November 26, 2025 (by: Lawrence F Muscarella, PhD; updated Jan. 21, 2026) – Earlier this month in a different article, Dr. Muscarella published an in-depth review — the first in a series of two articles — of the newly released “Multisociety guidance for sterilization and high-level disinfection.”
Jointly issued, in April, by several stakeholder organizations, including The Joint Commission, this 2025 multisociety guidance document “follows” the Centers for Disease Control and Prevention’s 2008 “Guideline for Disinfection and Sterilization in Healthcare Facilities,” according to the guidance’s authors.
Whereas Dr. Muscarella’s first article published earlier this month focused on sheathed semi-critical devices and endoscope-related infections, this supplemental article — the second in this series — focuses on the use of immediate use steam sterilization, or “IUSS,” to process surgical devices and implants used in operating room settings.
This second article, which includes an evidence-based position statement, may provide the most comprehensive review published to date on the use of IUSS. (This article is a draft and may be revised or updated without further notice.)
Accepting new clients: Dr. Muscarella is accepting new clients seeking expert guidance in infection prevention, the causes and prevention of healthcare-associated infections and other medical errors, disinfection and sterilization, and other related topics.
HIGHLIGHTS
- Earlier this month, Dr. Muscarella published an in-depth review—the first in a series of two articles—of the newly released “Multisociety guidance for sterilization and high-level disinfection,” which was issued in April and endorsed by several organizations including The Joint Commission.
- This 2025 multisociety guidance “follows” The Centers for Disease Control and Prevention’s 2008 “Guideline for Disinfection and Sterilization in Healthcare Facilities,” according to the guidance’s authors.
- This supplemental article—the second in this series—provides an evidence-based “position statement” on the use of immediate use steam sterilization, or “IUSS.”
- This second article’s advice on IUSS is two-tiered, distinguishing the potential clinical severity of a surgical site infection, or “SSI,” due to an improperly processed non-implantable surgical instrument to that of a SSI resulting from a contaminated implant. In comparison, the multisociety guidance on IUSS use is single-tiered, making no such distinction.
- This article’s “position statement” advises that IUSS may be used for surgical (non-implantable) instruments but only in a defined, documented “emergency situation.”
- Using two-tiered guidance, Dr. Muscarella urges against the use of IUSS for implantable devices due to the increased risk for processing errors and the potential for catastrophic implant-related SSIs.
- However, if IUSS is deemed absolutely necessary to process an implant in an exceptional, rare emergency, this supplemental article advises that certain criteria be met and information documented, including the IUSS cycle’s data and the name (and signature) of the surgeon or other authorized individual(s) approving IUSS’s use for an implant during the emergency.
- In addition, this article instructs — possibly for the first time — that the use of IUSS to process an implantable device, based on a failure mode and effects analysis and the potential for a catastrophic implant-related SSI, be disclosed and documented as part of the patient’s medical record to promote transparency and accountability in healthcare, advance a culture of safety, and eliminate preventable surgical site infections.
November 26, 2025 (by: Lawrence F Muscarella, PhD) – Several societies and organizations, including The Joint Commission, jointly issued new guidance, in April, for reprocessing reusable medical instruments including flexible endoscopes.
This endorsed 2025 document — titled “Multisociety guidance for sterilization and high-level disinfection” — provides guidance that “follows” the Centers for Disease Control and Prevention’s 2008 “Guideline for Disinfection and Sterilization in Healthcare Facilities,” according to the 2025 document’s authors.
Like the CDC’s 2008 guideline, the new multisociety guidance document discusses Spaulding’s classification scheme for categorizing medical devices; covering a reusable semi-critical device with a disposable sheath to prevent cross-infections; and the use of immediate use steam sterilization (“IUSS”), among other timely topics.
Presented as questions to which the 2025 document’s authors provide recommendations in response, several of this multisociety document’s strategies to prevent healthcare-associated infections are reasonable, practical and well referenced.
