Multisociety Guidance for Sterilization and High-Level Disinfection

American Society for Gastrointestinal Endoscopy

Infectious Diseases Society of America

Society for Healthcare Epidemiology of America

Association for Professionals in Infection Control and Epidemiology

Publication Date: Apr 28, 2025

Summary Publication Date: May 9, 2025

Page Last Updated: Oct 18, 2025

Summary of Recommendations

Apply point-of-use treatment promptly to initiate the cleaning process and/or to prevent soils from drying on the reusable medical device.
Perform point-of-use treatment in accordance with the MIFUs for the cleaning product and the medical device.
Treat reusable medical devices at the point-of-use with a process designed to begin cleaning and/or to keep devices moist until processing begins.
Select the product and/or process for point-of-use treatment following the device’s MIFU for compatibility and consideration for effectiveness and for limiting adverse interactions with common contaminants (eg, blood, silicone). Do not use products known to be fixatives (eg, alcohol) for point-of-use treatment.
In settings where there is a prolonged interval between the use of the medical device and initiation of processing, and in scenarios where reusable medical devices otherwise would dry out, use moisture retention products that are compatible with the devices, following the device’s MIFU and seeking technical data if needed.
If a delay occurs, follow the MIFU for remediation due to potential for biofilm formation and drying of soils. In the absence of guidance in the MIFU, follow the steps described in Section 2: Manufacturers’ instructions for use.
Keep reusable medical devices moist between use and the start of treatment to prevent soils from drying, unless prohibited by the MIFU.
Adhere to the MIFU for each specific lumened device, including instructions for use of the flushing solutions and the appropriate types and sizes of cleaning brushes.
Do not modify or adapt cleaning instructions intended for non-lumened devices for use on lumened devices.
Package or contain the reusable medical devices in accordance with OSHA requirements.
Transport contaminated critical or semi-critical devices to the location of processing in a manner that keeps reusable medical devices’ surfaces moist, unless prohibited by the MIFU, and prevents damage to the devices, exposure of individuals to body fluids, and contamination of the environment.
Use a closed, rigid container or closable, fluid-resistant bag to transport contaminated devices.
Apply the same principles to transport outside of the facility as transport inside the facility. Transport items in a manner that keeps the reusable medical device’s surface moist, unless prohibited by the MIFU, and prevents damage to the medical device or packaging, exposure of individuals to body fluids, and contamination of the environment.
Consider the effects of exposure to temperature extremes and the potential for damage to the reusable medical devices due to shock and vibration during transport outside of the facility.
Follow applicable state and federal regulatory requirements related to transport.
At the location of processing by sterilization or HLD, follow the reusable medical device’s MIFU, including specified steps such as placing it in the open position, disassembling the device and its accessories, actuating it, and cleaning it to remove soils from surfaces.
After manual cleaning, if recommended and in accordance with the MIFU, clean reusable medical devices with:
- A mechanical washer OR
- A mechanical washer with an ultrasonic cleaning phase.
Facilities do not need to segregate reusable medical devices for infection prevention reasons, with the exception of potentially prion-contaminated reusable medical devices. Prions are out of scope for this document.
Verify that all water supplied to the facility meets the requirements described in the mechanical washer’s MIFU.
Ensure that the water used in processing is part of the facility’s water management plan.
To confirm that mechanical washers adequately perform all stages of the cleaning cycle, perform cleaning verification testing per the equipment’s MIFU.
Record the results when the equipment is installed, after major repairs, and each day that it is used.
Incorporate verification tests for mechanical washers that:
- Monitor at the point-of-use
- Generate immediate results
- Indicate that all stages in the mechanical washer’s cleaning cycle meet the mechanical cleaning parameters.
Beyond the testing required to support a facility’s water management program, no recommendation can be made for point-of-use water quality testing for reducing the risk of transmission of infectious pathogens, except:
- When indicated by the MIFU.
- When recommended by the local or state public health department.
- In the setting of outbreak investigation when a water source is suspected.
- When investigating staining, damage, or residue on processed medical devices.
Beyond external visual inspection (see 42), no recommendation can be made for additional methods for cleaning verification to prevent transmission events.
No recommendation can be made for the use of surrogate tests to detect residual organic material (eg, ATP, protein, heme) to assess adequacy of cleaning. Currently, these tests are not correlated with reduction of risk for microbial contamination or transmission.
For training purposes, facilities may consider including surrogate tests for medical devices that have a higher incidence of cleaning failure, such as lumened endoscopes.
Ensure the change(s) are permitted by the MIFU.
Review the implications of changing methods (eg, effectiveness, materials compatibility, packaging, detergent or sterilant residues, absorption of sterilant by packaging, moisture, rust).
Monitor sterilizing conditions using a combination of physical, chemical, and biological indicators.
At minimum, include physical and chemical indicators for all sterilizations, with regular addition of biological indicators.
Always include biological indicators and Type 5 chemical indicators for sterilization of implants.
If a failure is identified by a biological indicator, immediately retrieve and reprocess all affected devices back to the last negative result.
If a failure is identified by a physical or chemical indicator, consider affected reusable medical devices non-sterile and embargo them while the cause of the failure is assessed.
Develop processes to investigate root causes of indicator failures.
Take a sterilizer out of service during the investigation of a failure.
Notify IPC and the areas using them for appropriate management (see 14, 16 and Supplementary Material Table 7 ) if reusable medical devices have been used before the failure was identified.
