Reusable Medical Devices Research Articles

Validation of the Device Feature Approach for Reusable Medical Device Cleaning Evaluations.

The identification of worst-case device (or device set) features has been a well-established validation approach in many areas (e.g., terminal sterilization) for determining process effectiveness and requirements, including for reusable medical devices. A device feature approach for cleaning validations has many advantages, representing a more conservative approach compared with the alternative compendial method of testing the entirety of the device. By focusing on the device feature(s), the most challenging validation variables can be isolated to and studied at the most difficult-to-clean feature(s). The device feature approach can be used to develop a design feature database that can be used to design and validate device cleanliness. It can also be used to commensurately develop a quantitative cleaning classification system that will augment and innovate the effectiveness of the Spaulding classification for microbial risk reduction. The current study investigated this validation approach to verify the efficacy of device cleaning procedures and mitigate patient risk. This feature categorization approach will help to close the existing patient safety gap at the important interface between device manufacturers and healthcare facilities for the effective and reliable processing of reusable medical devices. A total of 56,000 flushes of the device features were conducted, highlighting the rigor associated with the validation. Generating information from design features as a critical control point for cleaning and microbiological quality will inform future digital transformation of the medical device industry and healthcare delivery, including automation.

Improving Protein Assay Methods to More Accurately Assess Medical Device Cleanliness.

Protein assays commonly used to evaluate reusable device cleanliness do not always accurately measure the low concentrations of protein that are expected on reusable medical devices after processing. Methods often are adapted to provide an estimation of protein concentration; however, sensitivity issues in the portion of standard curves at the acceptance criteria of 6.4 μg/cm2 protein have been reported. Using analytical validation criteria, method improvements for the micro-bicinchoninic acid assay for protein residuals are demonstrated by incorporating a standard addition method, increasing the well volume, and changing the working reagent ratio. These improvements increased method sensitivity and accuracy in the reliable detection of protein levels for device cleaning validations.

Test Soil and Material Affinity for Reusable Device Cleaning Validations.

While selecting the test variables for a cleaning validation for reusable medical devices, the manufacturer must provide a simulative and clinically representative challenge for the device. An appropriate challenge must be identified with care so as not to overchallenge the cleaning process by selecting the worst case for every variable, thus leading to an impossible validation or unrealistic processing requirements. To appropriately select the testing variables, an understanding of the challenge to the cleaning process is important. The relationship among device material, test soil, and application method was investigated by testing 140 variable combinations, including seven materials (stainless steel, polyoxymethylene, polyether ether ketone, nitinol, aluminum, titanium, and silicone), four test soils (defibrinated blood soil, coagulated blood, modified coagulated blood, and Miles soil), and five soil application methods (pipetting neat, pipetting spreader, painting, handling with soiled gloves, and immersion). Stainless steel was the only material that showed consistent soil application in a thickness (at ~6 μL/cm2) that fully covered the test surface without some element of pooling, cracking, flaking, or soil migration with all test soils and application methods. The data collected using solubility testing indicated that a complex relationship for material adherence may exist between device materials and test soil. Stainless steel was the most challenging material tested.

Outsourcing the Management of Reusable Medical Devices in a Chain-Wide Care Setting: Mixed Methods Feasibility Study.

