Reusable Devices Research Articles

Quality control of rigid endoscopes: a comparative study between ScopeControl® and surgeons' evaluation.

In central sterile services departments (CSSD), the functionality of rigid endoscopes, which are complex and fragile reusable devices, is usually controlled visually and is considered a complex and subjective task. ScopeControl® was developed to provide an automated quality control of rigid endoscopes by measuring the value of six parameters: viewing angle (VA), field of view (FV), color correctness (CC), light transmission (LT), fibers transmission (FT), and focus (FC). The aim of the present study was to assess the ability of ScopeControl® to pre-emptively identify endoscope defects before the surgeon considers them as defective. The same endoscope was evaluated by surgeons during surgery using a scoring scale as well as the CSSD staff using the ScopeControl® during reprocessing. The ScopeControl® categorized the endoscope into 3 groups: "passed," "in danger," and "failed." Correlations between the surgeon's evaluation and results of the ScopeControl® were calculated. One hundred sixty-six controls were carried out concerning 51 different endoscopes. According to the surgeon's evaluation, 78.9% and 80.7% of controls were considered as satisfactory for image and brightness quality, respectively. Results obtained using ScopeControl® found that 13.3% of controls were considered as "passed," 31.3% "in danger," and 55.4% "failed," with poor correlation with the surgeons' evaluation. LT and FT parameters represented 95.2% of the reasons for failures. The ability of the ScopeControl® to detect endoscope defects earlier than surgeons was validated by tracking the results of endoscopes used and controlled several times. The ScopeControl® achieved an objective and consistent quality control of endoscopes and showed poor correlation with the surgeon's opinion. In practice, the ScopeControl® could avoid the use of defective endoscopes in the surgery unit and thus improve the quality of the surgical procedure.

Patient perceptions of the re-usable Respimatt® Soft Mist™ inhaler in current users and those switching to the device: A real-world, non-interventional COPD study.

The Respimat® Soft Mist™ inhaler (SMI) has recently been improved, with a re-usable device replacing the disposable version. Certain countries are currently phasing out the disposable inhaler. This study aimed to assess patient satisfaction with and preference for the re-usable device. This 4–6-week, multicentre, open-label, prospective, real-world, non-interventional study was conducted across six European countries. Patients with chronic obstructive pulmonary disease were enrolled between October and December 2019, in three cohorts: (1) currently using the re-usable Respimat SMI; (2) switched from disposable Respimat SMI at study entry; and (3) naïve to any Respimat SMI. Patients were assessed using the Patient Satisfaction and Preference Questionnaire (PASAPQ) and Ease of Handling Questionnaire. In total, 262 patients were enrolled. At follow-up, the mean PASAPQ score was 83.3/100 overall, with similar results across all three patient cohorts. Most patients were ‘satisfied’ or ‘very satisfied’ with the re-usable device. The overall score for willingness to continue using the device was 87.8/100. In total, 13 adverse events were recorded, none of which was classified as serious. This study provides real-world evidence for practitioners to start patients on Respimat re-usable, irrespective of a patient’s prior experience with this inhaler.Plain language summary:Inhalers are often used to treat patients with chronic obstructive pulmonary disease (COPD). However, there are many available, which can lead to confusion and poor inhaler technique. It is important for a patient to be happy with their inhaler. This study looked at how patients liked the re-usable Respimat® Soft Mist™ inhaler vs. their previous inhaler. It also asked whether they would be willing to continue using the device at the end of the study period.After 4–6 weeks of using the re-usable device, patients reported that they were happy with the inhaler and most would be willing to carry on using it.Overall, these results show that doctors can prescribe Respimat re-usable to patients, even if the patient has not used the inhaler before.

Connecting Across Competencies: Leveraging Best Practices for Processing.

The AAMI working group ST/WG 93 is finalizing a standard (AAMI ST98) for the cleaning validation of reusable medical devices based on guidance from the technical information report AAMI TIR30:2011/(R)2016. A number of analytical best practices are being considered for this new standard. Test method suitability for processing cleaning validations historically has been established using one positive control and performing an extraction efficiency. The new cleaning validation standard is proposed to require a change from only one replicate test sample to three when performing method suitability. This change will affect manufacturers; therefore, the value of and consideration for performing these additional replicates requires explanation. This article discusses how variation of validation parameters can affect the accuracy and precision during method suitability testing. Multiple replicates are needed to understand the variability of method extraction and impact on cleaning validations of reusable medical devices.

