Point of Use Treatment for Medical Devices: From Bedside to Battlefield

ABSTRACT

Introduction

Point of use (POU) treatment is a critical first step of medical device reprocessing. Reusable instruments and flexible endoscopes require a minimum of terminal sterilization or high-level disinfection, neither of which can be guaranteed if POU is performed incorrectly. Compliance considerations for POU include hospital accreditation readiness, unique austere surgical mission requirements, and the transition of future conflict towards Large Scale Combat Operations. This integrative review aims to describe POU for reusable instruments and endoscopes, and extrapolate implications for Military Health System policies and future considerations.

Materials and methods

The authors performed an integrative review and comprehensive literature search in PubMed and CINAHL with the keywords “point of use,” “point of use cleaning,” “POU,” “instrument,” “high-level disinfection,” “endoscope,” and “clean.” Articles were limited to “English” and “human” from 2017 to 2023. The authors also performed a thorough review of the Defense Health Agency and service-specific doctrine, as well as national guidelines regarding POU adherence.

Results

The literature review yielded 18 articles that discussed the transport and reprocessing of reusable medical devices. Regulatory standards and national guidelines were used to supplement the literature. Seventeen evidence-based criteria were extrapolated from the literature to generate two step-by-step guides for the POU treatment of endoscopes and reusable instruments (Tables I and II). Despite increased morbidity and mortality rates linked to inadequate device reprocessing, compliance with POU procedures remains low. Barriers to practice included complex POU processes, intricately designed surgical instruments and endoscopes, lack of healthcare worker (HCW) knowledge and competency, and inadequate or ambiguously written policies. Training, competency assessments, and clearly written policies and procedures can be cost-effective, evidence-based, and feasible solutions.

Conclusion

Completing POU treatment is critical to a successful surgical mission in both the hospital and austere environment. Implications to practice include implementing evidence-based POU programs that improve patient outcomes and readiness while decreasing costs.

INTRODUCTION

The point of use (POU) treatment process for reusable instruments and endoscopes is an emerging healthcare concern that has garnered considerable attention in recent years. Accreditation surveys through The Joint Commission (TJC) have highlighted the criticality of proper handling and transport of contaminated medical devices, underpinning the need for systems-level improvements nationwide.¹ The Association for the Advancement of Medical Instrumentation (AAMI) defines POU as removing gross soil from an instrument or device throughout the procedure or immediately after use.² Considered the first step in decontamination, POU is essential to prevent organic material and debris buildup on instrument and endoscope surfaces that can lead to negative surgical outcomes.³

In the United States, 5%—10% of hospitalized patients experience a healthcare-associated infection (HAI) every year, resulting in approximately 99,000 deaths and a $20 billion annual expenditure.⁴ Alfred purports that 20% of HAIs are classified as surgical site infections (SSI).⁴ The number of SSIs directly attributed to deficient instrument reprocessing is currently unknown.⁵ However, biofilm buildup from improperly cleaned instruments prevents detergents and sterilants from adequately contacting all device surfaces.³ Consequently, there is an increased risk of cross-contamination of infectious pathogens to subsequent patients.^3,6  Figure 1 illustrates grossly contaminated instruments that have not received the proper POU treatment during a surgical procedure. Literature indicates that upward of 50% of SSIs are preventable if perioperative and sterile processing staff employ evidence-based practice (EBP) solutions to instrument reprocessing.⁷

While professional organizations like AAMI and the Association for periOperative Registered Nurses (AORN) provide guidance on POU in a hospital setting, little is known about the impact of POU in austere environments, particularly during Large Scale Combat Operations (LSCO). This review article discusses the current practice standards for POU treatment, a review of recent literature addressing the solutions and barriers to effective POU treatment, policy and practice considerations regarding prolonged military field care, limited surgical capabilities, and the critical need for infection prevention.

METHODS

We applied an integrative review method and completed a comprehensive literature search in PubMed and CINAHL. The search criteria were limited to articles published from January 2017 to December 2023 in English and involving human subjects. Keywords included point of use, point of use cleaning, POU, instrument, clean, high-level disinfection, and endoscope.

Figure 2 displays the PRISMA diagram outlining the authors’ article search, screening, and review process. After removing duplicates, 78 abstracts were screened, with 35 full-text articles assessed. A total of 18 articles met the final inclusion criteria. Two reviewers screened abstracts and full-text articles for inclusion. Articles were excluded if they did not discuss the transportation of contaminated medical devices, POU treatment for reusable instruments or endoscopes, or recommended outdated practices. If an article was excluded, the reasons for doing so were discussed by both reviewers. A third reviewer adjudicated disagreements between reviewers. Four additional articles and three clinical practice guidelines were used to supplement the literature. Articles were appraised for level and quality using the Johns Hopkins Nursing Evidence-Based Practice tool. The levels and quality of evidence can be viewed in the supplementary material provided in Supplementary Table S1.

