Thursday, April 28, 2011

Happy 40th, OSHA!

The Occupational Safety and Health Act of 1970 was signed into law by President Richard M. Nixon on December 29, 1970. Forty years ago today, the Occupational Safety and Health Administration (OSHA) was established.

Over the past four decades, the nation has made dramatic progress in reducing work-related deaths and injuries. Since 1970, workplace fatalities have been reduced 65 percent, while reported occupational injury and illness rates have declined nearly 67 percent.

Unfortunately, far too many preventable injuries and fatalities still occur, with 12 workers dying on the job daily, while more than 3.3 million men and women suffer a serious work-related injury or illness annually.

Worse, millions more are exposed to toxic chemicals that may cause illness or death years in the future. Therefore, OSHA has established permissible exposure limits (PEL) - the legal exposure limit of employees - to hundreds of chemical substances and physical agents (29 CFR 1910.1000, Tbl Z-1)

Most of the PELs are time-weighted average (TWA) exposure concentrations over 8 hours. For some chemicals, OSHA mandates employee short-term exposure limits (STELs), calculated as a 15 minute TWA (also called the excursion limit for ethylene oxide) and ceiling limits to toxic substances in the workplace.

In the case of low temperature sterilization, even though equipment is designed to the highest safety standards, failures of equipment, ventilation systems, and mishandling of sterilants agents frequently occurs.

For hospitals, ambulatory surgical centers and healthcare facilities, employee exposure to sterilant concentrations exceeding OSHA mandates typically results in hazmat decontamination and evacuation. In addition to disrupting Sterile Processing Department operations productivity, co-dependent functions like surgery are impacted, which goes right to the hospital’s bottom line.

Higher capacity healthcare-related sterilization and disinfection, segments – medical device manufacturers, contract sterilization and pharmaceuticals – utilize sterilants in volume. Highly combustible, potentially catastrophic OSHA sterilant concentration employee expands the consequences of not continuously monitoring to multiple, serious work-related employee injuries or worse.

OSHA also mandates employee workplace respiratory injury prevention and protection standards for other sterilization and disinfection intensive sectors; specifically: aseptic packaging, food & produce processing and storage.

The ChemDAQ Steri-Trac® Sterilant Gas Monitoring System provides the optimal solution for workplace safety assurance, protecting personnel from serious health effects associated with exposure to toxic sterilant gases, disinfectant and anti-microbial agents such as Ethylene Oxide, Hydrogen Peroxide, Ozone and Peracetic Acid. The system is modular, ranging from a single area monitor to multi-point, multi-gas systems and can flexibly accommodate additional sterilizers as well as the introduction of new/different sterilant gases.

Modularity also increases system reliability. For instance, should one component fail, the rest of the system would continue to function normally and providing redundant protection. In addition, Steri-Trac sensors are electrochemical affording high sensitivity, continuous monitoring and fast response times.

Steri-Trac Area Monitors work in conjunction with ChemDAQ’s DAQ® Central Monitoring System to continuously track and analyze exposure values in areas where toxic gases are used or stored. The DAQ calculates the time weighted average exposures and alarms when OSHA and other federal, state and local regulatory agencies and professional organizations maximum exposure limits are exceeded. The system also provides impending alerts to allow remedial action be taken before a hazardous situation develops.

In the event of a significant sterilant gas or chemical leak the system provides visual and audible alarms based on the instantaneous gas concentration. Even when everyone is clear, the ChemDAQ system continues to monitor the air and lets management and employees know when it is safe to return.

ChemDAQ provides summaries of the complex OSHA Regulations, Recordkeeping and Health Risks covering low temperature sterilant gas and disinfectant agent exposure. As an industry thought-leaders, we also maintain reference links to Educational Opportunities & Articles Related to Workplace Safety on our website.

Providing a safe working environment for employees is an important consideration for any business, particularly those that use or store toxic gases as part of their normal processes. For this reason, Steri-Trac is the ideal solution for companies utilizing sterilization and disinfection processes as a critical component of their overall operation.

ChemDAQ, helping you protect what matters most.