Forensic Case Reviews, Expert Guidance, Infection Investigations: LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
Immediate use steam sterilization (IUSS)
Some of the multisociety’s 2025 other guidance, however, Dr. Muscarella found to be confusing and to raise questions about the potential for variations in clinical practices, different standards of patient care, and the risk of infections in endoscopic and operating room settings.*
As an example of some of its ambiguity, the newly endorsed multisociety guidance advises that facilities “not routinely use” IUSS.
While such advice is not unique to this 2025 guidance document, it can (unintentionally) create confusion and differing interpretations (e.g., due possibly to inadvertent confirmation bias) of what defines a “non-routine” practice, thus facilitating inconsistent, if risky, practices in operating room settings — unless the guidance were to clearly and explicitly explain these terms.
As rationale for its guidance not to use IUSS “routinely,” the 2025 multisociety document acknowledges that certain circumstances may arise with IUSS that “can result in pressure on operating room HCP (healthcare personnel) to eliminate or modify one or more steps prior to sterilization, increasing the risk for errors” — and, presumably, also the risk for associated surgical site infections (“SSIs”).
This article may provide the most comprehensive review and evidence-based guidance published to date on the use of IUSS for processing surgical devices, like scalpels, and implants, like orthopedic plates, in operating room settings. — Lawrence F. Muscarella, Ph.D.
This risk for errors and associated SSIs notwithstanding, the jointly-endorsed 2025 guidance states that IUSS “is an effective method of sterilization when properly performed” and “can produce a sterile medical device” — advice that admittedly is similar to the CDC’s 2008 guideline’s claim that IUSS “is considered acceptable for processing cleaned patient-care items that cannot be packaged, sterilized, and stored before use.”
However, such assessments claiming IUSS’s safety, quality and performance can cause confusion specifically when read alongside the directives of other published infection control guidelines restricting, or even expressly contraindicating, the use of IUSS, particularly for processing implantable devices due to “the potential for serious infections” as the CDC has acknowledged.
The Veterans Health Administration (VHA), for example — like the guidance, policies, and standards published by certain other healthcare organizations, groups, and medical facilities — explicitly restricts the use of IUSS for non-implantable instruments only to “an emergency when there is insufficient time to process by the preferred wrapped or container method.”
As rationale for its stance, the VHA’s directive states that evidence suggests a direct relationship between IUSS and infections.
IUSS must be used only in an emergency when there is insufficient time to process by the preferred wrapped or container method. — The Veterans Health Administration, U.S. Department of Veterans Affairs
Adopting a similar policy that had also previously been the norm in the U.S., a Canadian standard limits IUSS only to “emergency situations” — a term that can also facilitate confusion and inconsistent, if risky, practices in operating room settings, however, unless the guidance were to clearly and explicitly list all of the circumstances that would reasonably define “an emergency.”
Whereas some facilities and healthcare groups in this context might define an “emergency” as a clinical situation “in which any delay incurred places the patient at risk of imminent harm to life, or serious threat to health” (or, similarly, as “a situation where life, limb, or function is at risk“), other organizations may instead describe and limit an emergency (for which IUSS might be considered permissible) to specific, identified clinical examples such as when “a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately,” or when “an item has dropped on the floor and is needed to continue a surgical procedure.”
Nevertheless, these salient differences in published guidance notwithstanding, virtually all instrument sterilization guidelines emphatically prohibit the use of IUSS:
- for the sake of convenience or to save time
- as a substitute for low instrument inventory (e.g., due to cost considerations)
- insufficient staffing in the sterile processing department, and/or
- in response to observing bioburden on instrument trays in the operating room.
Like the VHA’s rationale for restricting IUSS’s use for non-implantable instruments (i.e., to an emergency), the Centers for Medicare & Medicaid Services (CMS) report that practices associated with IUSS “have been implicated in surgical site infections and are considered to pose an increased risk of complications because of potential barriers to thorough completion of all necessary reprocessing steps.”
Consistent with the VHA and CMS’s assessment of IUSS’s risks, a 2024 study identified “a 1.52 times higher risk of SSI following IUSS device reprocessing and significantly increased procedure-specific risk for transplant and plastic surgeries” (although it is acknowledged that a different study published in 2022 reported no statistically significant infection rate differences).
