healthcare
Environmental solutionsnews Covering Infection prevention, medical waste management & sustainable practices
VOL. XI NO. 3
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Fall 2015
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EPA Proposes RCRA Rules Easing Standards for Pharmaceutical Wastes and Revising Generator Standards
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By Chris Bryant, Senior Regulatory Analyst Bergeson & Campbell, P.C.
PA on August 31, 2015, proposed two rules under the Resource Conservation and Recovery Act (RCRA) that would alter fundamentally the hazardous waste regulatory program. One rule eases the standards for healthcare facilities that dispose of hazardous waste pharmaceuticals, while the other proposes some three score of revisions to the requirements for generators of hazardous waste. The rules will be published in the Federal Register shortly, and EPA will take public comment on them for 60 days. Both rules are less stringent than the existing hazardous waste regulations. If promulgated in final, RCRAauthorized states thus would not be required to adopt the rules. Pre-publication copies of the rules are available online. The rules are EPA’s first attempts in 35 years to tailor the one-size-fits-all RCRA hazardous waste program generator requirements to specific industry sectors. The proposed hazardous waste pharmaceuticals rule is intended to reduce the burden on healthcare workers and pharmacists working in healthcare facilities by creating a specific set of regulations for hospitals,
clinics, and retail stores with pharmacies and reverse distributors that generate hazardous waste. Some pharmaceuticals are regulated as hazardous waste under RCRA when discarded. Healthcare facilities that generate hazardous waste pharmaceuticals as well as associated facilities have reported difficulties complying with the RCRA Subtitle C hazardous waste regulations for a number of reasons. First, healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable about the RCRA hazardous waste regulations, but are often involved in the implementation of the regulations. Second, a healthcare facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed. Third, some active pharmaceutical ingredients are listed as acute hazardous wastes, which are regulated in small amounts. To facilitate compliance and to respond to these concerns, EPA proposes to revise the regulations to improve the management and disposal of hazardous waste pharmaceuticals
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Fall 2015
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Healthcare Environmental Solutions news
healthcare
Environmental solutionsnews Covering Infection prevention, medical waste management & sustainable practices
PUBLICATION STAFF Publisher / Editor Rick Downing Contributing Editors / Writers Chris Bryant 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 For subscription information, please call 440-257-6453. Healthcare Environmental Solutions news (ISSN #1557‑6388) is published quarterly by Downing & Associates. Reproductions or transmission of Medical Waste Management, 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. ©
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EPA Proposes RCRA Rules Easing Standards for Pharmaceutical Wastes and Revising Generator Standards Continued from page 1
and tailor them to address the specific issues that hospitals, pharmacies and other healthcarerelated facilities face. The revisions are also intended to clarify the regulation of the reverse distribution mechanism used by healthcare facilities for the management of unused and/or expired pharmaceuticals. EPA is specifically proposing to add a new Subpart P under 40 C.F.R. Part 266. This new subpart is a tailored, sector-specific regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors. If promulgated in final, healthcare facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all pharmaceutical reverse distributors, regardless of their RCRA generator category, will be required to manage their hazardous waste pharmaceuticals under Subpart P of 40 C.F.R. Part 266, instead of 40 C.F.R. Part 262. That is, the proposed standards are not an optional alternative to managing hazardous waste pharmaceuticals under 40 C.F.R. Part 262; they are mandatory standards. Under the proposal, healthcare facilities will have different management standards for their non-creditable and creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste pharmaceuticals (those that are not expected to be eligible to receive manufacturer’s credit) will be managed on-site similar to how they would have been under a previous proposal for managing these wastes: the 2008 Universal Waste proposal for pharmaceutical waste (73 Fed. Reg. 73520; December 2, 2008). When shipped off-site, they must be transported as hazardous wastes, including the use of the hazardous waste manifest, and sent to a RCRA hazardous waste treatment, storage and disposal facility (TSDF). Healthcare facilities will be allowed, however, to send potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors for processing manufacturers’ credit. In response to comments received on the Universal Waste proposal, EPA is proposing standards to ensure the safe and secure delivery of the creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors. EPA is also proposing standards for the accumulation of the creditable hazardous waste pharmaceuticals at pharmaceutical reverse distributors. Like healthcare facilities, pharmaceutical reverse distributors will not be regulated under 40 C.F.R. Part 262 as hazardous waste generators, nor will they be regulated under as TSDFs. Rather, the proposal establishes a new category of hazardous waste entity, called pharmaceutical reverse distributors. The proposed Fall 2015
