Pub Date : 2019-11-25DOI: 10.2345/0899-8205-53.6.426
A. Chopra
Lubricious polymer coatings are increasingly used on intravascular devices to facilitate easier access and navigation through tortuous blood vessels. Recent reports highlight the separation and downstream embolism of polymer particles affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges polymer coating embolism as an iatrogenic complication of intravascular devices and continues to close gaps in standards related to coating integrity. The Association for the Advancement of Medical Instrumentation established particulate testing as an industry standard for evaluating coating integrity of intravascular devices. The FDA recognizes this standard; however, challenges exist in setting particulate limits that may compromise device function without sufficient clinical data. The microscopic nature of polymer emboli not visible with available imaging modalities has impacted reporting. This has also resulted in a reduced number of manufacturer-driven product development projects related to coating integrity. On the other hand, recent procedural trends have supported the innovation of coated devices with expanded indications, requiring particulate evaluations and release limits. This article proposes a methodology to set particulate limits for intravascular devices given existing clinical, regulatory, and manufacturing challenges. The approach with standardization requirements enables characterization, comparison, and evaluation of lubricious coatings from various manufacturers. It incorporates a step-by-step procedure that adds scrutiny to the application of coatings while ensuring device function is not impacted. Together with particulate assessments, clinicopathologic and animal studies permit an understanding of particulate ranges from commercially available devices and setting of particulate limits for new device evaluations.
{"title":"Analysis: Particulate Limits for Intravascular Devices: Considerations for Polymer Coating Embolism.","authors":"A. Chopra","doi":"10.2345/0899-8205-53.6.426","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.426","url":null,"abstract":"Lubricious polymer coatings are increasingly used on intravascular devices to facilitate easier access and navigation through tortuous blood vessels. Recent reports highlight the separation and downstream embolism of polymer particles affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges polymer coating embolism as an iatrogenic complication of intravascular devices and continues to close gaps in standards related to coating integrity. The Association for the Advancement of Medical Instrumentation established particulate testing as an industry standard for evaluating coating integrity of intravascular devices. The FDA recognizes this standard; however, challenges exist in setting particulate limits that may compromise device function without sufficient clinical data. The microscopic nature of polymer emboli not visible with available imaging modalities has impacted reporting. This has also resulted in a reduced number of manufacturer-driven product development projects related to coating integrity. On the other hand, recent procedural trends have supported the innovation of coated devices with expanded indications, requiring particulate evaluations and release limits. This article proposes a methodology to set particulate limits for intravascular devices given existing clinical, regulatory, and manufacturing challenges. The approach with standardization requirements enables characterization, comparison, and evaluation of lubricious coatings from various manufacturers. It incorporates a step-by-step procedure that adds scrutiny to the application of coatings while ensuring device function is not impacted. Together with particulate assessments, clinicopathologic and animal studies permit an understanding of particulate ranges from commercially available devices and setting of particulate limits for new device evaluations.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"426-432"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2345/0899-8205-53.6.426","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43616679","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}
Pub Date : 2019-11-25DOI: 10.2345/0899-8205-53.6.438
S. Michaud
Advances in technology and the growing integration of medical equipment with information technology (IT) are changing the skill sets necessary for healthcare technology management (HTM) professionals to perform their jobs. As the field rapidly evolves on a technical level, HTM professionals also are expected to communicate and address the needs of individuals outside their departments—from patients, to vendors, to hospital administrators. HTM's expanding reach into other departments and disciplines brings with it a growing need for soft skills training. Unlike hard skills, which are specific, measurable qualities and abilities, soft skills refer to behaviors for effective and friendly interactions with other people. Examples of soft skills include: • Communication • Courtesy/customer focus • Flexibility/adaptability • Integrity • Interpersonal skills • Positive attitude/passion • Professionalism • Responsibility • Teamwork • Work ethic Without these skills, many in the field will feel underprepared when they are inevitably tasked with resolving workplace conflicts and developing professional relationships or as they transition into leadership positions. BI&T interviewed several members of the HTM community to learn more about the growing importance of soft skills training during various career stages, as well as how and where these techniques are being taught.
