicrobials

esearch findings published in the journal ACS Nano describe the new compound which kills gram-negative E. coli, including a multidrug resistant pathogen said to be responsible for millions of antibiotic resistant infections worldwide annually. In the study, “Using Nanoscopy To Probe the Biological Activity of Antimicrobial Leads That Display Potent Activity against Pathogenic, Multidrug Resistant, Gram-Negative Bacteria,” a team of scientists at the University of Sheffield and Rutherford Appleton Laboratory (RAL) have been testing new compounds to fight bacteria strains that can cause infections including pneumonia, urinary tract infections and bloodstream infections. A major challenge in antibiotic research has been effectively penetrating the microbes with drugs. The UK researchers have developed a compound that glows when exposed to light so they can observe its uptake and effect on bacteria using advanced microscope techniques available at RAL. In their study abstract, the study authors point out that membrane damage assays confirm that the complex disrupts the bacterial membrane structure before internalization. Cell culture and animal model studies indicate that the compound toxicity level does not have adverse effects and the scientists think it could be effective in destroying hard-to-treat, multiresistant, Gram-negative bacteria. The Sheffield and RAL studies have shown the compound seems to have several modes of action, making it more difficult for resistance to emerge in the bacteria. The scientists plan to test it against other multi-resistant bacteria.

manufacturers (unless they act as reverse distributors or production facilities) are not affected by the final rule. The new standards eliminate dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances. • The rule maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take back 2019 programs and events, HES 1/2 Page Islandwhile ensuring their proper disposal. 5-7/16” x 7-1/8” • Healthcare facilities receive regulatory •

•

relief for management of hazardous waste pharmaceuticals: Does not count toward generator status, eases labeling and manifesting and clarifies wastes to be shipped to reverse distributors. Nicotine patches, gums and lozenges no longer have to be managed as hazardous waste. The EPA is excluding certain FDA-approved over-the-counter nicotine replacement therapies from regulation as hazardous waste. A new policy is set for regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics.

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North Shore Medical Center Cut c. diff by 55 Percent

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alem, MA – Findings published in the April 2019 issue of The Joint Commission Journal on Quality and Patient Safety describe a four-year quality improvement initiative that reduced hospitalacquired Clostridium difficile infection (C. diff or CDI) at North Shore Medical Center. Of the four areas targeted – environmental services, infection prevention, antibiotic stewardship and emergency department processes – the investigators identified high-risk antibiotics and diagnostics as key areas for improvement. The most significant results were achieved in antibiotic stewardship and diagnostics. CDI declined 55.5 percent, from 12.2 to 5.4 cases/10,000 patient-days. Antibiotics stewardship accounted for a 20.6 percent reduction in hospital-acquired C. diff infections Antibiotic use declined 88.1 percent, from 63.7 to 7.6 days on treatment/1,000 patient-days. Infection prevention measures were the second-most effective intervention, accounting for a 13.0 percent reduction in hospital-acquired C. diff. Starting in November 2013, interventions were made as follows: 1. Environmental services: Housekeeping efforts included cleaning of high-touch surfaces as well as terminal cleaning with bleach and ultraviolet disinfection. 2. Infection prevention: Several measures were introduced to increase staff hand washing with soap and water after caring for C. diff patients, including colorful reminder signs posted on hand sanitizers outside patient rooms and anonymous observers to monitor hygiene compliance. When staff members raised concern that there were not enough sinks for hand washing, nine sinks were installed on five nursing units in two hospitals. 3. Antibiotic stewardship: In 2014, the medical center launched an effort to reduce use of clindamycin and fluoroquinolones. Studies have shown that clindamycin increases C. diff infection rates 20-fold, and fluoroquinolones increase risk 6-fold. A key component of the antibiotic stewardship initiative was an electronic decision support tool that encouraged clinicians to use alternative agents as substitutes for clindamycin and fluoroquinolones. 4. Emergency department processes: The ED staff developed an algorithm to identify and isolate patients with diarrhea or a recent C. diff infection. Inpatient nursing units were notified of patients who had been placed in isolation. Infection prevention practices in the ED were increased such as “SWAT teams” that properly cleaned and disinfected emergency room bays. Staff pharmacists played a crucial role in securing physician compliance with antibiotics stewardship by speaking directly with physicians. Also, distinguishing between colonization and actual illness was crucial. Not all colonization leads to active cases of C. diff., according to the study’s principal investigator.