Immediately remove improperly processed reusable medical devices from use.
Cease using any processing equipment suspected of not functioning properly.
Follow an organized, timely process using available data to assess the potential infection risk to patients from the processing failure.
With the guidance of IPC experts, involve partners, including public health authorities when appropriate, to determine and carry out follow-up actions.
Develop and implement preventive strategies based on the lessons learned from the failure in processing or identification of a potential transmission event.
Although immediate use steam sterilization (IUSS) is an effective method of sterilization when properly performed, facilities should not routinely use IUSS.
Design and implement processes that ensure that when IUSS is used:
- IUSS is performed by trained, competent HCP (see 43) in accordance with the reusable medical device or implant’s MIFU
- The sterilizer and the device or implant’s MIFUs include instructions for IUSS
- The device or implant is placed in a container validated for IUSS and legally marketed per FDA for this purpose
- The sterilization process is verified to be successful according to the appropriate indicator for the device or implant.
- Measures are taken to prevent contamination of the device or implant during removal from the sterilizer and transfer to the sterile field
- Before patient care, the device or implant that was subjected to IUSS is cooled to body temperature without compromising sterility.
As a last resort when the standard sterilization process cannot be performed (eg, intraoperative contamination of a unique device with no replacement available) and the risk of a delayed procedure exceeds risk of using IUSS, provided that all processing steps prior to IUSS are done according to the MIFU.
Only when the devices or implants are heat-stable, the MIFU provides instructions for IUSS, and the facility has a process in place that involves IPC, patient safety, risk management/legal, and appropriate clinicians to evaluate whether benefits exceed the risks of using the implant or device.
Clean and low-level disinfect portions of a device that do not come in contact with mucous membranes or non-intact skin (eg, cables, connectors) according to the device’s MIFU.
Sheaths do not eliminate the need for HLD for a semi-critical reusable medical device; unless otherwise specified by the MIFU, HLD is indicated.
Sterilization or HLD is not required for ultrasound probes applied to intact skin for the intended use of guiding percutaneous procedures, such as central line placement, amniocentesis, or biopsy.
Clean and low-level disinfect these ultrasound probes, following the MIFU.
Inspect non-lumened devices that have undergone HLD for damage, dry them, and store them in a manner that reduces the risk of contamination, in accordance with the MIFU.
Store ready-for-use reusable medical devices separate from contaminated (used) devices and ensure they are easily distinguishable (eg, prominently labeled as “patient ready”) from those that are not ready for use.
Ensure that germicide flows through lumened reusable medical devices’ channels unimpeded with appropriate flow dynamics. The physical force of fluid through the channels aids in removal of microorganisms and may aid in the removal of biofilms.
Passive flow is insufficient for removal of microorganisms. Positive pressure is required; however, no recommendation can be made for the minimum pressure required.
Dry exterior surfaces of the lumened reusable medical device according to the specifications in the MIFU (eg, cloth that is clean or sterile, low-linting, or lint-free).
Use pressure-regulated instrument air or HEPA-filtered air to dry the device’s lumens following HLD for the time specified by the device’s MIFU.
Always dry a device following HLD, even if it is planned for immediate use.
After HLD, store lumened reusable medical devices and their accessories in accordance with their MIFUs. This includes but may not be limited to:
- Completely drying lumened reusable medical devices and accessories (see 24).
- Storing lumened devices and accessories in a manner that protects them from contamination and damage, in accordance with their MIFUs.
- Placing lumened devices in the position indicated by their MIFUs (ie, vertical or horizontal position) and the validated design of the storage cabinet. If placed in a vertical position, the device should not be coiled and should not touch the bottom of the cabinet.
Place storage cabinets in a secure location that protects their contents from contamination and damage.
Ensure storage cabinets are kept clean and dry.
Adequately maintain storage cabinets per their MIFUs.
No recommendation can be made for the use of drying cabinets to prevent the transmission of infections.
Use lubricating or defoaming agents for medical devices when clinically needed and as permitted and specified by the MIFU.
Preferentially choose water-soluble agents over non-water-soluble agents, if permitted by the MIFU.
Prior to processing, clean the device after use to remove lubricating or defoaming agents in accordance with the MIFU.
For lumened, semi-critical reusable medical devices:
- Minimize the use of non-water-soluble defoaming agents consistent with the amount clinically needed for a successful completion of the procedure.
- When the device is used with simethicone:
  - Apply the minimum amount of simethicone required for a successful procedure.
  - Follow the MIFU for how to add the simethicone to the device.
  - If the MIFU does not specify the process for adding simethicone to the device, ideally deliver simethicone directly into the working channel, rather than into the irrigation water bottle.
  - After use, clean the device as specified by the MIFU.
HLD, when properly performed, is shown to be effective against human papilloma virus (HPV), multidrug-resistant microbes including multidrug resistant bacteria and fungi (eg, carbapenem-resistant Enterobacterales, C. auris). Mycobacteria, however, are relatively resistant to some high-level disinfectants.
Automated processing is preferred over manual HLD because it has been shown to result in more reliable processing and to achieve higher microbe elimination than manual HLD, and the use of automated processing systems may reduce exposure of HCP to chemicals.
Maintain automated processing systems according to their MIFUs.
Monitor compliance with the MIFU, including the concentration of the active ingredient(s) in a liquid chemical sterilant or high-level disinfectant (ie, the minimum effective concentration (MEC) and minimum recommended concentration [MRC]), temperature, and time.
No recommendation can be made for routinely using microbial cultures to assess the effectiveness of the HLD process.