standards for pharmaceutical reverse distributors are, in many respects, similar to the LQGs standards, with supplementary standards added to respond to commenters’ concerns. For both healthcare facilities and reverse distributors, EPA is proposing to prohibit facilities from disposing of hazardous waste pharmaceuticals down the toilet or drain (flushed or sewered). According to EPA, the proposal is projected to prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually. Further, EPA proposes that hazardous waste pharmaceuticals managed under Subpart P will not be counted toward calculating the site’s generator category. Additionally, EPA is proposing a conditional exemption for hazardous waste pharmaceuticals that are also controlled substances under Drug Enforcement Administration regulations. Finally, EPA is proposing management standards for hazardous waste pharmaceutical residues remaining in containers. The second rule proposed by EPA on August 31, 2015, is the Hazardous Waste Generator Improvements Rule. This rule proposes “a much-needed update to the hazardous waste generator regulations to make the rules easier to understand, facilitate better compliance, provide greater flexibility in how hazardous waste is managed, and close important gaps in the regulations,” according to EPA. Two key provisions where EPA is proposing flexibility are allowing a hazardous waste generator to avoid increased burden of a higher generator status when generating episodic waste provided the episodic waste is properly managed and allowing a conditionally exempt small quantity generator (CESQG) to send its hazardous waste to a large quantity generator under control of the same person. EPA also proposes to revise certain components of the hazardous waste generator regulatory program; address gaps in the regulations; provide greater flexibility for hazardous waste generators to manage their hazardous waste in a cost-effective and protective manner; reorganize the hazardous waste generator regulations to make them more user-friendly and thus improve their usability by the regulated community; and make technical corrections and conforming changes to address inadvertent errors, remove obsolete references to programs that no longer exist, and improve the readability of the regulations. EPA states that these proposed changes are both a result of EPA’s experience in implementing and evaluating the hazardous waste generator program over the last 30 years, as well as a response to concerns and issues identified by the states and regulated community. In addition to these two changes, EPA is proposing to revise
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HEALTHCARE ENVIRONMENTAL SOLUTIONS news
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News Briefs
EverGreenHealth Sustainability CDC Calls for $1.2 Billion to Efforts Make an Impact Strengthen Infection Control irkland, WA –Washington State’s EvergreenHealth has composted Over Five Years
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a record 75 tons of food waste this year – 20 tons more than 2014, according to KirklandReporter.com. The healthcare system’s achievement tops off seven years of sustainability efforts that have been recognized by King County. Innovations such as its streamlined waste sorting process, recycling and composting programs have saved more than an estimated $15,000 in landfill waste costs. Single stream recycling, which is practiced in all areas of the hospital, sends food scraps from kitchen food preparation to a composting facility, while the hospital’s battery collection and recycling program is keeping an estimated 0.85 – 1.5 tons of batteries out of landfill each year. In 2011, the system’s Surgical Services launched a highly successful program for recycling blue wrap, the sterile packaging from surgical equipment. The hospital is also reprocessing ‘single use devices’ and donating unused medical supplies to third world countries. For example, EverGreen’s nursery equipment that’s no longer needed gets shipped to a hospital in Uganda. The recycling programs came to life as a result of a hospital-wide mission that is carried out by the Green Team, volunteer staff members who stay on top of new ways to reduce waste and conserve energy. In addition, the Green Team promotes public transportation and bicycling, and has helped implement parking lot electric car chargers at the main campus. They even guided a plan for phasing out hazardous chemical use in the hospital. Each year the Green Team holds a community education event, the Annual Earth Day Fair where local environmental organizations and hospital vendors demonstrate all sorts of ways people can live more sustainably.
