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WEBINARS

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MEETINGS / EVENTS

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October 13 - 17 2012, 12:00 AM - 12:00 AM

ANESTHESIOLOGY 2012

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FDA MEDWATCH ALERTS

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May 16, 2012

Hydromorphone Hydrochloride Recall

Summary:

Hydromorphone Hydrochloride Recall

April 18, 2012

Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume

Summary:

Customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume. Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

March 05, 2012

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Component

Summary: FDA notified healthcare professionals and medical care organizations of the Class 1 recall of the listed AEDs which contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy, causing serious adverse health consequences, including death. The unit’s self test may not detect the failure or impending failure of the component.

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ASA FEATURED PRODUCT

Anesthesiology Continuing Education (ACE) Program

SKU: 30702-12CE

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Single Copies, Member Price: $300

Greening the Operating Room: Reduce, Reuse, Recycle and Redesign

Authors : T. Kate Huncke, M.D., Susan Ryan, Ph.D., M.D., William Paulsen, Ph.D., Caitlin Stanton, M.P.H., Spencer Yost, M.D., and Adam B. Striker, M.D.

Produced by the Committee on Equipment and Facilities, Charlotte Bell, M.D., Chair

Did you know?

  • Operating rooms generate 20-30 percent of total hospital waste?
  • Inhaled anesthetics are potent greenhouse gases?
  • Many anesthesia equipment and facility design choices can have significant environmental
    impact?

According to a study from the University of Chicago, the healthcare sector accounts for 8% of the United States total green house gas emissions (1). The investigators took into account the contribution generated by hospital activities, research, and the production and distribution of pharmaceuticals. The analysis found that hospitals by far were the largest contributors of carbon emissions. Although the findings are worrisome, they suggest that greener health care delivery will have a large positive impact on our environment.

This document has been developed by the ASA Committee on Equipment and Facilities but has not been reviewed or approved as a practice parameter or policy statement by the ASA House of Delegates. Variances from recommendations contained in this document may be acceptable based on the judgment of the responsible anesthesiologist. The recommendations are designed to encourage quality patient care and safety in the workplace, but cannot guarantee a specific outcome. They are subject to revision from time to time as warranted by the availability of new information.

This document is intended to be informative on the subject matter covered and is not intended to provide specific legal or professional advice.

The Committee on Equipment and Facilities is advocating for increased environmental consciousness in our practices and the facilities in which we work. Anesthesiologists can lead by improving operating room design, anesthetic agent choice and management, and waste disposal and diversion and can mitigate the negative environmental effect of anesthetic practice in all its forms. Like other industries, the environmental impact of our practice, if left unchecked, could trigger government regulation. Anesthesiologists, surgeons, and healthcare administrators are best positioned to reduce the negative impact our practice has on the environment by proactively examining these issues. Anesthesiologists have an opportunity, through education and research, to lead the development of hospital initiatives that foster environmentally friendly policies and programs.

These issues can be addressed by looking closely at the following areas:

  1. Environmental sustainability in anesthesia equipment choices
  2. Waste stream management and recycling opportunities
  3. Environment sustainability in perioperative settings and operating room design

1. Anesthesia Equipment Choices

Disposable versus Reusable Equipment

Many types of anesthesia equipment may be purchased in a disposable or reusable form. Both selections have potential to harm the environment. Traditionally, the choice focused on cost, patient safety, and ease of disposal and care of equipment. For example disposable equipment, such as disposable laryngoscope blades, has become increasingly popular because it eliminates the risk of cross contamination between patients. Money is saved by eliminating the costs of cleaning that involves labor, specialized equipment and quality control. Further, reusable items sometimes involve cleaning and disinfecting solutions that may be toxic to the environment. On the other hand, disposable items may be of lower quality and contribute substantially to the bulk waste of landfill or incinerators—where toxins are released into the atmosphere. The environmental impact of manufacturing, disposal, and waste management has not typically been considered in the cost of purchasing disposable items. A full ‘life cycle’ analysis may actually favor reusable items more often than is currently thought. Very few life-cycle analyses have been performed on anesthesia equipment. By interfacing with purchasing and sustainability coordinators, anesthesia and surgical practices can determine which items have the lowest cost and environmental impact.

