The Pandora’s Box of Orthopedic Tray Sets: A Call for Scrutiny on Multi-Reprocessed Implants

This article originally appeared in the Nov-Dec 2026 issue of Healthcare Hygiene magazine.

By Stephen M. Kovach, BS

Attending a recent medical device reprocessing meeting in Halifax, Nova Scotia offered a powerful reminder of how vital medical device reprocessing professionals are to the surgical continuum. Among the highlights was a presentation by an orthopedic surgeon who brought a unique, invaluable perspective to the podium—having at one time toured a medical device reprocessing department himself. He spoke candidly about the critical role of medical device reprocessing professionals play in positive patient outcomes, welcomed tough questions, and fostered an engaging dialogue.

During the question-and-answer session, a poignant and sobering moment unfolded that I had never encountered quite so directly before. An attendee stood up to share that her husband had developed a post-operative infection stemming from an orthopedic implant—whether a screw or a plate—housed in a multi-use surgical tray. Her experience brought a human, high-stakes reality to a debate that often stays confined to conference rooms and technical journals: what happens to the hardware that goes back into the sterilizer cycle time and time again when unused during previous procedures?
In the discussion that followed, both attendees and the guest physician noted a general uncertainty regarding what formal, published studies exist on this exact topic. For anyone tracking the science of medical device reprocessing, however, the literature is both eye-opening and deeply concerning.

The Hidden Risks in the Tray
In orthopedic surgery, implantable hardware like screws and plates are routinely housed within manufacturer-provided racks inside comprehensive surgical instrument trays. Because only a fraction of these implants are selected during any given procedure, the remaining screws and plates are repeatedly sent back through medical device reprocessing departments (MDRDs) to undergo continuous washing, packaging, and steam sterilization alongside general surgical instruments. This routine practice creates a quiet vulnerability in patient safety, raising serious questions about surface integrity, material fatigue, and the accumulation of build-up biofilm and chemical residues.
Let’s be honest—anyone who has ever processed an orthopedic instrument tray with screws has either experienced this firsthand or watched it happen in real time: you shift the tray or open the holder, and suddenly, the majority or even all of the screws spill out, scattering across the workstation.

When this happens, you are forced to stop, track them down, realign them, and painstakingly re-sort them into their proper positions. It is an all-too-common personal experience in the department, but it leaves you wondering afterward: Did that tumble scratch a screw? Did it cause micro-damage that went unnoticed?

While it is impossible to know for sure every time it occurs, this chaotic shuffling introduces an unnecessary handling risk. Securing screws properly within their holders isn’t just about keeping the tray organized—it’s about preventing potential compromises to the hardware before it ever reaches the sterile field.

The scientific community has increasingly turned its lens toward this exact dilemma, hardware integrity. Years ago, pioneering work by clinical microbiologist Dr. Michele J. Alfa brought widespread attention to the issue in her seminal publication, “The Pandora’s box dilemma: reprocessing of implantable screws and plates in orthopedic tray sets” (Biomedical Instrumentation & Technology, 2012). Dr. Alfa underscored that instructions for use (IFUs) from many orthopedic manufacturers failed to adequately account for the cumulative impact of multiple reprocessing cycles on tray-based implants, noting that dense screw racks can obstruct proper cleaning fluid access during automated washing. In addition to her peer-reviewed research, Dr. Alfa has extensively contributed non-peer-reviewed and educational articles for the professional community, breaking down the gaps in manufacturer IFUs and the practical obstacles faced daily by technicians MDRDs.

Subsequent independent investigations have heavily reinforced these findings. Research by Dayane de Melo Costa, Karen Vickery, Rodrigo França, and their collaborators—including studies published in 2018 and 2022 (“Providing sterile orthopedic implants: challenges associated with multiple reprocessing of orthopedic surgical trays”)—utilized advanced scanning electron microscopy (SEM) and microbiological assays to evaluate “patient-ready” orthopedic screws sourced from loaner systems.

Furthermore, landmark surface analysis research led by Rodrigo França, Michelle Alfa, and colleagues (Journal of Orthopaedic Research, 2017) utilized advanced nanoscale surface techniques—such as X-ray photoelectron spectroscopy (XPS) and time-of-flight secondary ion mass spectrometry (TOF-SIMS)—to characterize organic residues and endotoxins (lipopolysaccharides, or LPS) on stainless steel fixation screws. Because a single E. coli bacterium carries more than 2 million LPS molecules, and because these heat-stable toxins can withstand temperatures up to 180°C, their presence on hardware poses a severe, hidden threat. Their findings revealed alarming realities:

Residual Contamination and Endotoxins: Evaluated cortical screws frequently exhibited high rates of residual protein contamination, surface-adherent lipopolysaccharides, and chemical residues surpassing safe international thresholds.