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tlanta, GA – The Centers for Disease Control (CDC) is urging federal lawmakers to support a funding bill to expand and centralize infection control in the U.S., reports NBCNews.com. Although individual health systems are making headway to reduce infections, the CDC estimates that antibiotic-resistant bacteria make 2 million people sick and kill 23,000 every year in the United States. A new CDC report notes that more than half a million people could be spared debilitating infections and 37,000 lives could be saved over five years if two basic improvements could be made. First, hospitals and clinics need to coordinate individual efforts much more closely than they do. At the same time, health departments need the staff and authority to coordinate what hospitals, stand-alone clinics, dialysis and chemotherapy centers and other facilities are doing, according to the CDC report. Secondly, antibiotics use must be reduced significantly and a public education program must be kicked into high gear as soon as possible. The bill asks for $1.2 billion over five years to support the sweeping changes for inter-communication between healthcare systems and training programs, along with new authority structures and chains of command that the CDC is suggesting. The changes, however, would save the country $7.7 billion, the report says. Using computer-generated statistics, the CDC report shows how a centralized infection control program could prevent more than a half million cases of Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile and carbapenemresistant enterobacteriaceae or CRE.
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HEALTHCARE ENVIRONMENTAL SOLUTIONS news
Fall 2015
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News Briefs
SWS Environmental Services Approved as Ebola Waste Transporter
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anama City, FL – SWS Environmental S e r v i c e s ( S W S E S ) h a s re c e ive d approval from the U.S. Department of Transportation (DOT) to transport and manage medical waste associated with the treatment of the Ebola virus, reports BioPrepWatch.com. SWSES successfully passed a review by federal officials of its safety and biowaste management practices and says it is now prepared to handle large amounts of such material should the need arise. Per mitting for biowaste is granted through the Pipeline and Hazardous Materials Safety Administration’s (PHMSA) Office of Hazardous Materials and the U.S. Department of Transportation. SWSES is the latest among just 17 other companies nationwide that hold the special permit designation. The safe transport and disposal of medical waste were topics for high profile news stories following Ebola outbreaks in 2014.
New Hampshire Hospital Recognized for Heating Innovation
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orth Conway, NH – Switching from oil to biofuel saved North Conway’s Memorial Hospital $150,000 in heating bills the first season of use and cut its greenhouse gases by 85 percent, reports a New Hampshire Business Review article. The hospital’s new energy efficient system uses an advanced cellulosic biofuel known as RFO, which is made by Ensyn Fuels Inc. The feedstock comes from forest residues, which Ensyn processes and forms into pellets. Mount Washington Valley Chamber of Commerce named Memorial “Sustainable Business of the Year,” in recognition of its switch to renewable biofuel. The chamber also noted two other Memorial initiatives. One was completion of the first phase of converting all lighting to LED, which has reduced energy use by 62,000 kilowatt-hours and produced a savings of $8,000. The other recognizes the hospital’s waste recycling programs, such as the placement of bins throughout the facility collecting paper, bottles and cardboard.
