MWM 3rd Quarter 2010

Serving The Healthcare And Medical Waste Industries VOL. 6 NO. 3

jul-sep 2010

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Reprocessing Medical Equipment Reduces Waste, Cuts Costs

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By P.J. Heller

ospitals facing the double whammy of trying to contain costs and be environmentally friendly are finding that reprocessing single-use medical devices can accomplish both goals.

Not only are the hospitals substantially reducing the amount of medical waste they are disposing of, they are saving about half the cost of replacing single-use devices (SUDs) with new items. Those annual savings come to more than $100 million, according to reprocessing companies, with one industry analyst predicting savings of more than $1 billion in the future.

“It’s a compelling proposition to hospitals as well as to the healthcare industry in general because the amount of money spent on SUDs in the U.S. is enormous,” says Lars Thording, a spokesman for independent reprocessor Ascent Healthcare Solutions.

“The reprocessing/remanufacturing of medical devices is the single most impactful sustainability initiative currently undertaken by hospitals in the United States,” the Phoenix-headquartered company says.

An estimated 3,000 hospitals — about 70 percent of all hospitals in the U.S. — are reprocessing SUDs, either in-house or through third parties such as Ascent and SterilMed, according to published reports.

Ascent and SterilMed are the two major players among a handful of reprocessors in the market. The two companies handle about 95 percent of medical device reprocessing in the U.S. Ascent boasts more than 1,700 hospital clients; SterilMed, based in Maple Grove, Minn., provides its services to more than 1,200 facilities.

“Reprocessing is making a big difference for our customers,” reports Brian Sullivan, president and chief executive officer of SterilMed. “Reprocessing helps conserve our natural resources by reducing medical waste and also reducing hospital cost for waste disposal. Reprocessing saves over 2 million pounds of medical waste from being sent to landfills each year. A typical 300-bed hospital would divert 35,000 pounds of medical waste from landfills and reduce device purchase costs up to 50 percent with savings of over $400 per bed.”

Ascent says it saved its hospital clients $82 million and diverted more than 2.5 million pounds of waste from local landfills in the first six months of 2009.

While reprocessing SUDs is not new — it started about three decades ago — it is receiving more and more attention as medical facilities look at ways to cut costs and go green. Resistance to reprocessing has come largely from original equipment manufacturers who label their devices for “single use.” Those manufacturers contend that reprocessed SUDs are inherently unsafe because the devices are not designed to facilitate cleaning and sterilization; reprocessors argue that their procedures are safe and that the singleuse designation is mostly so original equipment manufacturers can increase their revenues.

The single-use designation is decided solely by the manufacturer, not at the direction of the U.S. Food and Drug Administration.

The FDA requires third-party or hospital reprocessors to comply with the same requirements that apply to the original equipment manufacturers.

Continued on page 3

Info Request #112 2

Medical Waste Management JUl-sep 2010

Reprocessing Medical Equipment Reduces Waste, Cuts Costs Continued from page 1 Reprocessing is allowed for Class I and II devices — non-life sustaining and generally low- to midrisk items — but not for Class III devices such as pacemakers, heart valves or other items to support or sustain human life.

“Available data show that SUDs can be reprocessed with a reasonable assurance of safety and effectiveness,” said Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health in 2006 Congressional testimony. “FDA

PUBLICATION STAFF Publisher / Editor Rick Downing Contributing Editors / Writers Kevin T. Bain P.J. Heller Joseph Lazzarotti 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.

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Medical Waste Management JUl-sep 2010

believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device.”

Despite such assurances — and the fact that nearly 80 percent of the 14 hospitals ranked by U.S. News & World Report as the nation’s best reprocess their medical devices — Sullivan and Thording say some hospitals still are hesitant to accept the practice.

Such hesitancy is due to a lack of information — or disinformation — about how safe the devices are and the impact they can have on a hospital, they contend.

“The medical device manufacturers (OEMs) continue to attack the concept of reprocessing because it reduces their sales of new devices and overall profits,” Sullivan says. “They systematically provide false and misleading information to the physician and nurse communities, which generates clinical resistance to broad adoption of reprocessing at a number of facilities.

“As the use of reprocessed devices has become more widespread, and awareness of the industry’s outstanding safety track record has increased, reprocessing is viewed more and more as a standard, non-controversial practice,” he adds. “This further reduces resistance to the use of reprocessed devices and helps reverse misconceptions.”

“This [reprocessing] is a practice that has been picked up so widely that it’s being considered more or less the gold standard of sustainable purchasing policies,” Thording says.

Even so, there are some who remain unconvinced. One of them is Jenny Westbrook, chief executive officer of Precision Surgical Supply of Denver.

“When you’re on the patient end of something such as an invasive procedure, it is a scary idea to go in and have someone reusing an item on you,” Westbrook says. “You’re going into a sterile operating room. I do realize that they say the FDA is involved in all of this and making sure that these reprocessed items are safe. However, they can’t all be safe. I just don’t believe it.”

Westbrook, whose company markets German stainless steel surgical instruments, says she does see the positive aspects of keeping SUDs out of the waste stream and agrees that OEMs have a valid complaint about the impact reprocessing has on their bottom line. “To me, though, it’s about patient care,” she insists. “It really is.”

Hospitals and physicians are not required to inform patients when reprocessed devices are being used or to obtain patient consent. Efforts have been made to enact legislation in some states to require such notice and consent.

“Patient consent is really an attempt by the OEMs to get patients to choose their devices over others,” Sullivan says. “This would only serve to confuse the patient and ask them to make a decision that their healthcare provider is responsible for

making. Proposed patient consent bills regarding reprocessed devices are designed to scare patients by implying that they are less safe.”

Westbrook says patients are already scared enough when hospitalized and shouldn’t have the added worry about whether the instruments being used on them are reprocessed.

“I think you’d want to know that everything was pristine, clean and taken care of in such a way that you’re not going to end up with some kind of weird infection or blood disease or something just from the instruments,” she says.

None of those outcomes have been attributed to reprocessed SUDs. The Government Accounting Office, in a letter to Congress in 2008, reported that the FDA “has found no causative link between a reprocessed SUD and reported patient injury or death.”

The Association of Medical Device Reprocessors, comprised of Ascent and SterilMed, insists that reprocessing is completely safe.

A reprocessed SUD is cleaned, inspected, sterilized and packaged “and is functional to the same, if not greater degree, as the original device before it is allowed to be commercially reprocessed,” the association says. “Unlike hospitals’ central sterile activities, commercial reprocessing is performed under FDA’s stringent oversight and pursuant to rigorously validated protocols.

“Comparing a reprocessed device to an original device is similar to comparing generic drugs to brand name drugs,” it adds. “Both are equivalent in the eyes of FDA and both must meet the same strict regulatory requirements.

