Unsafe: Sutures as an Unnecessary Risk for Clinicians and Patients: Editor’s Message

Q3 Medicine
Michelle L. Hawes
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After finishing this article, the reader will be able to: Discuss the Needle Stick Prevention Act (NSPA).Describe the components of the exposure control plan in the NSPA.Explain acceptable off-label use of devices.Recognize an action that can be taken to remove sutures as a securement option for vascular access devices (VADs).Sutures are excellent for wound closure but are not intended to secure external devices.1 All sutures used as improvised securement for VADs are labeled for wound closure and general soft tissue approximation and/or ligation.1According to the US Food and Drug Administration (FDA):If a device has been labeled for a certain clinical purpose, that means it has passed safety and efficacy standards for that purpose only.Engineered securement devices (ESDs) have achieved FDA labeling because they have passed safety and efficacy standards for the securement of external devices. The understanding of an FDA-labeled product is important because it defines the product’s use and confirms its safety within the boundaries of that use.2Sutures are not labeled as an ESD. The question is, could suture manufacturers seek an additional application of sutures as an ESD? The answer would be a definite no. There are 2 basic questions the FDA would pose around patient safety before the process of additional labeling could begin.2First, does the device pose unnecessary risk? The risk of needle stick exposure is not a part of current ESDs, which would categorize sutures as an unnecessary risk. Next, does the device pose unnecessary harm? Considering the damage caused by additional punctures in the patient’s skin, sutures used to secure VADs would cause 4–8 of these injuries. Current ESDs do not increase the number of punctures in the patient’s skin.How did sutures ever become the standard securement for CVADs? In the 1960s, when lifesaving CVADs were introduced, sutures were considered the best way to secure the new technology. This practice was still off-label but acceptable because of the lack of other options.3There is a place for off-label use. It is critical to the advancement of medicine and the creation of new devices. No one would have expected CVADs to be withheld until the 1990s, when the first ESD would become available. Physicians have the right to practice medicine when the patient’s need requires adaptation of available products.According to the FDA, here are the boundaries of off-label device utilization:Through tradition, convenience, and ignorance of options, sutures have been used continuously as a securement device as if the off-label practice was still necessary and the FDA’s guidelines do not apply.As part of the NSPA, a facility’s risk manager must perform an annual review that considers options to eliminate the unnecessary risk of sharps exposure.4 The NSPA states:Notice that it does not consider limiting the number of needle sticks but rather the number of exposures to needle sticks. Since the Occupational and Safety Health Administration (OSHA) requirement to implement safer medical devices has been in effect since 1992, the use of sutures as a securement for VADs should have ceased in the early 2000s.Several questions were asked early in the implementation of the NPSA about actions that could be taken if no safer device was available on the market. This issue is one of the purposes of the annual review of the ECP. According to OSHA:Using sutures as a securement device in 2023, when several devices are on the market to secure external devices, would be in violation of the NSPA. Willful noncompliance with the NPSA is enforced by OSHA with a daily penalty of $7000.Sutures are often the only medical device available for many surgical procedures, and in these cases, work practice controls are the sole option to limit risks imposed by unavoidable exposure to sharps. 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The traditional and convenient use of sutures is unacceptable and should be reported to your risk manager to improve safety for both the clinician and the patient.Part 3, Winter Editorial: Ineffective: Suture Failure as an Improvised Securement Option.","PeriodicalId":35321,"journal":{"name":"JAVA - Journal of the Association for Vascular Access","volume":"24 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAVA - Journal of the Association for Vascular Access","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2309/java-2023-28-03-editorial","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

