Sterilization Of Medical Devices Research Articles

Inventory of the Sterilization Units at a Tertiary-Level South Tunisian University Hospital

Sterilization of reusable medical devices (RMD) is considered as one of the major components of healthcare associated infection (HAI) prevention that should be strictly maintained. Microorganisms responsible for HAI can be transmitted from a common inanimate vehicle such as medical RMD to patients. Sterilization is a complete process with a set of successive steps to finally achieve a sterile RMD. In addition to these steps, which must be carefully controlled, the whole environment of this process should also conform to quality and security standards and criteria in order to ensure a robust sterilization process and a secure RMD. Therefore, a complete and exhaustive evaluation of this process is highly recommended. This evaluation aimed firstly to examine the inventory of sterilization process, architecture, and environment as well as to present recommendations to be adopted to adjust the practices and failures recorded accordingly.

Connaissances et pratiques des étapes préalables à la stérilisation des dispositifs médicaux thermorésistants : étude au centre hospitalo-universitaire Sahloul, Sousse-Tunisie – 2022

The standard process of central sterilization is crucial for the optimal functioning of the operating room. The outcome of this process is closely linked to the steps preceding the steps prior to the sterilization step itself. These steps include pre-disinfection carried out in the operating rooms and other stages, namely washing, drying and packaging, which must be performed in the central sterilization unit. In this context, this study aimed to describe the knowledge of the staff in the operating rooms and the central sterilization unit at Sahloul University Hospital in Sousse (Tunisia) in 2022, regarding the steps prior to the sterilization of reusable thermoresistant medical devices and to describe their practices in terms of compliance with these steps. A descriptive study was conducted from January 2022to June 2022with the aforementioned staff, using a self-administered questionnaire to assess their knowledge of the pre-sterilization steps and a direct observation audit of their practices with regard to these steps. Both measurement instruments were pre-tested. Out of 102self-administered questionnaires (knowledge assessment) distributed to the staff concerned, only 80were returned and correctly filled out, giving a response rate of 78.4%. Participants' responses regarding the order of steps prior to the sterilization were incorrect in 64% of cases. With regard to the evaluation of professional practices, 224observations were made in the study area (practice audit). In 82% of these observations, the pre-disinfection step was confused with the washing step. The use of Betadine brushes and scrubbing pads for device washing was noted in 89.3%, along with the absence of swabbing of the canals and hollow parts in 9.4% of cases and the absence of drying of the canals with compressed air. Mastery of the steps prior to sterilisation of reusable thermoresistant medical devices was insufficient in our institution, suggesting the importance of reinforcing the implementation of the procedure through a continuous training program followed by action plans.

FDA Facilitates Expand Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

FDA Facilitates Expand Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

Design of a fast cassette autoclaves for medical devices

Ensuring patient safety in healthcare necessitates the sterilization of medical devices. However, traditional autoclaves are impractical for certain medical settings due to their size, bulkiness, and time-consuming nature. To address this, a compact and portable alternative called a cassette autoclave was developed. This paper presents the design and manufacturing process of a high-speed cassette autoclave for medical devices. The autoclave features small dimensions, lightweight construction, and user-friendly operation. It achieves remarkable speed, sterilizing devices in approximately 3.5 minutes. Made of durable stainless steel, it includes a digital control panel for seamless management. Extensive testing and validation ensure compliance with sterilization standards. The results highlight the autoclave's effectiveness and safety, making a significant contribution to medical device sterilization.

Sabic showcased at MD&M West 2024 specialty materials for medical devices and introduces LNP™ Lubriloy™ compounds

On January 18, 2024, Sabic announced it would feature new and existing material solutions for potential use in critical medical devices through the company's exhibition and two presentations at MD&M West 2024 (Booth #3287). The company would spotlight specialty engineered thermoplastic materials that should be able to help the device industry address pressing issues, including withstanding increasingly harsh healthcare disinfectants; providing effective lubrication without the use of polytetrafluoroethylene (PTFE); and finding alternatives to EtO sterilization in the face of upcoming U.S. Environmental Protection Agency (EPA) regulations. SABIC's first presentation will focus on new material technology that is well suited for wear and friction applications and the second will cover material solutions for medical device sterilization.

Medical Device-Associated Healthcare Infections: Sterilization and the Potential of Novel Biological Approaches to Ensure Patient Safety.