RESULTS

Inadequate decontamination procedures render reusable devices incapable of being effectively sterilized. Saline solution, blood, and various chemical substances such as iodine and hemostatic agents possess corrosive properties that may lead to rusting and pitting of instruments if not immediately removed.^6,8 The depletion of the device lifecycle and the increased risk of damage to patients and surgical team members occur when the outer layer of instruments undergoes corrosion.⁶ If instruments that have become soiled are allowed to go through the drying process, a matrix of microbial cells can form on the surfaces of the instruments, leading to a permanent binding that hinders the effectiveness of disinfection and sterilizing procedures.^1,9 The phenomenon of microbe colonization, known as biofilm formation, has been seen to commence within a relatively short time frame ranging from 4 to 20 minutes.⁸ Ultimately, organic and inorganic debris buildup may negatively impact surgical patients.

The timeliness and quality of POU treatment are critical for endoscopes. Endoscopes cannot achieve high-level disinfection if POU treatment has not been performed to remove bioburden.¹⁰ Following the completion of a procedure, staff must immediately initiate the treatment process, as organic materials begin drying on internal and external endoscope surfaces within minutes.¹¹ Flexible endoscopes pose exceedingly difficult challenges since narrow channels and tips become ideal spaces for the accumulation of microorganisms and biofilm formation.¹¹ When endoscopes undergo high-level disinfection, a 6-log reduction in bacteria occurs.¹⁰ Literature indicates that effective POU and manual cleaning of endoscopes yields a decrease in bacterial load by 3 to 4 logs.¹⁰

Proper POU treatment, transport, decontamination, high-level disinfection, sterilization, and storage of medical devices require a multidisciplinary team of clinicians, practice managers, quality control, infection preventionists, and accreditation specialists.^1,12,13 There is a growing emphasis among accreditation surveyors on treating contaminated devices in operating rooms, endoscopic settings, and outpatient clinics where medical procedures are conducted.¹ Compliance with federal and state regulations, manufacturer instructions for use (IFU), and evidence-based guidelines are crucial in achieving compliance with POU treatment standards.¹  Tables I and II comprehensively outline 17 evidence-based steps for POU procedures related to flexible endoscopes and reusable instruments based on regulatory standards and national guidelines. These steps, widely substantiated in the literature, are accompanied by specific methods to ensure adherence and compliance.

DISCUSSION

The literature included in this review supports the translation of POU treatment to austere military settings. Reducing institutional variances, standardization of services, timely execution of EBP, and coordination between various military and civilian institutions are used to achieve compliance. The comprehension and proficient execution of POU treatment procedures for reusable medical devices are essential for meeting TJC certification standards, ensuring patient safety, and delivering secure surgical services. Organizations must understand and safeguard against barriers to POU compliance. Understanding solutions to common compliance barriers improves the safety and quality of medical device reprocessing programs.

Barriers to POU

The failure to follow safe and approved workflows during POU treatment of medical devices can lead to substantial negative outcomes, including patient morbidity and mortality, as well as injury to healthcare workers (HCWs).^3,6,11,13 Quality assurance monitoring shows that POU compliance for reusable instruments can be as low as 54%.⁴ An endoscope reprocessing quality improvement project with 16 tracers that was completed between April 2021 and October 2022 revealed a 68.8% non-compliance rate with IFU recommendations.¹⁴ Failure to perform proper POU treatment was primarily attributed to the complexity of the medical devices and cleaning processes, knowledge gaps³⁵ in processing requirements, lack of HCW competency, and inadequate or ambiguously written policies.^{3,4,8,11,13,15–19}

Complexity

The growing need for complex devices and procedures in clinical settings might lead to a failure to adhere to the IFUs during POU treatment, posing potential risks to following patients.^4,13,15,19 The instructions pertaining to assembly and cleaning methods differ depending on the manufacturer, necessitating HCWs to accurately remember and comply with distinct protocols for each device in order to maintain the integrity of the reprocessing cycle.^{2–4,11,13,16,19} Complexity adds needless decision points, which can reduce compliance with manufacturer IFU. Barriers to POU compliance found in the literature are accurate POU cleaning solution dilution.¹ A single-blind study evaluating POU solutions for endoscopes prepared at the bedside found significant variance between solutions prepared by different HCWs. Concentrations of some prepared solutions were too dilute, thereby increasing the risk of pathogenic material transmission, while others were too concentrated, thereby wasting resources.⁷ Consideration must also be given to contact times.² Pretreatment solutions will typically have a maximum efficacy contact time specified by the manufacturer.²

