Biomedical Instrumentation and Technology最新文献

{"title":"Assessing Detergent Residuals for Reusable Device Cleaning Validations.","authors":"Terra A Kremer,&nbsp;Daniel Olsen,&nbsp;Chad Summers,&nbsp;Alpa Patel,&nbsp;Julie Hoover,&nbsp;Marcin Cieslak,&nbsp;Dmitry Znamensky,&nbsp;Gerald McDonnell","doi":"10.2345/0899-8205-55.4.165","DOIUrl":"https://doi.org/10.2345/0899-8205-55.4.165","url":null,"abstract":"<p><p>Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641418/pdf/i0899-8205-55-4-165.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39600500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality Fade in Medical Device Manufacturing: Thinness of Airway Breathing Circuit Plastic.","authors":"R. Naftalovich, Marko Oydanich, Tolga Berkman, Andrew Iskander","doi":"10.2345/0890-8205-55.4.118","DOIUrl":"https://doi.org/10.2345/0890-8205-55.4.118","url":null,"abstract":"Mechanical respirators typically use a plastic circuit apparatus to pass gases from the ventilator to the patient. Structural integrity of these circuits is crucial for maintaining oxygenation. Anesthesiologists, respiratory therapists, and other critical care professionals rely on the circuit to be free of defects. The American Society for Testing and Materials maintains standards of medical devices and had a standard (titled Standard Specification for Anesthesia Breathing Tubes) that included circuits. This standard, which was last updated in 2008, has since been withdrawn. Lack of a defined standard can invite quality fade-the phenomenon whereby manufacturers deliberately but surreptitiously reduce material quality to widen profit margins. With plastics, this is often in the form of thinner material. A minimum thickness delineated in the breathing circuit standard would help ensure product quality, maintain tolerance to mechanical insults, and avert leaks. Our impression is that over the recent years, the plastic in many of the commercially available breathing circuits has gotten thinner. We experienced a circuit leak in the middle of a laminectomy due to compromised plastic tubing in a location that evaded the safety circuit leak check that is performed prior to surgery. This compromised ventilation and oxygenation in the middle of a surgery in which the patient is positioned prone and hence with a minimally accessible airway; it could have resulted in anoxic brain injury or death. The incident led us to reflect on the degree of thinness of the circuit's plastic.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48115768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Selecting a Passive Network Monitoring Solution for Medical Device Cybersecurity Management.","authors":"P. Upendra","doi":"10.2345/0890-8205-55.4.121","DOIUrl":"https://doi.org/10.2345/0890-8205-55.4.121","url":null,"abstract":"The number of cyberattacks and information system breaches in healthcare have grown exponentially, as well as escalated from accidental incidents to targeted and malicious attacks. With medical devices representing a substantial repository of all the assets in a healthcare system, network security and monitoring are critical to ensuring cyber hygiene of these medical devices. Because of the unique challenges of connected medical devices, a passive network monitoring (PNM) solution is preferred for its overall cybersecurity management. This article is intended to provide guidance on selecting PNM solutions while reinforcing the importance of program assessment, project management, and use of leading practices that facilitate the selection and further implementation of PNM solutions for medical devices. The article provides a detailed introduction to connected medical devices and its role in effective care delivery, an overview of network security types and PNM, an overview of the National Institute of Standards and Technology Cybersecurity Framework and its application for program assessment, essentials of project management for PNM solution selection and implementation, key performance indicators for measuring a solution's ability to meet critical cybersecurity needs for medical devices, and lessons learned from the author's professional experience, selective literature review, and leading practices. Rather than describing a complete list of guidelines for selecting PNM solutions, the current work is intended to provide guidance based on the author's experience and leading practices compiled from successful medical device cybersecurity programs.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46305102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality Fade in Medical Device Manufacturing: Thinness of Airway Breathing Circuit Plastic.","authors":"Rotem Naftalovich,&nbsp;Marko Oydanich,&nbsp;Tolga Berkman,&nbsp;Andrew John Iskander","doi":"10.2345/0899-8205-55.4.118","DOIUrl":"https://doi.org/10.2345/0899-8205-55.4.118","url":null,"abstract":"<p><p>Mechanical respirators typically use a plastic circuit apparatus to pass gases from the ventilator to the patient. Structural integrity of these circuits is crucial for maintaining oxygenation. Anesthesiologists, respiratory therapists, and other critical care professionals rely on the circuit to be free of defects. The American Society for Testing and Materials maintains standards of medical devices and had a standard (titled Standard Specification for Anesthesia Breathing Tubes) that included circuits. This standard, which was last updated in 2008, has since been withdrawn. Lack of a defined standard can invite quality fade-the phenomenon whereby manufacturers deliberately but surreptitiously reduce material quality to widen profit margins. With plastics, this is often in the form of thinner material. A minimum thickness delineated in the breathing circuit standard would help ensure product quality, maintain tolerance to mechanical insults, and avert leaks. Our impression is that over the recent years, the plastic in many of the commercially available breathing circuits has gotten thinner. We experienced a circuit leak in the middle of a laminectomy due to compromised plastic tubing in a location that evaded the safety circuit leak check that is performed prior to surgery. This compromised ventilation and oxygenation in the middle of a surgery in which the patient is positioned prone and hence with a minimally accessible airway; it could have resulted in anoxic brain injury or death. The incident led us to reflect on the degree of thinness of the circuit's plastic.