The Centers for Disease Control and Prevention (CDC) reports that healthcare professionals perform nearly 47 million surgical procedures each year, each involving contact of a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes. Because of this contact, the risk of pathogen transfer, and thus infection, is higher. Disinfection and sterilization are essential processes to help lower the risk of transmitting infectious pathogens to patients via medical and surgical instruments.
Sterilization – describes a process that destroys or eliminates all forms of microbial life using physical or chemical methods
Disinfection – describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects
Chemical sterilant – FDA-cleared germicide sterilant that provides high-level disinfection to kill all organisms, except high levels of bacterial spores
High-level disinfectant – agent capable of killing bacterial spores when used in sufficient concentration under suitable conditions, and is therefore expected to kill all other microorganisms
Low-level disinfectant – agent that destroys all vegetative bacteria (except tubercle bacilli), lipid viruses, some non-lipid viruses, and some fungi, but not bacterial spores
Cleaning – describes the removal of visible soil (e.g. organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water and detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because organic and inorganic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes
Decontamination – according to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal” [29 CFR 1910.1030]
Critical Items |
Semi-critical Items |
Non-critical Items |
|
Definition |
Objects that enter sterile tissue or the vascular system and therefore must be sterile to help reduce microbial contamination | Objects that contact mucous membranes or non-intact skin | Objects that come in contact with intact skin but not mucous membranes |
Examples |
Include surgical instruments, cardiac and urinary catheters, implants and ultrasound probes used in sterile body cavities | Include respiratory therapy and anesthesia equipment, some endoscopes, laryngoscope blades, esophageal manometry probes, cystoscopes, anorectal manometry catheters and diaphragm fitting rings | Include non-critical patient care items (bedpans, blood pressure cuffs, crutches, etc.) and non-critical environmental surfaces (bed rails, bedside tables, patient furniture, etc.) |
CDC Recommended Care |
Sterilization required
Heat-sensitive objects: EtO, hydrogen peroxide gas plasma or liquid chemical sterilants All others: Sterilization by heat/steam |
High-level disinfection required at minimum, using chemical disinfectants; glutaraldehyde, hydrogen peroxide, ortho-phthalaldehyde and peracetic acid with hydrogen peroxide are cleared by the Food and Drug Administration (FDA); cleaning is also recommended as follow-up | Low-level disinfection with an Environmental Protection Agency (EPA)- registered disinfectant and cleaning |
According to the Food and Drug Administration (FDA), carefully adhering to the general reprocessing steps described below can help with the proper handling and reprocessing of reusable medical devices for the next patient.
Discard protective covers. Segregate reusable devices from waste. Wipe devices clean of visible soil, keep moist, properly contain and transport to a dedicated cleaning area.
Cleaning is intended to render devices safe for handling and to prepare them for subsequent processing steps. Cleaning does not necessarily make the device suitable for patient use.
2a. Disassemble devices to facilitate cleaning and subsequent microbicidal steps
2b. Thoroughly clean with a compatible detergent and rinse to remove unsafe residues. You may use enzyme cleaners, ultrasound baths, and brushes. NOTE: You may return devices to service if thorough cleaning is adequate (non-critical devices are unlikely to be sources of cross-transmission or soiled by body fluids).
Route thoroughly cleaned devices (that are not returned directly to service) for terminal microbicidal process (e.g., disinfection/sterilization). After cleaning, you may perform additional microbicidal steps, depending on the device’s intended use, including either a disinfection or sterilization process, to render them safe for the next patient use.
For low level or intermediate level disinfection, instructions for non-critical reusable devices should describe how to effectively and safely apply the disinfectants to devices, and include the EPA label-recommended contact time (it should be conveyed that the disinfectant instructions should be followed exactly, especially with respect to contact time).
For high-level disinfection, treat devices using a validated, device-specific high level disinfection method. Rinse the device to remove residues and dry prior to storage.
For terminal sterilization, follow the validated sterilization instructions. Return the devices to service when the terminal process is completed.
Centers for Disease Control and Prevention. 2008 Guideline for Disinfection and Sterilization in Healthcare Facilities: Introduction. 2008: 8, 8-9, 10-12, 84, 98-99. Retrieved from: http://www.cdc.gov/hicpac/Disinfection_Sterilization/1_sumIntroMethTerms.html
Food and Drug Administration. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. March 17, 2015: 35. Retrieved from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm253010.pdf
Unless otherwise noted, the recommendations in this document were obtained from: Centers for Disease Control and Prevention. Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.