Discussion on construction scheme of aqueduct structure repair and water stop belt replacement in South-to-North Water Diversion project

Taking Shahe and Dalang River aqueducts as an example, this paper introduces a movable and reusable waterproof device for aqueduct construction, which is suitable for construction scheme of structure repair and waterstop belt replacement for large-scale water delivery aqueduct of Shahe River and Dalang River in South-to-North Water Diversion Project. It aims to solve structural damage and waterstop belt leakage of the aqueducts of Shahe River and Dalang River in the South-to-North Water Diversion Project, realizing the aqueduct construction with uninterrupted water supply, and structure repair and waterstop belt replacement in the waterless environment separated by watertight device in the aqueduct construction.

Dynamics of papillomavirus in vivo disease formation & susceptibility to high-level disinfection-Implications for transmission in clinical settings.

BackgroundHigh-level disinfection protects tens-of-millions of patients from the transmission of viruses on reusable medical devices. The efficacy of high-level disinfectants for preventing human papillomavirus (HPV) transmission has been called into question by recent publications, which if true, would have significant public health implications.MethodsEvaluation of the clinical relevance of these published findings required the development of novel methods to quantify and compare: (i) Infectious titres of lab-produced, clinically-sourced, and animal-derived papillomaviruses, (ii) The papillomavirus dose responses in the newly developed in vitro and in vivo models, and the kinetics of in vivo disease formation, and (iii) The efficacy of high-level disinfectants in inactivating papillomaviruses in these systems.FindingsClinical virus titres obtained from cervical lesions were comparable to those obtained from tissue (raft-culture) and in vivo models. A mouse tail infection model showed a clear dose-response for disease formation, that papillomaviruses remain stable and infective on fomite surfaces for at least 8 weeks without squames and up to a year with squames, and that there is a 10-fold drop in virus titre with transfer from a fomite surface to a new infection site. Disinfectants such as ortho-phthalaldehyde and hydrogen peroxide, but not ethanol, were highly effective at inactivating multiple HPV types in vitro and in vivo.InterpretationTogether with comparable results presented in a companion manuscript from an independent laboratory, this work demonstrates that high-level disinfectants inactivate HPV and highlights the need for standardized and well-controlled methods to assess HPV transmission and disinfection.FundingAdvanced Sterilization Products, UK-MRC (MR/S024409/1 and MC-PC-13050) and Addenbrookes Charitable Trust

Development and Implementation of Enzymatic and Volatile Compound-based Approaches for Instantaneous Detection of Pathogenic Staphylococcus aureus

Staphylococcus aureus (S. aureus) has a mortality rate of up to 30% in developing countries. In contrast, the mortality rate of S. aureus in the U.S. is less than 5%. One reason for the six-fold increase in fatality in underdeveloped communities is lack of access to a rapid, accurate, and user-friendly diagnostic method to enable timely detection of these infections. The purpose of this experiment was to determine if enzymatic and volatile compound-based approaches would perform more quickly in comparison to existing S. aureus diagnostic methods and to evaluate these novel methods on accuracy. Further, we sought to implement them in a reusable 3D-printed instantaneous detection device. A combination of droplet transmission tests and direct contact tests were developed and evaluated to create a comprehensive method by which individuals can diagnose their condition as pathogenic S. aureus, incorrect use of device, or another infection. We hypothesized that the approaches developed in this study would perform more quickly than existing approaches. Ultimately, our device provided results in less than 30 seconds, which is much quicker than existing methods that take anywhere from 10 minutes to 48 hours based on approach. Statistical analysis of accuracy provides preliminary confirmation that our device based on enzymatic and volatile compound-based approaches can be an accurate and time-efficient tool to detect pathogenic S. aureus.

Application of Processing Guidance: Case Study of Cleaning Validations on Flexible Endoscopes.

In 2015, the Food and Drug Administration (FDA) updated its guidance on test methods for cleaning validations for reusable medical devices. The changes include the condition and contamination of devices, test samples and controls, cleaning process performed during validation, extraction methods, and endpoints. This article reviews the FDA's changes to cleaning validations. Examples are presented using flexible endoscopes in order to provide a practical guide to performing cleaning validations.