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Bolster Patient Safety with IPC Knowledge and SPD Practices

he relationship between the Sterile Processing Department (SPD) and Infection Prevention and Control (IPC) can impact patient safety, writes Saskia v. Popescu, MPH, MA, CIC, in ContagionLive.com column. In her article, the hospital epidemiologist and infection preventionist with Phoenix Children’s Hospital emphasizes use of educational programming and tools, as well as applying the Spaulding approach to disinfection and sterilization. The Spaulding approach classifies items coming into contact with patients based on risk level for causing infection. High risk items used on patients are those that enter sterile tissue or the vascular system and must be sterilized; semi-critical items contact mucous membranes or nonintact skin and require high-level disinfection; and noncritical items come into contact with intact skin but not mucous membranes, which require low-level disinfectants. Citing a study conducted by Cedars-Sinai Medical Center, Popescu says that investigators tested infection prevention workers’ knowledge of SPD processes and practices, and then their compliance with infection prevention metrics. The average audit score improved dramatically the first year (from 67 percent to 84 percent). The study investigators found that, since 2016, the scores have remained consistent and SPD employee knowledge of cleaning techniques improved from 59 percent to 90 percent. They noted that they found a statistically significant increase in SPD audit scores and a reduction in bioburden events from the yearly average of 3.29 per 1000 procedures to 1.15 events per 1000 procedures over the course of 3 years.

New Genetic Test Method Can Reveal Hard-to-Identify Infections

os Angeles, CA – Scientists and clinicians at Children’s Hospital Los Angeles have developed a comprehensive genetic testing panel called OncoKids® to detect genetic markers that respond to targeted therapies for diseases including meningitis and encephalitis, a CHLA statement explains. Metagenomic next-generation sequencing, or mNGS, can be used to rapidly test clinical samples by comparing unknown genetic material from a patient sample against thousands of known pathogen genomes. According to study findings published in the New England Journal of Medicine, the genetic approach allows physicians to identify the cause of the disease, whether it’s a virus, bacteria, or some other infectious pathogen. This is especially important in diseases that could stem from multiple potential causes. Genetic tests can prevent delays in treating meningitis and encephalitis, which are serious central nervous system conditions that often arise from infection from pathogens, such as bacteria, viruses, fungi, and parasites. The steroids and immunosuppressive agents that are commonly used to treat autoimmune diseases make it harder for the body to fight infection. Until now, targeted testing has been difficult, the researchers say. A multi-center clinical trial led by led investigators from University of California, San Francisco and the Clinical Microbiology and Virology Laboratory at CHLA, conducted mNGS testing in pediatric patients with suspected meningitis or encephalitis. More than 200 patients at 8 hospitals, including CHLA, were enrolled in the year-long study. Cerebrospinal fluid was sampled from patients who presented with meningitis- or encephalitis-like symptoms. Samples were then analyzed using either standard laboratory testing or mNGS. Out of 58 total diagnoses, sequencing identified 13 infections - more than 20 percent - that were not detected in standard clinical testing. The sequencing method was developed and validated by University of California San Francisco researchers, who used it to test a 14-year-old patient’s cerebrospinal fluid (CSF) in 2017. The patient, who was near death with swelling in his brain, was found to have a bacterial infection called leptospirosis. He received targeted treatment with penicillin and recovered quickly.

www.bondtech.com summer 2019

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FDA Alert: Fecal Implant Treatment Screening

he US Food and Drug Administration (FDA) issued an alert to healthcare providers and patients that fecal microbiota for transplant (FMT) may transmit multidrug-resistant organisms, leading to serious or life-threatening infections. Two immunocompromised adults who received investigational FMT developed invasive bacterial infections due to the transmission of a multidrug-resistant organism (MDRO) from FMT (extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli). One of the patients died. In response to the two cases, FDA has determined stool donors be screened to address MDRO colonization risk factors and their stools be tested for MDROs. The agency advised exclusion based on unacceptable results of screening. According to the FDA new release, the FMT used in the two affected individuals were prepared from stool obtained from the same donor. The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use. After the infections occurred, stored preparations of FMT from this stool donor tested positive for ESBL-producing E coli identical to the organisms isolated from the two patients. Although FMT is not approved by the FDA for any use, the agency plays a critical role in supporting product development while assessing the risks and benefits to patients of unapproved therapies. The agency also works to strike a balance between assuring patient safety and facilitating access to unapproved treatments for unmet medical needs. health care professionals who administer FMT about this potential serious risk so they can inform their patients. In 2013, the FDA issued guidance in which it stated that it intends to exercise enforcement discretion, under limited conditions, regarding the investigational new drug requirements for FMT used to treat Clostridium difficile (C. diff) infection in patients for whom standard therapies fail. The guidance regarding FMT requires that treating physicians obtain adequate informed consent, which should include a statement that the use of FMT to treat C.diff is investigational, and that physicians discuss potential risks with patients. The safety communication underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise, the FDA emphasizes.

