Not monitoring Peracetic Acid, Hydrogen Peroxide or Ethylene Oxide?

Well here's 10 reasons why you should be:

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1. Antimicrobial chemicals are highly toxic!

All chemical usage involves risks, but workers deserve to know what those risks are and be given the tools to protect themselves from unnecessary harm.

Reason # 1 - Low temperature and liquid chemical sterilants are designed to kill all microorganisms including resistant spores and if they were not toxic, they would not be effective in sufficiently high concentration to destroy all microbial life including the chemically resistant sporoidal forms of certain bacteria. There are two main classes of sterilant chemical:

    1) the oxidizing agents such as Hydrogen Peroxide and Peracetic Acid, and

    2) the alkylating agents such as Ethylene Oxide.

The oxidizing agents destroy the cell wall and alkylating agents bind to proteins and DNA within the cell preventing their function. Needless say, these chemicals pose a significant risk to anyone who is exposed to them at high concentrations and even small leaks or exposures can have significant impact on health.

2. Sterilants pose serious health risks if exposed.

There have been many studies that have associated long term exposure of healthcare workers to even low concentrations of sterilant chemicals with a variety of problems including reproductive issues such as miscarriages, respiratory irritation and occupational asthma. While ethylene oxide is widely known to have been classified as a carcinogen by both the IARC and NTP, the hazards associated with the other common sterilants are less well known.

Exposure to Glutaraldehyde, Ophthalaldehyde (OPA) and EthyleneOxide are all found to increase occupational asthma in healthcare. Glutaraldehyde use has been banned in the United Kingdom because of the impacts on worker health and the loss of healthcare professionals from hospitals who leave the profession due to the symptoms of chemical exposure. While OPA has been widely touted as a safer alternative to glutaraldehyde, it is also a dialdehyde with similar chemical properties and there are reports of similar occupational exposure symptoms such as occupational asthma , and sensitization. There have also been reports that indicate that #PeraceticAcid may cause respiratory irritation and occupational asthma.

3. Sterilizers and re-processors can and do malfunction

Some facilities have an industrial hygienist visit once a year and believe that their employees are safe from possible exposure to sterilant gases. The problem with this approach is that it assumes if the sterilizers and other equipment were working normally yesterday, then they must be working normally today. Unfortunately, this assumption is often wrong. Any device can fail, especially if it has a few thousand cycles on it. When low temperature sterilizers and liquid chemical processors fail, they leak hazardous chemicals into the workplace.

Examples include a report from Japan that showed hydrogen peroxide sterilizers can leak over 100 ppm hydrogen peroxide. The researchers measured several hundred ppm of hydrogen peroxide at the exhaust because of a failure in the exhaust system.

There are many other cases where leaks of sterilant gas have occurred for different reasons: failure of the sterilizer, failure of the engineering controls or plain old human error. The manufactures of the sterilization equipment go to great lengths to make the sterilizers as safe as possible, but releases of sterilant gases still occur. 

4. Sense of smell is an unreliable method for detection  

Our sense of smell developed to tell us what was good to eat and what we should stay away from and many people expect our sense of smell to protect us from harmful chemicals as well. Unfortunately, smell is not a good method for determining if a sterilant vapor is present at a safe concentration or not. Sterilant vapors such as ethylene oxide and hydrogen peroxide plasma or vaporized hydrogen peroxide have no smell until far above safe levels, for example the odor threshold of ethylene oxide is around 430 ppm, compared to the OSHA permissible exposure limit (PEL) of 1 ppm calculated as an 8 hr Time weighted average (TWA). Hydrogen peroxide has almost no smell, and people typically first perceive it from the irritation caused by hydrogen peroxide on the eyes and respiratory systems.

Many gases and vapors, such as ozone, are subject to olfactory fatigue, whereby prolonged exposure to the gas or vapor reduces the sense of smell over time; and even for those gases which do not chemically cause a dulling of the sense of smell, prolonged exposure to most odors results in a dulling of the perception of smell as our minds wander to more imminent concerns. 

5. Employers have a legal duty to provide a safe work environment 

The Occupational Safety and Health Act (OSH Act) of 1970 created a legal duty for employers to provide a safe work environment (sec. 5) and a legal duty for employees to follow all workplace safety standards.

SEC. 5. Duties

(a) Each employer --

(1) shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees;

(2) shall comply with occupational safety and health standards promulgated under this Act.

(b) Each employee shall comply with occupational safety and health standards and all rules, regulations, and orders issued pursuant to this Act which are applicable to his own actions and conduct

This clause, known as the General Duty clause, provides a catch all regulation that permits OSHA to prosecute employers with dangerous work areas even when there is no specific regulation. OSHA has also promulgated a number of occupational safety and health standards (generally in 29 CFR) which are intended to provide a regulatory framework for safe work practices.