Evaluation of pyrogens remaining on reusable medical devices after washing and sterilization

Evaluation of pyrogens remaining on reusable medical devices after washing and sterilization

Clinical Efficacy of Ambu Aura Gain vs Laryngeal Mask Airway Proseal in Paediatric Patients Undergoing Elective Surgery under General Anaesthesia: A Randomised Controlled Trial

Introduction: Laryngeal Mask Airway ProSeal (LMA-P) is considered a gold standard among second generation supra glottis airway devices as an effective, safe and reusable ventilatory device. Ambu Aura Gain (AAG) is a newer single use second generation airway device with a soft inflatable cuff and preformed shape. Aim: To compare the clinical effectiveness and oral pharyngeal seal pressures between LMA ProSeal and AAG in children receiving controlled ventilation. Materials and Methods: This study was conducted in 100 paediatric patients in age group of 1 to 12 years, weighing 5 to 30 kg, fulfilling the criteria of American Society of Anaesthesiologists (ASA) Physical Status I and II and undergoing elective surgical procedures. Patients were randomised into two groups. Secondary objective was to compare the ease, success and total time for achieving effective ventilation and ease of placement of gastric tube and fibreoptic visualisation of glottis view in both the groups. Quantitative variables were compared using Independent t-test/Mann-Whitney Test and qualitative variables were compared using Chi-Square test/Fisher’s-Exact test. Results: The median (IQR) Oropharyngeal Seal Pressure (OSP) was much higher with AAG 22 cm (21-23) of water as compared to LMA ProSeal 21 cm (20-22) of water and the difference was statistically significant (p-value <0.0001). Time taken for achieving effective ventilation {median (IQR)} was significantly less with AAG {18 (17-19) seconds} as compared to that with LMA ProSeal {19 (18-20) seconds} (p=0.0005). The two devices were comparable in terms of success and ease of insertion of device, ease of placement of gastric tube and fibreoptic visualisation of glottis view. Conclusion: The study suggests that AAG, a single use device, is a useful substitute to LMA ProSeal to ventilate paediatric patients undergoing elective surgical procedures.

822. Structural Damage and Biofilm Accumulation on Patient-Ready Orthopaedic Implant (Least Used Cortical Screws), Acquired through Loaner System

BackgroundThe acquisition of reusable medical devices through loaner system is a worldwide phenomenon. Single-use implants, such as orthopaedic screws, that remain in the surgical tray are subjected to multiple handling and reprocessing until they are implanted. Exposure to physical, chemical and biological agents may compromise their quality/safety and favor biofilm formation. The aim of this study was to assess the surface integrity and microbiological conditions of patient-ready orthopaedic surgical implants (least used cortical screws), provided through loaner system.MethodsAfter full reprocessing, clinical trays used for small fragment surgery (3,5) provided through loaner system to a large Brazilian teaching hospital were randomly selected between August to November 2019. Trays were opened in a biological safety cabinet and the least frequently used cortical screws (numbers 10 and 38), therefore, the ones most exposed to biological, chemical and physical agents, were randomly removed and subjected to bacterial culture (n = 3 screws/tray, 9 trays) and Scanning Electron Microscopy (SEM) (n= 1 screw/tray, 5 trays). The 27 screws were individually cultured in Tryptic Soy Broth (TSB), sonicated and vortexed, and incubated at 35oC for up to 28 days (screws were left in TSB). Positive cultures were plate out for automated bacteria identification.ResultsBacterial growth was identified in 2/27 screws. Three bacterial species were isolated, Staphylococcus hominis resistant to rifampicin and Kocuria rhizophila (screw A), and Micrococcus luteus (Screw B). Structural damage and soil were visualized on all screws subjected to SEM (5/5). Extensive biofilms were detected on three screws (3/5) (Figure 1).Figure 1. Scanning electron micrographs of patient-ready orthopaedic implants (screws), acquired through loaner system showing extensive biofilm, with incorporated bacilli/rods and/or cocci shape bacteria. ConclusionRecovery of bacteria, biofilm accumulation and structural damage were detected on patient-ready least frequently used orthopaedic cortical screws. Screws frequently remain in surgical trays for multiple reprocessing, thus, they are repeatedly exposed to contamination and possible damage. These findings point to the need to discuss and review the way these single-use implants are currently made available for surgery.Disclosures All Authors: No reported disclosures