Healthcare-associated infections caused by multi-drug-resistant pathogens are increasing globally, and current antimicrobial options have limited efficacy against these robust species. The WHO details the critically important bacterial and fungal species that are often associated with medical device HAIs. The effective sterilization of medical devices plays a key role in preventing infectious disease morbidity and mortality. A lack of adherence to protocol and limitations associated with each sterilization modality, however, allows for the incidence of disease. Furthermore, issues relating to carcinogenic emissions from ethylene oxide gas (EtO) have motivated the EPA to propose limiting EtO use or seeking alternative sterilization methods for medical devices. The Food and Drug Administration supports the sterilization of healthcare products using low-temperature VH2O2 as an alternative to EtO. With advances in biomaterial and medical devices and the increasing use of combination products, current sterilization modalities are becoming limited. Novel approaches to disinfection and sterilization of medical devices, biomaterials, and therapeutics are warranted to safeguard public health. Bacteriophages, endolysins, and antimicrobial peptides are considered promising options for the prophylactic and meta-phylactic control of infectious diseases. This timely review discusses the application of these biologics as antimicrobial agents against critically important WHO pathogens, including ESKAPE bacterial species.

Optimisation de la date limite d’utilisation des dispositifs médicaux réutilisables. Expérience dans un établissement de santé

Sterilized reusable medical devices have a use-by date, after which sterility is no longer guaranteed. There is currently no consensus on how this should be determined. The aim is to re-evaluate the expiry date of reusable medical devices, by means of a risk analysis and an assessment of the maintenance of the sterile state of reusable medical devices over time. The risk analysis focused on the stages whose malfunction could compromise the sterility of reusable medical devices over time: packaging, transport and storage. Risk mapping was carried out in accordance with the methodology recommended by the French Health Authority. Based on standard NFENISO11737, the assessment of the maintenance of the sterile state was checked on reusable medical devices after two, four and six months storage and on reusable medical devices that had expired more than a year previously. The risk analysis identified four failures and sixty-eight potential causes. The most sensitive stage was storage, which accounted for most of the critical and major causes. Improvement actions were proposed, such as the definition of a container maintenance plan. At the same time, 256 reusable medical devices were tested. The cultures remained sterile for all the containers, for folded products tested at 6 months and more and for the sachets tested at 2 and 4 months and at more than one year of storage. The DLU has been extended to 4 months for sachets, 6 months for folded products and maintained at six months for containers.

Pulmonary Toxicity Assessment after a Single Intratracheal Inhalation of Chlorhexidine Aerosol in Mice.

Guanidine disinfectants are important chemical agents with a broad spectrum of activity that are effective against most microorganisms. Chlorhexidine, one of the most used guanidine disinfectants, is added to shampoo and mouthwash and applied in medical device sterilization. During the use of chlorhexidine, aerosols with micron particle size may be formed, which may cause inhalation toxicity. To assess the toxicity of inhaled chlorhexidine aerosol, mice underwent the intratracheal instillation of different concentrations of chlorhexidine (0, 0.125%, 0.25%, 0.5%, and 1%) using a MicroSprayer Aerosolizer. The mice were exposed for eight weeks and then sacrificed to obtain lung tissue for subsequent experiments. Histopathology staining revealed damaged lung tissues and increased collagen exudation. At the same time, pulmonary function tests showed that chlorhexidine exposure could cause restrictive ventilatory dysfunction, consistent with pulmonary fibrosis. The results of transcriptome analyses suggest that chlorhexidine may trigger an inflammatory response and promote the activation of pathways related to extracellular matrix deposition. Further, we identified that chlorhexidine exposure might enhance mucus secretion by up-regulating Muc5b and Muc5ac genes, thereby inducing fibrosis-like injury. These findings underscore the need for standardized use of disinfectants and the assessment of their inhalation toxicity.

Sterilization of 20 billion medical devices by ethylene oxide (ETO): Consequences of ETO closures and alternative sterilization technologies/solutions

BackgroundTo prevent healthcare-associated infections, it is essential that critical medical devices be sterilized before use. Although there are several sterilization technologies for medical devices, only ethylene oxide (ETO) sterilization has virtually universal material compatibility. MethodsWe searched the published English literature (Google, Google scholar and PubMed) for articles on the sterilization of medical devices by ethylene oxide, the consequences of ETO closures, and alternative sterilization technologies/solutions. ResultsETO’s compatibility and effectiveness with medical products allows for sterilization of many medical devices that would otherwise be rendered ineffective or unsafe if sterilized with an alternative method. ConclusionsAt present, there are no alternatives to ETO that provide the same sterility assurance and result in the same device performance as ETO; therefore, it is likely irreplaceable for years.

Advances in Vaporized Hydrogen Peroxide Reusable Medical Device Sterilization Cycle Development: Technology Review and Patent Trends.

