Continuing Education for Healthcare
If there were one organization in the medical device reprocessing industry in the US who had the most visible day-to-day impact on Sterile Processing departments, it would likely be AAMI (the Association for the Advancement of Medical Instrumentation). As the primary source of consensus standards for the medical device industry, both national and international, AAMI publications such as ANSI/AAMI ST79:2017 the "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" & ANSI/AAMI ST91:2015 "Flexible and semi-rigid endoscope processing in healthcare facilities" are some of the most thorough documents available to provide practical information and guidance to Sterile Processing professionals.
Even though AAMI is NOT a regulatory agency itself, many organizations look to its recommendations as a basis for industry best practice and industry consensus. Many SPD departments around the country develop policies and procedures that reflect the guidance provided by ST79:2017 and ST91:2015, along with other related documents.
Similar to AAMI, the ACGIH (American Conference of Governmental Industrial Hygienists) is NOT a regulatory agency itself, but many organizations look to its guidelines as a basis for industry best practice and industry insight for making decisions about unsafe levels of exposure to various chemical substances and physical agents found in the workplace.
ACGIH brings together a voluntary scientific community that publishes Threshold Limit Values (TLVs®) and Biological Exposure Indices (BEIs®) to ensure workplace exposure of chemicals does not create an unreasonable risk of disease or injury. These TLVs are an important part of determining what type of chemical exposure qualifies as an "Immediately Dangerous to Life or Health Concentration" (IDLH - more on that in another post!). If you work around chemicals while doing your job -- which is a basic part of Sterile Processing responsibilities -- this is one group you definitely want to know!
The Environmental Protection Agency (EPA) is a government agency responsible for enforcing a large scope of standards and laws that promote the health of individuals and the environment. For the Sterile Processing context, this is the group who oversees such things as ethylene oxide (ETO) emissions into the air, as made national headlines this year with the shutdown of the Sterigenics plant in Willowbrook, Illinois.
Unlike professional organizations who often develop "recommendations," government agencies such as the EPA issue "regulations" that have the force of law and require mandatory compliance. Some of the most applicable work that the EPA does in regards to Sterile Processing is to require the registration and regulation of environmental disinfectants, and how certain chemicals can be safely disposed of after use.
For more information on how the EPA impacts you, visit their website at: https://www.epa.gov/
Even though it may feel like your Sterile Processing department has more daily interactions with groups like AAMI, the Food and Drug Administration (FDA) actually touches nearly every aspect of your life in a hospital. From the review and approval of the complex and high-risk medical devices that you process, to the packaging used to wrap them, and the equipment used to process them -- the FDA is deeply involved in each and every step.
The FDA also requires reusable medical devices to have validated instructions for use (IFUs) so that your team can safely and properly clean and disinfect/sterilize them. If a medical device or reprocessing equipment ever malfunctions, the FDA provides the Manufacturer and User Facility Device Experience (MAUDE) database to track these failures and provide transparency to other industry users.
For more information about the FDA's role in medical devices, visit their website here: https://www.fda.gov/medical-devices
In some sectors of industry, word that Occupational Safety and Health Administration (OSHA) is onsite can cause as much anxiety as a surprise visit from the Center for Medicaid & Medicare Services (CMS) can cause in the hospital setting. OSHA is the government agency whose primary goal is to ensure safe and healthful conditions for working men and women by setting and enforcing standards and providing training, outreach, education and compliance assistance.
OSHA has a tremendous impact on Sterile Processing departments through its regulation of occupational exposure to bloodborne pathogens and airborne contaminants. Things such as Safety Data Sheets (SDS) and Standard Precaution information all comes through this agency. OSHA has also established occupational exposure limits (OEL) for a number chemicals used in Sterile Processing, including ethylene oxide and formaldehyde, and a general air contaminants standards that include hydrogen peroxide and glutaraldehyde. All facilities using such chemicals must implement engineering and work-practice controls to ensure that employees are not exposed to them at levels above the permissible exposure limits (PELs).
For more information about OSHA's role in healthcare, visit their website here: https://www.osha.gov/SLTC/healthcarefacilities/
One of the lesser known federal agencies who impact Sterile Processing professionals is The National Institute for Occupational Safety and Health (NIOSH). NIOSH is actually a part of the Centers for Disease Control & Prevention (CDC) and has more than 1,300 employees from a diverse set of fields including epidemiology, medicine, nursing, industrial hygiene, safety, psychology, chemistry, statistics, economics, and many branches of engineering.