815. Biofilm Accumulation in New Flexible Gastroscope Channels within 30 Days in Clinical Use

BackgroundFlexible endoscopes are complex-design reusable devices, with long and narrow channels, making reprocessing difficult. Biofilm formation is a key factor for persistent contamination, as it protects microorganism against cleaning and disinfection agents. The aim of this study was to assess the accumulation of biofilm on the inner surfaces of new flexible gastroscope channels after 30 days of patient-use and full reprocessing.MethodsThree flexible gastroscopes (FG) (GIF–Q150, OlympusTM) with new internal channels (TeflonTM) were subjected to 30 days of clinical use and reprocessing by trained nursing personnel, using a revised reprocessing protocol, at the endoscopy service of a Brazilian teaching hospital (235 beds). The reprocessing protocol included: pre-cleaning; manual cleaning; automated cleaning and disinfection - 2% Glutaraldehyde; manual drying (forced-air drying) and alcohol rinsing, and storage in vertical position in exclusive cabinets. Then, internal channels were removed from the three patient-ready FG (three biopsy, three air, three water and three air/water junction channels), and the inner surface subjected to bacteriological culture (~30 cm) (n=9) and Scanning Electron Microscopy (SEM) (~1 cm) (n=12). Air/water junctions (~1 cm) were subjected to SEM only.ResultsThe average of use/reprocessing of the FG was 60 times. Bacterial growth was detected in 6/9 channels (three from FG#1 showed residual moisture) and seven bacterial isolates were recovered, most from air or water channels (Fig 1). Inner surface structural damage was identified in 11/12 channels by SEM. Extensive biofilm was detected in air, water and air/water junction channels (7/12) (Fig 2). Residuals matter were detected in all channels (12/12).Fig 1. Distribution of bacterial growth and genera/species identified in new flexible gastroscope channels after 30 days of patient-use and reprocessing at the endoscopy service of a large Brazilian teaching hospital. *FG1: flexible gastroscope nº1 **FG2: flexible gastroscope nº2 ***FG3: flexible gastroscope nº3 ¥Moisture was visually detected inside the channels during longitudinal cutting for SEM. Fig 2. Scanning Electron Micrographs showing extensive biofilm, containing bacilli/rods and/or cocci shape bacteria, on the inner surface of new flexible gastroscope channels after 30 days of patient-use and reprocessing at the endoscopy service of a large Brazilian teaching hospital. *FG1: flexible gastroscope nº1 **FG2: flexible gastroscope nº2 ***FG3: flexible gastroscope nº3 ConclusionThe short timeframe before damage and biofilm accumulation in the channels were evident and suggests that improving endoscope design is necessary, while better reprocessing methods and channel maintenance needs to be investigated in detail. Improving design, maintenance and reprocessing of endoscopes will ensure safe use of these devices.Disclosures Michelle J. Alfa, B.Sc., M.Sc., Ph.D, Healthmark (Consultant, Other Financial or Material Support, Royalty monies from University of Manitoba that are provided through a License agreement with Healthmark)Kikkoman (Consultant)Olympus (Consultant, Advisor or Review Panel member, Speaker’s Bureau)STERIS (Consultant, Speaker’s Bureau)

Fabrication of A Diode-based Salt Solution Sensor

High blood pressure/hypertension is a severe medical issue among Malaysians that could be reduced by monitoring our salt/sodium intake. One way is to use intraoral salt sensor; this in-mouth method however may cause discomfort and adopts complex and costly fabrication processes. Hence, an external and reusable electronic device, that could be used as a “sweat-sensor”, is preferred in detecting the sodium intake of the body. In this study, a potentiometric diode-based salt solution sensor was designed and fabricated in order to detect different salt solution concentrations with applied external voltage. A p-n junction diode sensor was successfully designed and fabricated using four consecutive techniques; thermal wet oxidation, photolithography, thermal diffusion and metallization. The average sheet resistance and resistivity of the diode sensor were measured to be 3.50 x 105 ± 0.66 Ω⁄sq and 3.05 ± 0.5 Ωcm respectively. This sensor showed ideal I-V diode characteristics with a knee voltage of 11.5V in forward bias condition and breakdown voltage of -4 V in reverse bias condition. For salt concentration detection, the sensor was able to detect salt concentration changes with respect to current flow, up to 45 mg/mL.