Surface Degradation: Repeated mechanical handling and chemical exposure led to micro-grooves, pitting, and structural corrosion across the metal surfaces that can inhibit successful osseointegration.

Build-Up Biofilms: Scanning electron microscopy and nanoscale spectrometry successfully identified entrenched biofilms and protected microorganisms within the threading and micro-imperfections of hardware that had cycled through multiple medical device reprocessing loops, pointing directly to a potential root cause of aseptic loosening.

Implications for Patient Safety
The cumulative findings from these researchers point to critical vulnerabilities in the traditional handling of orthopedic hardware (see table on page 10 of the Nov-Dec 2026 issue).

The work of Dr. Michelle Alfa, alongside researchers like Karen Vickery, Dayane de Melo Costa, and Rodrigo França, underscores the urgent need for standardized manufacturing guidelines, improved tracking of reprocessing cycles, and a re-evaluation of how tray-based implants are managed to safeguard patient outcomes (how many times can they be processed over and over again, safely, is the question).
Addressing these issues requires collaboration among manufacturers, healthcare providers, and regulators to develop validated, clear protocols and possibly shift toward single-use solutions.

Improper Processing Practice
As explicitly outlined by major orthopedic manufacturers, trays, caddies, and cases—including those containing components, plates, and screws—strictly designed as organizational tools for surgery, storage, and final steam sterilization. They are not designed for cleaning or disinfection in the fully assembled state. Running a loaded case through an automated washer prevents the mechanical action and washing and rinsing solution from reaching all surfaces, leading to possible inadequate cleaning results and potentially retained bioburden.

Stryker policy: “Stryker’s trays and cases are intended for transport and storage of re-usable instruments. They are not designed for cleaning and/or disinfection in the fully assembled state. The instruments must be removed from the tray for adequate cleaning results” (Instructions for Spine Products, NSRDEV-RG-1 Rev-2, p. 6).

DePuy Synthes policy: “Soiled or used Synthes devices should not be loaded into a case for cleaning in a mechanical washer. Soiled Synthes devices must be processed separate from trays and cases. Synthes cases are designed to be an organizational tool for the steam sterilization process, a storage tool for all medical devices and an organizational tool for surgery” (Important Information with Cleaning and Sterilization Instructions; SE_023827 or equivalent system-specific processing guide, such as the Instructions for Use Synthes Cutting Tools).

Learning from Others: International Insights on Risk Governance Concerning Orthopedic Screws and Plates
As MDRDs across North America evaluate the lifecycle management and safety of surgical instruments and implants, looking outward provides critical perspective. A powerful benchmark can be found in the United Kingdom, where NHS Scotland transitioned to a policy of using pre-packed, pre-sterilized, single-use small orthopedic implants in the late 2000s. This precedent served as a vital reference point for Wales, prompting the Welsh NHS to commission evaluation work from the Surgical Materials Testing Laboratory (SMTL).

SMTL’s comprehensive briefing work—first published in 2010 and updated in recent years—addressed a major operational vulnerability: small screws and plates that are opened for surgery but left un-implanted are frequently returned to sterile services for repeated reprocessing, despite raising cleaning verification, surface wear, and traceability challenges. Remember they are considered single use but are processed repeatedly until they are used.

The core lesson for North American healthcare systems lies in how risk is governed. The Welsh model elevated the issue to a transparent, board-level organizational decision. Under this approach, if a facility chooses to continue reprocessing single-use hardware (until it is used), that decision requires formal risk assessment, multidisciplinary consensus, and executive sign-off ensuring that patient safety and regulatory clarity take precedence over historic habit or economic convenience.

Now What?
The sobering testimony from the audience in Halifax bridges the gap between abstract laboratory data and real-world clinical consequences. When an implant possibility gathers microscopic trauma, heat-stable endotoxins, and protected bioburden across successive unmonitored cycles until used, the risk profile shifts. Also, learning that other countries are also struggling with this issue and are taking steps to provided the best outcomes for their patients, we need to also look at this issue and find a better way.