Managing reusable medical devices incurs substantial health care costs and complexity, particularly in integrated care settings. This complexity hampers care quality, safety, and costs. Studying logistical innovations within integrated care can provide insights to medical devices use among staff effectively. This study aimed to establish the feasibility of a logistical intervention through outsourcing and a web portal. The goal was to provide insights into users' acceptability of the intervention, on whether the intervention was successfully implemented, and on the intervention's preliminary efficacy, thus benefiting practitioners and researchers. This paper presents a mixed methods feasibility study at a large chain-wide health care provider in the Netherlands. The intervention entailed outsourcing noncritical reusable medical devices and introducing a web portal for device management. A questionnaire gauged perceived ordering and delivery times, satisfaction with the ordering and delivery process, compliance with safety and hygiene certification, and effects on the care delivery process. Qualitative data in the form of observations, documentation, and interviews were used to identify implementing challenges. Using on-site stocktaking and data from information systems, we analyzed the utilization, costs, and rental time of medical devices before and after the intervention for wheelchairs and anti-pressure ulcer mattresses. Looking at the acceptability of the intervention, a high user satisfaction with the ordering and delivery process was reported (rated on a 5-point Likert scale). With respect to preliminary efficacy, we noted a reduction in the utilization of wheelchairs (on average, 1106, SD 106 fewer utilization d/mo), and a halted increase in the utilization of anti-pressure ulcer mattresses. In addition, nurses who used the web portal reported shorter ordering times for wheelchairs (-2.7 min) and anti-pressure ulcer mattresses (-3.1 min), as well as shorter delivery times for wheelchairs (-0.5 d). Moreover, an increase in device certification was reported (average score of 1.9, SD 1.0), indicating higher levels of safety and hygiene standards. In theory, these improvements should translate into better outcomes in terms of costs and the quality of care. However, we were unable to establish a reduction in total care costs or a reduced rental time per device. Furthermore, respondents did not identify improvements in safety or the quality of care. Although implementation challenges related to the diverse supply base and complexities with different care financers were observed, the overall implementation of the intervention was considered successful. This study confirms the feasibility of our intervention, in terms of acceptability, implementation success, and preliminary efficacy. The integrated management of medical devices should enable a reduction in costs, required devices, and material waste, as well as higher quality care. However, several challenges remain related to the implementation of such interventions.

The Use of 3D Printing and Nanotechnologies to Prevent and Inhibit Biofilms on Medical Devices

Biofilms remain one of the most pervasive complications of the medical field, representing 50–70% of all nosocomial infections and up to 80% of total microbial infections. Since biofilms contain intricately small matrices, different microenvironments, and accumulations of biodiverse microorganisms of different resistances, these structures end up being difficult to target. As we review in this paper, 3D printing and nanotechnology help overcome these unique challenges of targeting biofilms, especially within the medical field. These technologies bring versatility and more precise control to personalized reusable medical device development and implants, with enhanced antimicrobial characteristics. They allow for decreased surface roughness of the implants, smaller pores, more targeted topography, and even added antibiotic or drug-releasing abilities for the medical devices. Furthermore, combining 3D with nanoparticles allows for the creation of anodized nanosurfaces of medical implants with increased osseointegration and reduced polymerization while promoting cost efficiency, durability, and biocompatibility. In this review, we explore the potentially valuable antimicrobial consequences of applying 3D technology and nanoengineering to dental and orthodontic implants, oral prostheses, hearing aids, joint replacements, catheters, stents, endotracheal tubes, prosthetics, and bone scaffolds.

Effectiveness of a training program on health-care professionals’ knowledge and practices regarding thermo-sensitive reusable medical devices disinfection: A quasi-experimental study

IntroductionAppropriate knowledge of healthcare professionals (HCPs) on the various aspects of disinfection and reuse of medical devices is a basic requirement to ensure proper disinfection and to minimize the risk of healthcare associated infections. In this regard this study aimed to assess the effectiveness of a training intervention on knowledge and practices regarding thermosensitive reusable medical devices (TRMD) disinfection among HCPs. MethodsThis was a quasi-experimental study including a pre-test, an intervention (workshops, demonstrations, posters), and a post-test evaluation of the HCPs' knowledge and practices regarding the disinfection of TRMD. It was conducted between February and July 2022 at Hedi Chaker University hospital, Sfax, Southern Tunisia. ResultsOverall, 31 participants were females (54.4%). The global Knowledge Score (KS) had significantly risen from pre-to post-training test (61.0 ± 9 vs 74.0 ± 12.5; p < 0.001). According to the disinfection type, the KS of non-critical and critical TRMD disinfection had significantly increased between pre and post-intervention (60 (IQR = [40.0–80.0]) vs 80 (IQR = [40.0–80.0]), p < 0.001) and (66.6 (IQR = [50.0–66.6]) vs 83.3 (IQR = [66.6–100.0]); p < 0.001) respectively. The mean change in global KS of TRMD disinfection was statistically higher among females (17.5 ± 11.2 vs 8.5 ± 3.2; p = 0.006) and medical staff (18.9 ± 11.9 vs 7.1 ± 3.9; p = 0.019). Conformity scores did not significantly change after the training program (58.1 ± 22.7 vs 63.7 ± 19.6; p = 0.678). ConclusionThis study highlighted the effectiveness of the training intervention on HCP knowledge. However, practices were not improved. Conducting ongoing audits with on-the-job training is extremely needed.