Improving Fluid Output Monitoring in the Intensive Care Unit.

To assess the potential clinical impact of an automated urine output (UOP) monitoring system in the intensive care unit. Frequency of UOP documentation during a 20-month period was assessed in records of inpatients on the medicine floor, cardiac intensive care (CCU), and cardiothoracic-intensive care units (CTICU). Documentation timeliness (time between expected and observed UOP recording) was assessed over a 3-month period. A novel reusable device that monitors UOP based on continuous analysis of the weight of a urine collection container was tested in the CCU/CTICU. A total of 165,363 UOP measurements were recorded for 2,039 CCU/CTICU admissions. Sixty percent of CCU/CTICU admissions had UOP recorded in the electronic medical record (EMR) less than every 2 hours. One-third of CCU/CTICU measurements were documented more than 2 hours late, and only 10% were recorded less than 20 minutes late. Half of these patients had fewer than 2 measurements recorded per nursing shift and recordings were documented an average of 85 minutes late. There was no significant difference between daytime and nighttime shifts. UOP values obtained by the novel electronic monitoring device were within 27 ml (-224 ml, +228 ml) of nurses documented values, across 74 patients over a 24-hour period. Automating UOP monitoring using a reusable weight-based device is feasible and can improve timeliness of documentation and reduce nursing workload without compromising accuracy.

Cost comparison of single-use versus reusable flexible ureteroscope: A systematic review

Single-use flexible ureteroscopes (su-fURS) aim at overcoming the main limitations of conventional reusable flexible ureteroscopes (re-fURS) in terms of acquisition and maintenance costs, breakages, and reprocessing. We aimed to perform a literature review on available re-fURS and su-fURS performances with a focus on costs. A search of Medline, EMBASE, CINAHL, and Scopus databases was performed to identify articles published in English within the last 10 years addressing refURS and su-fURS characteristics, clinical, and cost data. Relevant studies were then screened, and the data were extracted, analyzed, and summarized. The Preferred Reporting Items for Systematic Reviews and Meta-analysis criteria were applied. A narrative synthesis was performed. To date, few studies have properly investigated the issue of costs in ureteroscopy. An important local and international variation in costs exists for both re-fURS and su-fURS in terms of acquisition, maintenance, and repair costs. Reusable scopes have high acquisition and ancillary (e.g. repair, involved personnel) costs, which are not considered in a pure su-fURS activity. However, only recently su-fURS were shown to have a similar efficacy as compared with reusable devices. In high-volume centers, with proper training for reusable ureteroscopes management, the cost per case of reusable and single-use scopes are overlapping ($1,212-$1,743 versus $1,300-$3,180 per procedure). There is a partial overlap in the ranges of costs for single-use and reusable scopes, which makes it important to precisely know the caseload, repair bills, and added expenses when negotiating purchase prices, repair prices, and warranty conditions for scopes.

This or That? Instructions for Use (IFU): IF U Could Pick Your Dream Printout Format

An Instructions for Use (IFU) is a critical element of a drug delivery device system user interface that is frequently used as risk mitigation when the product cannot be effectively mitigated by the design of the device itself. However, format of a printout IFU is often selected without thoughtful consideration or even neglected while the IFU contents such as wordings and images are iteratively improved over the course of device development. There is a limited number of research papers that exist on the effects of the IFU printout format on task performance, especially with a drug delivery device. This study was to evaluate two different IFU formats (spiral bound vs accordion style) on task performance for use of a complex reusable electromechanical injection pen device system for preparing and administering medication. This study provides valuable insights for biotech/pharmaceutical industry for optimizing their IFU design by selecting more appropriate hardcopy IFU format for their drug delivery device. This will enable creating optimal user experience as well as more effectively reducing use related risks as part of overall device user interface for a complex drug delivery device system.