How to Improve Hospital HandWashing Compliance

he following hand-washing compliance steps listed on MultiBriefs.com can help identify hygiene risk situations and quickly fix them to protect everyone in your care environment. 1. Provide antibacterial gel at patient bedsides. 2. Instruct nurses to check to make sure all patients use it throughout the day. 3. Monitor hand hygiene most rigorously toward the end of shifts. Research from the America Psychological Association found that this is the time healthcare workers skimp most on hand-washing, very likely because they are tired. Remind them to keep cleaning. 4. Utilize the “gross-out” factor. Post images of live bacteria, use them in online training courses and presentations. 5. Educate visitors through videos. Keep this video on screens in your lobby, waiting rooms, and hallways and post reminder signs outside of patient rooms. 6. Ask workers if their hands are clean. Friendly inquiries throughout the day to workers will spread the word that hospital administration is serious about hand hygiene — and your workers will be serious about paying attention. 7. Set a good example. Use antibacterial soap dispensers in hallways each time you pass one and every time you enter a patients’ room.

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New Potential Treatment for Candida Albicans

cientists think they have a new way to kill a common, yet antimicrobial-resistant fungus/yeast that can cause illness in those with weakened immune systems, according to study findings published in the journal, Antimicrobial Agents and Chemotherapy. The team of researchers from Temple University Komberg School of Dentistry and University at Buffalo, New York School of Dentistry tested off-label use of an iron-chelating compound, deferasirox, to treat Candida albicans in mice. The results are promising. The yeast is also the fourth leading cause of hospital-acquired bloodstream infections, which often have high mortality rates. Deferasirox is an FDA-approved iron chelating medication used to treat blood disorders. Used against Candida albicans, the drug literally starves the fungus, rendering it too weak to multiply. The investigators found that Candida albicans in the mice who received the treatment were less likely to survive attacks by the immune system, subsisting at a 12 percent survival rate compared to a 25 percent survival rate in mice who did not receive the treatment. Currently, only three major classes of clinical antifungal drugs exist. However, fungal drug resistance has steadily increased, and no new classes of antifungals have emerged in decades, according to the study authors.

Hospital-Acquired Pneumonia Spreads Through Close Human Interaction

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ccording to study findings published in the journal, PLOS Computational Biology, the hospital acquired infection, Klebsiella pneumoniae (ESBL-KP), is transmitted at distances closer than previously thought. A French research team, which included investigators from the Université de Versailles Saint Quentin, Institut Pasteur, Lyon Université and Sorbonne Université, focused on two multi-drug resistant hospitalacquired infections caused by extended-spectrum β-lactamase (ESBL)producing Enterobacteriaceae: Escherichia coli (ESBL-EC) and Klebsiella pneumoniae (ESBL-KP). After equipping the staff with wearable wireless sensors (i.e., RFID tags), the researchers traced Close Proximity Interactions (CPIs) with 329 patients in a 200-bed long-term care facility over four months. Interactions conducted at less than five feet were captured and recorded every 30 seconds. The investigators also tested the patients for Enterobacteriaceae via weekly rectal swabs. CPIs are a prime source for transmission of microorganisms and can lead to transmission of pathogens through both direct and indirect exposures. The use of wireless sensors allowed the researchers to assess the distance and volume of interactions between staff and patients, while bacterial data collection methodology tracked the transmission of ESBLproducing organisms. For pneumonia, the potential infector was identified in 80 percent of the bacterial acquisitions (16 of 20 incident-colonization episodes), while potential ESBL-EC infectors were identified in 54 percent (19/35) of the acquisitions, demonstrating that the transmission path of ESBL-EC is different from that of pneumonia. The results suggest that ESBL-KP but not ESBL-EC may be controlled by contact reduction interventions. Transmission patterns are highly variable among ESBL-producing Enterobacteriaceae species. Tracing ESBL dissemination in hospitals is an important step in the fight against the spread of multi-drug resistant bacteria. The study outcomes could help design more specific surveillance and control strategies to prevent in-hospital Enterobacteriaceae dissemination, the study authors wrote.