Reprocessed Equipment

Some single use devices (SUDs) or disposable items are suitable for reprocessing. Examples of items that are labeled as one time use but can be cleaned, reprocessed and resold at substantially reduced costs to the hospital are pulse oximeter probes, blood pressure cuffs, hundreds of surgical instruments including laparoscopic surgical trocars, and sequential compression devices. Several companies currently provide this service. Environmentally friendly pasteurization for sterilization may be used for equipment items that do not penetrate the skin; however, some companies use ethylene oxide for sterilization, which is more toxic but ensures invasive surgical equipment is adequately sterilized.

Government Oversight of Reprocessed Equipment

Reprocessing of equipment, especially invasive surgical devices, may raise concerns about performance and adequacy of sterilization. The Food and Drug Administration (FDA) currently requires that the reprocessing entity state in writing that the reprocessed medical device is “substantially equivalent” to the original equipment. Approximately 65% to 75% of reprocessed SUDs fall into Class II (medium risk), which requires submission to the FDA of a premarket notification report. The reprocessing entity must provide evidence of equivalence to the original device already on the market in terms of safety, effectiveness, and intended use. Class II devices include pulse oximeter sensors, ultrasound catheters, drills, compression sleeves, and most laparoscopic equipment. Because of safety concerns about the equivalency of SUDs, many physicians, manufacturers, and politicians have lobbied for legislation requiring written patient consent, documentation of all reprocessed SUDs used during treatment, and stricter systems of tracking SUD failures and injuries, while holding reprocessors fully liable for any adverse events.

The government has responded to these concerns by conducting several investigations and hearings about the reprocessing of SUDs and has introduced stricter regulations at all levels of production. Most notably, the Medical Device User Fee and Modernization Act (MDUMFA) of 2002 requires that all reprocessed SUDs be labeled and have the identification of the reprocessor. All adverse events can be more easily tracked and reported to the FDA. MDUMFA also created more stringent FDA oversight of reprocessed SUDs. In January 2008, the U.S. Government Accountability Office (GAO) released a report indicating that reprocessed SUDs do not present an increased health risk to patients (2). Of the 434 adverse events reported to the FDA between 2003 and 2006 in which reprocessed SUDs were identified, only 65 actually involved a reprocessed device, and all adverse events were similar to those reported for new devices.

Some major pulse oximetry companies currently offer reprocessed sensors at prices comparable to third party reprocessors. Contracting with an original equipment provider may ensure that the clinical performance is backed by the original source.

The Environmental Impact of Manufacturing and Disposing of Anesthesia Equipment

The assembly of anesthesia machines and monitors continues to have a negative environmental impact. Machines and monitors are composed of metals, molded plastics, and computer parts. Manufacturing and finishing of both metals and plastics often involves the release of environmental toxin. In 2008 the EPA amended the clean air act adding national emission standards for hazardous air pollutants (NESHAP). The legislation targets air pollution from nine metals including cadmium, chromium, lead, manganese and nickel which are often emitted into the air from various operations at metal and electronic fabrication and finishing plants. The computer industry uses over a thousand hazardous substances in the manufacturing of computer chips. Since these devices are manufactured in many locations around the world, there will need to be global cooperation from governments to reduce the resulting toxic wastes.