Reprocessed devices are as safe and effective as original equipment, and there is no evidence that the use of reprocessed devices increases the risks associated with a medical procedure.”

Single-use devices can be reprocessed multiple times, depending on the particular item.

Each device is required by the FDA to be stamped by the reprocessor so the SUD can be tracked and the number of reprocessing cycles recorded.

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Understanding the Public Health Implications of Household Pharmaceutical Waste in the US – Part One

By Kevin T. Bain The following article is the first part of a comprehensive two-part series exploring the public health and environmental impact of household pharmaceutical waste in the US.

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rescription and non-prescription pharmaceutical drugs are critical to maintaining the health and improving the quality of life for millions of Americans. In recent years, household pharmaceuticals have become ubiquitous in the US. Unfortunately, not all pharmaceuticals dispensed to or purchased by people are consumed or used. Frequently these unused pharmaceuticals are flushed down the toilet, poured down the drain or simply thrown in the trash. Improper disposal leads to a variety of detrimental effects to public and environmental health.

Just how pervasive is this problem? It has been estimated that hospitals and long-term care (LTC) facilities in the US waste at least 125 million pounds of pharmaceuticals annually – a staggering figure. As the pervasiveness of household pharmaceuticals continues to climb, the health care industry must find environmentally friendly and cost effective methods for reducing pharmaceutical waste and handling it once it has been generated.

Pharmaceutical Use in the US

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n the US, the use of prescription drugs, as measured by the number of prescriptions purchased and the annual rate of growth in prescription drug spending, increased considerably over the last 15 years. From 1993 to 2003, the number of prescriptions purchased increased 70 percent (from 2 billion to 3.4 billion). Between 1995 and 2004, the annual rate of growth in prescription drug spending was, on average, 13.4 percent per year. In 2005, approximately 3.6 billion prescriptions were purchased in the US, and in 2006, prescription drug spending increased 8.5 percent from the prior year to reach $216.7 billion.

The use of non-prescription drugs has also increased appreciably over time.

However, accurate estimates of non-prescription drug use are comparatively limited because many studies that approximate the use of pharmaceuticals either exclude non-prescription drugs or categorize over-the-counter (OTC) drugs and dietary supplements into one category.

Most US adults consume or use at least one pharmaceutical, and many consume or use multiple pharmaceuticals. Using data from the National Social life, Health and Aging Project (NSHAP), researchers studied pharmaceutical use among a nationally representative sample of community-residing individuals aged 57 through 85 years. Among 2,976 individuals, 81 percent used at least one prescription drug on a regular schedule and 29 percent used at least five. Overall, 91 percent of older adults in the US regularly used at least one pharmaceutical. This rate translates into approximately 50.5 million adults aged 57 to 85 years in the US. The Slone Survey, an on-going telephone survey of a random sample of the non-institutionalized US population, showed that among 2,590 individuals aged at least 18 years, 51 percent used at least one prescription drug during the preceding week and 7 percent used at least five.

Use of non-prescription drugs was also widespread. Forty percent used one or more vitamin or mineral supplements and 14 percent used at least one herbal/supplement during a given week. Overall, 81 percent of US adults used at least one pharmaceutical and 25 percent used at least five. These rates translate into approximately 169 million and 52 million adults aged 18 years and over, respectively, in the US. 4

Pharmaceutical Waste in the US

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harmaceuticals are wasted for a variety of reasons. For example, a person’s medical condition resolves before the pharmaceutical is completely consumed or used; the person experiences an intolerable adverse effect from the pharmaceutical and must stop taking or using it; the person refuses to take or use the pharmaceutical as instructed by his/her prescriber; the pharmaceutical is not effective and the prescriber discontinues or changes it; the pharmaceutical expires or spoils before it is completely consumed or used; or the person dies and leaves behind a supply of pharmaceuticals.

Because US consumers do not keep data on the waste they generate, national estimates of household pharmaceutical waste do not exist. However, in studies performed in and outside the US, enormous quantities of household pharmaceutical waste have been documented. In a US pilot study, for example, approximately 17,000 drugs were returned to a community pharmacy located in Houston, Texas over a six-month period. In disposal programs in Alberta, Canada, more than 204 tons of unused drugs were collected over an eight-year period. Two relatively new approaches to acquire data to assess the scope and magnitude of household pharmaceutical waste are to measure the quantity of drugs wasted by hospice programs and the inventories of drugs maintained by coroner offices.

In 2008, the last year for which complete data are available, an estimated 1.45 million patients enrolled in hospice programs; of those, 963,000 (66.4 percent) died, representing approximately 38.5 percent of all deaths in the US. Patients aged 65 years or older are the dominant users of hospice services, accounting for more than 80 percent of all hospice enrollees. These patients are also the dominant users of drugs, with nearly half using five or more drugs; among those, the most frequently used drugs are opioid analgesics, which are classified as controlled substances. When a hospice patient dies, most unused drugs are wasted, usually without violating state or federal regulations. As the US population ages, the quantity of drugs wasted by hospice programs is expected to grow, yet there are few data documenting the extent of this waste.

To begin to acquire data to assess the scope and magnitude of drugs wasted by hospice programs in the US, a group of researchers performed a retrospective chart review of 100 hospice patients who died consecutively between November, 2004 and March, 2005. After exclusion criterion was applied, the final sample was comprised of 51 hospice patients with a mean age of 73.3 years. At the time of death, the mean number of drugs per patient was 9.7. With the exception of haloperidol, all of the top ten drugs wasted were controlled substances. The quantity of drugs wasted totaled 4,762 milliliters, 2,496 tablets and 67 patches. The average cost of wasted drugs per patient was between approximately $100 and $200. Approximately 963,000 patients die in US hospice programs per year, which means up to $192,600,000 of drugs are being wasted by hospice programs nationally.

In 2007, another group of researchers performed a retrospective chart review of 105 hospice patients (mean age: 78 years) who died between April and June, 2007. Patients were included if they had a completed controlled substance waste destruction record. At the time of death, the overwhelming majority of hospice patients had unused controlled substances in the home.

The most commonly unused controlled substances were morphine concentrated

Continued on next page Medical Waste Management JUl-sep 2010

Continued from previous page solutions (99 percent of patients), lorazepam solution or tablets (64.8 percent of patients), fentanyl transdermal patches (9.5 percent of patients) and roxicodone solutions (6.7 percent of patients). Among those, more than three liters (3,184 mL) of morphine concentrated solution, 397 milliliters of lorazepam solution, 990 tablets of lorazepam, 57 fentanyl transdermal patches and 382 milliliters of roxicodone solution were wasted.

These findings indicate that a sizeable quantity of drugs are wasted when hospice patients die. Because countless quantities of wasted drugs are not recorded by hospice programs or have not been measured by researchers, it is possible that pharmaceutical waste generated by hospice programs in the US may be grossly underestimated.

