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Introduction: Point of use (POU) treatment is a critical first step of medical device reprocessing. Reusable instruments and flexible endoscopes require a minimum of terminal sterilization or high-level disinfection, neither of which can be guaranteed if POU is performed incorrectly. Compliance considerations for POU include hospital accreditation readiness, unique austere surgical mission requirements, and the transition of future conflict towards Large Scale Combat Operations. This integrative review aims to describe POU for reusable instruments and endoscopes, and extrapolate implications for Military Health System policies and future considerations., Materials and Methods: The authors performed an integrative review and comprehensive literature search in PubMed and CINAHL with the keywords "point of use," "point of use cleaning," "POU," "instrument," "high-level disinfection," "endoscope," and "clean." Articles were limited to "English" and "human" from 2017 to 2023. The authors also performed a thorough review of the Defense Health Agency and service-specific doctrine, as well as national guidelines regarding POU adherence., Results: The literature review yielded 18 articles that discussed the transport and reprocessing of reusable medical devices. Regulatory standards and national guidelines were used to supplement the literature. Seventeen evidence-based criteria were extrapolated from the literature to generate two step-by-step guides for the POU treatment of endoscopes and reusable instruments (Tables I and II). Despite increased morbidity and mortality rates linked to inadequate device reprocessing, compliance with POU procedures remains low. Barriers to practice included complex POU processes, intricately designed surgical instruments and endoscopes, lack of healthcare worker (HCW) knowledge and competency, and inadequate or ambiguously written policies. Training, competency assessments, and clearly written policies and procedures can be cost-effective, evidence-based, and feasible solutions., Conclusion: Completing POU treatment is critical to a successful surgical mission in both the hospital and austere environment. Implications to practice include implementing evidence-based POU programs that improve patient outcomes and readiness while decreasing costs., (© The Association of Military Surgeons of the United States 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site–for further information please contact journals.permissions@oup.com.)

Background: Reusable 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., Methods: We 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., Results: For 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., Conclusion: The 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.

Medical devices are sterilized before being used for invasive clinical procedures such as surgery, to prevent pathogen transfer. Failure to sterilize medical devices properly presents a risk of healthcare-associated infections. Studies and reports have indicated that inadequately sterilized medical devices are one of the causes of a higher rate of healthcare-associated infections in developing countries. Steam sterilization (autoclaving) is the most widely used method for sterilization and is considered the most robust and cost-effective method for sterilization of medical devices. The effectiveness of steam sterilization can be measured using biological indicators. A literature search was undertaken to understand the effectiveness of autoclaving in sterilizing reusable medical devices in healthcare facilities across the globe. Studies using biological indicators for measuring the effectiveness of autoclaving were obtained. Failures of steam sterilization practices were identified and discussed as a means of identifying factors that might be associated with the ineffectiveness of steam sterilization practices between different countries. The number of studies measuring the effectiveness of steam sterilization is small, and few evaluate the effectiveness of steam sterilization specifically in developing countries. There are fewer studies on higher level healthcare facilities than dental facilities. More evidence about the effectiveness of autoclaving in healthcare facilities is needed to draw firm conclusions, but the data suggest that there are inadequacies in autoclave procedures and operator education., Competing Interests: No Conflict of Interest is declared, (Copyright (c) 2019 Gopal Panta, Ann K Richardson, Ian C Shaw.)

