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Sterilization & the Spaulding classification1, 2, 3

Non-critical devices include those that contact intact skin but not mucous membranes. Secondary transmission may occur through contaminated hand/glove contact with the environment and transfer to the patient/resident. These devices require low or intermediate level disinfection. Low and intermediate level disinfectants include ethyl or isopropyl alcohol, quaternary ammonium (QUAT), QUAT with alcohol, hydrogen peroxide, chlorine, phenolics and iodophor.

Non-critical surfaces under the Spaulding classification

Non-critical devices include those that contact intact skin but not mucous membranes.

Secondary transmission may occur through contaminated hand/glove contact with the environment and transfer to the patient/resident. These devices require low or intermediate level disinfection.

Low and intermediate level disinfectants include ethyl or isopropyl alcohol, quaternary ammonium (QUAT), QUAT with alcohol, hydrogen peroxide, chlorine, phenolics and iodophor.

Low-level disinfection

Low-level disinfectants are used to disinfect noncritical items that come in contact with skin, such as stethoscopes, blood pressure and tourniquet cuffs, EKG leads, bedside equipment and environmental surfaces.

Low-level disinfection kills most vegetative bacteria, some viruses and some fungi, but cannot be relied on to kill mycobacteria or bacterial spores.

Intermediate-level disinfection

This procedure kills vegetative bacteria, most viruses and most fungi – including mycobacterium tuberculosis, all fungi and inactivates most viruses – but does not reliably kill bacterial spores. Appropriate for items such as stethoscopes, x-ray machines and bedside rails.

Intermediate disinfection is also part of environmental cleaning in healthcare facilities and includes housekeeping surfaces like floors, lighting, walls, overbed tables and carts. Cleaning frequency is dependent on high-touch areas, spills, soiled surfaces and patient care items.

Point-of-care device cleaning

Point-of-care cleaning describes the process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

Point-of-care devices like glucometers must be adequately cleaned and disinfected between patient use. Review manufacturer’s instructions for use (IFU) for cleaning procedures of the device.

Semi-critical objects are those that touch mucous membranes or skin that is not intact and require a high level of disinfection.

High-level disinfection

Eliminates all microorganisms except for small numbers of bacterial spores. Important for items that come in contact with mucous membrane or nonintact skin, such as endoscopes, ENT scopes, endocavity probes, laryngoscopes and cystoscopes.

Risks associated with improper disinfection or sterilization of equipment include breach of host barriers, person-to-person transmission (e.g. hepatitis B virus) and transmission of environmental pathogens. High-level disinfectants include glutaraldehyde, ortho-phthaladehyde (OPA) accelerated hydrogen peroxide and peracetic acid.

Sterilization

A process that destroys or eliminates all forms of microbial life and is carried out in healthcare facilities by physical or chemical methods. Steam under pressure, dry heat, ethylene oxide gas, hydrogen peroxide gas plasma and liquid chemicals are the principal sterilizing agents used.

Sterility assurance is an important aspect of modern healthcare, as it helps to minimize the patient’s risk for infection at the surgical site. Sterility assurance programs and testing assist users in meeting important quality assurance and CDC requirements.

Before sterilization, items must be cleaned using detergent or enzymatic cleaners. Cleaning should happen as soon as possible after instruments have been used. A manual cleaner or disinfectant ultrasonic washer is very effective in removing microorganisms.

Single-use device reprocessing

Reprocessing single-use devices involves reusing instruments that were designed and sold for single-use only.

These range from external items such as sequential compression device sleeves (SCD) to more invasive devices that include electrothermal equipment, laparoscopic trocars and cannulas that come in contact with blood or human tissue.

Reprocessing of single-use devices must be performed by an FDA-approved reprocessing facility and should not be done in individual facilities.

Sterilization indicators

Sterilization packaging

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