One way data can be acquired to assess the scope and magnitude of household pharmaceutical waste is to measure the inventories of drugs maintained by coroner offices. These inventories, which are compiled as standard protocol by most coroner offices in the US, are an accurate record of drugs wasted by decedents. Data from a pilot study conducted by the Clark County Coroner’s Office (CCCO) in Clark County, Nevada demonstrates proof of this concept. In 2005, the death rate for Clark County, Nevada was 0.008, which was also the death rate for the US during 2005. Among the 13,761 deaths reported in Clark County in 2005, 10,135 deaths were reported to the CCCO. The total number of cases accepted by the CCCO was 3,393; of those, 46.4 percent included drug inventories. During the calendar year of this pilot study, at least 325,000 doses of a wide array of drugs – not including liquids, powders or delivery systems such as inhalers, patches and syringes – were collected and disposed of by the CCCO. These doses represented greater than 102 kilograms of active pharmaceutical ingredients (APIs) disposed into the environment.

Extrapolating these data to the entire US deceased population, the CCCO estimated that at least 17.9 metric tons of APIs are disposed of by coroner officers annually. If this new approach to acquire data about drugs wasted by decedents was applied on a nationwide basis, it could increase

our understanding of the scope and magnitude of household pharmaceutical waste in the US.

How Household Pharmaceuticals Enter the Environment

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ousehold pharmaceuticals tend to enter the environment in three ways: (1) they are excreted by the human body; (2) they wash off the human body or (3) they are disposed. A certain amount of environmental pollution from pharmaceuticals is inevitable. After consumption, pharmaceuticals are metabolized in the body and excreted as either the unaltered parent compound or as metabolites, some of which are active compounds.

These byproducts are flushed down the toilet and subsequently released into sewage water. Some topical pharmaceuticals get washed off during bathing and find their way into the domestic sewage system as well.

A preventable source of environmental pollution, however, is the disposal of unconsumed or unused household pharmaceuticals. One commonly used method of disposal of household pharmaceuticals is to flush them down the toilet or pour them down the drain. In February 2007, the Office of National Drug Control Policy (ONDCP), in collaboration with the US Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), published federal guidelines for the proper disposal of drugs. The guidelines recommended that 13 specific drugs with a high potential for abuse or acute toxicity be flushed down the toilet. In October 2009, the guidelines were updated and the list of 13 specific drugs to be flushed down the toilet was removed. Now, the guidelines refer consumers to a new website launched by the FDA for an updated list of drugs that should be flushed down the toilet or poured down the drain.

The Drug Enforcement Administration (DEA) requires most long term care (LTC) facilities to dispose of unused controlled substances directly.

Following the death of a hospice patient, the US Code of Federal Regulations 42 CFR 418.96 states: “The hospice must have a policy for the disposal of

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Info Request #114 Medical Waste Management JUl-sep 2010

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Workplace Privacy, Data Management and Security Report

Shredding and Data Destruction Companies – A HIPAA-Covered Entity’s Best Friend

By Joseph Lazzarotti

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e recently reported that the Department of Health and Human Services (HHS) is issuing proposed regulations to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”).

These proposed regulations contain a number of important points to think about for HIPAA covered entities (and business associates), even though these rules are in proposed form.

One is avoiding HIPAA violations involving “willful neglect,” which under the HITECH Act will require a formal investigation and civil penalties.

To date, the Secretary of HHS has attempted to resolve complaints and certain violations by informal means, as required by § 160.312 of the current regulations. A significant change to the HIPAA enforcement scheme in the HITECH Act requires that if a preliminary investigation of the facts of a complaint indicates a possible

violation due to willful neglect, the Secretary is required to commence a formal investigation. If the formal investigation finds a HIPAA violation involving willful neglect, the Secretary must impose a civil money penalty.

What is “willful neglect”?

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illful neglect is defined at § 160.401 as the “conscious, intentional failure or reckless indifference to the obligation to comply with the administrative simplification provision violated.” The term not only presumes actual or constructive knowledge on the part of the covered entity that a violation is virtually certain to occur, but also encompasses a conscious intent or degree of recklessness with regard to the entity’s compliance obligations.

What does that mean?

What are some examples?

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he proposed regulations provide the following examples:

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1. A covered entity disposed of several hard drives containing electronic protected health information in an unsecured dumpster, in violation of § 164.530(c) and § 164.310(d) (2)(i). HHS’s investigation reveals that the covered entity had failed to implement any policies and procedures to reasonably and appropriately safeguard protected health information during the disposal process.

2. A covered entity failed to respond to an individual’s request that it restrict its uses and disclosures of protected health information about the individual. HHS’s investigation reveals that the covered entity does not have any policies and procedures in place for consideration of the restriction requests it receives and refuses to accept any requests for restrictions from individual patients who inquire.

3. A covered entity’s employee lost an unencrypted laptop that contained unsecured protected health information.

HHS’s investigation reveals the covered entity feared its reputation would be harmed if information about the incident became public and, therefore, decided not to provide notification as required by § 164.400 et seq.

In addition to having actual or constructive knowledge of one or more violations, the covered entities in the examples above, particularly Example 1, failed to develop or implement compliant policies and procedures and, thus, demonstrated either conscious intent or reckless disregard with respect to the compliance obligations under HIPAA. Based on the proposed regulations, covered entities can no longer expect the velvet hand of the regulators to resolve a violation informally in all cases. Covered entities that fail to have policies and procedure and make a good faith compliance effort likely will find themselves subject to mandatory formal investigations and penalties.

Covered entities like the one in Example 1 above might want to consider certain precautions, including: maintaining a record retention policy; maintaining media re-use policy; maintaining a data destruction policy; maintaining an e-discovery policy, and and engaging a good data destruction/shredding company.

Joseph Lazzarotti is an attorney with Jackson Lewis, LLP in White Plains, New York. To view additional articles from their blog, please visit www.workplaceprivacyreport.com.

