Monday, April 8, 2013

The Dangers of Formaldehyde Exposure in Beauty Salons and Healthcare

Formaldehyde is one the most widely used 'bad boys' of the chemical world, to use an expression favored by ChemDAQ's CFO. Formaldehyde is used, across many different industries, ranging from the production of amino (e.g. urea-formaldehyde polymers (glues & adhesives), melamine-formaldehyde (thermosetting rigid plastics), phenolic, and polyacetyl resins (engineering plastics), wood products, plastics, fertilizers and foam insulation; as a textile finish, preservative, stabilizer, and a disinfectant" [Merck Index, 12th Ed] to name just a few.

Formaldehyde is useful because of the wide range of chemical reactions in which it can participate. It is a strong reducing agent, it water soluble (formalin solution) and most importantly it is an alkylating agent and binds amine groups, and aromatic rings. These last properties are what makes formaldehyde useful in healthcare. Formaldehyde solution (formalin) is used as a fixative because it can cross link proteins and so fix tissue samples. It does the same thing in living organisms and so formaldehyde is strongly antimicrobial finding use as a disinfectant and sterilant (e.g. low temperature steam formaldehyde sterilization)

As with any chemical sterilant, formaldehyde poses significant risks to anyone exposed to it. Formaldehyde is a known carcinogen and causes cancer of the nasopharynx & sinonasal cancer and leukaemia. (IARC) and National Toxicology Program). It is also a sensitizer and a primary irritant [ATSDR].

These dangers are well known and OSHA has promulgated a standard for formaldehyde (29 CFR 1910.1048) and has set permissible exposure limits of 0.75 ppm (8 Hour time weighted average (TWA), and 2 ppm as a 15 minute TWA short term exposure level (STEL).

Formaldehyde is a very useful chemical, but it is often used in environments that are not set-up to handle chemical exposures. For example formaldehyde is often used in hair straightening formulations (similar chemical mechanism to the tissue fixative) and in the last couple years OSHA has targetted beauty salons, issued a press release a hazard alert and even created a website dedicated to the dangers of formaldehyde exposure in addition to citing them for violations of OSHA standards. However, most beauty salons have neither the equipment nor the training to protect their workers to the levels required by the OSHA standard.

The product manufacturers have been of marginal help, sometimes inadvertently leaving the formaldehyde off the product label ingredients, claiming that the levels are so low as to be safe or using one of the other chemical names for formaldehyde such as methylene glycol that is less easily recognized by those with limited chemical training. A much safer approach for both the salon workers and of course their customers would be to eliminate all formaldehyde from these applications.

Formaldehyde solution was widely used as a disinfectant and sterilant in healthcare, but in the US it has largely been replaced by glutaraldehyde as a liquid sterilant/high level disinfectant. Low temperature steam formaldehyde is still widely used in European and other countries in dedicated LTSF sterilizers. In the US formaldehyde is primarily used in health care as a tissue preservative and as a major component of embalming fluids.

Formaldehyde can be used safely provided that adequate safety precautions are taken. Employers using formaldehyde must provide the OSHA required Hazard Communication training for all workers using hazardous chemicals (29 CFR 1910.1200) as well as training on the formaldehyde specific standard.

Employers must ensure that their people are not exposed to formaldehyde concentrations over the OSHA PELs. Employers who use formaldehyde can do this by use of adequate engineering controls to prevent exposure, continuous gas monitors for formaldehyde to ensure that the other safety devices are sufficiently protective and provide warning to workers in something fails, suitable personal protective equipment and training on how to handle formaldehyde safety and what to do it things go wrong. These are similar to the requirements as for other sterilant and high level disinfectant chemicals such as ethylene oxide, hydrogen peroxide, peracetic acid, o-phthalaldehyde and glutaraldehyde.

Friday, April 5, 2013

ChemDAQ Steri-Trac® Monitors Saves Workers from Leaking EtO Sterilizer

We received a call from a hospital customer who said that over this past weekend, they had an ethylene oxide leak from one of their sterilizers and without the ChemDAQ Steri-Trac monitors no one would have known.

The leak arose because of an electrical fault in the scrubber and the entire exhaust system shut down, but there was no indication of this happening on any of their screens. The sterilizer was completing the cycle and when they opened the door, the ChemDAQ monitor alarms sounded and they were getting readings up to 50 ppm.

They immediately evacuated the department and were relieved they could see what was happening on the remote video display (RVD) outside the department.

If there had been no monitor they would have not known about the EtO leak and their people may well have been exposed to high concentrations of EtO.

Calls like this show the value of the ChemDAQ system and reminds us at ChemDAQ that our products are designed to save lives.

It also shows that even the best designed sterilization equipment can sometimes fail and that it is important to have a continuous gas monitoring system installed that will provide an immediate alert if there is a leak.

An automated alert is essential with ethylene oxide since EtO has no odor below about 400 ppm far above the OSHA permissible exposure limit of 1 ppm (8 hr time weighted average (TWA)) and the OSHA Excursion limit/15 minute TWA short term exposure limit of 5 ppm [29 CFR 1910.1047].

If anyone would like to share their story about sterilant gas leaks and/or detection of sterilant gases with continuous monitors, please fill out the comment box below.

Tuesday, April 2, 2013

Industry News - Recall of Sterrad 200 Sterilizers

The FDA published an announcement on March 30th that Advanced Sterilization Products (ASP) was recalling its Sterrad® 200 sterilizer. The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.

While oil mists can be irritating, a major concern is that there may be hydrogen peroxide vapor in with the oil mists since the OSHA permissible exposure limit for hydrogen peroxide vapor is only 1 ppm (8 hr time weighted average).

A recent letter dated January 23, 2013 from ASP to a customer said that "the vacuum pump in the Sterrad 200 system may cause the emission of a slightly increased level of hydrogen peroxide (H2O2) vapor into the surrounding environment if not regularly serviced or replaced." The letter goes on to describe one incident where a healthcare worker experienced temporary eye discomfort and throat irritation while in close proximity to the sterilizer, due to emissions caused by failure of an internal filter.
There have been other reports of workers being exposed to hydrogen peroxide vapor and/or oil mist vapor from not only sterrad sterilizers but other brands and models of hydrogen peroxide sterilizer (see for example the FDA's MAUDE database.)

If you suspect that your sterilizer is emitting hydrogen peroxide vapor, then ensure that all personnel clear the area until the hydrogen peroxide concentrations are within safe limits as indicated by a hydrogen peroxide monitor; and follow the sterilizer manufacturer's instructions to get the problem corrected. If a hydrogen peroxide monitor is not available, use appropriate PPE and other measures to ensure that workers are not exposed.

If you have had any first hand experience of oil mists, smokes or hydrogen peroxide emissions from sterilizers (any make and model), we invite you to add a comment to this blog and describe your experience.