Providing additional evidence in agreement with the findings of this 2024 IUSS study analyzing the risk of IUSS-related SSIs, a study just published notably identified an association between a reduction in the use of IUSS and a statistically significant decrease in hip SSIs.
This article’s citation: Muscarella LF. Immediate use steam sterilization (IUSS): Dr. Muscarella’s Recommendations and Position Statement. Discussions in Infection Control November 25, 2025.
IUSS for implantable devices?
For some guidelines, the use of IUSS to process surgical implants, compared to other types of surgical instruments, is a particular concern, based on risk assessments and the potential for adverse clinical outcomes. Consequently, a guideline may distinguish its IUSS guidance for implantable devices, such as orthopedic plates, from that for non-implantable instruments, such as surgical scalpels.
This distinction is generally based on reports documenting the potential for organ/space SSIs due to, for example, inadequately sterilized implants to be associated with more clinically severe outcomes and markedly higher complication rates compared to superficial incisional SSIs such as from a contaminated non-implantable device.
Deeper SSIs can lead to worse, more adverse patient outcomes (e.g., sepsis). Indeed, the clinical impact of an organ/space SSI resulting from a contaminated, improperly processed implant can be “catastrophic” and could require revision surgery.
Applying this two-tiered IUSS guidance based on the potential for a severe or catastrophic implant-related SSI, the CDC’s 2008 guideline, for instance, states that IUSS “is not recommended for implantable devices” (although the guideline concedes that IUSS may be unavoidable at times for some types of devices, such as an orthopedic screw or plate).
Because of the potential for serious infections, IUSS is not recommended for implantable devices. — The CDC (2008)
The VHA’s instruction is clearer, stricter and more exacting, emphasizing that IUSS is “not to be” used to process (non-biological) implantable devices. The previously noted Canadian standard similarly stresses that IUSS “shall not be used to sterilize implants or complete instrument sets.”
Despite these contraindications and the potential for serious SSIs, the 2025 multisociety guidance neither distinguishes between the severity of different device-related SSI types nor advises against IUSS for processing implantable devices.
Instead, the 2025 document — admittedly like a 2021 document by The Joint Commission on IUSS, which also fails to differentiate and compare the potential clinical severity, per a failure modes and effects analysis, of a deep organ/space implant-related SSI to that of superficial incisional SSI caused by contaminated non-implantable devices — states that IUSS may be used for any type of device, provided certain criteria are satisfied — such as only when “the devices or implants are heat-stable” and the manufacturer’s instructions for use (MIFU) provides specific directions for IUSS.
As justification, the 2025 multisociety document asserts that “IUSS is effective when devices or implants are properly cleaned prior to IUSS, appropriate temperature, pressure, and exposure times are met, and adequate drying and cooling occurs.”
No matter, sterilization guidelines that provide inconsistent advice on IUSS can create confusion, different standards of clinical patient care, an increased infection risk, and the potential for legal exposure.
Infection Case Reviews, Forensic Analyses, Expert Guidance: LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
Wet surgical instruments can pose an infection risk
The 2025 multisociety guidance discusses another practice, or terminal IUSS step, that raises additional questions of safety for Dr. Muscarella.
While emphasizing that the necessary measures be taken with IUSS “to prevent contamination of the device or implant during removal from the sterilizer and transfer to the sterile field,” the multisociety document also discusses consideration of a terminal practice after IUSS that could, however, potentially (although inadvertently) contaminate the processed device with exogenous microorganisms just prior to use.
Namely, due to the potential for a hot, flashed surgical device or implant burning the patient (understanding that the shorter IUSS cycle has minimal or no terminal drying phase), the 2025 guidance document discusses as a preventative step following IUSS “either air-cooling the instruments or immersion in sterile water.”
I advise caution whenever using IUSS to process an instrument, particularly a surgical implant — and I emphasize the concern if immersion of a hot, flashed implant terminally into a “sterile” solution or water following IUSS is being considered to cool the device prior to its immediate introduction into the sterile field. — Lawrence F. Muscarella, Ph.D.
