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
• 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.