The insights shared by our guest physician in Halifax—and the courageous question raised by an audience member—remind us that we cannot treat instrument trays as endlessly resilient black boxes. Safeguarding patient outcomes demands that we heed the foundational warnings of researchers like Dr. Alfa, Dr. Vickery, and Dr. França. It is time for our industry to critically re-evaluate how tray-based implants are tracked, manufactured, and managed before they ever cross the threshold of an operating room.

This meeting also highlighted the irreplaceable value of face-to-face meetings and conferences, demonstrating a distinct advantage over virtual formats like Zoom or Google Meet. While online education, webinars, and podcasts are fantastic additions, they cannot replace genuine interpersonal interaction. This dynamic is especially critical given our industry’s staff turnover, which I estimate at least 15 percent a year for departments in general.

Another major variable across MDRDs is the stark inconsistency in operational practices and oversight. Are all departments truly following the same standards, guidelines, and the original equipment manufacturer (OEM) settings for the medical automatic washer and sonic? How are they routinely testing their automated washers and sonic irrigators, and what checks and balances are in place to verify that staff are properly trained and certified? Furthermore, many orthopedic OEM IFUs demand very specific cycle parameters—questions must be asked: are those precise parameters being followed, or are shortcuts being taken? Eliminating these variables is essential to ensuring that implants and instruments are consistently and properly cleaned, inspected, and made safe for patient use.

I understand that original equipment manufacturers (OEMs) must conduct rigorous worst-case validation testing to satisfy FDA requirements and may possess internal white papers or studies demonstrating how screws and plates perform across a specified number of cycles. If such data exists, it should be transparently shared. Veterans of the field were always taught to ask vendors for these foundational internal studies, but a critical question remains: have we stopped asking? While OEMs validate maximum limits under extreme, worst-case laboratory conditions, daily MDRD reality can look very different. Somewhere along the way, this rigorous inquiry appears to have been lost to daily operational pressure, leaving us to wonder if we have forgotten how to properly train our new set of professionals and arm them with the right questions. It is time to revive it.

Because of this constant cycle of new personnel and operational variability, we must continually refocus on fundamentals and foundational education delivered through in-person interaction. I make this statement because when I spoke at this meeting in 2015, looking at a group picture of about 40 attendees, only four individuals from that meeting were at this one. Many new staff members had no idea these critical studies existed, and without gathering in person to share questions, experiences, and open dialogue, they still might not have known. This experience reinforces why we must actively maintain strong local (provincial and state) associations where we can regularly interact, ask hard questions, and share vital operational knowledge that needs to be continuously addressed and clarified.

As the medical device reprocessing profession continues to navigate complex global challenges—such as risk governance, single-use device reprocessing policies, and aligning department practices with evolving standards—our national meetings present a prime opportunity to drive deep, collaborative learning into this subject.

To build upon the Healthcare Sterile Processing Association (HSPA)’s tradition of exceptional education, I would like to propose introducing an interactive roundtable panel session for the 2027 annual conference to be held in Columbus, Ohio, modeled after successful international frameworks like those used by the WFHSS.

I, like many others who have attended and even presented at the WFHSS, like this type of format. HSPA, can do a session at the end of one of the days and call it “The Science of Reprocessing”, make it an annual session with international speakers and make the topic know a year in advance, a topic that impact every person doing medical device reprocessing. I have always believed what we do is science. We can still do this at the annual meeting in 2027,so let’s do it.

Rather than a traditional single-speaker lecture, this session would feature a moderated roundtable discussion bringing together international decontamination researchers, clinical leaders, and medical device reprocessing experts. The goal would be to foster real dialogue, debate operational hurdles transparently, and share
international insights on risk management and device lifecycle safety.

Inviting international voices to participate directly in a conversational
format would give our attendees actionable, diverse perspectives to
take back to their healthcare facilities.

As I have always stated for any medical devices to be either
sterilized or high-level disinfected (HLD) you must “Keep it Clean
and Functional!”

Stephen M. Kovach, BS, retired as educator emeritus at Healthmark,
A Getinge Company, in January 2025, culminating a distinguished career
in the medical device reprocessing field that began in 1975 when he
started out as a sterilization orderly. He holds a bachelor of science degree
in Biology from Central Michigan University. Throughout his decades in
industry, Kovach has shared his expertise by speaking and presenting at all
levels—from local chapters to national and international conferences—on
topics ranging from importance of certification, quality process, infection
control, cleaning, inspection, assembly and sterilization of medical devices.
A dedicated contributor to industry advancement, he has been a voting
member of various standards groups and has held numerous leadership
positions across professional organizations dedicated to medical device
reprocessing, currently serving as the treasurer for the Michigan Society for
Healthcare Central Service Personnel (MSHCSP). He started using a tag line
in1994, “Keep it Clean,” adjusted over time to “Keep it clean and functional”
for any medical device. In addition to his standards and committee work,
Kovach has written numerous articles and book chapters on medical device
reprocessing and has earned widespread recognition across both his personal
life and his professional field.