6. Workers cannot be exposed to levels about OELs

Everyone knows that toxic gases are toxic, but at what concentration is the gas hazardous? In the US, the American Conference of Government and Industrial Hygienists (ACGIH) developed what later became the threshold limit values (TLVs) in the 1940s, and regularly updated them as more data became available. There are now more than 700 chemicals and physical agents listed. The ACGIH is a private organization and so its TLVs are not law, though the laws of some countries reference them directly.

In the US, OSHA can prosecute an employer under the General Duty clause (discussed above) using the relevant TLV as a threshold to indicate whether a work environment is free from “recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.”

OSHA recognizes the risks that healthcare workers face:

“Healthcare workers face a number of serious safety and health hazards. They include bloodborne pathogens and biological hazards, potential chemical and drug exposures... includ[ing] ..ethylene oxide, glutaraldehyde, and paracetic acid [sic] used for sterilization; and numerous other chemicals used in healthcare laboratories.”

7. A method to warn of high chemical exposure is required by OSHA

The Hazardous Communication standard reads: "Employee training shall include at least: Methods and observations that may be used to detect the presence or release of a hazardous chemical in the work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc.)..."

Many of the sterilant chemicals used today to sterilize temperature sensitive medical devices are imperceptible to human senses until at concentrations well above dangerous levels and even those that are perceptible are not quantifiable by smell. Therefore, it is important to have an automatic means to detect the presence of the sterilant gas in the even that it escapes from the sterilizer or associated equipment.

By their very nature, leaks are unpredictable since the predictable leaks will prevented by good design and preventative maintenance. While modern sterilizers are made to the highest standards, any equipment can and sometimes does fail and so a continuous gas monitor is necessary in order to alert employees in the event of a sterilant gas or vapor leak.

8. Mitigate risk of litigation, OSHA fines

If OSHA discovers non-compliance  with chemical safety during an inspection they may issue warnings or fines, the magnitude depending on the severity and frequency of the infraction. All OSHA fines are public information and many facilities fear the bad publicity of an OSHA fine more than the financial impact. Obviously creating a safe work environment is key to avoiding OSHA fines. The penalties are set out in section 17 of the OSH Act.:

"(a) Any employer who willfully or repeatedly violates the requirements of section 5 of this Act, any standard, rule, or order promulgated pursuant to section 6 of this Act, or regulations prescribed pursuant to this Act, may be assessed a civil penalty of not more than $70,000 for each violation, but not less than $5,000 for each willful violation..."

OSHA penalties are increased each year to adjust for inflation. The penalty for a serious violation is $13,494 per violation in 2020, which increases to $134,937 for a willful violation. Increased accidents and OSHA fines also increases the risk of greater insurance premiums and litigation/workers compensation claims against the employer arising from injuries.

9. Reduce lost work days 

Exposure to chemical sterilants high level disinfectants can result in lost work days if workers become sick or injured, high turn over costs as workers look for safer employment and higher workers compensation rates if workers make a claim following injury from over exposure.

According the Bureau for Labor Statistics, in 2018 there were 512,000 injuries and 32,700 illnesses in the healthcare and social assistance industries, or 310 per 10,000 full-time workers. The BLS commented that “Health care and social assistance had the highest number of injuries and illnesses [of any private industry sector], accounting for approximately 1 in 5 injury and illness cases reported by private industry employers in 2018.” The numbers have not changed much in the last decade. In 2010, the injury and illness rate for health care support workers was 283 cases per 10,000 full-time workers, almost 2 1/2 times the rate for all private and public sector workers at 118 cases per 10,000 full-time workers.

The primary goal of healthcare is patient safety, but patient care cannot be successful absent the safety of healthcare workers.

10. Value and Retain Employees

Sterile processing is becoming increasingly complex and the costs of frequent employee turnover are often overlooked. In a 2008 survey, respondents indicated that it took between 3 to 12 months to train a sterile processing technician and that most employers spend two to three months working with new employees with a training cost of over $40,000 (at 2008 $).

This sentiment was echoed by Nyla "Skee" Japp, president of the American Society of Healthcare Central Service Professionals who said, “I believe that the greatest challenge facing central service departments throughout the nation is turnover of staff."

If employees feel valued then they will perform better and are much less likely to change jobs. Feeling appreciated is a strong motivator in the workforce, as significant as monetary rewards. An employer who fails to train their employees about how to work safely, fails to provide the engineering controls, continuous monitors and other measures to keep their workforce safe will not enjoy the respect and appreciation of their workforce and will face issues of retention, employee dissatisfaction and low motivation.

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