Info Request #141 6

Medical Waste Management JUl-sep 2010

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Info Request #106

0411_RHS_RWC_Ad_3rdQtr_10.indd 1

Date: 06.16.10 Client: Rehrig Pacific 2010 Job #: 04112009 Medical Waste Management JUl-sep Account Director: Artime

Designer: Brillhart

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Understanding the Public Health Implications of Household Pharmaceutical Waste Continued from page 5 household trash, especially in impermeable containers, results in less water controlled drugs maintained in the patient’s home when those drugs are no pollution than flushing pharmaceuticals down the toilet or pouring them down longer needed by the patient.” Researchers have shown that hospice programs the drain because landfills do not empty directly into waterways. commonly dispose of unused controlled substances in the home by flushing them down the toilet or pouring them down the drain. Flushing is also the most common method used by coroners to dispose of pharmaceuticals remaining Household Pharmaceuticals in the Environment in the household following a person’s death. Pharmaceuticals disposed in ver time, the use of pharmaceuticals in the US has been steadily this manner are released directly to the environment after passing through increasing, driven by both pharmaceutical development and an aging wastewater treatment plants or domestic septic systems, which often are not population. As a result, the amount of household pharmaceutical designed to remove pharmaceuticals from the effluent. The result is that small waste that ends up in the environment is also increasing. Only recently has concentrations of pharmaceuticals can end up in drinking water. improved testing equipment been capable of detecting pharmaceuticals at low The ONDCP and FDA recommend that most pharmaceuticals be disposed concentrations. Even with improved testing equipment, however, it has been of by: (1) taking them out of their original containers; (2) mixing them with difficult for scientists to determine the exact sources of pharmaceuticals in the an unpalatable (or undesirable) substance such as used coffee grounds or kitty environment and their correlations to the quantities of unconsumed or unused litter; (3) putting the mixture into an impermeable, non-descript disposable pharmaceuticals in the home. Nevertheless, pharmaceuticals are increasingly container with a lid such as an empty coffee can or into a sealable plastic bag; being detected in our nation’s water, and the massive amount of pharmaceuticals (4) concealing or removing any personal information from the empty original being flushed down the toilet, poured down the drain and thrown in the trash containers; and, (5) throwing the sealed container or plastic bag with the mixture might aggravate an emerging public health problem. and the empty original containers in the household trash.

The US Geological Survey (USGS) provided the first and largest Disposal of household pharmaceuticals by flushing them down the toilet nationwide investigation of the occurrence of organic wastewater contaminants, or pouring them down the drain is the most significant contributor to water including pharmaceuticals, in streams. During 1999 – 2000, USGS personnel pollution, but disposal into the household trash can also contribute to water sampled water from 139 streams across 30 states to determine if organic pollution. Pharmaceuticals disposed in this manner are delivered to landfills. If wastewater contaminants are entering US streams. One or more of the 95 these pharmaceuticals are not biodegraded and protected from environmental organic wastewater contaminants evaluated were detected in 80 percent of the exposure they may leach into groundwater and eventually end up in streams, streams sampled for this study, with most (75 percent) of the streams having rivers or drinking water. Certain antibiotics (e.g. tetracyclines) have a strong mixtures of various contaminants. Among the pharmaceuticals detected, nontendency to bind with sewage sludge, soils and sediments and, therefore, take prescription drugs were found with greater frequency than prescription drugs. months to biodegrade. Generally, however, throwing pharmaceuticals into the Continued on next page Medical Waste Mgt Mag 5.125h x 8.375w Color Advt:Layout 1 7/16/2010 4:26 PM Page 1

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Medical Waste Management JUl-sep 2010

Continued from previous page The most commonly detected nonprescription drug was acetaminophen and the most commonly detected prescription drug was the antibiotic class, including erythromycin, lincomycin, sulfamethoxazole and trimethoprim. Collectively, these specific drugs comprised 16.7 percent of the 30 most frequently detected organic wastewater contaminants.

Many pharmaceuticals survive wastewater treatment. In March 2008, as part of an ongoing investigation, the Associated Press shockingly reported that trace concentrations of various pharmaceuticals – including antibiotics, anticonvulsants and sex hormones – were detected in the water supplies of 24 major metropolitan areas that provide drinking water for at least 41 million Americans. Although the measured concentrations of pharmaceuticals in the water supplies were low, the findings are still disconcerting. Currently, few wastewater treatment plants even test for the presence of pharmaceuticals and the federal government has not set safety limits. It is possible that even in trace concentrations, pharmaceuticals could be affecting aquatic organisms and human health.

Effects on Aquatic Life

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cientists theorize that chronic exposure to even extremely small concentrations of pharmaceuticals could produce harmful effects in aquatic life. In recent years, scientists have found evidence that pharmaceuticals are causing the presence of intersex characteristics in fish. This abnormality has been found in a number of waterways in the US, including Oregon and West Virginia. As part of its Chesapeake Bay studies, the USGS found that intersex characteristics in fish were widespread throughout the Potomac and Shenandoah Rivers. USGS scientists believe that one potential cause of this abnormality is certain pharmaceuticals (e.g. estrogens) that act as endocrine disruptors, chemicals that interfere with the natural balance of hormones in living organisms.

Scientists have not been able to conclude from field studies, however, that pharmaceuticals directly cause intersex characteristics in fish. Household pharmaceutical waste is, after all, only one source of endocrine disruptors

in US waters. Thus, the contribution of household pharmaceutical waste to fish-related problems is unknown. Further study is needed, but identifying the pharmaceuticals that impact aquatic life and their source will only help scientists develop solutions for the problem.

Effect on Human Life

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ecause there are no testing requirements or safety limits for pharmaceuticals in drinking water, millions of Americans are unwittingly consuming an array of drugs that may be harmful to their health. Potential health concerns from the presence of pharmaceuticals in drinking water include: increased risk of developing cancer, reproductive impairment and the development of antibiotic-resistant bacteria. These concerns focus on certain drug classes: chemotherapeutic drugs or hormones that can be carcinogenic, hormones that can fetter reproduction or development and antibiotics that can allow bacteria to mutate into more dangerous forms. Estradiol and synthetic estrogens, which are common constituents of contraceptives and hormone replacement therapies, are established carcinogens in humans.

Based on this evidence, some scientists believe that environmental exposure to pharmaceuticals containing estradiol and synthetic estrogens contribute to many unexplained cases of cancer, particularly female breast cancer. People who reside in locations where the water is highly polluted by household pharmaceutical waste might take in exogenous estrogens by drinking water. Once ingested, these foreign chemicals may promote the development of breast cancer in a variety of ways, such as through vasculogenesis. Although it is difficult for scientists to link household pharmaceutical waste to female breast cancer, the evidence showing that exogenous estrogens induce carcinogenesis in humans suggests that estrogens in the environment may be a contributing factor.

Exogenous estrogens also pose a health hazard to men. Experimentally, reproductive abnormalities and testicular cancers have occurred in laboratory animals exposed to exogenous estrogen in utero. Exposure to exogenous estrogens in fetal life could lead to adverse changes in male reproductive

Continued on page 10

Info Request #140 Medical Waste Management JUl-sep 2010

9

Understanding the Public Health Implications of Household Pharmaceutical Waste Continued from page 9 development and function in humans. One of the factors that could, at least theoretically, be partly responsible for the increased exposure of infants to exogenous estrogen during gestation is increased levels of synthetic estrogens in the environment – a potential consequence of household pharmaceutical waste.