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641416/pdf/i0899-8205-55-4-118.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.","authors":"G. Mcdonnell, Harold S. Baseman, Lena Cordie-Bancroft","doi":"10.2345/0890-8205-55.4.143","DOIUrl":"https://doi.org/10.2345/0890-8205-55.4.143","url":null,"abstract":"In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49491865","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices.","authors":"Paolo Masci,&nbsp;Sandy Weininger","doi":"10.2345/0899-8205-55.4.132","DOIUrl":"https://doi.org/10.2345/0899-8205-55.4.132","url":null,"abstract":"<p><p>This article reports on the development of usability engineering recommendations for next-generation integrated interoperable medical devices. A model-based hazard analysis method is used to reason about possible design anomalies in interoperability functions that could lead to use errors. Design recommendations are identified that can mitigate design problems. An example application of the method is presented based on an integrated medical system prototype for postoperative care. The AAMI/UL technical committee used the results of the described analysis to inform the creation of the Interoperability Usability Concepts, Annex J, which is included in the first edition of the new ANSI/AAMI/UL 2800-1:2019 standard on medical device interoperability. The presented work is valuable to experts developing future revisions of the interoperability standard, as it documents key aspects of the analysis method used to create part of the standard. The contribution is also valuable to manufacturers, as it demonstrates how to perform a model-based analysis of use-related aspects of a medical system at the early stages of development, when a concrete implementation of the system is not yet available.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641419/pdf/i0899-8205-55-4-132.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.","authors":"Gerald McDonnell, Hal Baseman, Lena Cordie-Bancroft","doi":"10.2345/0899-8205-55.4.143","DOIUrl":"10.2345/0899-8205-55.4.143","url":null,"abstract":"<p><p>In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641420/pdf/i0899-8205-55-4-143.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thermal Disinfection Validation: The Relationship Between A0 and Microbial Reduction.","authors":"Terra A Kremer,&nbsp;Gerald McDonnell,&nbsp;Emily Mitzel,&nbsp;Nupur Jain,&nbsp;Henri Hubert,&nbsp;Klaus Roth,&nbsp;Philippe Labrie,&nbsp;Alex Villella","doi":"10.2345/0899-8205-55.3.85","DOIUrl":"https://doi.org/10.2345/0899-8205-55.3.85","url":null,"abstract":"<p><p>Validating a thermal disinfection process for the processing of medical devices using moist heat via direct temperature monitoring is a conservative approach and has been established as the A0 method. Traditional use of disinfection challenge microorganisms and testing techniques, although widely used and applicable for chemical disinfection studies, do not provide as robust a challenge for testing the efficacy of a thermal disinfection process. Considerable research has been established in the literature to demonstrate the relationship between the thermal resistance of microorganisms to inactivation and the A0 method formula. The A0 method, therefore, should be used as the preferred method for validating a thermal disinfection process using moist heat.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8657843/pdf/i0899-8205-55-3-85.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39199495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deviation from Clinical Routines Can Reveal Sources of Device Design Vulnerability.","authors":"Rotem Naftalovich,&nbsp;Andrew J Iskander,&nbsp;Faraz Chaudhry,&nbsp;Steven Char,&nbsp;Jean Daniel Eloy","doi":"10.2345/0899-8205-55.3.100","DOIUrl":"https://doi.org/10.2345/0899-8205-55.3.100","url":null,"abstract":"<p><p>The ability to adequately ventilate a patient is critical and sometimes a challenge in the emergency, intensive care, and anesthesiology settings. Commonly, initial ventilation is achieved through the use of a face mask in conjunction with a bag that is manually squeezed by the clinician to generate positive pressure and flow of air or oxygen through the patient's airway. Large or small erroneous openings in the breathing circuit can lead to leaks that compromise ventilation ability. Standard procedure in anesthesiology is to check the circuit apparatus and oxygen delivery system prior to every case. Because the face mask itself is not a piece of equipment that is associated with a source of leak, some common anesthesia machine designs are constructed such that the circuit is tested without the mask component. We present an example of a leak that resulted from complete failure of the face mask due to a tiny tear in its cuff by the patient's sharp teeth edges. This subsequently prevented formation of a seal between the face mask and the patient's face and rendered the device incapable of generating the positive pressure it is designed to deliver. This instance depicts the broader lesson that deviation from clinical routines can reveal unappreciated sources of vulnerability in device design.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8657845/pdf/i0899-8205-55-3-100.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39346807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Case for Medical Device Cybersecurity Hygiene Practices for Frontline Personnel.","authors":"Stephen L Grimes,&nbsp;Axel Wirth","doi":"10.2345/0899-8205-55.3.96","DOIUrl":"https://doi.org/10.2345/0899-8205-55.3.96","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8657844/pdf/i0899-8205-55-3-96.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39201995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}