References:

1. Alfa, M. J. (2012). The Pandora’s box dilemma: reprocessing of
   implantable screws and plates in orthopedic tray sets. Biomedical
   Instrumentation & Technology, 46(3), 224–230.
2. Alfa, M. J. (Various educational and professional trade publications).
   Expert insights and reviews addressing manufacturer
   Instructions for Use (IFUs), cleaning validation challenges, and practical
   limitations of tray-based implant reprocessing in central service.
3. Costa, D. de M., Vickery, K., et al. (2018). Reprocessing safety
   issues associated with complex-design reusable surgical instruments
   and single-use implants in orthopaedic loaner sets.
4. Costa, D. de M., Vickery, K., Tipple, A., Hu, H., et al. (2022).
   Providing sterile orthopedic implants: challenges associated with
   multiple reprocessing of orthopedic surgical trays.
5. França, R., Alfa, M., Olson, N., Yahia, L’H., & Sacher, E. (2017).
   Characterization of endotoxins on orthopaedic fixation screws, using
   physicochemical surface analyses. Journal of Orthopedic Research,
   35(2), 240–247.
6. https://content.yudu.com/web/1u0jl/0A1up6l/CSJ-September-
   2026/html/index.html?page=80&origin=reader
7. SMTL & Welsh Decontamination Guidance: Technical briefs and
   updates can be referenced through the NHS Wales Shared Services
   Partnership (NWSSP) and the official SMTL publications portal.

Resilient Surgical Instrument Reprocessing During Healthcare Disasters and Outbreaks

Oct. 1, 2026

Surgical instrument reprocessing is essential for infection prevention and continuity of surgical care. However, evidence on barriers and adaptive strategies for maintaining reprocessing capacity during healthcare disruptions remains fragmented. This systematic review by Nematollahi, et al. (2026) synthesized evidence on reprocessing vulnerabilities, barriers, and adaptive strategies across infectious outbreaks, emergency preparedness contexts, infrastructure disruptions, and resource-constrained settings.

PubMed, Scopus, Web of Science, and Google Scholar were searched through February 2026 in accordance with PRISMA 2020 guidelines. Eligible studies evaluated reusable surgical instrument reprocessing during infectious outbreaks, infrastructure disruptions, emergency preparedness contexts, or other healthcare disruption settings.

Eleven studies from nine countries were included, comprising outbreak investigations, preparedness surveys, cohort and case-control studies, case series, and quasi-experimental or implementation-oriented studies. Most studies focused on infectious outbreaks associated with failures in reprocessing complex reusable devices. Recurrent barriers included incomplete cleaning workflows, inadequate lumen decontamination, equipment malfunction or contamination, contaminated water or rinsing systems, limited emergency preparedness, workforce gaps, and incomplete instrument-tracking systems. Infrastructure disruptions and limited sterilization capacity were associated with delays or interruptions in surgical services. Reported adaptive strategies included standardized multistep cleaning protocols, environmental monitoring, workforce training and simulation, instrument traceability systems, mobile or container-based sterilization capacity, and contingency reprocessing approaches.

The authors conclude that, “Current evidence suggests that challenges in surgical instrument reprocessing across healthcare disruption contexts are associated with interacting operational, infrastructural, technological, and organizational factors rather than isolated technical failures alone. Strengthening routine reprocessing reliability, workforce preparedness, environmental monitoring, infrastructure reliability, instrument traceability, and flexible reprocessing capacity may support continuity and safety of surgical services during healthcare disruptions. However, the evidence base remains small and heterogeneous and is weighted toward infectious outbreak investigations and observational studies. Further empirical research is needed to evaluate scalable and context-appropriate approaches to reprocessing preparedness across diverse emergency, disaster-related, and resource-constrained settings.”

Reference: Nematollahi MS, et al. Resilient surgical instrument reprocessing during healthcare disasters and outbreaks: a systematic review of barriers, preparedness gaps and policy strategies. Antimicrobial Resistance & Infection Control. Published Aug. 28, 2026. Volume 15, article number 114 (2026)