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Revealing the Hidden Risks: Urgent Reforms Needed in Surgical Instrument Sterilization

In the complex world of healthcare, a prevailing assumption among surgeons—that their sterile processing departments are reliable—collides with a harsh reality unveiled by data. The consequences of improperly sterilized surgical instruments manifest in unexpected rates of morbidity, mortality, and soaring costs, urging us to reassess our current practices. In the article below, we detail some of the latest findings on the risks associated with reusable surgical instruments as well as the beacon of hope provided by pivoting toward single-use.

The Startling Truth: Compliance and Sterilization Failures

Astonishingly, over half of hospitals (51%) and nearly half of ambulatory surgery centers (43%) fail Joint Commission spot inspections on instrument sterilization.[1] The gravity of this situation is underscored by an alarming 74% of “Immediate Threat to Life” deficiencies traced back to improperly sterilized equipment.[1] What may seem like isolated incidents collectively form a crisis that has been steadily escalating for over a decade.[2] The rates of improperly sterilized equipment and surgical site infections (SSIs) caused by antibiotic-resistant strains have surged from 12% in 2000 to a staggering 54% today.[3]

Navigating the Design Dilemma: Reusable Instruments and Sterilization Challenges

Delving into the crisis reveals a fundamental flaw in the design of reusable surgical instruments. A meticulous study by the University of Michigan Medical Center exposed a staggering 98% retention of blood, bone, and tissue, even in instruments cleaned and sterilized in strict accordance with manufacturer recommendations.[4] Dr. Daniel Schwartz, former Chief Medical Officer of CMS, starkly stated that most surgical instrument designs are “impossible to clean.”[4]This design dilemma becomes a breeding ground for infections and poses a significant hurdle in achieving reliable sterilization.

Human Element: Training, Pay, and Management Challenges

The human element in this crisis adds another layer of complexity. Sterile processing department (SPD) staff, often paid less than fast-food workers and lacking formal training on many complex instruments they have to clean, operate in an environment that requires precision and expertise. Surgeons express their frustration at the risk posed to patients due to SPD inadequacies, citing poor management and a culture of blame. As one former hospital SPD director explained, management’s mentality toward SPD staff is driving increasing failures: “fire someone . . .replace . . . run them into the ground, blame them, repeat.”[5] This critical aspect of the problem underscores the need for investing in training, elevating the status of SPD staff, and fostering a culture of accountability.

A Culture of Secrecy: Underreporting and Lack of Transparency

Jahan Azizi, a clinical engineer and nationally renowned expert on instrument cleaning has remarked on the “culture of secrecy” surrounding instrument sterilization failures, perpetuating the crisis.[6] Faced with a sense of futility and financial incentives, hospitals refuse to disclose data on SSIs and sterilization failures.[6] An HHS study reveals that a staggering 86% of instruments identified as improperly sterilized were never internally reported.[6] The lack of transparency not only impedes progress but also contributes to alarmingly low reporting rates, perpetuating a cycle of underreporting. Within the context of these findings, it is clear that improperly cleaned and sterilized surgical instruments are far and away the greatest cause of avoidable SSIs.

A Call for Change: The Role of Single-Use, Sterile, Pre-Packaged Instruments

In the face of this multifaceted crisis, a beacon of hope emerges in the form of single-use, sterile, pre-packaged (SSP) implants and instruments. Pioneering this shift is the Sure Retractor, the first and only SSP surgical retractor ( SSP instruments present a tangible solution, offering reliability in sterilization and breaking the chain of infections. This shift is not merely an option; it’s a necessary leap toward ensuring patient safety and the efficacy of surgical practices.

Looking Ahead: The Promise of SSP Instruments

In the second part of this series, we’ll delve into the profound impact of SSP instruments on reducing infections. With over 30,000 Americans succumbing to SSIs annually, the imperative to redefine industry standards is clear. SSP instruments not only reduce morbidity, mortality, and cost but are poised to become the new surgical best practice. The adoption of SSP instruments is not just a change; it’s a commitment to a safer and more effective future in healthcare.

Conclusion: Urgency in Embracing Change for Safer Surgical Practices

As we navigate an ever-evolving healthcare landscape, acknowledging challenges is not enough. We must actively pursue innovative solutions. The tens of thousands of lives lost annually to SSIs are a clear indicator that the time to redefine industry standards is now. The adoption of single-use, sterile, pre-packaged instruments is not just a practical step; it’s a moral imperative, ensuring the safety of patients and the success of surgical practices.



[1] Improper sterilization and high-level disinfection of equipment challenges organizations. The Bulletin. (2017, August 1).

[2] One more thing: Improperly sterilized equipment is “a growing problem.” Betsy Lehman Center. (2017, June 22).

[3] RG;, Y. P. (Epub 2014, October 3). Surgical site infections. The Surgical clinics of North America.

[4] Eaton, J. (2022, January 28). Filthy Surgical Instruments: The hidden threat in America’s Operating Rooms. Center for Public Integrity.

[5] Bouffard, K., & Kurth, J. (2016, April 25). Dirty, missing instruments plague DMC surgeries. -ial-rports/2016/08/25/dirty-instruments-plague-dmc-surgeries/89303582/

[6] Kurth, J., & Bouffard, K. (2016, August 25). Hospital records kept from public. Detroit News.

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