The disposal of monitoring equipment, computers, and anesthesia machines also poses problems for the environment. Chip factories in Silicon Valley have left a legacy of pollution, creating 29 superfund sites in Santa Clara County alone. However, machines and monitors contain recyclable metals such as stainless steel, aluminum, brass, zinc, nickel and copper. The challenge is to separate the recyclable metals from the non-reusable materials. It is important to arrange environmentally friendly disposable with hospital waste management. An independent metal recycling facility may be more successful at recovering metal parts. Older anesthesia machines and monitors can also be refurbished and sold to a lab, another health care facility or veterinary clinic. There are also medical missions that will accept used equipment.

A variety of batteries used in many pieces of anesthesia and medical equipment have well developed recycling programs. This is because of the passage of the Mercury-Containing and Rechargeable Battery Management Act (The Battery Act) by the federal government in 1996. This act required that all states comply and establish programs for the collection, transport and disposal of environmentally hazardous rechargeable batteries This act required that all Nickel-Cadmium (Ni-Cd) batteries and Lead acid batteries be labeled with three chasing arrows, a phrase stating the batteries must be recycled and mandated that the rechargeable batteries be easily removal for purposes of proper disposal. The law led to the replacement of Ni-Cd batteries with Lithium-Ion (Li-ion) batteries. Although the toxic cadmium has been removed these rechargeable batteries can be recycled through the Rechargeable Battery Management Act programs. Lead acid batteries which are used in anesthesia machines and other hospital equipment must be recycled. If machines are serviced under the manufacturers’ service contract, batteries will be properly recycled according to protocol. If machines are serviced in-house or by other companies, more effort may be required to insure proper handling of these toxic materials. Lead acid battery reuse leads the recycling effort with 98% of lead acid batteries being recycled in the United States.

The Battery Act also required that mercury be removed from disposable batteries making them safe for disposal in regular trash. Many businesses however recycle disposable alkaline batteries such AAA, AA, C, D and 9 volt batteries because they contain trace amounts of hazardous metals and because the metal part of the batteries are recyclable. Some states have adopted laws requiring disposable battery recycling. There are mail in programs that can be used to recycle disposable batteries.

2. Waste Stream management and Recycling Opportunities

Types of Operating Room Waste

Current estimates suggest that operating rooms are responsible for 20-30% of total hospital waste. Packaging material used to protect and maintain the sterility of supplies and equipment accounts for a large part of the waste. Also, increased use of disposable supplies and equipment contributes to the problem. Infectious material, sharps and certain medications, which are hazardous to the environment, must be discarded into special containers and fall under the category of regulated medical waste (RMW).

Solid Waste Recycling Opportunities

Most of the material generated in the operating room is solid waste, which can be recycled if it has not been contaminated by bodily fluids. A report from the Department of Anesthesia at Western Hospital in Australia notes that anesthesia waste stream represented 25% of the total operating room waste and 60% of anesthesia waste is recyclable (3). This report also found that one of the barriers to recycling is failure to separate infectious waste from clean waste.

Successful operating room recycling programs have procedures to recycle material such as plastics, glass, paper and blue wrap in recycle bins before the patient enters the room. Much of the recyclable waste is generated when materials are opened and prepared before the case begins. Closing the bags or bins before the patient enters the room eliminates infectious contamination. Hospitals regulations often require that all waste remain in the operating room suite until the conclusion of the case to ensure that the trash can be inspect if the sponges, needles or equipment counts are incorrect. Recycle bins will often need to remain in the room until the wound is closed.

Recycled materials have monetary value and can be sold to recycling facilities. This decreases the expense of solid waste disposal. Operating room recycling also increases awareness of waste segregation. It can often be tied in with RMW reduction, which is far more expensive than solid waste disposal. Many US hospitals report substantial cost savings when recycling is utilized effectively in the operating room.

Regulated Medical Waste Reduction

The Centers for Disease Control and Prevention (CDC) suggests that only 2-3% of hospital waste needs to be disposed of as infectious waste. This is much lower than the 50-70% of waste that is generally put in the biohazard waste stream. A more realistic goal would be to reduce RMW to 6-15% of the total waste from the operating room. Waste reduction can be accomplished with ongoing staff education. Posters with pictures of what truly qualifies as RMW has led to reductions in the volume of red bag, or RMW, refuse. RMW must be treated before it is sent to landfill. Limiting the volume of RMW for disposal leads to substantial dollar and environmental savings for the hospital since the cost can be as much as 500% higher.