Use of real-time immersive digital training and educational technologies to improve patient safety during the processing of reusable medical devices: Quo Vadis?

Hospital acquired infections stemming from contaminated reusable medical devices are of increasing concern. This issue is exaggerated with the introduction of complex medical devices like endoscopes and robotic instrumentation. Although medical device manufacturers validate their cleaning instructions for use, evidence in the literature demonstrates that effective device processing is not being performed consistently within sterile processing departments in clinical settings. The result is increased risks to patient safety. As a solution to this problem, focused one-on-one training increases compliance to the medical device manufacturer's processing instruction. However, often this is not a practical solution for the volume of healthcare staff responsible for device processing activities. This constitutes the first paper to address the blended use of educational and digital technologies to address these challenges and as a result inform safety and sustainability for the medical device sector. Cognitive learning theory is an evidence-based framework for learning. It supports the use of immersive educational experiences using emerging extended reality technologies (e.g., virtual or augmented reality) to increase learning comprehension. The delivery of educational content via these technologies provides an innovative option for repeatable leaning and training outcomes. The motivation is to decrease patient risk of contaminated reusable medical devices. The proposed approach while primary motivated by safety can also enhance sustainability and efficiency enabled by artificial intelligence and robotic instrumentation.

An approach to quantify ortho-phthalaldehyde contamination on work surfaces.

Ortho-phthalaldehyde (OPA) is used as a high-level disinfectant for reusable medical devices in healthcare settings. The ACGIH recently adopted a Threshold Limit Value-Surface Limit (TLV-SL; 25 µg/100 cm2) for OPA surface contamination to prevent induction of dermal and respiratory sensitization following dermal exposure. However, there is no current validated method to measure OPA surface contamination. This study aimed to develop a standardized approach for sample collection and quantitative determination of OPA from work surfaces for use in risk assessment practices. The reported method utilises readily available commercial wipes to collect surface samples coupled with direct detection of OPA via liquid chromatography time of flight mass spectrometry (LC-ToF-MS). This approach avoided complex derivatization steps commonly required for the analysis of aldehydes. Method evaluation was conducted in accordance with the Occupational Safety and Health Administration (OSHA) surface sampling guidelines. Overall recoveries of 25 µg/100 cm2 of OPA from stainless steel and glass surfaces were 70% and 72%, respectively. The reported LOD for this method was 1.1 µg/sample and the LOQ was 3.7 µg/sample. OPA remained stable on the sampling medium for up to 10 days, when stored at 4 °C. The method was demonstrated in a workplace surface assessment at a local hospital sterilising unit, successfully detecting OPA on work surfaces. This method is intended to supplement airborne exposure assessment and provide a quantitative assessment tool for potential dermal exposure. When used in conjunction with a thorough occupational hygiene program that includes hazard communication, engineering controls, and personal protective equipment, skin exposure and consequent sensitization risks in the workplace can be minimized.

Human Versus Machine

This article implements a method for classifying adverse incidents involving reusable medical devices according to their underlying cause and assesses the level of agreement between different raters. To achieve this, the adverse incidents were classified into 1 or more of 62 separate categories, and the level of agreement between 3 experienced human raters was established. Moreover, the ChatGPT artificial intelligence tool was used to replicate the classification process used by human raters. The results showed that there was a fair level of agreement between human raters and a slight agreement between human raters and ChatGPT. This suggests that, although ChatGPT can intelligently classify adverse incidents, it was not able to replicate the performance of experienced human raters when given access to only the limited incident details and classification categories as provided for in this study.

Current issues in reprocessing of medical and surgical instruments

By the very nature of reusability, processing for reusable medical devices has been and continues to be risk prone. Healthcare systems have historically been slow to embed best practice quality control elements into everyday reprocessing workflow. The identification of weak points and an openness to change are necessary to allow for a proactive culture of safety. Infection preventionists can play key roles in establishing and maintaining related quality control and oversight.