Despite the fact that there is no direct evidence from human studies validating a causal link between exposure and effect, trepidation exists and is supported by reports of reproductive and developmental impairment in animals.

Resistance to antibiotics constitutes a major threat to public health.

Research has shown that a multitude of antibiotics are present in freshwater.

In a national study of antibiotic resistance in freshwater, scientists found that antibiotic-resistant bacteria were widespread in water samples from 16 US rivers. One reason cited is that the exposure of water to antibiotics selects for resistant bacteria. A growing body of evidence supports that even low-level concentrations of antibiotics in the environment could increase the rate at which bacteria develop resistance to antibiotics.

Nevertheless, several entities, such as the Pharmaceutical Research and Manufacturers of America (PhRMA), have concluded that pharmaceuticals tested to date in surface and drinking water pose no appreciable risk to human health because environmental concentrations are generally found to be several orders of magnitude below therapeutic or toxic levels. Based on their research, scientists conducting these studies and PhRMA believe that the detection of household pharmaceuticals in the environment reflects nothing more than better analytical technology. While it is true that better analytical technology now allows scientists to detect household pharmaceuticals in the environment at very low or minute concentrations, currently no data are available on countless

Info Request #133

Continued on page 14

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Info Request #138 Medical Waste Management JUl-sep 2010

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news briefs

Reprocessing Medical Equipment Reduces Waste, Cuts Costs Continued from page 3 Ascent collects SUDs from its client hospitals and ships the devices to either Lakeland, Fla., or Phoenix for reprocessing. Hospitals then can purchase the reprocessed items.

SterilMed also collects SUDs and guarantees that the same devices collected at a hospital are returned to the same facility. The company has technicians on-site at hospitals to manage the collection process. Devices are shipped back to SterilMed’s Minnesota site for reprocessing.

Both Sullivan and Thording agree that the demand for reprocessing is continuing to grow.

“The reprocessing industry has experienced steady growth in the past three years and SterilMed expects this trend to continue as reprocessing continues to grow more widely accepted as a way to both drive cost savings and protect the environment,” Sullivan says.

He also points to three OEMs who he says have FDA clearance to reprocess their own SUDs. “It’s a very, very rapidly growing area, both in terms of new hospitals signing on to this kind of practice and for hospitals who have dabbled in it and are now realizing, compared to other environmental initiatives, this produces huge results right away in terms of reducing waste,” Thording says. “Compared to other cost-savings initiatives, there’s no up-front capital investment and the result on your bottom line shows up the next month.”

In a commentary in March in Academic Medicine, Drs. Peter J. Pronovost and Martin A. Makary, both of Johns Hopkins University School of Medicine, issued a call for healthcare to go green by reprocessing medical equipment.

“Reprocessing offers healthcare institutions a solution to reduce waste and to reduce costs; as such, it should be explored,” they say.

Half of US Hospitals Recycle Medical Waste According to New Report

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ccording to a recent report released by the New York Times, half of all hospitals in the US are recycling at least a portion of their medical waste. Though it’s unclear just how much medical waste is produced in the US on an annual basis – and thus, how much is recycled (there hasn’t been a tally for several decades) – the report is nevertheless encouraging news for the future growth of the medical waste recycling industry. The Times attributes the prolonged stress of the economic downturn as the major factor driving the increase in medical waste recycling.

In other words, recycling saves hospitals money. For example, Hospital Corporation of America, a company that owns 163 hospitals in the US, saved more than $82 million in supply chain costs in the first half of 2009 alone by recycling 94 tons of medical waste. The use of disposable single-use medical devices took off in the 1980s over concerns about HIV transmission. But in recent years, an increasing number of hospitals are sending their single-use medical devices to processing centers for recycling and sterilization. By recycling single-use devices, they are not only keeping waste out of landfills, they are also saving between 40 to 60 percent in equipment costs.

Despite protests by the Advanced Medical Technology Association, a medical device trade group, in 2008 the Government Accountability Office has stated that using recycled single-use devices poses no increased risk to patient health. Some hospitals have even begun taking the initiative to lower costs and protect the environment by requiring medical device OEMs to reduce the amount of packaging and equipment included in packs of single-use devices – thereby reducing their overall waste production.

Cover photos courtesy of Ascent Healthcare Solutions. Page 3 photo courtesy of SterilMed.

Info Request #129 12AD Canada_dic 09.indd

1

Medical Waste Management JUl-sep9.58.28 2010 28/12/2009

newsMedicalWM_TQ_ad_8.2006_A briefs

8/24/06

8:54 AM

Page 1

Virginia Sees Problems with Disposal of Hospital Medical Waste

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tate and local officials in Virginia are facing problems with medical wastes from local hospitals, reports hamptonroads.com. The regional waste authority, the Southeastern Public Service Authority, threatened both Norfolk General and Sentara Leigh hospitals that it would refuse pickup until the two took corrective actions on problems that had spanned eight months.

Altogether, four local hospitals were seen to improperly discard medical waste bags on 13 occasions, said the Virginia Department of Environmental Quality, also including Sentara Bayside Hospital and Bon Secours DePaul Medical Center. Waste Industries, a private company, had accidently picked up red bags of medical waste from the Sentara hospitals and dropped them at SPSA facilities.

The issues were deemed serious, but specifics went undisclosed, and no fines or punishments were leveled. Regulators noted that no one was injured and no medical wastes exposed to the public or buried in a landfill. Sentara Leigh produces about 5,000 lbs of medical waste, enough to fill 500 red bags, each week, and Norfolk General fills more than 2,300 red bags in that time.

Such materials must be bagged separately and handled by a licensed medical waste hauler, generally to be incinerated in Maryland or North Carolina.

The local newspaper, the Virginian-Pilot, found out through the Freedom of Information Act about the problem. The hospitals found the problems were related to newly hired employees unfamiliar with daily disposal protocol. In response to the incidents, Norfolk General and Leigh limited the number of people with access to trash bins, improved lighting in the areas, and installed surveillance cameras. They also conducted staff and individual training sessions. Officials say the situation shows how difficult it is to regulate medical wastes and the role of human error in creating dangerous disposal situations.

Waste Management Acquires Medical Waste Processing Facility and Business in Phoenix

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M Healthcare Solutions, Inc., a subsidiary of Waste Management, Inc.recently announced that it has acquired a medical waste processing facility and certain other medical waste business assets located in Phoenix, Arizona, from Milum Textile Services Co., a provider of linen services and medical waste collection and treatment services.

According to company officials, the purchase of the medical waste autoclave facility fits into Waste Management’s strategy to manage solid waste, medical, recycling and pharmaceutical waste for the healthcare industry. The 35,000 square-feet facility today serves approximately 250 licensed healthcare facility customers, employs six people and has the capacity to process 30 tons of medical waste per day.