Donations

Donation of unused items to medical missions is an excellent way to reduce waste. Many clean or opened/unused items that would be placed in landfill can be collected and sent to developing countries. Med Share International is a nonprofit organization that provides staff training, receptacle bins and pick up services to collect medical equipment that cannot be used in the United States due to FDA regulations, expiration or break in sterility. Recovered Medical Equipment for the Developing World (REMEDY) is another non-profit organization that provides institutions with a ‘how to’ training kit for setting up your own donation service in your institution. Both organizations accept dozens of pieces of equipment that are used every day in our practices. This may, in fact, shift some disposal issues to other countries that may not have the means or environmental awareness to provide proper disposal; this issue should be addressed as part of equipment use education when the items are donated.

3. Environmental Sustainability in Perioperative Settings and Operating Room Design

Green Guidance for Remodeling and Construction of Operating Room Facilities

It is important that operating room design and health care facilities strive to limit their environmental impact. The Leadership in Energy and Environmental Design (LEED) (www.usgbc.org) and Green Guide for Health Care (www.gghc.org) offer green design guidance for remodeling or new construction. LEED certification specifically for healthcare is in development. In order for a new project or renovation to be LEED certified, it must accumulate a required number of points in the following six areas of green design and operation: sustainable sites, water efficiency, energy and atmosphere, materials and resources, indoor environmental quality, and innovation and design. A total of 100 points is available and based on the degree of compliance, projects will receive LEED certificate rating of “certified” with 40-49 points, “silver” with 50-59 points, “gold” with 60-79 points or “platinum” with 80 or more points. LEED certification is voluntary, but state and local governments may offer tax incentives when a facility meets the required level of achievement. While there are other programs of sustainable certification in use, LEED certification offers a clear example of how goals common to these programs can be achieved.

1.Features of a Sustainable Site

LEED certification points in this area depends upon evaluation of factors such as site selection, site development (protecting habitat, maximizing open space), alternative transportation (accessibility to public transportation, bicycle storage, parking capacity, and low-emission vehicles), storm water design, and light pollution. A maximum of 26 points can be earned in this category, and as a prerequisite, the site must prevent pollution during construction.

2. Water Conservation

A reduction in water use is important for certification. Low-flow fixtures should be utilized in urinals, toilets, and showers; and sensing ‘turn off’ devices should be used at sinks. Reclaiming water that doesn’t interfere with patient safety, infection control and operative sterility needs should be considered in the design. The building will be rated for efficient use of water in landscaping, continued water use reduction, and wastewater technology.

3. Energy Conservation

Energy and atmosphere evaluation examines energy performance. Points are based on several benchmarks including optimal energy efficiency, the use of onsite renewable energy, monitoring and tracking usage, and “green” power usage such as wind or solar power. The use of natural lighting is encouraged and when artificial lighting must be used, motion sensors can help conserve energy. Light emitting diode (LED) bulbs are now available for use in OR surgical lighting. Substantial cost savings can be generated through energy conservation.

4. Use of Low Impact Materials for Construction

Materials and resources should encourage the use of eco-friendly material. It requires, at a minimum, the storage/collection of recyclable materials. Additional points are given for building reuse (maintaining existing walls, roof, etc.), construction waste control, materials reuse, and for using recycled, regional or materials that are quick to renew. Health care waste and diversion is a special area of concern. Activities in surgical suites and perioperative areas produce voluminous waste with more biohazardous waste than other areas of a healthcare facility. Recycling opportunities will be improved by thoughtful OR design that allows for sufficient space and separation of uncontaminated material prior to the patient entering the OR or patient contamination.