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summer 2019

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News Briefs

Ebola Virus Jumps From DRC to Uganda

ampala, Uganda – In early June, the Uganda Ministry of Health and the World Health Organization (WHO) confirmed its first cases of Ebola Virus Disease in Uganda during the ongoing outbreak in neighboring Democratic Republic of the Congo (DRC), according to a Afro.WHO statement. A five-year old and his 50-year-old grandmother, who had entered from DRC at the border town, Bwera, have died. A 3-year-old brother also was confirmed to have tested positive for Ebola. The three family members had traveled with his family from Democratic Republic of the Congo on June 9, 2019. When they entered Uganda, they sought medical care for the 5-year-old at Kagando hospital where health workers identified Ebola as a possible cause of illness. Ebola infection was confirmed by the Uganda Virus Institute (UVRI). The Ministry of Health and WHO dispatched a Rapid Response Team to Kasese to identify other people who may be at risk, and ensure they are monitored and provided with care if they also become ill. At least eight healthcare workers had come into contact with the family. Uganda has previous experience managing Ebola outbreaks, according to WHO. In preparation for a possible imported case during the current outbreak in DRC, Uganda has vaccinated nearly 4700 health workers in 165 health facilities (including in the facility where the child is being cared for); disease monitoring has been intensified; and health workers trained on recognizing symptoms of the disease. Ebola Treatment Units are in place. An investigational vaccine being used in DRC and by health and frontline workers in Uganda has so far been effective in protecting people from developing the disease and has helped those who do develop the disease to have a better chance of survival, the WHO statement said.

Patient Registries Could Prevent Spread of Antibiotic-Resistant Bacteria

ccording to findings published in the journal, Clinical Infectious Diseases, a team of researchers from Public Health Computational and Operations Research, Baltimore, Maryland, Rush University Medical Center (Chicago), and McGill University (Ontario, Canada) say that using a registry for patients infected with carbapenem-resistant Enterobacteriaceae (CRE) can reduce further cases. The study, “How Introducing a Registry with Automated Alerts for Carbapenem-Resistant Enterobacteriaceae (CRE) May Help Control CRE Spread in a Region,” looked at 402 health care facilities in and around Chicago, Illinois. The highest reductions were seen when all of the facilities participated. Even when only a quarter of the facilities used the registry, the tracking strategy was shown to be an effective public health tool. Approximately 9 percent fewer patients came down with CRE infection over a three-year period when a quarter of the facilities participated in the registry at both participating and non-participating facilities. The rate for new cases increased to almost 12 percent when all of the facilities used the registry and overall prevalence of CRE dropped by close to 8 percent. The study covered 90 acute care hospitals, 9 long-term acute care hospitals, 351 skilled nursing facilities, and 12 ventilator-capable skilled nursing facilities in the Chicago metropolitan area, surrounding communities, and patient flow using the Regional Healthcare Ecosystem Analyst software platform.

Incentive for Developing New Antibiotics – Granting Drug Makers Exclusivity

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summer 2019

os Angeles, CA – Addressing the Milken Institute Global Conference, former Food and Drug Administration Commissioner and conference panelist, Dr. Margaret Hamburg suggested stimulating new drug development by instituting new incentives for antibiotics, including exclusivity, according to a StatNews.US report. In the U.S. alone, some 2 million people are infected with antibioticresistant strains of bacteria annually, and 23,000 people die. Globally, about 700,000 people die each year thanks to antimicrobial resistance, according to a UN committee report. By 2030, the authors believe superbugs may kill up to 10 million people each year. The panelists agreed on encouraging public-private partnership with government entities and investors supporting the industry to find new and better treatments. Under the current policy, drug companies typically get five years of market exclusivity if they develop a new chemical entity. If a drug treats a rare disorder, however, they’ll get seven years. Such incentives could be written into law to help prevent or control global public health crises. For certain diseases such as malaria, a company could secure 30 years of technological exclusivity where a drug is found to cure a huge number of cases worldwide. Another panelist suggested “transferable market exclusivity vouchers” to incentivize biopharma to reenter the antimicrobial market in which bonus exclusivity years can extend to different, and potentially more profitable, drugs in the pipeline. This extension concept could be applied if a drug reduces overall government healthcare spending by a predetermined amount. Granting an extra year or more in advance where a drug is found to improve symptoms of a disease by a certain percentage could spark more interest in antimicrobials. Rewarding companies for overall drug efficacy, and broader impact on global health, might allow them to ultimately profit enough that they’ll want to invest in the initial research and development in the first place, summed one panelist.

Operational Sustainability

Infection Prevention •

Prevent handling and exposure to infectious waste.

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Eliminate public exposure to infectious waste.

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Eliminate aerosolized pathogens from long term storage.

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“Total-kill” treatment efficacy.

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Fortify emergency & pandemic readiness. •  •

Reduce carbon emission from RMW transport.

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Reduce landfill consumption with 6:1 compaction.

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Reduce RMW output from 15% to 1%.

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First clean & green alternative to incineration.

Multi-function sterilization cycles (re-usables, linen, waste). •

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Built in surge capacity & back up.

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Free-up valuable real estate.

Reduce operating expenses by up to 70%. Investment delivers an aggressive return. •

Cost stabilization for 20+ years.. •

Reduce MSW hauling costs. •

Reduce labor.

•  Reduce legal liability while enhancing regulatory compliance.

Environmental Sustainability

Financial Savings

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