Vaporized hydrogen peroxide (VHP) terminal sterilization is one of the most promising techniques for sterilizing temperature-sensitive medical instruments like endoscopes. This technique requires only electricity and sterilant containers to perform the sterilization process in less than 1 h without any substantial safety concerns for patients, personnel, and the environment. This review studies recent advances and future trends in VHP sterilization cycle development using U.S. patent applications and 510(k) premarket notifications. In this regard, the patents focused on increasing VHP concentration or handling residual moisture are discussed in depth. The expired patents are analyzed to introduce existing unencumbered technologies, and active patents are presented to show the most current novelties and technology trends. In addition, 510(k) premarket notifications are explored to evaluate implemented technologies in US market-leading commercial products.

Cytocompatibility of titanium and poly(etheretherketone) surfaces after O2 non-thermal plasma sterilization.

The sterilization of medical devices is paramount to achieve an acceptable level of sterility assurance and to prevent hospital-acquired infections. However, some medical devices cannot be sterilized by usual processes such as autoclave (AC) and gamma-ray irradiation (GI). A new non-thermal plasma (NTP) process using sealed bag that preserves the sterile state of the devices could be used as an alternative sterilization method. The aim of the study was to assess the cytocompatibility of titanium and poly(etheretherketone) (PEEK) surfaces after O2-NTP sterilization compared to GI and AC. MG-63 osteoblast-like cells were seeded on titanium (TA6V) and PEEK disks sterilized by AC, GI and O2-NTP. The cells' viability and proliferation, determined by WST-1 and DNA quantification respectively, were enhanced whatever the material types from 3 to 10 days. When seeded on titanium, MG-63 cells showed a higher viability and proliferation after GI and O2-NTP treatment compared to AC treatment. When cultured on PEEK, MG-63 cells showed a higher viability after O2-NTP treatment. No difference of proliferation was observed whatever the sterilization processes. The cell colonization of the materials' surface was confirmed by scanning electron microscopy. Lactate dehydrogenase (LDH) assay revealed no cytotoxicity. Thus, O2-NTP led to similar cell responses to AC and GI and could be a cost-effective alternative process to the usual sterilization methods for fragile medical devices.

EFFORTS TO PREVENT CROSS-INFECTION IN THE DENTAL CLINIC DURING THE COVID 19 PANDEMIC AT THE PATEK HEALTH CENTER, ACEH JAYA REGENCY

In the context of healthcare, the principle of prevention plays an important role in minimizing the risk of infection. Infections can be caused by various factors, including accidents such as being pricked by sharp instruments, contamination from unsterilized hands, or respiratory transmission. Therefore, infection control becomes a key strategy for dentists to avoid the risk of cross-infection that could potentially harm patients and medical staff. The role of dental nurses in avoiding or preventing cross-infection cannot be ignored, especially in pandemic situations such as Covid-19. Sterilization of dental medical devices is a crucial step that must be carried out appropriately and correctly to ensure the safety of patients and medical staff. This study aims to explore the understanding of ways to prevent cross-infection during the Covid-19 pandemic, especially in the context of the dental clinic at the Patek Health Center, Aceh Jaya Regency. The research method used was an analytic survey with a cross-sectional study approach, where data were collected simultaneously at one point in time. The study population consisted of two dental nurses and patients visiting the dental clinic. The sample taken was the total population available. Data collection was carried out using a questionnaire to measure the level of knowledge and a checklist sheet to record the actions taken.

Impact of X-ray irradiation as an equivalent alternative to gamma for sterilization of single-use bioprocessing polymers.

Irradiation sterilization of polymeric pharmaceutical processing systems and medical devices, an essential healthcare technology, is facing critical business continuity challenges, driving the need to qualify equivalent alternative irradiation technologies, such as X-ray. Whereas the underlying there is a paucity of cross-industry published data evaluating X-ray irradiation effects on plastics as compared to gamma irradiation. That leads to regulatory uncertainty in the levels of costly validation data regulators will require and overall apprehension in the rate of X-ray irradiation adoption. The present study evaluates the impact of X-ray versus gamma irradiation on a wide range of polymers with more than 36 single-use (SU) components, using a comprehensive set of industry aligned methods for characterization of bioprocess polymers. Whereas many of these techniques readily demonstrate changes in polymer properties following irradiation, all of the polymers evaluated demonstrated that the impact of X-ray irradiation was to the same degree or less as compared to gamma. Increased publication of studies evaluating the impact to polymers of X-ray versus gamma irradiation is critical to leveraging extensive, existing validation packages on bioprocess systems and medical devices obtained following gamma irradiation, and essential in qualifying X-ray irradiation as an equivalent technology (i.e., materials are impacted to the same extent or less than gamma) that can overcome business continuity challenges to ensure continued availability of critical patient therapies.