Such guidance to cool a hot, flashed instrument is not unique, however. One hospital’s on-line procedure for IUSS advises that devices processed by IUSS “are still hot when received by scrub nurse. Be sure to cool items before passing to surgeon, sterile water on field may be used.”
Similarly, CMS states in a 2014 memorandum that the instrument or item “may be cooled aseptically in cold sterile water” after IUSS and immediately prior to use.
Nevertheless, while this terminal cooling step on its face seems potentially pragmatic, it raises important questions about safety, violations of aseptic technique, and whether this “workaround” measure indeed solves a concern (for burns) or, instead, may increase the likelihood of a SSI, particularly a deep organ/space SSI if the item just processed with IUSS is a surgical implant.*
Published evidence indicates that the clinical use of wet (or moist) surgical instruments can increase the risk of bacterial re-contamination. Several organizations and agencies have discussed this specific infection concern, including:
- CMS memorandum (2014): CMS advised in this same 2014 memo that IUSS is associated with “an increased risk of inadvertent contamination during transfer” of the device to the sterile field, as well as “risks related to wet instruments and the potential for burns.”
- Multisociety guidance (2025): The multisociety guidance published earlier this year, in April, acknowledges that “residual moisture poses a risk to patients by supporting microbial growth.”
- CDC policy (2008): The CDC’s 2008 guideline states that “[s]terile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces.”
- FDA instruction (2019): An FDA warning letter in 2019 affirms that “[r]etained moisture, also called ‘wet loads,’ following terminal steam sterilization may be viewed as sterilization process failures.”
Unclear is whether The Joint Commission, which conducts accreditation surveys of U.S. medical facilities, has adequately considered the risk of potentially catastrophic implant-related SSIs when using IUSS, particularly if the processed implant is actively cooled terminally in water immediately before use to prevent clinical burns, which can further increase the infection risk, understanding that The Joint Commission’s endorsed the 2025 multisociety guidance, including its single-tiered IUSS advice (grouping non-implantable devices with implants).
Due to this published risk and severity of bacterial SSIs (and potential legal exposure), this article (by Dr. Muscarella) advises caution whenever considering IUSS, particularly to process an implantable device — and based on both a SSI risk assessment and a failure mode and effects analysis, this advisory is even further emphasized when the terminal immersion of a hot, flashed surgical implant into a cooling solution (e.g., “sterile” water) is being considered following IUSS to prevent clinical burns during the procedure.*
This article is likely the first to instruct that the use of IUSS to process an implantable device be disclosed and recorded as part of the patient’s medical record to promote transparency in healthcare, improve safety, and reduce the risk of preventable SSIs. — Lawrence F. Muscarella, Ph.D.
Even use of wet, semi-critical endoscopic instruments much less invasive than surgical implants has been directly linked to infections, sometimes causally.
Reports including a review by Nelson and Muscarella (2006) describe multiple cases documenting an association, and in some cases a causal relationship, between patient exposure to wet (or improperly dried) flexible endoscopes, including gastrointestinal endoscopes, and outbreaks of waterborne microorganisms (e.g., Pseudomonas aeruginosa), with significant patient morbidity and mortality.
For several of the cases they reviewed, Nelson and Muscarella (2006) found that the outbreaks (which included pseudo-outbreaks) were abruptly terminated following the implementation of endoscope drying.
Failure to dry the disinfected flexible endoscope terminally, Nelson and Muscarella (2006) emphasized, “can render the reprocessing procedure invalid and clinical use of the endoscope an infection risk.” These two researchers concluded in the same review that the contribution of drying to the prevention of bacterial infections “cannot be overstated.”
Forensic Case Reviews, Expert Guidance, Infection Investigations: LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
Position statement — IUSS
Due to the documented safety concerns, only use IUSS to process non-implantable surgical instruments in a defined, documented “emergency situation.”
Do not use IUSS for implantable devices due to the potential for serious organ/space SSIs; however, if IUSS for an implant is deemed absolutely necessary (i.e., as a last resort with no other option available), then in addition to satisfying certain other criteria, record on the appropriate forms the specific exceptional emergency situation/circumstance requiring IUSS’s use along with the name (and signature) of the surgeon or other authorized individuals approving IUSS to process the implant.
