1128 - “The $20.6 Million Shortcut” (Jake Gleeson MLS Soccer IUSS Case)

Learning Outcome: 1️Eighty percent (80%) of learners will report an increased ability to identify risks associated with emergency-use sterilization, including IUSS, and the critical role of perioperative oversight in mitigating these risks.

2️Eighty percent (80%) of learners will report an increased understanding of how informed consent and emergency-use sterilization protocols contribute to patient safety and legal defensibility in perioperative practice.

Overview/Abstract: This session explores the high-profile case of Jake Gleeson, former Portland Timbers goalkeeper, whose professional soccer career ended due to a preventable surgical site infection. The infection was linked to the use of improperly sterilized orthopedic implants that underwent Immediate-Use Steam Sterilization (IUSS). A panel consisting of the patient, attorney Jason Kafoury, orthopedic surgeon and expert witness Dr. Peter Nichols, and sterile processing/medical device innovation expert and expert witness Shawn M. Flynn, will examine this case from every angle. The session offers a rare and practical deep-dive into the consequences of compromised reprocessing, lack of traceability, and breakdowns in OR/SPD coordination. The session also challenges perioperative leaders to evaluate how their department’s oversight of sterile processing impacts patient safety. Attendees will explore ways to support and empower SPD teams—who often work without sufficient visibility, authority, or resources—despite being foundational to every surgical procedure. The case argues for stronger perioperative leadership accountability in advocating for SPD infrastructure, staffing, and integration into quality and risk strategy.

Description of Current State: The immediate-use steam sterilization (IUSS) of surgical instruments, including implants, continues to be a critical point of risk in perioperative practice. While regulations and guidelines emphasize that IUSS should only be used in true emergencies—and never for implants in elective cases—real-world practice often deviates due to factors such as poor planning, inventory shortfalls, and communication breakdowns.

Sterile processing departments (SPD) are frequently under-resourced and disconnected from perioperative decision-making, yet they bear significant responsibility for ensuring the safety and sterility of surgical instruments. This disconnect, combined with inadequate documentation practices and a lack of proactive interdisciplinary communication, creates an environment ripe for preventable surgical site infections (SSIs) and legal exposure.

Recent high-profile cases, including the $21.6M jury award linked to improperly reprocessed implants in the Jake Gleeson case, underscore the urgent need for perioperative leaders to take ownership of SPD oversight, strengthen IUSS protocols, and align informed consent practices with real-world reprocessing risks.

Description of Desired/Achievable State: In the desired state, perioperative leaders will ensure that sterile processing departments (SPD) are fully resourced, empowered, and integrated into surgical services planning. Participants will be able to define clear criteria for what constitutes an IUSS “emergency,” ensuring that implants are never subjected to immediate-use sterilization in elective cases.

Participants will strengthen the alignment of informed consent processes with real-world sterilization risks, proactively disclosing the potential use of IUSS when appropriate and obtaining explicit patient consent if emergency-use sterilization might be anticipated. They will implement robust documentation and tracking practices—including BI usage, load traceability, and vendor tray validation—that support legal defensibility and patient safety.

Ultimately, perioperative leaders will recognize their critical role in elevating SPD as a core pillar of safe surgery, advocating for infrastructure investment, staff education, and cross-departmental collaboration to prevent avoidable SSIs and improve patient outcomes.

Audience Engagement: This session will use a dynamic, panel-driven format featuring perspectives from a patient, legal counsel, orthopedic surgeon, and sterile processing expert, fostering immediate audience engagement through real-world storytelling.

To engage and re-engage attendees, the session will incorporate:

1. Polling questions to assess initial knowledge of IUSS protocols, legal implications, and informed consent practices.

2. Case-based discussion where participants analyze key moments in the Jake Gleeson case, identifying decision points and proposing safer alternatives.

3. Small group or partner sharing to reflect on participants’ own experiences with IUSS, consent protocols, and cross-departmental collaboration.

4. A Question & Answer period to deepen understanding and apply learning to diverse practice settings.

A post-test or reflective prompt may be used to solidify key takeaways, encouraging learners to identify at least one action they can take to strengthen SPD oversight and patient safety in their own organizations.

Additional Information: Additional Information and Considerations
This session addresses an increasingly urgent topic in perioperative practice—immediate-use steam sterilization (IUSS) of implants—and bridges clinical, legal, and operational insights. The inclusion of a real-world patient case (Jake Gleeson) brings a powerful and human element that will resonate deeply with attendees, while also emphasizing the institutional consequences of inadequate SPD support and oversight.