Studies on the comparative effectiveness of X-rays, gamma rays and electron beams to inactivate microorganisms at different dose rates in industrial sterilization of medical devices

The radiation resistance of Bacillus pumilus spores to gamma rays, X-rays, and electron beam (e-beam) was investigated using industrial irradiators operating at various dose rates. The dose rates were as follows: gamma 1 and 10 kGy/h; X-ray 10 and 200 kGy/h; e-beam 2000 kGy/h. The regression analysis showed that survivor curves were log10 linear for all three sources within the investigated absorbed dose range of 1–6 kGy, irrespective of the dose rate applied. All irradiation technologies were equally efficient to inactivate the spores, which is reflected in their comparable D-values (p > 0.05), and dose rate had no impact on the microbicidal efficacy. These results suggest that wherever a specified minimum dose is delivered, the sterilization dose can be transferred between irradiation technologies in industrial sterilization of medical devices without any impact on product sterility. These findings from a novel single study encompassing all available industrial radiation technologies for the purpose of medical devices sterilization, advance our understanding of microbial destruction as related to exposure to important sterilization modalities, which will help inform future applicability of these technologies for emerging industry opportunities.

SG-APSIC1112: The quality enhancement in sterilization processes at Naresuan University Hospital

Background: Disinfection and sterilization of medical devices, instruments, and medical supplies are a crucial part of hospital infection control. The significant problems include insufficient cleaning, incorrect registration in the request form, no basic cleaning at the point of use (POS), and incorrect labelling. These problems were analyzed according using the fishbone diagram process. Objectives: We sought to decrease insufficient cleanliness of items after washing, to increase data accuracy in transferring contaminated devices from wards (from end users), to increase the rate of decontamination at the point of use, and to decrease incorrect labelling on instrument packaging. Method: The Community of Practice in Sterilization (CoP Sterile) team revised the disinfection and sterilization system of the Naresuan University Hospital Central Sterile Supply Department (CSSD) using root-cause analysis of subprocess problems and implementing prioritized solutions. A regular monthly meeting was set up to ensure active response, and closed monitoring was performed to ensure the implementation of the revised protocol according to the plan–do–study–act (PDSA) process. Results: From 2019 to 2021, the percentages of annual insufficient cleanliness of items after washing decreased from 4.8% to 3.6% to 3.1% each year. The percentages of incorrect request forms decreased from 14.59% to 2.91% to 1.84% during these same years. The percentages of decontamination ignorance at the point of use decreased from 3.13% to 0.12% to 0.03% from 2019 to 2021. The percentages of incorrect labelling were 0.013%, 0.008%, and 0.013% each year. Conclusions: The CoP Sterile team used quality improvement tools and regular monitoring to achieve reductions in insufficient cleanliness and incorrect request forms and to increase knowledge of decontamination procedures.

SG-APSIC1127: Digital transformation of the central sterile supply department: Justify by tracking system

Background: Avoidable infections in healthcare (healthcare-associated infections or HAIs) occur globally. The causes of HAI are influenced by a complex combination of gaps in policies, infrastructure, organization, knowledge, healthcare worker behavior, and patient-related factors. Through knowledge, best practices, and infrastructure improvement, the infection prevention and control (IPC) team aims to prevent harm to patients and healthcare workers due to HAIs. The most common HAIs are surgical site infections (SSIs) caused by harmful device-reuse practices, inadequate sterilization, and/or inadequate decontamination procedures. Disinfection and sterilization of instruments and medical devices play very important roles in HAI and SSI prevention. World Health Organization (WHO) Collaborating Centre in Quality Improvement Program certification, the first pilot project in Thailand, included the Central Sterilizing Services Association of Thailand and 15 hospital central sterile supply departments (CSSDs). This quality improvement program for sterilization reprocessing aimed to prevent harm to patients and healthcare workers due to HAIs. Objectives: We sought to reduce damage to instruments caused by inadequate reprocessing sterilization to zero incidents. We sought to reduce inadequate packing to ≤3 events per month. We sought to reduce the need to resterilize instruments by >80%. Methods: A root-cause analysis meeting was held by CSSD staff, and an IT vendor was consulted about developing an electronic alert system. The following changes were implemented: Staff packed instruments using a list of pictures for each set. Sticker labels were applied showing the proper number of pieces in the set. Identification O-rings were added to instruments with inventory dates, serial numbers, and instructions for use. Stickers were added to indicate the method of sterilization, such as ethylene oxide gas only or hydrogen peroxide only. Results: Reports of damage due to the sterilization process decreased to zero. No events related to the packing process were reported, and resterilization of instruments decreased by 98.94%. Conclusions: In this project, we implemented a quality improvement process and tracking system, reduced defects, and increased healthcare worker competency to improve patient safety.