Objectives: As a university teaching hospital, the call for tender for dental medical devices (dental implants and consumables) is done with the help of a team of hospital pharmacists and users. In order to optimize the definition of needs and evaluation criteria, an exhaustive review of the products was carried out., Methods: Dental medical devices suppliers were consulted in 2017 for reviewing their products. Their technical, clinical and economic data were compared. The products have been gathered into categories and its results had been submitted to a commission of dental experts of our university hospital for clinical opinion., Results: More than 30,000 references from 30 different suppliers were analyzed (orthodontics, dental implants, membranes and bone substitutes, various dental consumables). Relating to oral implantology, the opinions converged on clinical studies. On the contrary, diverging opinions have been proffered on the systematic use of single-use drills and customized guides for surgery and on the implant's choice. The definition of needs has been specified for orthodontics and consumables. Other criteria played a great role: single packaging (unit doses), product's sterility, paediatric needs, presence of allergens, traceability of devices and supplier diversity., Conclusions: This review led to the identification of new needs in more precise terms. The complexity and diversity of dental products and techniques requires this careful review and a better collaboration with practitioners., (Copyright © 2019 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Ethylene oxide gas is an agent in the sterilization of medical devices due to its effectiveness and compatibility with most materials. The advantages and disadvantages, as well as its recommended uses, are explored in this review article. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the design and validation of the sterilization process.

ISO 11137-1:2006 Sterilization of Healthcare Products-Radiation requires that the potential for induced radioactivity be evaluated for medical devices irradiated with electrons with energy more than 10 MeV. For a manufacturing operation where new devices are being developed, a practical program for making such an evaluation should be engrained in the process, including the device design phase, where selection of materials can make a difference in the potential for activation to occur as a result of the irradiation process. The program, which is based on general assumptions as to the likely activation processes and generalized process assessments is being implemented in three phases: (1) incorporating materials consideration in the design phase, (2) evaluating potential activation empirically, including measurement at the point of irradiation, and (3) implementing routine procedures for the program, including developing a data base of results for consideration in future design efforts.

Special Operations Forces medical providers are often deployed far beyond traditional military supply chains, forcing them to rely on alternative methods for field sterilization of medical equipment. This literature review proposes several alternative methods for both sterilization and disinfection of medical instruments after use and cleaning of skin and wounds before procedures. This article reviews recommendations from sources like the United Nations, the World Health Organization, the Special Operations Forces Medical Handbook, and the Centers for Disease Control and Prevention., (2016.)

Objectives: to adapt and validate, by expert consensus, a set of indicators used to assess the sterilization process of dental, medical and hospital supplies to be used in PHC services., Method: qualitative methodological study performed in two stages. The first stage included a focal group composed of experts to adapt the indicators to be used in PHC. In the second stage, the indicators were validated using a 4-point Likert scale, which was completed by judges. A Content Validity Index of ≥ 0.75 was considered to show approval of the indicators., Results: the adaptations implemented by the focal group mainly referred to the physical structure, inclusion of dental care professionals, inclusion of chemical disinfection, and replacement of the hot air and moist heat sterilization methods. The validation stage resulted in an index of 0.96, which ranged from 0.90 to 1.00, for the components of the indicators., Conclusion: the judges considered the indicators after adaptation to be validated. Even though there may be differences among items processed around the world, there certainly are common characteristics, especially in countries with economic and cultural environments similar to Brazil. The inclusion of these indicators to assess the safety of healthcare supplies used in PHC services should be considered.

The reprocessing of medical devices for low pathogen or sterile use is in itself potentially risky even though the aim of reprocessing is the avoidance of hygienic or technically functional risks. The methodological principles of risk management for medical devices are described in the standard DIN EN ISO 14971. The recommendations of the Commission for Hospital Hygiene and Infectious Disease Prevention (Kommission für Krankenhaushygiene und Infektionsprävention KRINKO) of the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (Bundesinstituts für Arzneimittel und Medizinprodukte BfArM) "hygiene requirements for the reprocessing of medical devices" clarify numerous reprocessing-specific risks and are structured with reference to the different steps of reprocessing. The aim was a practical combination of the normative risk management methodology with the process-oriented KRINKO/BfArM recommendations, which has provided an interdisciplinary group of experts moderated by the Association of German Engineers (VDI). The main contents of the VDI 5700 guidelines on "hazards associated with the reprocessing--risk management in the reprocessing of medical devices--measures for risk control" and the process of the development of these guidelines is described.