“Our acquisition of Milum’s medical waste autoclave facility is another step forward in growing our medical waste business,” said Mike Archer, general manager of WM Healthcare Solutions. “This investment represents an important strategic opportunity to offer disposal options, consulting and cost savings for hospitals, clinics, laboratories, doctors’ offices and a variety of other healthcare businesses in Arizona. The acquisition also adds to our capacity and geographic presence to treat and manage waste from healthcare customers,” Archer said.

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news briefs

Understanding the Public Health Implications Continued from page 10 pharmaceuticals being used by consumers. Even with improvements in analytical technology, it is doubtful that even the best technology will be able to predict the long term impact of continual exposure to combinations of pharmaceuticals on highly complex organisms such as humans.

Much is yet to be learned about the effects on humans exposed to low-level concentrations of household pharmaceuticals. Nevertheless, if exposure to low-level concentrations of certain pharmaceuticals, such as exogenous estrogens, does pose a threat to human health, reductions in exposure will provide an opportunity for primary prevention.

Info Request #111

Kevin T. Bain is a board certified pharmacotherapy specialist certified geriatric pharmacist and a certified public health professional. He is currently the Vice President of Clinical Support for excelleRx, an Omnicare company (www.excellerx. com). His concentrated fields are medication therapy management and hospice and end-of-life care. If you should have any questions regarding this series of articles, please contact Kevin at kbain@excellerx.com.

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For schedule and registration information, visit www.ashes.org/conference ASHES | www.ashes.org | (312) 422-3860 | ashes@aha.org 14

Medical Waste Management JUl-sep 2010

news briefs

South Carolina Clinic Ignores State Fine

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n Aiken, SC, medical clinic, the Fishbach Family Medicine and Ophthalmology clinic, is in trouble with the board for the SC Department of Health and Environmental Control, with a $16,500 fine for 12 violations of the state’s infectious-waste regulations documented one year ago, reports npaper-wehaa.com/bluffton-today. The clinic’s landlord complained to DHEC about infectious waste left behind after its relocation.

DHEC staff inspected the site and found 16 abandoned and undated containers of sharps.

It cited the clinic for that and for the clinic’s failure to label waste with a biohazard symbol, with no steps taken to prevent the public and the environment from being exposed to the waste. An employee was blamed for not knowing the proper procedures. So far, the clinic has not paid its fine, and its legal representative is unresponsive. The Fishbach Clinic produces 50-999 pounds of infectious waste monthly, say state records.

Four Massachusetts Hospitals Face Major Breach of Pathology Records

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ens of thousands of paper pathology records were found recently at a Boston area recycling station by a Boston Globe photographer dropping off his trash, reports healthdatamanagement.com. There were pathology reports from 2007 to early 2010, and included names, addresses, dates of birth, diagnoses, insurance policy numbers and Social Security numbers. The occurrence caused major problems for Carney Hospital, Holyoke Medical Center, Milford Regional Medical Center and Milton Hospital and their pathology practices, who then began investigating how the records breach occurred. They found the records were dumped by the former owner of a billing company; he sold the firm this summer, and the new owner kept only records from this year.

The breach made available results of more than 15,252 tests performed at Milton during the three-year period on 8,000 to 12,000 patients and affected 16,000 to 24,000 of Holyoke’s patients. The Milford and Carney facilities did not have estimates at the time of this report. The Carney, Holyoke, Milton and Milford facilities posted public notices of the breach on their Web sites. The former owner of the billing company acknowledged he had the records dropped off at the recycling site but declined to go on record, because of impending legal action.

Medical Waste Management JUl-sep 2010

Boston Medical Center Fined for Improper Waste Disposal

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oston.com reports that Boston Medical Center (BMC) has been fined $39,000 by the Massachusetts Department of Environmental Protection (DEP) for sending hazardous medical waste to an unlicensed facility. A DEP spokesperson says BMC sent the waste out for disposal because its autoclave machine, which sterilizes and shreds materials, was not working properly. In May of last year, investigators with the Massachusetts Environmental Strike Force used footage from surveillance cameras to identify BMC as the source of discarded blood bags and biohazardous materials found on a street outside the unlicensed facility.

Since the incident, BMC officials have made a number of changes to ensure safe disposal of the hospital’s medical waste, including building a new biological waste storage area, retraining custodial staff and instituting a system of regular inspections. For these efforts the DEP reduced BMC’s fine by almost $13,000.

Medical Waste Company Recycles to Fuel Concrete Production

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harps Compliance, a medical waste management company, is working on a way to convert used syringes, needles, lancets and other medical waste into fuel used to produce concrete, reports chron.com. Plus, the resultant ash can be used as an additive, like flyash is used today, in the concrete. The company collects about 100,000 lb. of waste daily, at its plant in Carthage, TX. This can be sterilized and compressed into pellets to be used as fuel for cement production.

The program has environmental and economic benefits, attracting business from those who want to reduce their carbon footprint.

Sharps Compliance now has a $40 million contract with a federal agency to dispose of medical waste generated during national emergencies. Cement manufacturers also will benefit from lower expenses and fewer environmental costs without having to burn coal, and Sharps Compliance will be able to eliminate $60,000 to $70,000 in annual dumping fees at landfills.

NSWMA Comments on Proposed EPA and OSHA Rules

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nstitutes of the National Solid Wastes Management Association (NSWMA) recently submitted comments regarding proposed rules by the United States Environmental Protection Agency (EPA) and the U.S. Occupational Safety and Health Administration (OSHA). NSWMA’s Landfill Institute offered comments on EPA’s proposed rule regarding amendments to the mandatory reporting of greenhouse gases, and NSWMA’s Healthcare Waste Institute recently submitted comments regarding OSHA’s blood-borne pathogens standard.

With the comments regarding greenhouse gas reporting, the Landfill Institute argued that the proposed rules substantially change the requirements for municipal solid waste landfills, imposing substantial new data collection requirements mid-reporting year. NSWMA’s Landfill Institute believes that EPA should not retroactively impose these requirements for reports that are to be submitted in 2010 and, in some cases, provide an opportunity for formal public comment. Proposed rule changes include amendments to the definition for construction and demolition landfills; how landfills measure waste quantities; and the methodology, decay rates and values of degradable organic carbon used to estimate greenhouse gas emissions.

Regarding these changes, NSWMA President and CEO Bruce J. Parker stated, “While some of EPA’s changes appear to provide a more reasoned approach to account for the amount of water that might infiltrate into a landfill, other changes impose substantial new data collection requirements mid-reporting year without the benefit of adequate public comment.”

In the comments regarding the bloodborne pathogens standard, NSWMA’s Healthcare Waste Institute stated that the current standard is a necessary part of protecting healthcare workers and should be updated to consider changes in health settings such as medical treatment in non-traditional facilities.