{"title":"Feature: As HTM Evolves, Soft Skills Become More Important.","authors":"S. Michaud","doi":"10.2345/0899-8205-53.6.438","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.438","url":null,"abstract":"Advances in technology and the growing integration of medical equipment with information technology (IT) are changing the skill sets necessary for healthcare technology management (HTM) professionals to perform their jobs. As the field rapidly evolves on a technical level, HTM professionals also are expected to communicate and address the needs of individuals outside their departments—from patients, to vendors, to hospital administrators. HTM's expanding reach into other departments and disciplines brings with it a growing need for soft skills training. Unlike hard skills, which are specific, measurable qualities and abilities, soft skills refer to behaviors for effective and friendly interactions with other people. Examples of soft skills include: • Communication • Courtesy/customer focus • Flexibility/adaptability • Integrity • Interpersonal skills • Positive attitude/passion • Professionalism • Responsibility • Teamwork • Work ethic Without these skills, many in the field will feel underprepared when they are inevitably tasked with resolving workplace conflicts and developing professional relationships or as they transition into leadership positions. BI&T interviewed several members of the HTM community to learn more about the growing importance of soft skills training during various career stages, as well as how and where these techniques are being taught.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"438-442"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2345/0899-8205-53.6.438","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41842286","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}
Pub Date : 2019-11-25DOI: 10.2345/0899-8205-53.6.465
W. Balch
{"title":"Sterilization Straight Talk: Staying Clean in a Dirty World: The Environmental Challenges of Sterile Processing.","authors":"W. Balch","doi":"10.2345/0899-8205-53.6.465","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.465","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"465-467"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49426570","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}
Pub Date : 2019-11-25DOI: 10.2345/0899-8205-53.6.468
B. Crossley
{"title":"Troubleshoot It: Laser Safety in Healthcare Facilities Is a Big Deal, for a Variety of Reasons.","authors":"B. Crossley","doi":"10.2345/0899-8205-53.6.468","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.468","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"468-469"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46806236","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}
Pub Date : 2019-11-25DOI: 10.2345/0899-8205-53.6.412
G. Stern
On May 12, 2017, the WannaCry ransomware bug struck. The cyberattack infected more than 300,000 computer systems in 150 countries, including several U.K. National Health Service facilities. 1 The ransomware affected unpatched Windows systems, encrypting data and demanding payment to release it. A patch was available, and if it had been applied to these systems, they would not have been affected.
2017年5月12日，“想哭”勒索软件漏洞爆发。这次网络攻击感染了150个国家的30多万台计算机系统，其中包括英国国家医疗服务体系(National Health Service)的几个设施。该勒索软件影响未打补丁的Windows系统，加密数据并要求付费释放数据。补丁是可用的，如果它被应用到这些系统上，它们就不会受到影响。
{"title":"Preparing for the Next Cyber Storm: Are You Ready?","authors":"G. Stern","doi":"10.2345/0899-8205-53.6.412","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.412","url":null,"abstract":"On May 12, 2017, the WannaCry ransomware bug struck. The cyberattack infected more than 300,000 computer systems in 150 countries, including several U.K. National Health Service facilities. 1 The ransomware affected unpatched Windows systems, encrypting data and demanding payment to release it. A patch was available, and if it had been applied to these systems, they would not have been affected.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"412-419"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2345/0899-8205-53.6.412","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44735797","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}
Pub Date : 2019-11-25DOI: 10.2345/0899-8205-53.6.420
Debra R. Milamed, N. S. Jones
The Centers for Disease Control and Prevention has reported that more than 300,000 patients are ventilated in the United States each year. Human factors and communication issues have been cited as the two most common causes of ventilator-related sentinel events, according to reports of patient mortality or severe harm received by The Joint Commission during 2004–15. Over a decade ago, it was determined that the scope of the International Electrotechnical Commission (IEC) standard IEC 60601-1:2005 had to be extended to consider equipment usability in its third edition. The Joint Working Group (JWG) of the International Organization for Standardization (ISO) and IEC subcommittees responsible for critical care ventilators (ISO/TC 121/SC 3 and IEC TC/SC 62D/JWG 1) concurred that there was a wide recognition that a key factor adversely affecting lung ventilator usability was the lack of a standardized vocabulary relating to the modes of operation for these devices. At that time, ISO 4135:2001 was the only international standard that included terms related to devices of that type; however, its scope was restricted to defining terms that were used in standards related to the performance of such equipment and therefore did not cover usage factors. The terms in general clinical use had origins in the early days of mechanical ventilation, when the emphasis was on saving the lives of patients who were unable to breathe on their own, with little attention given to patients' respiratory activity.