Additionally, this article advises — perhaps for the first time — that the use of IUSS to process a surgical instrument — particularly and especially implantable devices — be documented in the patient’s medical record (i.e., be disclosed — for example via post-operative informed consent), based on a SSI risk assessment and a failure mode and effects analysis’s concern for catastrophic deep organ/space SSIs.
Such advised disclosure is consistent with CMS’s stated objectives and goals to promote transparency and accountability in healthcare, advance a culture of safety, and eliminate preventable harms, including SSIs.
Some of Dr. Muscarella’s related articles:
- Dr. Muscarella’s Review of the New Multisociety Guidance for Disinfection and Sterilization in Healthcare Facilities. (2025)
- A Proposal to Include Endoscope-Associated Infections as a Reportable Medicare Measure to Promote Patient Safety (2025)
- In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model (2024)
- Esophageal Tissue Tears and Other Adverse Events Reported When Using Duodenoscopes with a Single-Use Endcap (2023)
Summary, Recommendations
The following recommendations for IUSS are provided to healthcare facilities and surgeons to reduce the risk of confusion, errors and infections, particularly implant-related SSIs.
These recommendations are based on Dr. Muscarella’s extensive review of the literature, published guidance, and medical facilities’ policies and procedures for using IUSS.
The revision of evidence-based sterilization guidelines to ensure consistency and increased patient safety is recommended, understanding that conflicting instrument sterilization guidance — with some directives explicitly discouraging or contraindicating use of IUSS for implants due to documented infection concerns, while other guidance instead suggests the risk and potential severity of SSIs associated with IUSS-processed implants are not statistically different from those associated with non-implantable surgical devices — can cause confusion, different standards of care, an increased infection risk, and the potential for legal exposure.
With a focus on improving safety in medical facilities, this article — the second in a series of two — may provide the most comprehensive review to date on the use of IUSS to process surgical devices and implants in operating room settings.
1. Only use IUSS to process a non-implantable surgical instrument in a defined, documented “emergency situation.”
A. Ensure that the facility’s policy and procedures (P&Ps) restrict the use of IUSS for processing a surgical instrument to only emergency situations.
Rationale: A study published in 2024 reported IUSS to be associated with a significantly higher risk of SSIs for transplant and plastic surgeries. A second, more recent study identified an association between a reduction in the use of IUSS and a statistically significant decrease in hip SSIs.
B. Confirm that these P&Ps either define an “emergency situation” or, alternatively, provide an inclusive list of virtually all of the specific clinical emergency scenarios that might justify or permit the use of IUSS to process an instrument.
a. Examples of such clinical circumstances may include the re-sterilization of a non-replaceable, unwrapped instrument that accidentally dropped on the operating room floor during the surgical procedure.
Note: Some facilities may define “an emergency” in the context of IUSS more broadly as “a clinical situation in which any delay incurred places the patient at risk of imminent harm to life, or serious threat to health.”
B. If an “emergency situation” is encountered (as defined in the facility’s P&Ps) for which IUSS may be justified:
a. Review the surgical instrument’s instructions for use (IFUs) to ensure its labeling does not explicitly contraindicate the use of IUSS in any circumstance.
b. Record on the appropriate forms (i.e., the IUSS log and/or the early release form) the details of the specific clinical circumstance and reason(s) justifying IUSS’s use, consistent with the facility’s P&Ps.
i. In addition, record on the appropriate forms:
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- the IUSS cycle’s time, temperature and pressure
- the load’s contents
- the results of the biological indicator (BI) contained within a process challenge device (PCD)
- the patient’s name (or the patient’s unique identifier); and
- all other relevant cycle and case information (e.g., the surgeon’s name).
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Notes: Such documentation is important for epidemiological tracking (e.g., in the case of a surgical site infection, or a positive BI result).
Further, this article recommends that each use of IUSS to process the surgical instrument be documented as part of the patient’s permanent medical record (i.e., disclosed via post-operative informed consent) to promote transparency and accountability in healthcare, advance a culture of safety, and eliminate preventable harms including SSIs.