The primary function of NIOSH is to conduct research and make recommendations for the prevention of work-related injury and illness. NIOSH has published two Health and Safety Practices Surveys of Healthcare Workers, one focused on High-Level Disinfectants:
and one focused on Chemical Sterilants:
Both surveys highlighted the need for additional training and compliance in safe use and limiting exposure to these chemicals.
For more information about NIOSH, visit their website here: https://www.cdc.gov/niosh/
The average workplace exposure to any hazardous contaminant or agent.
The 8-hour TWA PEL is the level of exposure established as the highest level of exposure an employee may be exposed to without incurring the risk of adverse health effects.
When driving in a car, your TWA would be your miles per hour. Miles per hour gives you an exact idea of when you will reach your destination. With TWA, you are able to tell if workplace exposure will become too high at a certain point. If your TWA is increasing, then it is known that you will reach a point of overexposure quicker.
The overall goal of TWA is to help people monitor their surroundings, so that the point of overexposure is known before it actually happens.
"Acute Exposure Level Guidelines (AEGLs) are used by emergency planners and responders worldwide as guidance in dealing with rare, usually accidental, releases of chemicals into the air. AEGLS are expressed as specific concentrations of airborne chemicals at which health effects may occur...
AEGLs are calculated for five relatively short exposure periods – 10 minutes, 30 minutes, 1 hour, 4 hours, and 8 hours – as differentiated from air standards based on longer or repeated exposures. AEGL “levels” are dictated by the severity of the toxic effects caused by the exposure, with Level 1 being the least and Level 3 being the most severe.
All levels are expressed as parts per million or milligrams per cubic meter (ppm or mg/m3) of a substance above which it is predicted that the general population could experience..."
"Occupational exposures to chemicals have long been recognized as having the potential to adversely affect the lives and health of workers... The Immediately dangerous to life or health air concentration values (IDLH values) developed by the National Institute for Occupational Safety and Health (NIOSH) characterize high-risk exposure concentrations and conditions... IDLH values are established (1) to ensure that the worker can escape from a given contaminated environment in the event of failure of the respiratory protection equipment and (2) to indicate a maximum level above which only a highly reliable breathing apparatus, providing maximum worker protection, is permitted.
Since the development of the original IDLH values in the 1970s and their subsequent revision in 1994 (NIOSH Documentation for Immediately Dangerous to Life or Health Concentrations (IDLH) NIOSH has continued to review relevant scientific data and conduct research on methods for developing acute exposure guidelines..."
The term "Long Term Exposure Limit" is less commonly used than many of the other acronyms discussed in this series. LTEL is simply the maximum exposure to chemicals permitted over an 8-hour period. This is particularly important since it mirrors the typical 8-hour workday that would reflect expected chemical exposures of a full day working around, for instance, an automated endoscope reprocessor or low temperature sterilizer.
More commonly recognized in Europe, the comparison to LTEL in the United States would be PEL (Permissible Exposure Limit), which alone is measured in 8 hours and 15-minute periods. When focusing on the 15-minute time window, this is referred to as a STEL (Short-Term Exposure Limit).
As important as short-term exposure limits are, understanding the long term impact of particular chemical exposure is a critical part of keeping yourself and your team safe during normal job functions of the cleaning, disinfection, and sterilization of medical devices.
"An occupational exposure limit (OEL) is an upper limit on the acceptable concentration of a hazardous substance in workplace air for a particular material or class of materials. It is typically set by competent national authorities and enforced by legislation to protect occupational safety and health. It is an important tool in risk assessment and in the management of activities involving handling of dangerous substances... OELs have been established for airborne workplace chemicals by multiple regulatory & authoritative organizations around the world for well over 60 years...
Although peer-reviewed health-based OELs are preferred for establishing safe levels of exposure or for implementing adequate controls to provide worker protection, the lack of publicly available OELs have led to other sources of safe levels to protect workers. Industrial or Occupational Hygienists are often on the front line of anticipating and recognizing the hazards of chemical exposure for workers, and must assess the risk of exposure through the use of OELs so that proper control strategies can be implemented to keep workers below the OEL values..."