Follow the MIFU for how to handle reusable medical devices that have undergone HLD and are ready for storage.
Perform hand hygiene before handling devices that have undergone HLD.
No recommendation can be made for the use of gloves in addition to hand hygiene to reduce the risk of transmission of infectious agents to patients. Gloves are not a substitute for hand hygiene.
No recommendation can be made for a maximum time after which facilities should repeat HLD for devices, including lumened devices, if a maximum time is not specified by the MIFU, and the devices have been properly cleaned, processed, and stored without evidence of breaches or events leading to potential contamination (eg, flood, non-contained construction).
If a maximum time is not specified by the device MIFU, a facility may use a risk assessment to determine whether to use a time- or event-based method for defining how long to store non-lumened and lumened devices.
If there is evidence of contamination, repeat HLD, processing the device in accordance with the MIFU.
No recommendation can be made for the use of more than one cycle of HLD for the purpose of reducing microbial contamination.
When sterilization technologies are shown to be effective in clinical settings and cycle specifications are validated and included in the MIFU, facilities should begin developing an institutional process for converting from HLD to sterilization for semi-critical reusable medical devices that are associated with a high risk of transmission of infection to patients.
Facilities may choose to evaluate sterilization along with other alternatives to HLD, eg, use of sterile, single use devices (see 36) or alternative therapeutic or diagnostic modalities as appropriate, while considering infection outcomes, clinical functionality of the devices, feasibility, and patients’ access to care.
Choose duodenoscope designs that have sterile, single use components and accessories to lower the risk of transmission of infection.
Use endoscope components and accessories that are compatible with the endoscope, recommended by the endoscope’s MIFU, and are legally marketed per FDA.
Facilities may choose sterile, single use endoscopes to eliminate the risk of transmission of pathogens from the device to patients, especially when the available resources (physical space, expertise, training, and staffing) do not support processing.
Only use investigational devices following:
- Issuance by FDA of an investigational device exemption (IDE) or approval of an investigational new drug (IND) application, OR
- Approval by the facility’s Institutional Review Board (IRB) with determination that the device is “minimal risk” and with approval of cleaning and sterilization or HLD instructions by both IPC experts and the IRB.
When using investigational devices in accordance with the above recommendations, involve IPC in processing protocols developed for investigational reusable medical devices.
Ensure that devices that are 3D-printed are legally marketed per FDA.
Follow the validated processing instructions provided in the MIFU.
When a 3D-printed device is considered investigational, follow the requirements for investigational devices.
Use electronic tracking for reusable medical devices’ preventative and interval maintenance by the manufacturer. If electronic tracking is not feasible, records may be kept on paper.
Adhere to recordkeeping practices per state and local requirements.
No recommendation can be made for when to replace a device with a new device.
Follow the device’s MIFU for the service life of the device, including requirements for preventive and interval maintenance.
Facilities should not use any devices with known or suspected damage for patient care.
Perform risk assessments to identify the reusable medical devices that should be tracked, focusing on the reusable medical devices that have a high risk for processing failure and transmission of infection (eg, duodenoscopes, bronchoscopes).
It is at the discretion of the facility to expand tracking beyond the highest risk reusable medical devices.
No recommendation can be made for implementing tracking to reduce the risk of transmission or to improve HCP compliance with processing steps, although tracking is often necessary to effectively respond to failures in processing, outbreaks, and product recalls.
No standardized and readily implementable methods exist for routine, internal (endoscope channels) visual inspection of reusable medical devices; however:
- Visually inspect reusable medical devices at various stages for retained debris (prior to sterilization or HLD, after HLD, and before use) per the MIFU. Specifications may include use of lighted magnification to improve the external visualization of reusable medical devices.
- Send for repair or properly discard any reusable medical devices found to be damaged. Damage can impair function, cleaning, sterilization, and HLD.
- If a reusable medical device is found to have retained debris, treat it according to the MIFU and reprocess it.
- If a lumened device is found to have retained debris that cannot be removed:
  - Do not proceed with reprocessing.
  - Return the device to the manufacturer for further assessment.
- When the manufacturer returns the reusable medical device after inspection or repair, follow the MIFU for returning the medical device to service.
- No recommendation can be made for the use of borescopic examination to assess the integrity of lumened devices before processing.
Ensure that all HCP are educated, trained, and assessed for competency in sterilization and/or HLD based on their job responsibilities:
- Before working independently
- When new equipment or when new sterilization or HLD methods are implemented
- When processes are changed.
No recommendation can be made for the optimal frequency of ongoing education, training, and competency assessments for HCP who are engaged in sterilization and HLD; however, facilities should adhere to specific requirements from manufacturers, state and local regulatory agencies, and accrediting organizations. Absent specific requirements, facilities should establish their own policies.
No recommendation can be made for the use of periodic audits to assure that HCP are compliant in performing all steps in the MIFU.
Review the factors described in the peer-reviewed literature that contribute to common failures in sterilization and HLD. These include the environment where sterilization and HLD activities occur, organizational processes, and individual factors.
Implement effective interventions and best practices to reduce the risk of failure.
No recommendation can be made for processing structure; however, facilities should assess the role of centralized or decentralized processing structures in minimizing the risk of processing failures, patient risk, and risk to HCP.