2. Do not use IUSS for implantable devices due to the potential for serious organ/space SSIs.
A. Confirm that the facility’s P&Ps are based on a two-tiered, severity-based SSI assessment (and failure mode and effects analysis) that advises against the use of IUSS for processing an implantable device due to the potential for legal exposure and concerns for catastrophic organ/space SSIs (the advice of certain other guidance documents notwithstanding).
Rationale: This article’s IUSS recommendations — which are in general agreement with the guidance published by the VHA, CMS and CDC (i.e., in 2008), which explicitly discourage or contraindicate use of IUSS for implants — distinguish between the potential clinical severity of a deep organ/space implant-related SSI compared to that of a superficial incisional SSI due to a contaminated non-implantable surgical instrument.
Published evidence documents the potential for the former SSI type due to an inadequately processed implant to be associated with a more clinically severe outcome and markedly higher complication rate than the latter SSI type.
A study published in 2024 reported IUSS to be associated with a significantly higher risk of SSIs for transplant and plastic surgeries. A second, more recent study identified an association between a reduction in the use of IUSS and a statistically significant decrease in hip SSIs.
Note: While this article’s risk-based recommendations and position statement, like the VHA’s directive, advises against using IUSS to process implants, it recognizes that the 2025 multisociety guidance (as well as the policies of some U.S. medical facilities) permit this practice (under certain circumstances).
B. However, if IUSS is deemed absolutely necessary to process an implant (i.e., as a last resort with no other option available) per the findings of the facility’s documented risk assessment, then in addition to the other IUSS cycle data and patient information detailed above:
a. Record on the appropriate forms (i.e., the IUSS log and/or the early release form), consistent with the facility’s P&Ps, the specific exceptional emergency situation justifying the use of IUSS along with the name (and signature) of the surgeon or at least one other authorized individual approving the use of IUSS to process the implant.
b. Additionally, document each use of IUSS to process an implantable device as part of the patient’s medical record (and disclosed — for example, via post-operative informed consent) due to among other additional rationale:
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- the documented risk for implant-related organ/space catastrophic SSIs;
- an “increased risk of inadvertent contamination” of the flashed implant with exogenous microorganisms during the device’s transfer into the sterile field;
- the “risks related to wet instruments“;
- the “potential for burns” from a hot, flashed instrument; and
- CMS’s stated goals and objectives to promote transparency and accountability in healthcare, advance a culture of safety, and eliminate preventable harms.
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Note: CMS advises: “If IUSS must be used for an implantable device, the name of the patient/patient’s unique identifier and any other information needed to accurately link the instrument processed using IUSS back to the patient must be recorded.” CMS clarifies further that “the facility must ensure that any implant subjected to IUSS is accurately traceable to the recipient patient.”
c. Use a BI (along with a Class 5 chemical indicator) to monitor every IUSS cycle when the load contains an implant.
i. Confirm that the results of the BI have been recorded.
ii. Whenever possible, quarantine the implant (e.g., on the back table) releasing it only after the BI (e.g., a rapid-acting BI) yields a negative result.
Note: As the CDC wrote in a 2003 guideline, “Because all implantable devices should be quarantined after sterilization until the results of biological monitoring are known, unwrapped or flash sterilization of implantable items is not recommended.”
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Article by: Lawrence F Muscarella, PhD. LFM Healthcare Solutions, LLC. Dr. Muscarella is the president and founder of LFM Healthcare Solutions, LLC, an independent quality improvement company. Click here for a list of his quality improvement healthcare services. E: Larry@LFM-HCS.com. [LFM-ver-2.0]
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* Additional disclosures: This article features Dr. Muscarella’s opinions, perspectives and recommendations based on his review and interpretation of the multisociety guidance document (2025). His views are necessarily subject to debate, disagreement and further discussion. Indeed, some of his conclusions and insights about IUSS herein may be incomplete or even potentially incorrect (thus warranting independent review for accuracy). While unrelated to this article, Dr. Muscarella has provided guidance on occasion for Ambu, a manufacturer of single-use flexible endoscopes.