美国疾病控制与预防中心(Centers for Disease Control and Prevention)报告称，美国每年有超过30万名患者接受呼吸机治疗。根据2004 - 2015年联合委员会收到的患者死亡或严重伤害报告，人为因素和沟通问题被认为是导致呼吸机相关哨点事件的两个最常见原因。十多年前，国际电工委员会(IEC)标准IEC 60601-1:2005的范围必须扩展，以考虑其第三版的设备可用性。国际标准化组织(ISO)联合工作组(JWG)和IEC负责重症呼吸机的小组委员会(ISO/TC 121/SC 3和IEC TC/SC 62D/JWG 1)一致认为，人们普遍认为，影响肺呼吸机可用性的一个关键因素是缺乏与这些设备的操作模式相关的标准化词汇。当时，ISO 4135:2001是唯一包含与该类型设备相关术语的国际标准;但是，它的范围仅限于定义与这种设备的性能有关的标准中使用的术语，因此不包括使用因素。一般临床使用的术语起源于机械通气的早期，当时的重点是挽救无法自主呼吸的患者的生命，很少关注患者的呼吸活动。
{"title":"Analysis: Classifying Ventilation Modes and Improving Operator Training with ISO 19223:2019.","authors":"Debra R. Milamed, N. S. Jones","doi":"10.2345/0899-8205-53.6.420","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.420","url":null,"abstract":"The Centers for Disease Control and Prevention has reported that more than 300,000 patients are ventilated in the United States each year. Human factors and communication issues have been cited as the two most common causes of ventilator-related sentinel events, according to reports of patient mortality or severe harm received by The Joint Commission during 2004–15. Over a decade ago, it was determined that the scope of the International Electrotechnical Commission (IEC) standard IEC 60601-1:2005 had to be extended to consider equipment usability in its third edition. The Joint Working Group (JWG) of the International Organization for Standardization (ISO) and IEC subcommittees responsible for critical care ventilators (ISO/TC 121/SC 3 and IEC TC/SC 62D/JWG 1) concurred that there was a wide recognition that a key factor adversely affecting lung ventilator usability was the lack of a standardized vocabulary relating to the modes of operation for these devices. At that time, ISO 4135:2001 was the only international standard that included terms related to devices of that type; however, its scope was restricted to defining terms that were used in standards related to the performance of such equipment and therefore did not cover usage factors. The terms in general clinical use had origins in the early days of mechanical ventilation, when the emphasis was on saving the lives of patients who were unable to breathe on their own, with little attention given to patients' respiratory activity.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"420-424"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2345/0899-8205-53.6.420","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46628225","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}
Pub Date : 2019-11-25DOI: 10.2345/0899-8205-53.6.462
M. Jump
{"title":"Setting Standards: AAMI TIR97: A Vital Resource in the Postmarket Management of Medical Device Security.","authors":"M. Jump","doi":"10.2345/0899-8205-53.6.462","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.462","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"462-464"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2345/0899-8205-53.6.462","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41789736","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}
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