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News Briefs
Researchers Strategize to Outsmart Bacteria
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ice University scientists are developing strategies to keep germs from evolving resistance to antibiotics by heading them off at the pass. The Rice lab of biochemist Yousif Shamoo identified a genetic mechanism that allows bacteria to develop resistance while simultaneously and quickly spreading the capability to others in a population. “This is really a double whammy,” Shamoo said. “Our finding that these bacteria become more antibiotic-resistant while at the same time spreading their resistance more efficiently was really surprising and worrying.” The researchers hope this knowledge will help predict when and how bacterial strains are likely to develop resistance to future antibiotics and perhaps act to halt — or at least slow — the process. The research appeared in the journal Molecular Biology and Evolution. Antibiotic resistance is responsible for hundreds of thousands of infections acquired in American hospitals, according to the Centers for Disease Control and Prevention. These infections kill thousands of patients. While progress is being made to control microbes that spread infection, the overriding concern remains that drugs developed to kill germs will ultimately stop working. Until now, the only effective way to keep antibiotics from losing their potency has been to use them sparingly, said Kathryn Beabout, a Rice graduate student and lead author of the new paper. “The best you can do is try to manage when you use the antibiotic,” she said. “But our idea is that if we can predict how resistance is going to emerge, we can come up with strategies to use antibiotics in a more intelligent way.” The lab used experimental evolution to study a specific combination of bacteria and an antibiotic that had not been in common contact. The bacteria of interest was Enterococcus faecalis, found in the gastrointestinal tract. The antibiotic was tigecycline, a highly effective but sparingly used derivative of tetracycline. The goal was to see how horizontal gene transfer – the means by which cells pass along favorable mutations – would work in the presence of the antibiotic. It worked quite well, they found. That was due mostly to a chunk of mutant DNA known as Tn916, a transposon that can change its position along the genome, duplicate itself and pass to other cells in a process known as parasexuality, the exchange of genetic material between cells. Tn916 carries the tetracycline-resistance gene called tetM, which has been found in many pathogens, according to the researchers. Without tigecycline, Tn916 moves only infrequently, as about one in 120,000 bacteria transfer their resistance to another bacteria. But in the presence of the antibiotic, Tn916 movement rose to one in 50 bacteria, due to a mutation that also causes overproduction of tetM. The resistance mechanism required the presence of two mutations, to Tn916 and to a gene that encodes the ribosomal S10 protein, both of which could be easily identified through pre- and post-experiment gene sequencing. “Tetracyclines bind to the cell’s ribosome and prevent it from making proteins,” Beabout said. “TetM is a protein that comes in and kicks tetracyclines off and frees the ribosome, but it doesn’t usually work against tigecycline. We didn’t expect to see it emerge.” In their experiments, the researchers discovered the mutations led to the production of large amounts of tetM proteins. “When you have an abundance of tetM, they’re able to have an effect against tigecycline,” Beabout said. “What’s really interesting is that tetM is on a conjugative transposon (Tn916), which is a DNA element that’s able to move around the genome and can be transferred to other cells. “An additional effect of this tetM overexpression is that the Tn916 transposon moves more,” she said. “It passes from cell to cell more. So we are seeing both resistance and an increase in the frequency at which resistance is able to transfer from cell to cell and move around genomes.
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News Briefs Continued from previous page That’s definitely worrisome.” The lab allowed colonies of E. faecalis to grow rapidly in bioreactors for 19 and 24 days. The results showed the bacteria were remarkably proficient at picking up the resistance gene. “All the cells at the beginning had one copy of the transposon, and throughout the experiment they started acquiring additional copies. The copy number of the transposon was increasing very rapidly.” Shamoo hopes the research leads to drugs that inhibit resistance mechanisms and preserve the effectiveness of new antibiotics. “Our lab does a form of evolutionary reconnaissance into how bacteria will become resistant in the future,” Shamoo said. “The pharmaceutical industry and other labs can use this information to develop drugs to stay ahead of the pathogens.” Co-authors of the paper are postdoctoral associate Troy Hammerstrom, undergraduate Tim Wang and faculty fellow Gerda Saxer, all at Rice; and postdoctoral fellow Minny Bhatty and Peter Christie, a professor of microbiology and molecular genetics at the University of Texas Medical School at Houston. Shamoo is a professor of biochemistry and cell biology and Rice’s vice provost for research. The U.S. Army Edgewood Chemical Biological Center, the National Institute of Allergy and Infectious Diseases and the Defense Threat Reduction Agency supported the research.