Knowledge gaps

Knowledge gaps naturally result from working in increasingly complex environments and can result in omitting or incorrectly following appropriate workflows.¹⁷ The vast amount of information that HCWs must correctly recall can create barriers to compliance. Large medical centers, for instance, may have as many as 250,000 instruments in their inventory, and staff performing POU must recollect their individual IFU.⁴ Scarcity of training resources can lead to knowledge gaps. These knowledge gaps can be exacerbated in the presence of staffing shortages where HCW apathy or fatigue may result in hurried or skipped procedural steps due to time and resource constraints.¹³ Without adequately supported standardized training programs, HCWs may encounter difficulties in recognizing and effectively addressing harmful practices.²

Policies

The presence of policies that lack clarity and specificity hinders the ability to effectively implement and comply with best practices in the clinical setting. The lack of clearly defined policies creates ambiguity among HCWs regarding the individuals accountable for carrying out and ensuring the quality of POU procedures. The absence of policies results in a deficiency in both consistency and accountability.^8,13 As a result, the lack of standardization in training and competency arises among staff members and units.^8,13

Solutions to Improving POU Compliance

Standardization

Standardizing methodologies for POU is key to improving POU compliance.¹⁷ An example of standardization to improve POU treatment is purchasing pre-made solutions. This decreases HCW workload while increasing compliance and safe practice.¹⁷ Due to the extensive range of reusable devices available, organizations may have time and resource constraints when developing training programs for each unique instrument. Existing literature has demonstrated that using standardized reprocessing guidelines for high-risk devices, such as intraocular instruments, effectively mitigates adverse outcomes.² Automated processes reduce the likelihood of human error.¹³ Best practice also includes quality assessment through checklists, audits, and gap analysis. These methods serve to evaluate compliance and identify areas for potential quality improvement activities in the future.^2,13,18

Competency

Competency evaluation requirements and recommendations are addressed by hospital infection control departments, accrediting bodies, and prominent medical device reprocessing organizations such as AORN and AAMI.^{2,9,11,15,16,18,20,21} To establish the proficiency of HCWs in efficiently performing POU treatment, it is necessary to administer competency evaluations at various stages, including throughout the initial hiring process, annually, and subsequent to any alterations in professional practice.^2,12 The proficiency of the staff is of utmost importance in ensuring the safe and successful completion of surgical procedures. It serves as one of the final safeguards before the terminal reprocessing stage.¹³

Policy

To solve the barrier of ambiguous policies, leaders should use multi-disciplinary teams to evaluate POU treatment policies and procedures to ensure they are clear, feasible, and easily accessible when needed.^3,8,12 Revised policies must reflect current POU standards and clearly delineate who is accountable for ensuring compliance.^8,12 To maintain evidence-based clinical practices, policies should encompass several components, including training and competency prerequisites, delineation of suitable workflows, and a strong emphasis on compliance with the manufacturer’s IFUs.²

Implications for Policy and Future Practice in Austere Environments

In austere environments, policies incorporating effective training and competency assessments improve the survivability of traumatically injured patients.^22–24 Infection control policies applied during definitive surgical interventions in theater are critical to reducing morbidity and mortality in injured service members.²⁵ Irrespective of the level of austerity observed in the surgical environment, implementing infection control techniques has been shown to decrease infection rates effectively.²⁶ Estimates are that 25% of combat-injured service members coming from austere environments and arriving at U.S. Military treatment facilities develop infections. Although a significant proportion of these cases can be attributed to contamination during the time of injury, around 60% of patients who experienced SSIs were determined to be avoidable.²⁶ POU for reusable medical devices is one critical component in preventing the transmission of pathogenic organisms from contaminated devices to patients.²⁶ Compliance with correct POU treatment is vital in mitigating the risk of combat-related SSIs associated with long-term morbidity after initial hospitalization.²⁵

With increased casualty rates expected during LSCO, continuous surgical volumes may be required for extended periods of time.²³ To maintain surgical readiness, continuous instrument reprocessing will also be required.²⁶ These efforts will significantly impact the work/rest cycle for those nurses and surgical technologists assigned to reprocess instruments and assist in surgical procedures. Therefore, a realistic work/rest cycle must be instituted that supports a continuous operating room schedule and accounts for continuous medical device reprocessing requirements.²⁷ Reprocessed medical devices costing HCW resources are the second- and third-order repercussions of ineffective POU adherence.

High-intensity conflict battlefields involving LSCO will likely differ from those seen in low-intensity conflicts such as Iraq and Afghanistan, further increasing the challenges for POU treatment. Combined efforts during LSCO, with a shared understanding of POU processes between multinational organizations, must be considered, especially with organizations that may not share the same POU standards for medical devices. Improved interoperability between U.S. Military joint medical capabilities and cooperative medical efforts between the USA and its allies is critical to meeting the surgical mission.^28,29 Medical interoperability between ally military units and military and civilian medical services has been mandated by the North Atlantic Treaty Organization since 2016.³⁰ Interoperability and cooperation must be maintained during processes such as POU treatment to guarantee the highest levels of combat casualty survivability and recovery.