Gynecological Speculums in the Context of the Circular Economy

This study discusses the issue of disposable and reusable medical devices in the context of the circular economy. Its objective is to analyze the opinions of physicians in gynecological practice on the use of disposable and reusable gynecological speculums (GS). A questionnaire survey was carried out in a sample of 206 healthcare facilities in the Czech Republic. In addition to this, the cost of both examination methods was calculated and compared using data provided by a gynecological department of a typical district hospital. The calculations and cost analysis were performed using the life-cycle costing (LCC) method. The economic comparison shows that the use of disposable gynecological speculums is less expensive, having, however, a greater negative impact on the environment. The cost of reusable speculums for 25 examinations per day for 15 years is EUR 51,579, while it is EUR 23,998 for disposable speculums for the same use and time horizon. The questionnaire survey shows that both physicians and patients are more likely to prefer disposable speculums for examination, although without a clear rationale.

Analysis and Research on Intelligent Management and Control System of Reusable Medical Devices

Focusing on the influencing factors of the operation and processing process of reusable medical devices, the management problems of reusable medical devices are analyzed from the processing processes of device assembly, packaging, handover, inventory and information recording. In the specific practice of designing the intelligent management and control system of reusable medical devices, the medical processes in different periods from device addition, packaging, disinfection, transfer, transportation, distribution, recycling to scrapping are integrated into the intelligent service system. Through the changes of medical device treatment, this study comprehensively explores the innovative ideas and specific problems in the construction of intelligent process system of hospital disinfection supply center.

SG-APSIC1084: Reduce cost and resterilization rate of reusable medical device sets by reorganizing and rearranging packaging and process

Objectives: We evaluated the resterilization rate, user satisfaction, and cost of resterilization after rearranging and packing of reusable instrument sets. Methods: For 1 month in July 2018, we conducted an observational prospective study in 39 service departments for which sterilization and instrument packing was done by the central sterile supply department (CSSD). Common sterile instrument sets (eg, intercostal drainage (ICD) sets, bone-marrow aspiration sets, or suture sets) were analyzed to set up basic surgical instruments for common procedures and specific instruments for each procedure. Sets for common procedures were then packed and rearranged for use universally in various procedures separately from specific instruments. A questionnaire survey was delivered to all 39 service departments to evaluate user satisfaction. The resterilization rates and cost analyses before and after the rearranging and packing were compared for their effectiveness. The data were analyzed using descriptive statistics for percentage, mean, standard deviation, and inferential statistics. Categorical data were analyzed using the χ2 test and continuous data were analyzed using a t test with significance level of 0.05. Results: The resterilization rate decreased significantly from 7.1% to 0.1%. The cost of resterilization decreased from 76,500 Thai baht (US $2,287) to 4,800 Thai baht (US $143) within 1 month. Overall, user satisfaction regarding this intervention was 85.2%. Conclusions: This study highlights the need for the evaluation of process and customer demand to improve user satisfaction and reduce hospital cost by customizing the sterilization packaging and rearranging process.

Pathogenic Drug Resistant Fungi: A Review of Mitigation Strategies.

Fungal pathogens cause significant human morbidity and mortality globally, where there is a propensity to infect vulnerable people such as the immunocompromised ones. There is increasing evidence of resistance to antifungal drugs, which has significant implications for cutaneous, invasive and bloodstream infections. The World Health Organization (WHO) published a priority list of fungal pathogens in October 2022, thus, highlighting that a crisis point has been reached where there is a pressing need to address the solutions. This review provides a timely insight into the challenges and implications on the topic of antifungal drug resistance along with discussing the effectiveness of established disease mitigation modalities and approaches. There is also a need to elucidate the cellular and molecular mechanisms of fungal resistance to inform effective solutions. The established fungal decontamination approaches are effective for medical device processing and sterilization, but the presence of pathogenic fungi in recalcitrant biofilms can lead to challenges, particularly during cleaning. Future design ideas for implantable and reusable medical devices should consider antifungal materials and appropriates for disinfection, and where it is relevant, sterilization. Preventing the growth of mycotoxin-producing fungi on foods through the use of appropriate end-to-end processes is advisable, as mycotoxins are recalcitrant and challenging to eliminate once they have formed.

Cleaning Challenges: Can Extended Soil Dry Times Be Reversed?