5. Air Quality

LEED certification requires the building to meet two prerequisites for indoor environmental quality: minimum indoor air quality and the control of tobacco smoke. It is then evaluated for monitoring outside air delivery, enhanced ventilation, and low-fume materials (glues, paints, flooring systems, wood products). In addition, factors such as temperature comfort, daylight, and views are also rated.

6. Creativity and Innovation in Green Design Scores Points

Finally, innovation in design awards credit is granted to projects that demonstrate quantifiable environmental benefit through new strategies and techniques not specifically addressed in the LEED rating system. Also, additional points are earned if the designer or architect is LEED accredited. Several examples of design which can promote more environmentally sustainable anesthesia include inhaled anesthesia systems design and space considerations to avoid contamination. Anesthetic gas waste discharged into the atmosphere is currently not regulated. However, this may be a future area worthy of design innovation since volatile agents act as greenhouse gases and nitrous oxide both depletes the ozone layer and acts as a greenhouse gas. Inhaled anesthetic reclamation systems under development will be helpful for reducing or neutralizing waste gases. Providing space that prevents contamination of recyclable materials and unopened equipment will also decrease unnecessary waste.

Helpful Links

Greening the OR, Practice Greenhealth: An initiative by Practice Greenhealth to tackle the problem of environmental impact by identifying key interventions that can reduce waste, energy, worker exposure to hazardous chemicals and save money. This initiative is an attempt to collect data on these interventions and share them as a means to encourage widespread adoption across the sector. See website for ways to become involved. http://www.practicegreenhealth.org/educate/greening/greening-the-or/

Healthcare without Harm: Global organization working to implement ecologically sound and healthy alternatives to health care practices that pollute the environment and contribute to disease. http://www.noharm.org/

Practice Greenhealth: A networking organization that offers information, best practices, and solutions for greening healthcare practices and facilities. Members include hospitals, healthcare systems, businesses and other stakeholders engaged in the greening of healthcare to improve the health of patients, staff and the environment. http://www.practicegreenhealth.org/

CleanMed: Annual environmental conference to catalyze environmental improvements in the healthcare sector. http://www.cleanmed.org/

Greenseal: An independent non-profit organization that provides a guide to green cleaning products. http://www.greenseal.org/

REMEDY: Recovered Medical Equipment for the Developing World: Describes rationale and methods for donation of medical equipment. http://www.remedyinc.org/

Medshare: Medical Equipment Recovery Service: Provides efficient recovery and redistribution of surplus medical supplies and equipment to underserved healthcare facilities in developing countries. http://www.medshare.org/

Healthier Hospitals Initiative: A coalition of major health systems and organizations committed to improving sustainability and safety across the healthcare sector. www.healthierhospitals.org

Sustainable Hospitals: Provides technical support for health care industry looking to select products and work practices that reduce environmental and occupational hazards. http://www.sustainablehospitals.org/cgi-bin/DB_Index.cgi

Vanderbilt anesthesia gas recycling technology. http://www.vanderbilt.edu/magazines/vanderbilt-magazine/2009/03/recycled-anesthetic-technology-saves-dollars-environment/

Blue Zone technologies anesthesia gas recycling technology. http://www.bluezone.ca/

Battery Recycling: Information about various types of batteries and recycling. http://www.batteryuniversity.com/partone-20.htm

References:

  1. Chung JW, Meltzer DO: Estimate of the carbon footprint of the US Health Care Sector. JAMA. 2009;302:1970-72
  2. United States Government Accountability Office. Report to the Committee on Oversight and Government Reform, House of Representatives. Reprocessed Single-Use Medical Devices: FDA Oversight has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk. Washington, DC: United States Government Accountability Office. January 31, 2008.
  3. McGain E, Hendel SA, Story DA. An audit of potentially recyclable waste from anesthetic practice. Anaesth Intensive Care 2009; 37:820-3.