The work presented here is with a view to improving performance of sterilization services in hospitals. We carried out a survey in a large number of health establishments in the Rhône-Alpes region in France. Based on the results of this survey and a detailed study of a specific service, we have built a generic model. The generic nature of the model relies on a common structure with a high level of detail. This model can be used to improve the performance of a specific sterilization service and/or to dimension its resources. It can also serve for quantitative comparison of performance indicators of various sterilization services.

The reuse of medical devices marked as 'single use' by manufacturers has been going on for several decades. The process has been rationalized and legislated in the West as well as in Japan. However, the practice continues in an unregulated manner in India due to a paucity of guidance from the Food and Drug Administration in India. We trace the evolution of reuse policies, look at the prevalent practices in the Indian and international contexts, analyse the available Indian literature and address the ethical and economic implications of reuse. We also suggest some guidelines which may be adopted to formulate policies., (Copyright 2012, NMJI.)

Cleaning of medical devices, and the validation and verification of this cleaning, has advanced greatly, even in the last five years. It is recognized as an essential part of the reprocessing of reusable medical devices, and is becoming more and more consistent as device manufacturers and the FDA give cleaning more consideration when a device is brought to market. Scrupulous care must be taken to ensure that the cleaning approach for each device is appropriate (but similar items can be reprocessed in a similar manner). There is no replacement for excellent training and maintainance of equipment, but available tests can help ensure that failures are caught earlier rather than later.

Hospitals are under continual pressure to improve turnaround times for surgical procedures and to find ways to release sterilized product without the need to wait for biological indicator (BI) results. Current procedures used in healthcare do not allow for release of sterilized products based on parameters because hospitals do not validate their sterilization processes. Once a sterilization process is validated for a particular product family, those loads may be released based upon evaluation of the sterilization parameters achieved in the cycle, i.e., parametric release. Typically, hospitals do not perform validation studies to demonstrate that a sterility assurance level (SAL) of 10(-6) is being achieved in the sterilized product, relying instead on inactivation of BIs and/or chemical indicators (CIs) in each load. If a healthcare facility can demonstrate achievement ofa SAL of l0(-6) in a particular product family then it will be possible to release the products in that product family based on achievement of parameters without waiting for BI results. This does not mean that the healthcare facility can eliminate use of all BIs and CIs as part of the criteria for a comprehensive quality assurance program, but dependence on their results and the cost of their use may be greatly reduced. Validation provides another component in a quality assurance program to demonstrate that the highest SAL possible is being provided to patients while still providing the services required by today's healthcare facility.

A new type of ultrasonic washer-disinfector-sterilizer, able to clean, disinfect and sterilize most kinds of reusable medical devices, has been developed by using the ultrasonic levitation function with umbrella-shape oscillators and ozone bubbling together with sterilization carried out by silver electrolysis. We have examined the biomedical and physicochemical performance of this instrument. Prokariotic and gram-negative Escherichia coli and eukariotic Saccharomyces cerevisiae were killed by silver electrolysis in 18 min and 1 min, respectively. Prokariotic and gram-positive Geobacillus stearothermophilus and Bacillus atrophaeus, which are most resistant to autoclave and gas sterilization, respectively, were killed by silver electrolysis within 20 min. Prokariotic and gram-negative Pseudomonas aeruginosa was also killed by silver electrolysis in 10 min. The intensity distribution of the ultrasonic levitation waves was homogeneous throughout the tank. The concentration of ozone gas was 2.57 mg/ kg. The concentration of dissolved silver ions was around 0.17 mg/L. The disulfide bond in proteins was confirmed to be destroyed by silver electrolysis.

Sterilization is an essential step in the process of producing sterile medical devices. To guarantee sterility, the process of sterilization must be validated. Because there is no direct way to measure sterility, the techniques applied to validate the sterilization process are based on statistical principles. Steam sterilization is the most frequently applied sterilization method worldwide and can be validated either by indicators (chemical or biological) or physical measurements. The steam sterilization conditions are described in the literature. Starting from these conditions, criteria for the validation of steam sterilization are derived and can be described in terms of physical parameters. Physical validation of steam sterilization appears to be an adequate and efficient validation method that could be considered as an alternative for indicator validation. Moreover, physical validation can be used for effective troubleshooting in steam sterilizing processes.