Background: Cleaning is essential to ensuring the safe processing of reusable medical devices, and most manufacturers' instructions for use (IFUs) specify that clinical soil should not be allowed to dry on devices. If soil is allowed to dry, the cleaning challenge could be increased due to change in soil solubility. As a result, an additional step could be needed to reverse the chemical changes and return a device to a state where cleaning instructions are appropriate. Methods: Using a solubility test method and surrogate medical devices, the experiment described in this article challenged eight remediation conditions to which a reusable medical device might be exposed if soil is dried on a device. These conditions included soaking with water or neutral pH, enzymatic, or alkaline detergent cleaning agents, as well as conditioning with an enzymatic humectant foam spray. Results: The results demonstrated that only the alkaline cleaning agent was able to solubilize the extensively dried soil as effectively as the control, with a 15-minute soak being as effective as a 60-minute soak. Discussion: Although opinions vary, the overall data demonstrating the risk and chemical changes that occur when soil dries on medical devices are limited. Further, in cases in which soil is allowed to dry on devices for an extended time outside of the guidance from leading practices and manufacturers' IFUs, what additional steps or processes may be necessary to ensure that cleaning can be effective? Conclusion: This experiment demonstrated the effectiveness of a soaking step with an alkaline cleaning agent as an additional step if soil is dried on reusable medical devices, thus reversing the effect of an extended soil dry time.

Chemical Changes Over Time Associated with Protein Drying.

Upon drying, physical changes of the characteristics of proteins are observed by coagulation, but the nature and chronology of these changes have not been well studied. Coagulation changes the structure of protein from liquid to a solid or a thicker liquid by heat, mechanical action, or acids. Changes may have implications regarding the cleanability of reusable medical devices; therefore, an understanding of the chemical phenomena associated with drying of proteins is essential to ensuring adequate cleaning and mitigation of retained surgical soils. Using a high-performance gel permeation chromatography analysis with right-angle light-scattering detector at 90°, it was demonstrated that as soils dry, the molecular weight distribution changes. From the experimental evidence, the molecular weight distribution trends over time with drying to higher values. This is interpreted as a combination of oligomerization, degradation, and entanglement. As water is removed through evaporation, the distance between proteins decreases and their interactions increase. Albumin will polymerize into higher-molecular-weight oligomers, decreasing its solubility. Mucin, commonly found in the gastrointestinal tract to prevent infection, will degrade in the presence of enzymes releasing low-molecular-weight polysaccharides and leaving behind a peptide chain. The research described in this article investigated this chemical change.

Assessment of the prevention of healthcare-associated infections in the dental practice in Rabat

in dentistry, many treatments are invasive and can lead to infections. The purpose of this study was to evaluate the prevention of healthcare-associated infections in the dental practice in Rabat. a survey on the prevention of healthcare-associated infections in Rabat dental practices was conducted among 324 practitioners. A self-administered questionnaire was used to assess their training, hygiene, protection, organization of premises, asepsis, antisepsis and use of medical devices. Data were collected using JAMOVI version 1.8.4, the χ2 and Fisher tests were used to compare the variables, the significance level was set at P<0.05. only 80 subjects took part in the study. All the dentists had protective equipment, but 68 (85%) did not have instructions on what to do in case of accidental exposure to blood; 41 (62.1%) operators had qualified assistants, 36.4% had a team vaccinated against hepatitis B and 61.3% of operators and assistants had been trained to handle reusable medical devices. Seventy-six studies had isolated examination rooms, 41 had a steam steriliser and a sorting area with sharps collector. However, 35.1% had a contract for the collection of waste generated by health-care activities, posing a significant risk of infection. the results of this study show that most practitioners in Rabat comply with the majority of the aseptic and hygienic standards in dentistry. However, more needs to be done to ensure that staff are vaccinated.