Document Overview

Document Title: Multisociety Guidance for Sterilization and High-Level Disinfection

Authoring Societies

American Society for Gastrointestinal Endoscopy

Infectious Diseases Society of America

Society for Healthcare Epidemiology of America

Association for Professionals in Infection Control and Epidemiology

Document Publication Date: Apr 28, 2025

Page Last Reviewed/Updated: Oct 18, 2025

Document Type: Consensus

Country of Publication: United States

Full Text Freely Available: Yes

Full Text Guideline: www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/multisociety-guidance-for-sterilization-and-highlevel-disinfection/CF829F279CADE2BF9AC2655EEB742DF8

Source Citation: Shenoy ES, Weber DJ, McMullen K, et al. Multisociety guidance for sterilization and high-level disinfection. Infection Control & Hospital Epidemiology. Published online 2025:1-23. doi:10.1017/ice.2025.41

Document Scope, Criteria, and Use Cases

Document Objectives: SHEA, in partnership with ASGE, APIC, AAMI, AORN, HSPA, IDSA, SGNA, and The Joint Commission, developed this multisociety infection prevention guidance document for individuals and organizations that engage in sterilization or high-level disinfection (HLD). This document follows the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. This guidance is based on a synthesis of published scientific evidence, theoretical rationale, current practices, practical considerations, writing group consensus, and consideration of potential harm when applicable. The supplementary material includes a summary of recommendations. The guidance provides an overview of the Spaulding Classification and considerations around manufacturers’ instructions for use (MIFUs). Its recommendations address: point-of-use treatment prior to sterilization or HLD, preparation of reusable medical devices at the location of processing, sterilization, and immediate use steam sterilization (IUSS), HLD of lumened and non-lumened devices, processing of reusable medical devices used with lubricating or defoaming agents, monitoring for effectiveness of processing, handling of devices after HLD, augments and alternatives to HLD, processing of investigational devices, tracking of reusable medical devices, and approaches to implementation.

Scope: Management, Prevention

Keywords: Disinfection, Sterilization

Target Provider Population: Individuals involved with sterilization and HLD for healthcare facilities, including all locations where healthcare is delivered

Inclusion Criteria: Male, Female, Adult, Older Adult

Health Care Settings: Hospital, Operating and Recovery Room, Outpatient

Intended Users: Epidemiology/Infection Prevention, Nurse, Nurse Practitioner, Physician, Physician Assistant