April 2000

Circulate to:

____ Safety                  ____ Infection Control

____ Plant Operations ____ Other

This marks the first issue of a new OHA publication, devoted to health care environmental and occupational safety issues.

Hospitals have become one of the most regulated entities in the world.  How many businesses, for example, must comply with regulations governing infectious, hazardous, radioactive, and solid waste – plus deal with recycling and confidential waste streams?  How many businesses must follow state and federal regulations governing radiation-generating equipment and use of radioactive materials?  How many businesses must comply with multiple inspectors and various regulatory schemes, whether from OSHA, EPA, state and local health departments, FDA, Medicare validation teams, AOA, JCAHO, etc.?

Oh, by the way, hospitals care for sick and dying people, too.

The goal of this newsletter is not to duplicate what you already receive.  Our ambition is to provide you with a periodic update of state and federal matters of importance to you.  This first issue deals with the OHA/OEPA pollution prevention campaign, OSHA’s proposed ergonomics rules as commented upon by OHA, the safe-needle debate including pending Ohio legislation, FDA’s device reuse proposal as commented upon by OHA, and Ohio’s bioterrorism preparations.

Your comments are welcome.

Peg Baird, Environmental Policy Committee Chair

In their Ohio Healthy Hospitals Pollution Prevention Initiative, OHA and the Ohio Environmental Protection Agency (EPA) are collaborating to reduce hospital waste volumes, eliminate mercury waste, and educate health care professionals on pollution prevention activities, in a partnership like that between the American Hospital Association (AHA) and U.S. EPA. These national organizations reached a 1998 Memorandum of Understanding as a reaction to hospitals' role in generating mercury emissions from incinerators and solid waste, including dioxin. As a result, hospitals have begun to close incinerators, reduce pollution at the source, and adopt recycling programs, saving money in the process.

To diminish the pollution associated with hospital waste management, OHA and the Ohio EPA seek collaborative ways that both help the environment and make financial sense. The two plan to highlight special programs already undertaken by Ohio hospitals, to identify key areas where hospitals can make new, fiscally sound, advances through education and wise use of resources. To facilitate learning about any of these programs, a major part of this initiative involves completion of a survey on waste management and pollution prevention by Ohio hospitals. Currently, a number of surveys have been completed, although many hospitals have not yet replied. As more surveys are returned, OHA and the Ohio EPA can better understand the status of hospital waste management in this state.

Hospitals that control their total waste stream or reduce mercury waste can realize financial benefits, enhance their reputation in the market and prevent possible regulatory action. Some hospitals have reduced the environmental impact of hospital waste, while simultaneously enhancing worker safety and community health, realizing cost savings on worker sick leave, enhancing community reputation and reducing waste processing expenses. By proactively reducing waste, in cooperation with regulatory agencies, Ohio hospitals can also avoid new, costly regulatory mandates in the future. Thus, Ohio hospitals could reduce both risks and costs by participating in this collaborative campaign.

In the Mercury Challenge, mercury wastes represent a special focus of the waste reduction initiative. The element is a nephrotoxin and neurotoxin that reaches the bloodstream through inhalation or skin penetration, and only four grams in a lake can trigger a fish advisory. Hospitals produce mercury wastes because the metal is used in sphygmomanometers, thermometers, intestinal and esophageal dilators, fluorescent fixtures and some chemicals.  However, safer substitutes exist for most of this equipment, so AHA and the EPA agreed to virtually eliminate mercury from the hospital waste stream.

For advice on managing mercury and other wastes, the Ohio EPA's Office of Pollution Prevention has contracted with CGH Environmental Strategies of Burlington, Vermont. CGH is nationally recognized in working with hospitals and AHA to reduce the costs and risks associated with waste management and to help hospitals comply with environmental regulations. The environmental consultant will recommend strategies to the Ohio EPA and OHA to assist hospitals in eliminating mercury use and reducing waste volume from various hospital operations.  A mercury elimination resource guide should be available for hospitals later this spring.

OHA and the Ohio EPA have explored ways to recognize hospitals that participate in this joint program. All hospitals have received a helpful videotape developed specifically for this collaborative campaign, along with a button signifying their commitment to "green hospitals." In addition, program participants will receive recognition through publicity, including:

·         Certificates suitable for public display.

·         Presentation of Certificates by OHA field staff,

      when available.

·         Listing in a press release on Earth Day, April 22.

They will also receive an analysis of the survey findings, including benchmarks that can be used by individual hospitals.

Of further benefit to hospitals will be the workshop on limiting waste management costs and preventing pollution at the OHA Educational Summit. The Summit, entitled "Sustaining the Commitment While Shaping the Future," will take place at the Greater Columbus Convention Center on April 17‑18. Hollie Shaner and Glenn McRae of CGH will present at this conference, and a vendor display will highlight many specific tools for pollution prevention and waste management. In addition to their recent collaboration with the OHA/Ohio EPA initiative, both speakers are internationally recognized for their expertise in reducing hospital waste while saving money, and they have authored two manuals published by AHA on this subject.