Dual-Band Microstrip Resonant Sensor for Dielectric Measurement of Liquid Materials

A novel compact microstrip resonant dielectric permittivity sensor with dual-band operation is presented in this paper. The circuit makes use of a single stepped-impedance-resonator as the sensing element, working at the 2.45-GHz and 5.8-GHz ISM bands, under differential and common modes, respectively. Sensitivity of the circuit and resonator coupling at each band can be configured independently. Moreover, testing of the sample is done by using a single sensing region without the need of duplicating the sample location. Experimental measurements are carried out using a very small amount of liquids and the results are presented validating the theory. This work delivers a compact, reusable, label-free and non-destructive microwave device and paves a way for sensing dielectric properties of chemicals with accuracy due to the dual-band performance.

A Behavioral Change Intervention System to Support the Hydration Habits of Nurses in Hospital Wards

This paper reports on the design and development of a Behavior Change Intervention (BCI) device and service provision aimed at supporting the personal hydration habits of the UK’s National Health Service (NHS) ward-based nurses. A conceptual solution is proposed that has been developed using an iterative design process, following an adapted version of the double-diamond approach, over a seven-month time period from 11 October 2019–13 May 2020. The research was completed in collaboration with the Guy’s and St Thomas’ NHS Foundation Trust, United Kingdom. A thematic review of related literature was completed to identify key research questions. Consultation with a senior long-serving NHS nurse and a real-time observation study was completed in an NHS ward to answer these questions within the research scope. Collected data were analyzed and insights into the behaviors of nurses and the contextual factors influencing them were provided. Reusable BCI devices and a habit formation program, incorporating a smart fob watch and water station, are proposed inside of a cradle-to-cradle system. Finally, the parameters of the developed solution are defined, and the device and user experience are visualized using computer renders and storyboards. Aspects of the device functionality and feasibility have been proven and visualized using graphic devices, and their use for data collection to inform healthcare management and improvements is discussed.

Plug-and-play acoustic tweezer enables droplet centrifugation on silicon superstrate with surface multi-layered microstructures

Previous works have demonstrated the use of acoustic waves to manipulate microparticles and biological samples on bare glass and silicon superstrates. Traditionally, the surface acoustic wave (SAW) is converted into a Lamb wave propagating within a bare silicon superstrate via a thin coupling agent. The potential impact of acoustically driven microfluidics could be further augmented if applied to superstrates integrated with sensing structures that would allow sequential analysis after sample treatment. In this work, we demonstrate the applicability of acoustically-driven micro-centrifugation on a superstrate with multiple thin film layers to mimic sensing structures on a chip, and characterize the underlying performance. We propose an integrated plug-and-play platform comprised of a reusable SAW device interfaced to a disposable surface-micromachined silicon (SMS) superstrate processed with five layers of thin films. To address the shortcomings of existing coupling agents, we examine and compare the transmission efficiency and long-term stability of four kinds of coupling agents with the aim to enable disposable acoustofluidics applications. To investigate the effect of different superstrates on the performance of droplet centrifugation, we characterize and compare centrifugation on different superstrates. High-performance concentration was realized on the SMS superstrate under different conditions, such as input power, temperature, droplet volume, and particle size and density. In terms of more advanced fluidic handling functionality on a multi-layered SMS superstrate, we demonstrate ultrasonic isopycnic separation between microbeads differentiated by density on the SMS superstrate. The results herein lay the groundwork for realizing particle concentration on complex superstrates processed with multilayer films that represent a range of microfabricated sensors towards a broader goal of integrating acoustically driven concentration capabilities and sensing for applications in diagnostics and fundamental analysis.

Compliance of primary and secondary care public hospitals with standard practices for reprocessing and steam sterilization of reusable medical devices in Nepal: findings from nation-wide multicenter clustered audits