Sharps Compliance Acquires Route-Based Pick-Up Service Alpha Bio/Med to Serve Pennsylvania, Maryland & Ohio; Also Launches Route-Based Service in Texas
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harps Compliance Corp., a full-service national provider of comprehensive waste management solutions including medical, pharmaceutical and hazardous, recently announced the acquisition of Alpha Bio/Med Services LLC, a route-based pick-up service located in Pennsylvania. Additionally, Sharps announced the launch of a Company-sponsored route-based pick-up operation in Texas serving Dallas, Houston, San Antonio and Austin, Texas as well as Shreveport, Louisiana. David P. Tusa, President and Chief Executive Officer of Sharps, commented, “Alpha Bio/Med Services is a very well run organization and a great fit for Sharps as it allows us to service the Pennsylvania, Maryland and Ohio areas with both a route-based pick-up service as well as our traditional line of Sharps Recovery System™ mailback solutions. With this acquisition we are exploring opportunities to build and permit a treatment facility in the northeast to most efficiently service our strong and growing customer base in the region.”
Waste Management Settles in Medical Waste Spill Case
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onolulu, HI – Waste Management of Hawaii has agreed to pay a $400,000 fine and set aside $200,000 for environmental projects in settlement for a medical waste spillage incident that happened four years ago, reports KHON2.com. The medical waste - bags of blood vials, needles and syringes - had washed out of Waimanalo Gulch Sanitary Landfill into the ocean on the island’s Leeward side in 2011. In May 2014, the U.S. Attorney’s office filed an indictment against Waste Management of Hawaii, saying the company had lied to health inspectors about the spill. In the settlement, the government has agreed to drop felony charges against the company. Misdemeanor negligence charges under the Clean Water Act filed against two employees, were allowed to stand, however. The employees will be fined $25,000 each.
www.mark-costello.com
Fall 2015
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News Briefs
Rapid Ebola Test Could Play Key Role in Efforts to End Lingering Outbreak
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esearch presented at the 2015 AACC Annual Meeting & Clinical Lab Expo will expand on the studies that led to a fingerprick Ebola test becoming the first and only rapid diagnostic for this disease to receive approval from the World Health Organization (WHO). This test could prove vital to breaking Ebola’s grip on West Africa by identifying suspected Ebola cases within minutes, and enabling healthcare workers to isolate and treat these patients much faster than is currently possible. More than 11,000 people have died since the Ebola epidemic began in March 2014, and though cases have been declining, the international emergency response that the outbreak prompted has not been able to drive the virus back underground. The fight against the disease achieved a significant victory in May, when Liberia—one of the nations hardest hit by the virus—was declared Ebolafree by WHO. Less than 2 months after this win, however, new cases of the disease were discovered in the country. The first of these was a 17-year-old boy who was misdiagnosed with malaria and who, before passing away, came into contact with at least 102 people who may have caught the disease from him. This case
tragically illustrates the need for a fast way to accurately identify Ebola cases so that patients get the care they need and transmission can be halted. The Viral Hemorrhagic Fever Consortium, which is led by Tulane University and the diagnostic company Corgenix, has developed such a rapid test for Ebola. Called the ReEBOV Antigen Rapid Test Kit, this test uses a few drops of blood and the same technology used in at-home pregnancy tests to provide results in 15 minutes. In comparison, the current gold standard test for Ebola, qRT-PCR, can take up to a day to return a diagnosis. Matt Boisen, Program Director of Infectious Diseases and Emerging Technologies at Corgenix and Development Director of In Vitro Diagnostics at the Viral Hemorrhagic Fever Consortium, will present the findings of two studies by WHO and Corgenix, respectively, demonstrating ReEBOV’s efficacy at the 2015 AACC Annual Meeting. The WHO study, conducted in Ebola-hotspot Sierra Leone, compares ReEBOV’s performance with that of qRT-PCR. By testing 292 stored patient samples with both methods, researchers found that ReEBOV performed nearly as well as the gold standard, and agreed with qRT-PCR on 91.8%
of infected samples and 84.6% of non-infected samples. ReEBOV’s accuracy was also recently confirmed by a third separate study published in The Lancet. This means that ReEBOV could be used as a complement to qRT-PCR, enabling healthcare workers to act immediately on potential Ebola cases without having to wait for the qRT-PCR results to come in. “All three studies—the internal emergency use authorization study, the WHO study, and The Lancet paper—show that the rapid test can provide a plus 90 percent accuracy when paired with the PCR test,” said Boisen. “This really establishes that the rapid test can be used as a triage method to quickly provide patient results that can later be confirmed by PCR. This represents a breakthrough in the detection of Ebola for this and future Ebola virus outbreaks.”