Thursday, March 3, 2011

If Healthcare Were Only More Like Retail

The hazards of hydrogen peroxide (H2O2) and peracetic acid sterilants are well known and well documented. Unfortunately many Central Sterile Supply Department (CSSD) counter a proposal to monitor sterilant gases with the statement “we won't monitor, until we’re required to do so.”


This isn’t the case in retail, as noted in the February 26, 2011 Washington Post article, “Wal-Mart Bypasses Federal Regulators to Ban Controversial Flame Retardant.” The story clearly illustrates how industry self regulation is often ahead of federal regulators in self-mandating protection against products endangering human health and the environment.

While Wal-Mart is banning a controversial flame retardant - polybrominated diphenyl ethers, or PBDEs - found in hundreds of consumer goods, from couches to cameras to child car seats, telling its suppliers to come up with safer alternatives. Studies have linked PBDEs to problems with the liver, thyroid and reproductive systems and brain development in laboratory animals.

Increasingly, other retailers are barring specific chemicals from products in their stores in response to concerns from consumers and advocacy groups, including Whole Foods which has banned bisphenol A, or BPA - a widely used component in plastic linked to reproductive problems, cancer and other health disorders. Both Toys R Us and Wal-Mart have followed Whole Foods’s lead, despite the fact that federal regulators permit the use of BPA and the chemical industry attests to its safety.

Sears and Kmart have phased out products with polyvinyl chloride, or PVC, containing phthalate plasticizers out of concern that these plasticizers may disrupt the endocrine system in humans and cause other health effects, despite contrary chemical industry claims.

These examples really show how some markets are able to move decisively and faster than government regulatory bodies, but why not in healthcare’s CSSD?

Even when the health effects of H2O2 are well documented, including:

• Concentrations >5% can cause injury to eye surface/ulcerations.
• Inhalation hydrogen peroxide vapor may result in severe pulmonary irritation.
• Repeated exposure may cause chronic irritation of the respiratory tract and partial or complete lung
  collapse.
• Inhalation of high concentrations may result in seizures, cerebral infarction or cerebral embolism; ensuing
  damage to the CNS may cause permanent neurological deficits or death.

Several U.S. governmental agencies have a direct regulatory impact on safety in the CSSD, including the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC), with OSHA being the most important for workplace safety.

OSHA recognizes the hazards presented by hydrogen peroxide and has established permissible exposure limits (PELs) for H2O2.

A PEL is the average concentration of a chemical in the air to which a worker can be exposed over a specific time period (usually eight hours). OSHA has established a 1 part per million (ppm) PEL for H2O2 air concentrations as an eight-hour time-weighted average (TWA) [29 CFR 1910.1000 Tbl. Z-1], the same as ethylene oxide (EtO).

Furthermore, the Centers for Disease Control (CDC) National Institute for Occupational Safety and Health (NIOSH) has established an immediately dangerous to life and health (IDLH) threshold of 75 ppm for H2O2, less than 10% of the IDLH for EtO.

The same OSHA rules apply in a hospital as in a steel mill and so OSHA simply mandates that employers must assess the risks and take whatever measures are necessary to provide a safe work environment. OSHA does not mandate particular actions, such as monitoring or particular engineering controls in order to allow the employer to best methods for their particular circumstances. Thus facilities should use engineering controls, including ventilation systems, establish procedures for safe work practices, provide personal protective equipment (PPE), and use other methods to ensure that occupational exposure limits are not exceeded.

In addition, guidelines from voluntary standards organizations - Association for the Advancement of Medical Instrumentation (AAMI), The Joint Commission, and National Fire Protection Association (NFPA) - also impact CSSD safety procedures, and while not legally binding, these standards often significantly impact healthcare worker safety by establishing standards of care and best practices.

The word “safe” means free from risk, danger or injury. There are many environmental hazards in the CSSD, and ChemDAQ has safe products, services and strategies are designed to minimize risk, danger or injury to employees. CSSD management, health/safety, healthcare administrators and employees must work together to develop and maintain conditions that minimize opportunities to cause harm or injury.

For further information on the Steri-Trac® H2O2 Sterilant Gas Monitoring System, click here.