Some of the important points of the revised ISO 11607, Packaging for Terminally Sterilised Medical Devices, are reviewed here. In addition, the contents of a Technical Information Report (TIR), which is scheduled to be approved and published in early 2007, are described. This TIR will provide in-depth guidance on how to comply with the requirements of the standard.

Webinars on the revisions to ISO 11607, Packaging for Terminally Sterilised Medical Devices, have prompted many questions from manufacturers and package engineers concerned with validating their packaging under the new requirements. A selection of those questions are reviewed here.

The standards relating to ethylene-oxide sterilisation of medical devices are being revised. This article examines the implications of the changes for medical device manufacturers and advises what process innovations and other actions can be taken to ensure compliance.

Changes in the ethylene-oxide sterilisation process are providing manufacturers with greater speed to market. Developments that are reducing process times are reported here together with study findings for a number of product families.

The major changes that are expected in a revised standard on radiation sterilisation are discussed. Manufacturers should anticipate some challenges in meeting the proposed requirements.

An experimental set up, assembled principally from components of commercially available filter test equipment, has allowed assessment of physical particulate barrier performance of porous materials. Employing twelve specially made papers with graded and widely different barrier properties, a physical particulate/microbiological correlation has been derived covering the 50,000 fold range of microbiological barrier performances seen in commercial porous medical packaging materials. The derived correlation has been shown to be independent of sheet structure and is applicable to the diverse structures that comprise commercial materials. A simple measurement of particle penetration is proposed as a means of assessing microbial barrier properties of such materials.

Medical device manufacturers who need contract sterilisation services sometimes lack extensive knowledge of the technical aspects of sterilisation processes. For this reason, they may have problems assessing quality requirements for subcontractor sterilisation services. This article discusses important quality issues that should be considered when selecting a sterilisation subcontractor.

Controlling sterilization costs is a necessity if medical device manufacturers are to remain competitive. This article looks at ways the industry can reduce these costs and also considers the benefits to be gained by improving relationships with sterilization contractors.

Users of in-dwelling medical devices, prostheses and surgical dressings rely implicitly on their sterility. Rarely do consumers give any thought to what sterility really means. The general assumption is that manufacturers have adopted the most efficient and cost-effective methods of achieving sterility. Currently, terminal sterilization processes appropriate for the manufacture of medical devices are those that are deemed to give less than one chance in a million of a single, finished product item containing a viable organism. Such a definition of sterility is embodied in the European standard EN556 as a Sterility Assurance Level of 10(-6), based on the properties of heat-resistant endospores. However, is this level of sterility assurance appropriate for all categories of medical device? Moreover, do all medical devices which are labelled as sterile require the same level of treatment? This paper will demonstrate that in some instances, the high standards set for sterilization processing are unreasonable, not cost-effective and exclude new sterilization technologies from being accepted by the regulatory authorities.

The safe reuse of medical devices involves two distinct issues: the regulatory requirements of the FDA for devices intended for reprocessing and reuse by another patient and labeled as such by the manufacturer and the regulation of the off-label reuse of single-use medical devices that are neither designed nor labeled for reprocessing and reuse. This article discusses the risks, complications, and common discussions on the issue of reusing medical devices.

Device traceability means recording and storing of data collected during the various steps of reprocessing of medical devices. We describe the purpose and methods to achieve device traceability.

There are three aspects that manufacturers must address when validating radiation sterilization. These are the minimum dose that ensures sterility, the maximum dose at which radiation affects the functionality of the device, and the dose distribution throughout the product. This article defines a validation protocol that satisfies current radiation sterilization standards.

Manufacturers of terminally sterilized medical devices must ensure that packaging protects the device from damage, allows it to be sterilized, and provides an effective barrier against microbiological contamination. The previous article in this column discussed quality system requirements for packaging. Recently, an international standard concerning sterile packaging has been developed and this article provides an overview of the standard.