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News Briefs
Shred-It Scraps IPO, Becomes Unit of Stericycle, Inc.
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ntario Canada – Stericycle has announced plans to acquire Shred-It International for $2.3 billion in cash, reports Bloomberg.com. The purchase allows Stericycle Inc. to expand its waste management services to businesses, such as healthcare, that must comply with privacy regulations. By combining, each company expects to save as much as $30 million. Shred-It earlier this year had announced a C$600 million ($465 million) in an initial public offering. The Toronto-based company is owned by buyout firm Birch Hill Equity Partners, and had received takeover interest earlier this year from document-management company, Recall Holdings Ltd. Stericycle has been expanding its biowaste management business aggressively this year, with 15 international acquisitions in the first quarter. According to a press release, the deals are expected to add $42.5 million in annual sales. The Shred-It purchase is hoped to boost cash earnings per share by at least 10 percent in 2016, according to a Stericycle statement. According to its website, Shred-it was established in 1988 as one of the first paper shredding companies in the world. The company offers services to about 400,000 customers in 18 countries and has a fleet of about 2,400 trucks. Shred-It has been active with acquisitions of its own, including buying out Iron Mountain’s international secure shredding business in the U.K., Ireland and Australia and striking a deal with Cincinnati-based Cintas Corp. to manage its document shredding business.
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win Cities, MN – A Minnesota jobs program that provides meaningful work for developmentally disabled individuals so far has processed 75 tons of blue wrap to be recycled into plastic, a TwinCities.com article reports. Blue wrap, the spongy plastic material used for packaging sterile surgical and other equipment comes from nineteen hospitals in the Twin Cities area. The recycling program, now run by the nonprofit, Merrick, Inc. was originally created by Minnesota Waste Wise Foundation. The blue wrap is collected, baled and sold to be manufactured into new plastic products, such as automotive parts. Blue wrap was identified for the pilot program because it is an easy and important recyclable to remove from hospital waste streams. Although it weighs next to nothing, except in large quantities, the puffy material doesn’t compact well and it takes up a lot of space in waste receptacles and bins, not to mention hospital trash compactors. Although the price of recycled plastic has been dropping along with the price of crude oil, blue wrap, composed of a single polymer polypropylene #5, is ideal for plastic recycling because it’s clean. Twin Cities-generated blue wrap waste has slowly risen from 7 cents a pound to 14 cents, said Jill Curran, executive director of Waste Wise. One Merrick customer, Polywrap Recycling in Sheboygan, Wis., processes it into pellets and resells it on the international commodities market. Merrick plans to expand the program to surgical centers and additional hospitals in the metro area.