For further information, see the Ohio EPA site, at http://www.epa.state.oh.us/opp/hospital.html.

     In late 1999, the Occupational Safety and Health Administration (OSHA) issued its Proposed Ergonomics Standard, intended to prevent job‑related musculoskeletal disorders (MSDs) caused by repetitive stress motions. If adopted, this proposed regulation would require employers, including hospitals and health care providers, to provide broad‑based ergonomics preventive programs in the workplace.

Under this proposal, employers with manufacturing or manual handling jobs, including hospitals, would be required to implement a basic program that provides:

·         Management leadership and employee participation in program development.

·         Hazard information to employees.

·         A reporting mechanism for injured employees.

For employee problems that can be corrected quickly, the proposal’s "quick fix" mechanism allows prompt care for the injured employee and hazard elimination, if completed within 90 days.

If the "quick fix" fails to correct the problem or another MSD of the same type occurs within three years, then a full program must follow, providing:

·         Job hazard analysis, continual job monitoring, and worker protective measures.

·         Periodic employee training.

·         Prompt care and continued pay and benefits for

      injured employees, at employer expense.

·         Program re‑evaluation every three years, with

      record‑keeping requirements.

A grandfather clause would cover some employers with pre-existing, effective programs that meet OSHA standards.

OHA has joined the American Hospital Association in opposing this standard, on the recommendation of OHA's Environmental Policy Committee. In its Comment to OSHA on this proposal, OHA asserted that the regulation represents a burdensome, complex initiative that would alter state worker's compensation laws and the Americans with Disabilities Act. The regulation mandates high employer costs based on subjective perceptions of worker discomfort, without clear distinction between work‑related and pre‑existing injuries. At a time when the Bureau of Labor Statistics reports a decline in worker injuries, especially at hospitals, OHA believes that OSHA should await the early 2001 results of a National Academy of Science ergonomics study for further scientific consensus on the issue.

OHA's comment on the proposed regulation is available at http://www.ohanet.org in the "What's New" section.

In late 1999, the Occupational Safety and Health Administration (OSHA) outlined new enforcement procedures for its 1991 Bloodborne Pathogen Standard, which protects against needlestick injuries, updating its 1992 compliance directive. This standard has required training and controls to minimize exposure to infectious materials. Unlike a regulation, however, a compliance directive allows for no comment period.

While hospitals face no specific needle system requirement under this revised directive, they must use readily available safety technology. New mandates include:

·         Comprehensive exposure prevention programs that include engineering and work practice controls, to

       be updated yearly to reflect technology changes.

·         Use of recessed needle systems with Food and Drug Administration‑specified design features.

·         Hospital rejection of particular safety devices that fail to increase safety.

·         Logging all injuries from contaminated sharps.

The prevalence of needlestick injuries and the alleged failure of hospitals to use available safer needles, as publicized by unions and nursing groups, prompted OSHA to update this directive. The National Institute of Occupational Safety and Health (NIOSH) claims yearly national needlestick injury totals of up to 800,000. Although HIV is seldom acquired, exposures transmit diseases like hepatitis B or C. The Centers for Disease Control (CDC) estimates that safe-needle systems could prevent up to about 75 percent of needlesticks, and the FDA has approved over 250 systems. However, only 15 percent of hospitals reportedly use them, due to increased expense and clinician misgivings, although new safe-needle systems have attracted greater hospital interest.

Congress and at least 25 state legislatures, including Ohio, are considering whether to mandate safe-needle systems. California in 1999 became the first of six states to legislate needle safety. These state laws range from  merely commissioning feasibility studies to actually requiring safe-needle use.

The Congressional bill directs OSHA to amend the Bloodborne Pathogen Standard to require safe-needle systems, with employee evaluation. Issuance of OSHA's revised directive, however, has diluted support for this legislation. AHA argues that the directive replaces the need for legislative measures.

Already passed by the Senate, a bill in the Ohio House requires public healthcare employers to follow exposure control rules regarding safe-needle systems, as developed by the Public Employment Risk Reduction Advisory Commission (PERRAC). However, OHA is concerned about conflicting standards and believes that the rule‑making process, unlike legislation, allows more flexibility in updating safety standards per hospital experience and safety advances.

A recent OHA survey reveals that most Ohio hospitals have safe-needle system policies, while others have seriously considered them. However, survey respondents cite increased costs and practitioner resistance as continuing challenges. Safe-needle systems cost from 7 to 70 cents more per needle or IV catheter. Hospitals will see whether these costs are offset by hospital savings in payments for workers compensation, disability, sick leave, post‑exposure prophylaxis and legal liability. Nationally, hospital employee surveys reveal that adequate training on use eases healthcare worker acceptance of new needle systems. An additional concern includes the safe-needle shortages experienced by California hospitals, as orders overwhelm vendors, prompting many hospitals to retain back‑order notices for CalOSHA inspectors. However, California hospitals now use an estimated 75 percent safe-needles, compared to 20 percent before the law.

