By Jack Egnatinsky, MD

You will notice that I put the word “department” in quotes in the headline, because what constitutes a department responsible for sterilization and disinfection of instruments and other devices is often an enigma to me when I do accreditation surveys.

In a hospital OPD or a large ASC there is usually a Central Sterile Department with a well-trained staff. In a typical ASC, this can vary from a dedicated “tech” – often an OR tech who has had limited formal training – to “whoever brings the instruments to the workroom” having the responsibility for cleaning and packaging for sterilization.

As part of the AAAHC infection control and prevention review during an accreditation survey, we will be looking closely at your sterilization and high-level disinfection practices. I expect that the person showing me the cleaning and sterilization area(s) to be able to answer and/or demonstrate, at a minimum, the following:

• How do you know if any particular item has been cleaned or disinfected or sterilized?

• Can you tell me the difference between critical and non-critical instruments/devices?

• What kind of high-level disinfection and sterilization do you have in your center?

• Is it all overseen by one person?

• What training and demonstration of competence does the person (or persons) in charge undergo?

• Are you doing high-level disinfection? If yes, what chemicals do you use? Do you monitor their temperature? How often?

• Do you monitor their end of use date? Are you using test strips? How often? Do you record these?

• If you are not using closed systems, do you have an exhaust hood over the disinfection area? If not, are your employees wearing glutaraldehyde monitoring badges or something similar?

• Are you doing EO sterilization? Is your system completely closed and in a well-ventilated area? Do you assure that all three phases, pre-conditioning, gas dwell or continuous exposure phase and aeration, are all carried out according to the manufacturers recommended time? How do you assure that aeration is complete before you use the instruments? What BI (biological indicator) and CI (chemical indicator) are you using?

• Are you using a hydrogen peroxide gas plasma based unit or a peracetic acid unit? How do you know what instruments are safe to sterilize in your unit? Do you know the requirements for dry, damp, wet?

• Dry heat sterilizers? Steam sterilization – do you have gravity or vacuum assist units, or both? Do you do any immediate use sterilization? How much? How do you wrap or otherwise place your instruments in the autoclaves? Where do you place them? What CI or BI are you using?

• CIs and BIs – are you using integrator strips? What class? Why? Do you use instant, rapid, slow BIs?

• Logs: What logs are you keeping? Can you identify which instruments were sterilized or disinfected in a specific load by checking your records?

• PM – how often is your disinfection and sterilization equipment undergoing preventive maintenance?

• What is your procedure if a CI or BI indicates that sterilization was not complete?

The functions noted above are critical to your operations. Make sure that you have properly trained, preferably certified, individuals who undergo regular continuing education in infection control and prevention. This is a vitally important field that changes frequently. Your staff must keep up to date if your organization is determined to maintain quality care.

About the Author

Dr. Jack Egnatinsky is an anesthesiologist with extensive experience in the ambulatory surgery arena, both HOPD and ASC. He is a Past-President of the Board of FASA, a predecessor to the ASC Association, and Past-President of AAAHC. He is also on the board of the Accreditation Association for Hospital and Health Systems (AAHHS) and is a representative of Acreditas Global, the international arm of AAAHC. He remains extremely active as a Medical Director for AAAHC, in addition to being a well-traveled AAAHC accreditation surveyor in the USA and internationally.