"The permissible exposure limit (PEL or OSHA PEL) is a legal limit in the United States for exposure of an employee to a chemical substance... Permissible exposure limits are established by the Occupational Safety and Health Administration (OSHA). Most of OSHA’s PELs were issued shortly after adoption of the Occupational Safety and Health (OSH) Act in 1970.
For chemicals, the chemical regulation is usually expressed in parts per million (ppm), or sometimes in milligrams per cubic meter (mg/m3).
A PEL is usually given as a time-weighted average (TWA), although some are short-term exposure limits (STEL) or ceiling limits. A TWA is the average exposure over a specified period, usually a nominal eight hours. This means that, for limited periods, a worker may be exposed to concentration excursions higher than the PEL, so long as the TWA is not exceeded and any applicable excursion limit is not exceeded.
In dealing with gaseous chemicals, which have an incredible amount of particles, it is difficult to understand just what a part per million really is. So to make it a little easier to comprehend, we’ve come up with a few analogies:
A single ppm is…
The first step of a 380 mile walk.
One hair on your head and on the head of nine of your friends.
One second out of 11.6 days.
One penny out of 19 – 5 gallon water jugs filled with pennies.
One drop of water (.05ml) in a 13 gallon tank.
Now that you have an idea of just how small one ppm really is, consider this. The average sterilizer uses several percent by volume of the active sterilant gas in the chamber. Just one percent of that volume is equivalent to ~10,000ppm. Therefore, even the smallest leak or simply the off gassing of sterilized equipment could release an amount of toxic gas into the breathing zone capable of significantly affecting the health of those exposed. Without a continuous monitoring system, workers wouldn’t know that they were being exposed until the concentrations of gas in the air have reached levels far above the PELs, thus putting their health in jeopardy.
"A recommended exposure limit (REL) is an occupational exposure limit that has been recommended by the United States National Institute for Occupational Safety and Health (NIOSH). The REL is a level that NIOSH believes would be protective of worker safety and health over a working lifetime if used in combination with engineering and work practice controls, exposure and medical monitoring, posting and labeling of hazards, worker training and personal protective equipment. To formulate these recommendations, NIOSH evaluates all known and available medical, biological, engineering, chemical, trade, and other information. Although not legally enforceable limits, RELs are transmitted to the Occupational Safety and Health Administration (OSHA)...for use in promulgating legal standards.
All RELs are located in the NIOSH Pocket Guide to Chemical Hazards, along with other key data for 677 chemical or substance groupings..."
For more info, check out this ChemDAQ blog: What is the difference between a REL and a PEL? - https://tinyurl.com/t86kj8s
"A short-term exposure limit (STEL) is the acceptable average exposure over a short period of time, usually 15 minutes as long as the time-weighted average is not exceeded. STEL is a term used in occupational health, industrial hygiene and toxicology. The STEL may be a legal limit in the United States for exposure of an employee to a chemical substance. The Occupational Safety and Health Administration (OSHA) has set OSHA-STELs for ethylene oxide. For chemicals, STEL assessments are usually done for 15 minutes and expressed in parts per million (ppm), or sometimes in milligrams per cubic meter (mg/m3).
The American Conference of Governmental Industrial Hygienists (ACGIH) publishes a more extensive list of STELs as threshold limit values (TLV-STEL)."
"Threshold Limit Values (TLVs) are the maximum average airborne concentration of a hazardous material to which healthy adult workers can be exposed during an 8-hour workday and 40-hour workweek—over a working lifetime—without experiencing significant adverse health effects.
A TLV has three components:
Time-weighted Average (TWA) concentration: The concentration of a contaminant averaged over a workday (usually 8 hours long). It's measured in a workplace by sampling a worker's breathing zone for the whole workday. ACGIH recommends that the TWA should not be exceeded for up to an 8-hour workday during a 40-hour workweek.
Ceiling value: A concentration of a toxic substance in air that ACGIH recommends should not be exceeded at any time during the workday. This value is often used in conjunction with the TWA.
Short term Exposure Limit (STEL) value: A TWA concentration over 15 minutes that ACGIH recommends not to exceed—even if the 8-hour TWA is within the standards. TWA-STELs are given for contaminants for which short-term hazards are known."