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News Briefs
EPA Proposes RCRA Rules Easing Standards for Pharmaceutical Wastes and Revising Generator Standards Continued from page 3
about 60 provisions in the RCRA hazardous waste regulatory program applicable to generators. Many of the changes proposed by EPA alter long-entrenched regulatory requirements. EPA is proposing to revise the definition of “small quantity generator” and add definitions for the other two generator categories as well as a definition for “central accumulation area.” In addition, EPA proposes to change the name of the “conditionally exempt small quantity generator” category to “very small quantity generator” or VSQG. EPA is also proposing four changes to the hazardous waste identification regulations. First, EPA is proposing to add a new provision that would explain what generator category would apply to a generator that generates both acute and non-acute hazardous waste in the same calendar month. Second, EPA would revise the regulations at 40 C.F.R. Sections 261.5(h) and (i) and 261.3 that address the mixing of a non-hazardous waste with a hazardous waste. Third, EPA is proposing to amend 40 C.F.R. Sections 261.5(f)(3) and (g)(3) to allow CES QGs to send their hazardous waste to LQGs that are operated under control of the same person. Under this proposal, a CESQG that wants to take advantage of this provision would need to comply with the proposed requirements. Finally, EPA is proposing to amend 40 C.F.R. Section 261.6(c) to require biennial reporting for owners or operators of facilities that recycle but do not store hazardous waste before the recycling. EPA is proposing a number of changes to the regulations for generators
of hazardous waste at 40 C.F.R. Part 262 to improve the understanding of the RCRA generator regulations to encourage increased compliance by the regulated community. These proposed changes include the following: • Revising the scope and applicability section to distinguish between independent requirements and conditions for exemption for generators of hazardous waste; • Revising the regulations for making hazardous waste determinations; • Requiring re-notification by SQGs and LQGs; • Revising the regulations for labeling and marking of containers, tanks, drip pads, and containment buildings when accumulating hazardous wastes; • Revising the closure provisions for LQGs; • Updating the preparedness, prevention, planning and emergency procedures provisions for SQGs and LQGs; • Revising the provisions for satellite accumulation areas (SAA) for SQGs and LQGs; • Revising the SQG regulations for accumulating hazardous waste on drip pads; • Deleting obsolete regulations that refer to the Performance Track program; • Revising the biennial reporting provisions for LQGs; and • Adding a provision that hazardous waste generators are prohibited from disposing liquid hazardous waste in landfills.
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Benefits: • Disinfects infectious fluid surgical waste streams containing bloodborne pathogens and other infectious agents, exceeding STATT Level III • Eliminates employee exposures with closed system • Reduces medical waste disposal expenses over current practices, including solidification, red-bagging, autoclaving, transportation, and incineration • Reduces biohazard exposure risks to wastewater workers • Prevents spread of infectious agents to the environment Features: • Compatible with current fluid waste management systems • Patented in-line continuous flow, self-cleaning process • Installs to existing sewer drain for down the drain disposal to sewer system • Easy plug and play design for maintenance and repair • Smart technology for with remote monitoring • Minimal space required For more information visit www.innovasan.com.
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HEALTHCARE ENVIRONMENTAL SOLUTIONS news
Newmedtek Introduces Innovative, Affordable Sharps Management Device (NeedleShark)
Fall 2015
very year, hundreds of thousands of healthcare workers sustain accidental needle stick injuries costing billions in insurance and healthcare cost. NeedleShark is a “Hands Free” shredding device that is quick, safe and effective reducing injuries and workers comp claims. NeedleShark quietly shreds the contents into micro-sized fragments rendering needles harmless to employees, trash handlers and assisting in eliminating needle & syringe theft. NeedleShark can easily dispose up to 20cc needles and syringes. The unit’s 2.5-quart sharps container has a 5-to-1 volume reduction that dramatically reduces the cost of waste disposal. NeedleShark is compliant for tough OSHA safety standards with an exclusive patent-pending HEPA filtering system that ensures emitting potentially hazardous airborne aerosols every disposalsequence. It’s environmentally friendly reducing the waste footprint in landfills. The Ohio EPA states using our sharps management device, “The actions of shredding the sharps does reduce the laceration and puncture potential of the needle and prevents the re-use of the sharps.” The NeedleShark saves money, saves time, saves the environment and saves lives! For more information find us online at Newmedtek.com or call 1-844-NEW-MEDT / 1-844-639-6338.