In support of the current regulations, Parker stated, “The current standard ensures a level playing field for companies that should provide health and safety protection for their employees. Without a federal standard, it is less likely that healthcare facilities will be willing to pay for worker protections against bloodborne risks or that they will be willing to cover the costs associated with reducing risks for waste management services.”

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Massachusetts Hospital Loses Back-Up Records from 800,000 People

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oston’s South Shore Hospital has lost back-up computer files containing 14 years’ worth of personal and financial information, covering the time between Jan. 1, 1996, and Jan. 6, 2010, for about 800,000 people, including patients, employees, donors, volunteers and vendors, reports bostonherald. com.

South Shore notified those whose data were lost and posted updates on its website.

The hospital has no evidence that information has been accessed by anyone. An independent information-security consulting firm said that specialized software, hardware and technical skill would be needed to access it. The hospital refused to identify the data management company that lost the files, but it is looking into the matter.

The state Attorney General’s Office, state and federal health agencies have been notified, and the hospital is working with Massachusetts Attorney General Martha Coakley to set up a toll-free automated information line to provide people with information. Coakley’s office suggests that people involved with this or other cases of data loss should call one of the nation’s three major credit bureaus and place a fraud alert on their credit report.

E-Waste Becomes a Top Priority for EPA Action

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Info Request #113 16

hen it comes to international environmental challenges, climate change is among the most commonly cited top priorities. But EPA Administrator Lisa Jackson recently added e-waste and four other issues to the agency’s areas of focus, reports environmental-expert.com.

In a memo from the meeting of the Commission for Environmental Cooperation in Guanajuato, Mexico, Jackson spelled out why e-waste has become a top-level concern for the administration.

‘The electronics that provide us with convenience often end up discarded in developing countries where improper disposal can threaten local people and the environment,’ Jackson wrote. ‘EPA recognizes this urgent concern and will work with international partners to address the issues of e-waste. In the near-term, EPA will focus on ways to improve the design, production, handling, reuse, recycling, exporting and disposal of electronics.”

Canadian Province to Invest Over $7 Million to Develop New Biomedical Waste Facility

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he province of Manitoba, Canada recently announced that it will invest over $7 million to improve capacity, efficiency and environmental protection with a major reconstruction of the biomedical waste facility at the Brandon Regional Health Centre in Brandon, Manitoba, according to a recent report issued by the Manitoba Chambers of Commerce (www.mbchamber.mb.ca).

“Manitoba is taking a major step forward in its environmental protection agenda with the development of a provincial plan for biomedical waste management,” said Health Minister Theresa Oswald. ”This facility will provide an innovative, environmentally friendly and costefficient way to manage biomedical waste.”

The new biomedical waste facility in Brandon will reduce greenhouse-gas emissions and comply with Canada-wide standards on dioxins and furans, toxic emissions released when plastic products are burned. In addition to improving air quality in Brandon, the new waste disposal facility is required to keep up with expanding health services in the region, the minister said.

There are also 20 older incinerators in smaller hospitals around rural Manitoba. Rural regional health authorities (RHAs) have been seeking solutions for biomedical waste disposal and will have access to the Brandon facility once complete, which could serve up to nine rural RHAs in Manitoba. Specific guidelines will be set for proper containers that comply with all applicable safety standards markings. All regulations, guidelines and safety precautions will be taken within the RHAs when handling and preparing to handle any hazardous waste.

This new state-of-the-art facility will use a combination of recycling non-medical cardboard, wood and papers, shredding and sterilizing sharps, gloves and other non-recyclable materials and incineration of biomedical waste materials. Hospital incinerators account for nearly 90 per cent of dioxins and furans released into the atmosphere in Manitoba and these emissions will be eliminated with the new Brandon facility and phasing-out of non-compliant incinerators in rural Manitoba, Oswald said.

Subscribe today to Medical Waste Management. by calling 440.257.6453.

Medical Waste Management JUl-sep 2010

news briefs

Registration is Open for the 2010 Michigan Green Health Care Conference

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he MHA Michigan Green Healthcare Committee will sponsor The 2010 Michigan Green Health Care Conference, being held on Friday, October 22 at Spectrum Health Butterworth Hospital in Grand Rapids, Michigan. The Michigan Green Healthcare Conference is intended for individuals that work in the health­care field. Specifically, it is for those individuals that are affiliated with the engineering, en­vironmental services and quality departments.

This conference is designed to teach individuals in the health care field tactics to reduce their ecological footprint. Strategies on how to properly build a green team, alternative energy ideas like geothermal use, storm water design, recycling and EPA’s Waste Wise Program are going to be discussed. The conference includes a first-hand tour of green initiatives Spectrum Health Butterworth Hospital currently has in practice.

Register online at: http://www.michigan.gov/deq/0,1607,7-135-3308_3333_4169-238782--,00. html. You may also contact Paige Hathaway (phathaway@mha.org) at the MHA.

Silver Recovery Creates Revenue

Barnett Medical Services Announces the Formation of the IMWTA; A National Alliance of Independent Medical Waste Transporters

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arnett Medical Services, an independently owned and operated provider of medical supplies and waste removal services in Northern California since 1961, recently announced the formation and launch of the Independent Medical Waste Transporters Association (IMWTA) designed to allow member businesses significant exposure and resources to compete nationally.

According to Barnett officials, IMWTA members will have the ability to align with other Independent Medical Waste Transporters to bid on national contracts that will provide significant cost-reductions to medical waste generators throughout the Unites States. According to Brett Espicha, President and CEO of Barnett Medical Services, the IMWTA creates the ability to participate in bidding and servicing national contracts, receive national recognition for these services, attend events and educational sessions, and receive member benefits such as optimal pricing on products offered to the association as a whole.

Mr. Espicha continued, “By the end of 2010, we anticipate having more than 200 Independent Medical Waste Transporter Members, covering the entire U.S, collectively involved in the transporting of over $500 million in medical waste annually. The IMWTA members will have access to regional and national Requests For Proposal (RFPs), national bidding and contracting support, and additional infrastructure and services enabling networked transporters to compete as one organization across the nation.”

MedClean Technologies Signs Distribution Agreement with Ace Technologies to Serve Canadian Healthcare Market

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edClean Technologies, a provider of onsite technology for the treatment and disposal of medical waste and the destruction of confidential documents and related media, recently announced it has signed a distributor agreement with Ace Technologies, Inc., an industry provider of full turn-key network solutions, security, and monitoring services in Canada.

To facilitate distribution, Ace has formed a new company, MedClean Canada, to provide integrated onsite medical waste disposal and onsite document destruction technology and services to healthcare facilities throughout Canada.