Effective cleaning and decontamination of the internal air and water channels, heads and head-gears of multiple contra-angle dental handpieces using an enzymatic detergent and automated washer-disinfection in a dental hospital setting

Dental handpieces (DHPs) are reusable invasive medical devices that must be cleaned, decontaminated, lubricated and steam sterilized after use. DHPs have a complex internal design including narrow channels, contamination of which can compromise sterilization. DHPs are not designed for routine disassembly, making cleaning/decontamination efficacy difficult to monitor. Washer-disinfection is the preferred method of decontaminating DHPs, but few studies have investigated its direct effectiveness at reducing microbial contamination internally. To use contra-angle DHPs as a model system to investigate the effectiveness of washer-disinfection at reducing microbial contamination of internal components of multiple DHPs. The air and water channels and heads of 10 disassembled contra-angle DHPs (BienAir, Biel/Bienne, Switzerland) were inoculated separately with 108 colony forming units (cfu) of Pseudomanas aeruginosa, Staphylococcus aureus, Enterococcus hirae or Candida albicans in the presence of 0.3% bovine serum albumin (BSA) (clean conditions), 3.0% BSA or 10% artificial test soil (dirty conditions). After reassembly, all 10 DHPs underwent washer-disinfection simultaneously in a Míele (Míele Ireland Ltd., Dublin, Ireland) PG8528 washer-disinfector and were tested for reductions in micro-organisms and protein. Additional experiments were undertaken with three lubricated DHPs inoculated with S.aureus and 10% test soil. All experiments were repeated in triplicate. On average, an approximate 5 log or greater reduction in microbial cfu and a >93% reduction in protein from DHP heads and channels was consistently recorded following washer-disinfection for all DHPs under all conditions tested. The internal components of multiple DHPs can be effectively cleaned and decontaminated by washer-disinfection.

Healthcare workers' knowledge and attitudes towards sterilization and reuse of medical devices in primary and secondary care public hospitals in Nepal: A multi-centre cross-sectional survey.

BackgroundHealthcare facilities reprocess and sterilize reusable medical devices before each invasive clinical procedure, such as surgery, to prevent person-to-person or environmental transmission of pathogens through medical devices. We conducted a nationwide multi-centre cross-sectional survey in primary and secondary-care public hospitals in Nepal to assess the knowledge and attitudes of healthcare workers towards sterilization and reuse of medical devices.MethodsWe carried out a multi-centre cross-sectional survey comprising eleven primary-care (two district-level and nine district hospitals) and two secondary-care (zonal hospitals) public hospitals which covered all seven provinces of Nepal. Survey questionnaires were distributed to 234 healthcare workers including doctors, nurses, paramedics, and office assistants (involved in medical device reprocessing); 219 (93.6%) returned the completed questionnaire. Descriptive analyses of demographic information, knowledge and attitude responses of survey participants were performed. Logistic regression and ordinal regression models for complex samples were used to investigate associations between responses and independent variables.ResultsExcept for a few areas, more than 70% of healthcare workers had proper knowledge about different aspects of sterilization and reuse of medical devices. Paramedics and office assistants were less likely to have the correct knowledge in different aspects compared to nurses. Permanent staff were more likely to give correct answers to some knowledge questions compared to temporary staff. Previous infection control training was positively associated with correct responses to some knowledge items. Most of the healthcare workers had positive attitudes towards different aspects of sterilization and reuse of medical devices, and nurses were more likely to have positive attitudes compared with other staff categories.ConclusionsMost of the healthcare workers had correct knowledge and positive attitudes towards most areas of sterilization and reuse of medical devices. However, they need proper education and training in some areas such as sterilization procedures, storage of sterilized devices, prion decontamination and standard precautions.

Assessing nonsexual transmission of the human papillomavirus (HPV): Do our current cleaning methods work?

Human papillomavirus (HPV) is thought to be sexually transmitted; however, there have been a few studies investigating a possible iatrogenic source of infection. Therefore, it is important to assess the cleaning methods of reusable medical devices. This study assessed whether cleaning methods of flexible endoscopes in an otolaryngology clinic are effective against HPV. There were 24 patients with a history of head and neck cancer in the study; however, two outliers were excluded. Nine patients were confirmed to have HPV-associated cancer. PCR was used to measure and quantify the viral genomes of samples collected before and after cleaning. After cleaning, few HPV+ samples had endoscopes with less DNA than before cleaning. Additionally, for several patients with non-HPV-associated head and neck cancer, PCR showed more DNA after cleaning than before cleaning, suggesting residual HPV DNA within the cleaning solution. There was no significant difference (p > 0.05) between pre- and post-cleaning in both cohorts. Current cleaning methods of reusable endoscopes may not be effective in completely removing viral DNA.