Critical Issues in Cleaning Medical Devices in the Office Setting
All medical devices should be labeled by the manufacturer as either single-use or reusable. If a device is reusable the manufacturer should provide instructions for cleaning and disinfection or sterilization as appropriate. A single-use device will be labeled as such and is intended only for a single use and does not have reprocessing instructions.
The key to preventing patient to patient transmission of infectious agents in medical devices is proper cleaning and maintenance. The level of cleaning and reprocessing of medical devices is based on the risk for transmitting infections if the device is contaminated at the time of use. There are three categories (also known as Spaulding Classifications): critical, semi-critical and non-critical. Although the initial cleaning steps are similar, each classification requires a different level of processing.
Critical items are devices that enter sterile tissues. Examples include intravenous devices, surgical instruments, and urinary catheters. Critical items must be sterilized and are often purchased sterile and disposed of after a single use.
Processing reusable critical equipment involves general cleaning followed by sterilization. Sterilization involves the destruction of all microbial life. Sterilization can be achieved using heat with or without steam and chemicals.
For more information on steam sterilization (also known as autoclaving) please refer to Table Top Sterilizers - Processing Instruments - Protecting Patients - Ensuring Safety.
Heat-sensitive items must be processed using chemical sterilants such as gluteraldehyde, hydrogen peroxide, ortho-pthaldehyde (OPA) or paracetic acid with hydrogen peroxide – sometimes referred to as cold sterilization. Follow the manufacturer's recommended guidelines for processing and the chemical manufacturer's guidelines for use. In order to assure reliable sterility, cleaning procedures including temperature, solution concentration, contact time, and pH must be followed precisely. Chemical solutions must also be changed (refreshed) according to manufacturer recommendations. Practices using cold sterilization for reusable critical instruments should consult with an infection prevention specialist to insure their processes are sound. For an in-depth review of chemical sterilants please refer to the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 available at www.CDC.gov.
Semi-Critical devices come in contact with mucous membranes or non-intact skin. Examples include laryngoscopes, endoscopes (bronchial, esophageal, sigmoid, colon and cysto), anoscopes, vaginal specula, nasal specula, tonometers, cryosurgical equipment, endocavitary ultrasound probes, and point of care blood testing devices.
Processing semi-critical devices involves general cleaning followed by high-level disinfection. High-level disinfection eliminates most or all of the pathogenic organisms except spores. It involves soaking the instrument in a chemical sterilant so that the equipment is disinfected but not sterile. It is important to ensure the chemical sterilant chosen is compatible with the instrument for long-term use. Chemical sterilants that can be used for high-level disinfection include gluteraldehyde, hydrogen peroxide, ortho-pthaldehyde (OPA) or paracetic acid with hydrogen peroxide. Follow the manufacturer's recommended guidelines for processing and the chemical manufacturer's guidelines for use. For an in-depth review of chemical sterilants please refer to the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 available at www.CDC.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf
High-level disinfection should occur in a clean environment to prevent recontamination of devices. Cleaning/decontamination and high-level disinfection areas should be separate and material should flow from dirty to clean to storage.
Cleaning Semi-Critical and Critical Devices Prior to High-Level Disinfection or Sterilization
The following are general instructions for cleaning semi-critical and critical devices prior to high-level disinfection or sterilization. These are general instructions and practices should know and follow the manufacturer's recommended guidelines for processing and the chemical manufacturer's guidelines for use.
- Prepare device for cleaning
- Pre-clean device
- Disinfect device
- Inspect the instrument to make sure there are no cracks, defects or loose pieces
- Proceed with high-level disinfection or sterilization
- Store device
Cleaning Flexible Endoscopes
According to the CDC, while the incidents of infections associated with endoscopes is very low, more healthcare-associated infections have been linked to contaminated endoscopes than to any other medical device. Therefore it is of the utmost importance that practices know and follow the manufacturer's recommended guidelines for processing and the chemical manufacturer's guidelines for use when reprocessing endoscopes.Staff members who clean endoscopes and other medical devices should receive appropriate training. The practice should maintain documentation of staff members’ demonstration of competency in cleaning and reprocessing medical devices.
Non-Critical items may come in contact with intact skin but not mucous membranes. Examples include patient care items such as blood pressure cuffs, stethoscopes, and crutches; and environmental surfaces such as stretchers, countertops, and grab bars.
Non-critical equipment should be cleaned after every use (between patients) using a low-level disinfectant on a cloth or in a spray bottle. Follow the manufacturer's recommended guidelines for processing and the chemical manufacturer's guidelines for use. Most disinfectants carry a wet contact time. This is the amount of time the agent must remain wet on the surface before the manufacturer will guarantee the product is effective. Wet contact time and concentration will depend on the low-level disinfectant chosen. Examples include: 70% isopropyl alcohol, 10% bleach solution and various commercial wipes such as Sani-Cloth and Chlorox Healthcare. Be sure staff is aware of the wet contact time for the agents they are using to clean non-critical items.
Cleaning Point of Care Blood Testing Devices for example, a glucose meter, INR monitors)
Follow the device manufacturer's recommendations.
Outbreaks of hepatitis B virus (HBV) have been associated with blood glucose monitoring. According to the CDC, blood glucose monitors should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, following the manufacturer’s instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared. Manufacturer’s instructions for cleaning and disinfecting the device should be located with the device, so staff can readily access the instructions.
Key Recommendations for Cleaning, Disinfection, and/or Sterilization of Medical Devices in Outpatient Settings:
- Develop and maintain policies and procedures for handling of devices that are contaminated with blood or body fluids.
- Ensure that reusable medical equipment (e.g., blood glucose meters and other point of care devices, surgical instruments, endoscopes) is cleaned appropriately prior to use on another patient.
- Inventory all reusable medical devices and instruments, determine the level of criticality (Spaulding Classification) and establish protocols for reprocessing based on classification and manufacturer's recommendations.
- Reusable medical equipment must be cleaned, reprocessed (disinfection or sterilization) and maintained according to the manufacturer's instructions. If the manufacturer does not provide such instructions, the device may not be suitable for multi-patient use.
- Before using any chemical, obtain and review the Safety Data Sheet and ensure all healthcare personnel who will be using the chemical are appropriately trained regarding proper use, necessary personal protective equipment, and what to do if there is an exposure or spill.
- Assign responsibilities for reprocessing of medical equipment to appropriately trained healthcare personnel.
- Maintain copies of the manufacturer's instructions for reprocessing of equipment in use at the facility; post instructions at locations where reprocessing is performed.
- Observe procedures to document competencies of healthcare personnel responsible for equipment reprocessing upon assignment of those duties, whenever new equipment is introduced, and on an ongoing periodic basis (e.g., quarterly).
- Assure healthcare personnel have access to and wear appropriate personal protective equipment when handling and reprocessing contaminated patient equipment.
CDC. (2016). Guide to Infection Prevention For Outpatient Settings: Minimum Expectations for Safe Care.
CDC. (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities.
Infection Prevention during Blood Glucose Monitoring and Insulin Administration https://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
American Society for Gastrointestinal Endoscopy and the Society for Healthcare Epidemiology of America. (2011). Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. Gastrointestinal Endoscopy, 73 (6): 2011 1075-1084.
Medical Mutual Insurance Company of Maine's "Practice Tips" are offered as reference information only and are not intended to establish practice standards or serve as legal advice. MMIC recommends you obtain a legal opinion from a qualified attorney for any specific application to your practice.