Reviewers should consider that the session aligns with AORN’s strategic focus on safety, interdisciplinary collaboration, and perioperative leadership accountability. It reinforces the critical role of perioperative leaders in strengthening informed consent practices, redefining emergency-use sterilization protocols, and advocating for SPD resourcing and representation.

Speaker Requirements
-- Jake Gleeson (Patient): Availability for main-stage panel participation, discussion and audience Q&A.

-- Jason Kafoury, JD (Lead Attorney): AAvailability for main-stage panel participation, discussion and audience Q&A.

-- Dr. Peter Nichols (Orthopedic Surgeon and Expert Witness): Availability for main-stage discussion and audience Q&A.
Participation in clinical case analysis and response to audience questions.

-- Shawn M. Flynn (Business Unit Director – SPD, Skytron and Expert Witness): Available for presentation, panel facilitation, and Q&A; provides subject matter expertise on SPD, reprocessing technologies, and compliance frameworks.

Content/Topics: 1️Introduction to the Case

* Overview of Jake Gleeson’s surgical experience and infection outcome
* Context: Importance of reprocessing practices and perioperative oversight

2️IUSS: Definitions and Misuse

* Definition of IUSS and its intended use in true emergencies
* Discussion of common misapplications, especially involving implants in elective cases

3️Case Dissection: Clinical and Operational Failures

* Timeline of events leading to the infection
* Identification of process breakdowns in OR/SPD communication, documentation, and compliance
* Legal insights into chain-of-custody failures and their impact on patient safety and liability

4️Informed Consent and Legal Implications

* Importance of disclosing sterilization risks and obtaining informed consent
* Proposed protocols for integrating IUSS risk disclosure into surgical consent forms
* Legal defensibility and patient safety considerations

5️ Perioperative Leadership’s Role in SPD Support

* The impact of under-resourcing SPD departments
* Strategies for perioperative leaders to advocate for infrastructure, staffing, and cross-departmental collaboration
* How to define a defensible IUSS “emergency”

6️Interactive Engagement Activities

* Polling questions assessing baseline knowledge and risk awareness
* Case analysis and group discussion on decision points and alternative approaches
* Q&A with the panel, including the patient, attorney, surgeon, and SPD expert

7️Practical Tools and Takeaways

* Key documentation practices for SPD and perioperative teams
* Practical frameworks for managing sterilization emergencies
* Strategies to integrate SPD into safety and risk planning

8️Call to Action

* Reinforcing the need for perioperative leaders to elevate SPD visibility and infrastructure
* Advocacy for long-term systemic change to prevent avoidable SSIs

References: 1. Association for the Advancement of Medical Instrumentation (AAMI). (2017). ANSI/AAMI ST79:2017/(R)2022 with Amendments A1–A4: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. AAMI. https://www.aami.org/standards/featured-standards/ansi-aami-st79

2. Association of periOperative Registered Nurses (AORN). (2025). Guidelines for perioperative practice: Sterilization. AORN. https://www.aorn.org/guidelines-resources/guidelines-for-perioperative-practice

3. Centers for Disease Control and Prevention (CDC). (2008). Guideline for disinfection and sterilization in healthcare facilities, 2008. U.S. Department of Health and Human Services. hhttps://www.cdc.gov/infection-control/media/pdfs/Guideline-Disinfection-H.pdf

4. Rutala, W. A., & Weber, D. J. (2004). Disinfection and sterilization in healthcare facilities: What clinicians need to know. Clinical Infectious Diseases, 39(5), 702–709. https://doi.org/10.1086/423182

5. Crall, V. D., Lewis, C. L., Risnear, A., Miller, J., Sherer, J., Ayres, A. M., & Snyder, G. M. (2024). Immediate-use steam sterilization and the effect on surgical site infection risk in an acute care facility. Antimicrobial Stewardship & Healthcare Epidemiology, 4(1), e138. https://doi.org/10.1017/ash.2024.408

6. Davis, J. (n.d.). Retained bioburden on surgical instruments after reprocessing: Are we just scraping the surface? Pennsylvania Patient Safety Authority. https://collections.nlm.nih.gov/catalog/nlm:nlmuid-101711388-pdf

7. Agarwal, A., Schultz, C., Agarwal, A. K., Wang, J. C., Garfin, S. R., & Anand, N. (2019). Harboring contaminants in repeatedly reprocessed pedicle screws. Global Spine Journal, 9(3), 284–289. https://pubmed.ncbi.nlm.nih.gov/30984497/