SG-APSIC1043: Creating an urgent operating room alert using Kaizen automation

Objectives: We sought to reduce waiting time for instruments in the operating room, to develop technology for communication between zones, to record data in real time for planning instrument management, and to increase trust and satisfaction of customers. Methods: The central sterile supply department (CSSD) provides sterilization of instruments and medical devices, mostly to the following departments: operating room, dental unit, outpatient otolaryngology, and obstetrics and gynecology. The CSSD processes 557,588 units per month, among which 30.05% are for the operating room. In the normal process when the operating room send instruments for decontamination, the operating room staff places stickers on the item or uses a form to document the request. The normal turnaround time was 3 hours and 9 minutes and urgent turnaround time was 2 hours and 14 minutes. For color control, we used white color for normal requests and pink for urgent requests. We redesigned our record keeping using Google forms and sent data on dashboards with real-time alerts in the CSSD application to notify staff of an urgent request. Results: Staff in the dirty zone placed an urgent tag on the instrument baskets of the auto-washer. After the door was opened in the clean zone, staff noted the urgent tag and marked a validation sheet, then placed a red unilock on the rigid constrainer. Peel pouches were marked “urgent,” advising sterile storage zone staff to separate the basket from normal baskets and to apply the “urgent” paper form and labelling. Conclusions: Turnaround time improved by 15 minutes for urgent instruments. Lead time to export data for analysis increased from 80% to 95.49%. Because of facility design, it was difficult to ensure communication between separate dirty, clean, and sterile storage zones. We redesigned our process using new technology to improve turnaround times, reduce waste, improve communication, and increase productivity.

Effect of Sterilization Methods on Electrospun Scaffolds Produced from Blend of Polyurethane with Gelatin

Fibrous polyurethane-based scaffolds have proven to be promising materials for the tissue engineering of implanted medical devices. Sterilization of such materials and medical devices is an absolutely essential step toward their medical application. In the presented work, we studied the effects of two sterilization methods (ethylene oxide treatment and electron beam irradiation) on the fibrous scaffolds produced from a polyurethane-gelatin blend. Scaffold structure and properties were studied by scanning electron microscopy (SEM), atomic force microscopy (AFM), infrared spectroscopy (FTIR), a stress-loading test, and a cell viability test with human fibroblasts. Treatment of fibrous polyurethane-based materials with ethylene oxide caused significant changes in their structure (formation of glued-like structures, increase in fiber diameter, and decrease in pore size) and mechanical properties (20% growth of the tensile strength, 30% decline of the maximal elongation). All sterilization procedures did not induce any cytotoxic effects or impede the biocompatibility of scaffolds. The obtained data determined electron beam irradiation to be a recommended sterilization method for electrospun medical devices made from polyurethane-gelatin blends.

Experimental Investigation of Low-Pressure Microwave Plasma with Oxygen and Argon for Internal Sterilization of Medical Devices with Slender Catheters

This study explores the application of microwave plasma sterilization methods to prevent surgical site infections, specifically targeting the challenge of sterilizing slender catheters used in medical devices. An experimental setup was designed to verify the sterilization effectiveness by varying input power levels, treatment times, and the ratio of injected gases. The temperature inside the sterilization setup was closely monitored to ensure that the death of bacterial spores was not caused by thermal effects. The results demonstrate that microwave plasma has a robust sterilization effect when the microwave power is 200 W, the treatment time is 10 minutes, and the ratio of oxygen to argon is higher than 14.45%. The study highlights that the sterilization effect of plasma significantly depends on the composition of the discharge gas. The experimental setup is capable of simulating sterilization inside slender catheters, indicating the potential of microwave plasma sterilization for such medical devices.

Monte Carlo simulations demonstrating physics of equivalency of gamma, electron-beam, and X-ray for radiation sterilization

The sterilization of medical devices using the gamma rays from the decay of cobalt-60 has accumulated decades of experience of the performance of the materials and devices that are irradiated. The use of radiation using electron beams and x-rays has much less experience and this leads to questions of equivalency between these three technologies. Computer simulations were conducted to model the relevant physical processes of the interactions of each of the three forms of radiation in order to compare the spectra of electron energies at energies below 500 keV. It is predominantly the electrons below this threshold that produce the sterilization dose. No difference in energy spectra was seen between the three types of initial radiation. It is concluded that there is no energy dependent difference between gamma, electron, and x-ray for radiation sterilization.