A detailed OHA Bulletin on this proposed standard is available at http://www.ohanet.org (password required).

Reversing a policy that essentially exempted hospitals from regulatory oversight, the Food and Drug Administration (FDA) announced that hospitals that reprocess single-use medical devices must meet the same scrutiny as reprocessors and manufacturers. However, it has found no increased failure rates in reused single-use devices, compared to initial use. In its premarket review of products labeled for single use, the FDA typically does not address questions of risk regarding any attempt to reprocess or reuse the device. However, reprocessing of single-use devices has been widespread in hospitals since the 1970s, in response to rising costs and managed care pressures to save money. One‑third of hospitals now reprocess medical devices, either themselves or through commercial reprocessors.

Initially, the agency released a proposed strategy in late 1999, seeking public review and comment. In February, the agency updated its proposal in two draft guidances, which represent the FDA's interpretation of its regulations, to guide the public in compliance.

Under the two proposed FDA guidances, reprocessors must present scientific evidence of device safety and effectiveness, just like original manufacturers, and must meet standards for premarket notification and approval, adverse event reporting, manufacturing and labeling, and tracking. At the core of the guidances is a three‑tiered stratification scheme centering on the risk level of single- use devices. One guidance details risk categorization of devices as low, moderate or high based on the complexity of the procedures used to reprocess them, the risk of infection from reuse, and published data on reprocessing for the device. Factors used for categorization relate to risks of infection or of performance failure, but designations would be flexible to account for emerging data. Under the second guidance, the FDA would phase in enforcement, setting priorities based on risk categorization level, beginning with the high‑risk devices.  Hospitals would have six months after the adoption of the final guidances to comply with some new regulations.

Reacting to these proposed guidances, proponents of device reuse claim that reprocessing has been common for years and that manufacturers unnecessarily label some devices for single use only. Opponents claim that reused products may fail or bring infection after inadequate sterilization. Economics also plays a role in these reactions, since manufacturers lose sales with every reused device, while hospitals save money through reuse.

The American Hospital Association (AHA) submitted comments on both the original proposed strategy and the two updated guidances. OHA attorneys also submitted a comment on the two guidances after participating in an AHA-sponsored national teleconference on the effect of these policies on hospitals.  Both AHA and OHA encouraged the FDA to:

·         Limit the extent of hospital regulation and allow hospitals ample time to prepare for new standards.

·         Direct research on reprocessing safety to complex,

      high‑risk devices.

·         Apply standards to other health care providers, in addition to hospitals.

·         Develop consensus standards using "community best practices" for low‑risk devices.

·         Exempt devices in an opened but unused package.

·         Make manufacturers justify "single use" labels with

       evidence that reuse is unsafe.

·         Exempt hospitals from duplicative reporting requirements.

According to the FDA's enforcement chief, the final guidance documents will likely take effect later this year, although he admits that the agency will need JCAHO involvement to handle the many new requirements.

OHA's comment on the draft guidances is available at http://www.ohanet.org in the "What's New" section.

ODH Plans Community Response to Threat of Bioterrorism

The Ohio Department of Health (ODH) recently published guidelines for localities to develop disaster response plans to "threatened human biologic incidents," or bioterrorism. The department acted in response to public health concerns about threatened or actual acts of bioterrorism in recent years and their potential dire consequences. The chief of ODH's Bureau of Environmental Health and Technology, Steve Wagner, describes hospitals as the "lynchpin to any planning for a bioterrorism incident. Hospitals perform the major surveillance and will have to deal with the consequences."  With its "Threatened Human Biologic Incident: Ohio Guidelines," the state agency urges local health departments to coordinate disaster relief plans with hospitals, EMS, law enforcement, fire officials, and appropriate state agencies. A related release, "A Checklist for ODH Ohio Guidelines," defines responsibilities of the various, involved parties for the notification, response, recovery, and restoration phases of disaster management.

ODH emphasizes the difference between chemical and biologic events. Whereas chemical event patients have immediate symptoms and present in large groups at hospitals, biologic events often last for several days. ODH and hospitals must evaluate patients carefully to determine the existence of a biologic incident as soon as possible, whether terrorists have made prior threats or the attack is covert. The released guidelines cover threatened incidents, while ODH is developing guidelines for covert events. ODH is also developing a mechanism to report infectious and suspected diseases with confidentiality protection, since reporting is critical to early treatment initiation and information assembly.

ODH has worked with OHA's Environmental Policy Committee on developing these guidelines, available at http://www.odh.state.oh.us/public/public-­f.htm, under "Fact Sheets."

Please contact the committee officers or OHA staff with your concerns about environmental and occupational safety issues that affect your hospital.

Peter M. Hazelton, Health Policy and Legal Consultant

Rick Sites, Staff Legal Counsel

OHA EnviroNews Editors