BackgroundReusable medical devices in healthcare facilities are decontaminated and reprocessed following standard practices before each clinical procedure. Reprocessing of critical medical devices (those used for invasive clinical procedures) comprises several processes including sterilization, which provides the highest level of decontamination. Steam sterilization is the most used sterilization procedure across the globe. Noncompliance with standards addressing reprocessing of medical devices may lead to inadequate sterilization and thus increase the risk of person-to-person or environmental transmission of pathogens in healthcare facilities. We conducted nationwide multicenter clustered audits to understand the compliance of primary- and secondary-care public hospitals in Nepal with the standard practices for medical device reprocessing, including steam sterilization.MethodsWe developed an audit tool to assess compliance of hospitals with the standard practices for medical device reprocessing including steam sterilization. Altogether, 189 medical device reprocessing cycles which included steam sterilization were assessed in 13 primary and secondary care public hospitals in Nepal using the audit tool. Percentage compliance was calculated for each standard practice. Mean percentage compliances were obtained for overall primary and secondary care hospitals and for each hospital type, specific hospital and process involved.ResultsFor all primary and secondary care hospitals in Nepal, the mean percentage compliance with the standard practices for medical device reprocessing including steam sterilization was 25.9% (95% CI 21.0–30.8%). The lower the level of care provided by the hospitals, the lower was the mean percentage compliance, and the difference in the means across the hospital types was statistically significant (p < 0.01). The mean percentage compliance of individual hospitals ranged from 14.7 to 46.0%. The hospitals had better compliance with the practices for cleaning of used devices and transport and storage of sterilized devices compared with the practices for other processes of the medical device reprocessing cycle.ConclusionThe primary and secondary care hospitals in Nepal had poor compliance with the standard practices for steam sterilization and reprocessing of medical devices. Interventions to improve compliance of the hospitals are immediately required to minimize the risks of person-to-person or environmental transmission of pathogens through inadequately reprocessed medical devices.

Efficacy of Double Manual Cleaning Versus Automated Cleaning for Removal of Biofilm of Hinged Surgical Instruments

Objectives: To evaluate the efficacy of double manual cleaning (DMC) with enzymatic followed by alkaline detergent for removing biofilm on hinged surgical instruments compared to automated cleaning by the washer-disinfector. Methods: Biofilm of Staphylococcus aureus (ATCC 25923) was formed in vitro on hemostatic forceps (Fig. 1). Biofilm-covered forceps were rinsed in distilled water and subjected to one of the following cleaning regimes (n = 5 forceps each): Group 1 forceps were soaked in sterile water for 5 minutes. Group 2-DMC forceps were soaked in enzymatic detergent, brushed 5 times on each face, rinsed with filtrated water (0.2 µm), soaked in alkaline detergent, brushed 5 times each face, rinsed with filtrated water (0.2 µm), and dried with sterile cloth. For group 3-DMC plus hinge inner brushing (n = 5), the forceps were soaked in detergents and brushed as in group 2, including hinge inner brushing (2-mm lumen brush) (Fig. 1). In group 4 (automated cleaning in a washer/disinfector), forceps were prewashed, washed once, washed again, rinsed, thermally rinsed, and dried. After the treatments, forceps were evaluated for microbial load (counting of colony-forming units), residual protein (BCA protein assay kit), and biofilm (scanning electron microscopy). Results: There was no statistically significant differences between the microbial load and protein level contaminating the forceps subjected to DMC (group 2) and the positive control group. The DMC with hinge inner brushing group (group 3) and the automated cleaning group (group 4) demonstrated a significantly reduced microbial load: reduction averages of 2.8 log 10 (P = .038) and 7.6 log10 (P ≤ .001), respectively. The protein level remaining on the forceps also significantly decreased: 2.563 μg (P = .016) and 1,453 μg (P = .001), respectively, compared to the positive control group. There was no statistically significant difference between DMC with hinge inner brushing and automated cleaning (groups 3 and 4) for all of the tests performed. None of the cleaning methods completely removed biofilm and/or soil from the forceps hinge internal region (Fig. 1). Conclusions: Automated cleaning had the best efficacy for removing biofilm. However, DMC with hinge inner brushing was an acceptable alternative cleaning method for sterilizing service units with only manual cleaning available, as is the case in most low- and middle-income countries. Neither automated nor any manual cleaning regimes were able to completely remove biofilm and soil from the forceps hinged area, and the amount of protein left after automated and DMC plus hinge brushing was higher than the recommended. Cleaning is the most important step for the reprocessing of reusable medical devices; thus, efforts must be undertaken to improve cleaning in different social and economic realities and scenarios.Funding: This study was supported by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – CAPES.Disclosures: None