News Briefs
CDC Funding Helps States Address Infectious Disease Threats
T
he Centers for Disease Control and Prevention (CDC) recently announced awards of nearly $110 million to help states and communities strengthen their capacity to track and respond to infectious diseases. The awards represent an increase of about $13 million over fiscal year 2014 funding, with increases going to vaccine-preventable-disease surveillance, foodborne-disease prevention and advanced molecular detection, among other projects. The funding is allocated through the Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement (ELC), with a goal of helping states fight infectious disease outbreaks more quickly and develop better interventions to protect the public’s health. Of the nearly $110 million, $51 million is provided through the Affordable Care Act’s Prevention and Public Health Fund. That funding will support: • Infectious disease surveillance and outbreak response • Public health laboratories • Health information systems • Efforts to combat zoonotic, vector-borne and foodborne diseases; vaccine-preventable infections; influenza; and healthcareassociated infections.
a new Northeast Regional center. • More than $2 million to help states build their capacity for advanced molecular detection, an emerging field that combines next-generation genomic sequencing with bioinformatics to more quickly identify and respond to disease outbreaks. • Approximately $1.5 million to help states fight Lyme and other tickborne diseases. CDC research shows that Lyme disease has been spreading geographically in recent years and CDC estimates that it affects about 300,000 people per year. • Approximately $9.2 million to aid state, local, and territorial health departments in building and maintaining disease detection, surveillance, and prevention programs to reduce the number of human infections with West Nile virus and other mosquito- and tick-
borne arboviruses. • Resources to help states on the U.S.-Mexico border prepare for and respond to potential outbreaks of the mosquito-borne chikungunya virus. Chikungunya surfaced in the Western Hemisphere for the first time in late 2013 and last year infected more than 1.5 million people throughout the Caribbean, Mexico and Central America. Funding through the ELC mechanism also supports the nation’s fight against healthcareassociated infections and the growing threat of antibiotic resistance, efforts in which multiple federal agencies and private-sector organizations are participating. For more information on CDC’s ELC cooperative agreement and the breakdown of FY15 funding, visit http://www.cdc.gov/ncezid/ dpei/epidemiology-laboratory-capacity.html.
Expanded funding for state, local, and territorial health departments
“I
n the last year alone, states were hit with emerging diseases, like chikungunya and respiratory infections from enterovirus D-68, while also responding to outbreaks of measles, foodborne illness, and other threats. These awards lay the foundation for those on the front lines – state and local health departments – to act quickly to prevent illness and deaths,” said Beth P. Bell, M.D., MPH, director of CDC’s National Center for Emerging and Zoonotic Infectious Diseases. CDC funds all 50 state health departments, six local health departments (Chicago, the District of Columbia, Houston, Los Angeles County, New York City and Philadelphia), and eight territories or U.S. affiliates, including U.S. Virgin Islands, Puerto Rico and Guam, through the ELC mechanism. The funding helps pay the salaries of nearly 1,500 epidemiologists, lab technicians, and health information systems staff in the state, territorial, local, and tribal health departments. This year’s funding includes: • $6 million to establish local, state and territorial health coordinators to track vaccine-preventable diseases like measles and pertussis. • $17.4 million for foodborne disease prevention and tracking – a $4 million increase over fiscal year 2014 funding. This includes increased support for the PulseNet surveillance system and outbreak response and for the Integrated Food Safety Centers of Excellence to establish
sanipak@sanipak.com www.sanipak.com
Fall 2015
HEALTHCARE ENVIRONMENTAL SOLUTIONS news
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Formerly Medical Waste Management
healthcare
Environmental solutionsnews
6075 Hopkins Road • Mentor, OH 44060
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Ph: 440-257-6453 • Fax: 440-257-6459 Email: downassoc2@oh.rr.com
Mentor, OH Permit No. 2
Covering Infection prevention, medical waste management & sustainable practices
VOL. XI NO. 3
FALL 2015
TOP STORIES EPA Proposes RCRA Rules Easing Standards for Pharmaceutical Wastes and Revising Generator Standards
PAGE 1
CDC Calls for $1.2 Billion to Strengthen Infection Control Over Five Years
PAGE 4
Researchers Strategize to Outsmart Bacteria
PAGE 6
Rapid Ebola Test Could Play Key Role in Efforts to End Lingering Outbreak
PAGE 8
CDC Funding Helps States Address Infectious Disease Threats
PAGE 11
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