Wednesday, January 12, 2011

Peracetic Acid Uses, Health Risks & Workplace Guidelines

Peracetic or peroxyacetic acid (PAA) is a strong oxidizing agent used for high level disinfection and sterilization at low temperatures. It is water soluble, and leaves no solid residue after rinsing and the end products are only water, oxygen and acetic acid (vinegar), making PAA a very environmentally friendly compound.

In healthcare, the demand for faster turnaround time of heat sensitive reprocessed multiple-use medical devices led to the development of PAA liquid sterilization, given ethylene oxide’s longer required aeration time at the end of the sterilization cycle to vent the gas. In addition, the food packaging and waste water treatment industries have adopted PAA as a preferred disinfectant and sterilant wash because of its environmental properties.

Health Risks of PAA Exposure

As an antimicrobial agent, PAA is broadly effective against a wide range of microorganisms; it disrupts bonds in proteins and enzymes and interferes with cell membrane transportation through the rupture of cell walls, oxidizing essential enzymes and impairing vital biochemical pathways.

The properties of PAA that make it an efficient sterilant and environmentally friendly make it potentially dangerous to any employees exposed to it in the workplace. Unfortunately the health risks to workers from PAA exposure are not known by many employers. Hospitals, food handling and processing industries commonly use PAA, in concentrations that can be harmful to workers if they are exposed.

Specifically, the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances identifies PAA as a primary irritant, known tumorigen and mutagen.

The New Jersey Department of Health and Senior Services Occupational Health Service released a study on the the health effects of PAA exposure. The study also found that PAA is very irritating to the skin, eyes, nose, throat, and lungs, with the potential for causing permanent scarring of the skin, cornea, and throat. Higher exposures in the short term can also cause pulmonary edema as well as liver and kidney effects.
PAA Workplace Guidelines

While there are no Occupational Saftey and Health Administration (OSHA )regulations specifically for PAA - most OSHA PELS have not been updated since their initial adoption in 1972 - the Environmental Protection Agency (EPA) has issued Acute Exposure Guideline Levels (AEGLs) for PAA, specifically:

AEGL-3 (death/permanent incapacity) 1.3 ppm: the threshold above which mortality and/or irreversible effects could be observed for an exposure of up to 60 minutes. AEGL-3 is analogous to the NIOSH Immediately Dangerous to Life or Health (IDLH) chemical listing concentrations and documentation values, which are 75 ppm for hydrogen peroxide and 800 ppm for ethylene oxide.
AEGL-2 (disability) 0.51 ppm: the threshold level above which intense lacrimation, extreme nose discomfort and transient incapacitation (inability of self protection but without residual consequences) could be observed for an exposure of up to 60 minutes.

AEGL-1 (discomfort) 0.17 ppm: the level above which discomfort could be observed for an exposure of up to 8 hours per day. AEGL is analogous to the OSHA PEL (1 ppm for both hydrogen and ethylene oxide, calculated as an 8 hour time weighted average. See OSHA Standard 1910.1000, Table Z1 Limits for Hydrogen Air Contaminants and OSHA Standard 1910.1047 for Ethylene Air Contaminants.

PAA Continuous Monitoring Solution

Designed specifically for occupational safety, the ChemDAQ PAA monitoring system gives immediate indication of PAA concentration in the work area so that workers can protect themselves from acute and chronic exposure. The Steri-Trac® area monitor has alarm limits and a real time display of PAA concentrations in ppm to provide safety from acute exposure. The DAQ® Central Monitoring System tracks EPA AEGL-1 and AEGL-2 with alerts to provide a level of safety from chronic exposure to PAA.

The continuous monitoring of PAA can help protect employees from the acute and chronic health affects by reporting the toxic concentrations in real time and providing alarms for proactive protection. Many employers whose workers have experienced symptoms of exposure and expressed concern are looking for solutions. A continuous monitoring system along with a comprehensive education program and safe work practices are the best ways to assure worker safety and maximize productivity.

For more information, check out the ChemDAQ Steri-Trac Peracetic Acid Area Monitor.