“MedClean Canada can now offer medical waste disposal and document destruction technology on-site to its healthcare clients throughout Canada,” commented David Laky, President and CEO, MedClean Technologies, Inc. “We are very excited about becoming a full, turn-key distributor of MedClean Technologies in Canada, and pleased to have the opportunity to establish MedClean Canada, a new organization, to target hospitals throughout Canada,” added Eric Chetrit, Ace Technologies President.

Medical Waste Management JUl-sep 2010

X-ray Defibrillator pads Medical files Antimicrobial Dressings Main Line Catheters

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www.gemark.com 1-866-943-6275 Info Request #120 17

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Kaiser Permanente Roseville, Calif. Begins Recycling Emergency Department Waste

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ccording to sacbee.com, Kaiser Permanente Medical Center in Roseville, California is now recycling 2,500 pounds of polypropylene a month and the other five Kaiser facilities near Sacramento are following their example. It started with a nurse’s suggestion, and soon the hospital had bought hampers for its blue wrap. Kaiser’s blue wrap recycling program soon had other medical personnel wanting to recycle other plastic used in the operating room.

The facility arranged with Chicago-based Smurfit-Stone to take its cardboard, paper, polypropylene and shrink wrap and sell the recycled goods to manufacturers of toys, patio furniture and shower curtains. Kaiser Roseville receives $100 per quarter from Smurfit-Stone for recycling its cardboard, shrink wrap and blue wrap.

According to Hospitals for a Healthy Environment, hospitals nationwide produce a combined 6,600 tons of waste on average every day. Theoretically, 85% of hospital waste can be recycled. The remainder is regulated medical waste: radiological, hazardous and infectious waste such as needles and surgically removed parts that is incinerated or treated with chemicals.

About 80% of plastic waste comes from the operating room, where one-use plastics are used to preserve a germ-free environment, not only in blue wrap but also in containers for liquids, such as saline solutions and medicine. Hospitals have a higher percentage of plastic waste than homes, according to Davis Baltz of CleanMed, an organization that works with hospitals on recycling and other green intiatives.

Polypropylene is high quality and chemical-resistant, used for wrapping hospital goods to keep them sterile as well as for liquid containers for saline and medicine. Less than 10% of it is recycled, and there are fewer plants designed to recycle polypropylene than soft-drink bottles.

Clean Harbors Offering Customized Pharma Waste Services

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lean Harbors, a provider of environmental, energy and industrial services throughout North America, recently announced that it is offering custom-designed pharmaceutical waste management and removal programs for hospitals and other healthcare facilities.

According to company officials, Clean Harbors services will include waste removal, sorting and disposal programs that support each organization’s procedures by using pharmaceutical waste management practices that conform to the operational structure while meeting regulatory requirements.

Clean Harbors pharmaceutical waste management offering is available either as a comprehensive on-site service that eliminates the need for in-house waste management staff or as a menu of services to address specific needs. Services include: Rx Waste Characterization, Rx Program Design, Medical Floor Rx Collection Services, Main Accumulation Area Management and Transportation & Disposal at Clean Harbors company owned and operated facilities.

Officials also stated that Clean Harbors pharmaceutical waste services adhere to Environmental Protection Agency (EPA) Resource Conservation and Recovery Act (RCRA) and Universal Waste (UW) handling regulations. Clean Harbors services also include the handling and disposal of mercury, chemotherapy and reactive materials, as well as solvent recycling.

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First-Ever USGS Study Finds Drug Makers Play Big Role in Environmental Pharmaceutical Contamination

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n a five-year, first-of-its-kind, study, U.S. Geological Survey scientists found that pharmaceutical manufacturing facilities can be a significant source of the pharmaceuticals found in the environment. The study, which ended last year, found effluents from two wastewater treatment plants that receive discharge from pharmaceutical manufacturing facilities had 10 to 1000 times higher concentrations of pharmaceuticals than did effluents from 24 wastewater plants that do not receive such discharge.

Measured pharmaceuticals could be found downstream as much as 30 k from one plant’s outfall. These pharmaceutical formulation facilities are where ingredients are combined to form final drug products and products are packaged for distribution.

In this study, 35 to 38 effluent samples were collected from each of three wastewater plants in New York State and one effluent sample was collected from each of 23 strategically selected wastewater plants across the U.S. The samples were analyzed for seven target pharmaceuticals including opioids and muscle relaxants, some of which have not been previously studied in the environment. Pharmaceutical concentrations in effluents from two of the three NY plants, both of which receive more than 20% of their discharge from PMFs, were compared to the measurements made at the third NY plant in New York State and other non-NY 23 plants.

Maximum pharmaceutical concentrations in effluent samples from those treatment plants rarely exceeded one part per billion. In contrast, maximum concentrations in effluents from the two NY plants receiving pharma discharge were as high as 3,800 ppb of metaxalonem 1,700 ppb of oxycodone, greater than 400 ppb of methadone, 160 ppb of butalbital, and greater than 40 ppb of both phendimetrazine and carisoprodol.

Ongoing studies are documenting the levels at which these additional pharmaceuticals occur in the environment. For more information on this study visit www.toxics.usgs.gov.

Trinova Medical Waste Solutions, LLC Appoints Thomas Bang Chief Executive Officer

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rinova Medical Waste Solutions, LLC, recently appointed Thomas Bang as Chief Executive Officer. Bang will lead the global market expansion of the TrinovaMed Monarch Green Machine, a patent-pending, environmentally friendly solution for the treatment and management of regulated medical waste (RMW). The Green Machine was unveiled in February 2010.

Bang has more than 30 years of experience in the healthcare industry.

Bang comes to Trinova from San Diego-based A-Life Medical, Inc., where he was CEO and President. Prior to A-Life Medical, Bang was CEO at Patientline, LLC, a patient-care technology provider. Bang has also held various executive positions at American Hospital Supply, Baxter International, Cardinal Health and the Pyxis Corporation.

“Tom brings strategic insight forged by his industry knowledge to Trinova and will serve as a catalyst in transforming the way the industry thinks about managing medical waste. Tom has the passion and vision to guide our organization forward into the future as the leading provider of green waste management solutions. This is a very exciting time for Trinova,” said Jim Smith, Chairman of the Executive Committee.

Medical Waste Management JUl-sep 2010

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Serving The Healthcare And Medical Waste Industries

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TOP STORIES Reprocessing Medical Equipment Reduces Waste, Cuts Costs

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Understanding the Public Health Implications of Household Pharmaceutical Waste in the US

PAGE 4

Workplace Privacy, Data Management and Security Report

PAGE 6

NSWMA Comments on Proposed EPA and OSHA Rules

PAGE 15

First-Ever USGS Study Finds Drug Makers Play Big Role in Environmental Pharmaceutical Contamination

PAGE 18

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