Prolonged field care is an anticipated aspect of LSCO. This is attributed to the expected lack of air superiority impacting medical evacuation capabilities, an increased number and severity of injuries, possible bioagent exposure, and increased evacuation distances.^22–24 Backlogs in urgent patient evacuations will likely necessitate more surgical interventions at lower echelons of care to maintain patient physiologic status and survivability, thus increasing the workload and volume of medical device reprocessing.³¹

Future Lines of Effort (LOE) for POU include evidence-based training and standardization. Reforming operational surgical reprocessing workflows based on EBP enables critical surgical capabilities to remain ready and effective during mass casualty scenarios.³² Clinical practice guidelines (CPG) standardize healthcare delivery across the military. Future efforts should include POU principles in CPGs to standardize POU training and competency verification, thereby improving effective and safe operational surgical planning and practices.

Perioperative nurses within the military community demonstrate the skill, organizational communication, and collaboration to lead these LOE. Perioperative nurses routinely coordinate efforts to ensure that logistics, adjunct resources, training, and compliance are readily available and maintained throughout the perioperative continuum.^3,12 This distinctive skill set makes them uniquely qualified for this POU process improvement initiative and qualifies them as force multipliers, capable of bridging the gap between clinical EBP and the operational environment.¹²

LIMITATIONS

POU research is limited due to the ethical and safety concerns of deliberately exposing patients to contaminated devices. The literature review produced a limited number of articles (n = 18). Therefore, current POU literature primarily encompasses literature reviews and expert opinions. Language across the literature is inconsistent; POU treatment can also be called POU cleaning, cleaning, and pre-cleaning. Little is known about POU methodologies concerning the austere environment or operational settings. Challenges in finding credible records from austere/operational environments assessing the quality of reprocessing programs over the past 20 years are mainly responsible for this knowledge gap. Qualitative research methods are particularly well-suited for exploring complex phenomena. Further research regarding POU, particularly within the Military Health System, can offer valuable insight to guide future practice in military treatment facilities and austere environments. Moreover, understanding the complexities of POU treatment from the user’s perspective could further highlight the challenges and pitfalls in the workflow process.

CONCLUSION

Ineffective POU treatment hinders surgical readiness and further exhausts an already overburdened system, reducing capabilities and critically delaying vital lifesaving, damage control, and definitive surgical interventions. POU treatment is crucial in preventing biofilm development on reusable devices. Barriers to POU compliance include complexity, knowledge deficits, and inadequate policies. Solutions to counter these barriers involve implementing evidence-based POU training, competency assessment, and policies.

The increased operational tempo of LSCO, juxtaposed with a lack of resources, will require disciplined compliance to POU treatment to maintain surgical readiness, prevent surgical delays, and continue to provide immediate, life-saving surgery for those injured in combat. HCWs must perform effective and efficient device reprocessing regardless of their environment. POU treatment during device reprocessing must be a fundamental component of surgical planning and practices in garrison and austere environments to support the joint health service warfighting function.

ACKNOWLEDGMENTS

The authors would like to acknowledge Dr. Ann Nayback-Beebe, PhD, TriService Nursing Research Program, and Uniformed Services University of the Health Sciences Adult-Gerontological Clinical Nurse Specialist faculty for their mentoring and assistance in editing this manuscript.

CLINICAL TRIAL REGISTRATION NUMBER

Not applicable.

INSTITUTIONAL REVIEW BOARD APPROVAL

The Directorate of Quality Management at Walter Reed National Military Medical Center approved this evidence-based practice project, and it received a non-research determination.

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)

Not applicable.

INDIVIDUAL AUTHOR CONTRIBUTION STATEMENT

The authors confirm contribution to the article as follows: Study conception, Design: GE, BA, and JS. Implementation of the research: GE, BA, and JS. Drafted the original manuscript: GE, BA, and JS. Data collection: GE, BA, and JS. Data management and data cleaning: GE, BA, and JS. Analysis and interpretation of results: GE, BA, and JS. All authors reviewed the results and approved the final version of the manuscript.

SUPPLEMENTARY MATERIAL

SUPPLEMENTARY MATERIAL is available at Military Medicine online.

FUNDING

None declared.

CONFLICT OF INTEREST STATEMENT

None declared.

DATA AVAILABILITY

The data that support the findings of this literature review can be accessed online via DOI link or provided on request by the corresponding author.

REFERENCES

Author notes