Abstract

This is part 2 of a 3-part series on sutures used as an improvised securement for external devices. After finishing this article, the reader will be able to: Discuss the Needle Stick Prevention Act (NSPA).Describe the components of the exposure control plan in the NSPA.Explain acceptable off-label use of devices.Recognize an action that can be taken to remove sutures as a securement option for vascular access devices (VADs).Sutures are excellent for wound closure but are not intended to secure external devices.1 All sutures used as improvised securement for VADs are labeled for wound closure and general soft tissue approximation and/or ligation.1According to the US Food and Drug Administration (FDA):If a device has been labeled for a certain clinical purpose, that means it has passed safety and efficacy standards for that purpose only.Engineered securement devices (ESDs) have achieved FDA labeling because they have passed safety and efficacy standards for the securement of external devices. The understanding of an FDA-labeled product is important because it defines the product’s use and confirms its safety within the boundaries of that use.2Sutures are not labeled as an ESD. The question is, could suture manufacturers seek an additional application of sutures as an ESD? The answer would be a definite no. There are 2 basic questions the FDA would pose around patient safety before the process of additional labeling could begin.2First, does the device pose unnecessary risk? The risk of needle stick exposure is not a part of current ESDs, which would categorize sutures as an unnecessary risk. Next, does the device pose unnecessary harm? Considering the damage caused by additional punctures in the patient’s skin, sutures used to secure VADs would cause 4–8 of these injuries. Current ESDs do not increase the number of punctures in the patient’s skin.How did sutures ever become the standard securement for CVADs? In the 1960s, when lifesaving CVADs were introduced, sutures were considered the best way to secure the new technology. This practice was still off-label but acceptable because of the lack of other options.3There is a place for off-label use. It is critical to the advancement of medicine and the creation of new devices. No one would have expected CVADs to be withheld until the 1990s, when the first ESD would become available. Physicians have the right to practice medicine when the patient’s need requires adaptation of available products.According to the FDA, here are the boundaries of off-label device utilization:Through tradition, convenience, and ignorance of options, sutures have been used continuously as a securement device as if the off-label practice was still necessary and the FDA’s guidelines do not apply.As part of the NSPA, a facility’s risk manager must perform an annual review that considers options to eliminate the unnecessary risk of sharps exposure.4 The NSPA states:Notice that it does not consider limiting the number of needle sticks but rather the number of exposures to needle sticks. Since the Occupational and Safety Health Administration (OSHA) requirement to implement safer medical devices has been in effect since 1992, the use of sutures as a securement for VADs should have ceased in the early 2000s.Several questions were asked early in the implementation of the NPSA about actions that could be taken if no safer device was available on the market. This issue is one of the purposes of the annual review of the ECP. According to OSHA:Using sutures as a securement device in 2023, when several devices are on the market to secure external devices, would be in violation of the NSPA. Willful noncompliance with the NPSA is enforced by OSHA with a daily penalty of $7000.Sutures are often the only medical device available for many surgical procedures, and in these cases, work practice controls are the sole option to limit risks imposed by unavoidable exposure to sharps. However, in the case of VAD securement, sutures are in violation of the NSPA and increase the risk of harm to both the clinician and the patient. ESDs have been available since the late 1990s and continue to evolve and improve. The willful noncompliance of some clinicians to ignore the safer securement options available can no longer be tolerated. The traditional and convenient use of sutures is unacceptable and should be reported to your risk manager to improve safety for both the clinician and the patient.Part 3, Winter Editorial: Ineffective: Suture Failure as an Improvised Securement Option.
不安全:缝合线作为临床医生和患者不必要的风险:编者的信息
这是关于作为外部设备临时固定的缝合线的3部分系列的第2部分。读完这篇文章后,读者将能够:讨论针扎预防法案(NSPA)。描述NSPA中暴露控制计划的组成部分。解释可接受的标签外使用器械。认识到可以采取的行动,以解除缝合作为血管接入装置(vad)的安全选择。缝合线用于缝合伤口是很好的,但不用于固定外部装置所有用于vad临时固定的缝合线都被标记为伤口闭合和一般软组织近似和/或结扎。根据美国食品和药物管理局(FDA)的说法:如果一种器械被标记为某种临床目的,那就意味着它已经通过了该目的的安全性和有效性标准。工程安全装置(esd)已经获得了FDA的标签,因为它们已经通过了外部设备安全的安全性和有效性标准。了解fda标签产品是很重要的,因为它定义了产品的用途,并确认了其在使用范围内的安全性。缝合线没有贴上ESD标签。问题是,缝合线制造商是否可以寻求缝合线作为ESD的额外应用?答案肯定是否定的。在额外的标签程序开始之前,FDA会围绕患者安全提出两个基本问题。首先,该设备是否会带来不必要的风险?针头暴露的风险不属于当前esd的一部分,它将缝合归类为不必要的风险。其次,该设备是否会造成不必要的伤害?考虑到患者皮肤上的额外穿刺造成的损伤,用于固定vad的缝合线将导致4-8的这些损伤。目前的静电放电不会增加患者皮肤穿刺的次数。缝合是如何成为cvad的标准安全措施的?在20世纪60年代,当挽救生命的cvad被引入时,缝合被认为是确保新技术安全的最佳方法。这种做法仍然是标签外的,但可以接受,因为缺乏其他选择。这里有一个超说明书使用的地方。它对医学的进步和新设备的创造至关重要。没有人会预料到cvad会被扣留,直到20世纪90年代,第一个ESD才会出现。当病人需要对现有产品进行调整时,医生有权行医。根据FDA的说法,以下是说明书外设备使用的界限:由于传统、方便和对选择的无知,缝线一直被用作安全设备,好像说明书外的实践仍然是必要的,FDA的指导方针并不适用。作为NSPA的一部分,工厂的风险经理必须执行年度审查,考虑消除不必要的尖锐暴露风险的选择NSPA声明:注意,它没有考虑限制针头的数量,而是考虑限制接触针头的次数。由于职业与安全健康管理局(OSHA)实施更安全医疗设备的要求自1992年起生效,因此使用缝合线作为vad的安全措施应该在21世纪初停止。在实施NPSA的早期,有几个问题被问到,如果市场上没有更安全的设备,可以采取什么行动。这个问题是环境保护计划年度检讨的目的之一。根据OSHA的说法:在2023年,当市场上有几种设备用于保护外部设备时,使用缝合线作为安全设备将违反NSPA。故意不遵守《国家安全规划》由职业安全与健康管理局强制执行,每日罚款7000元。缝线通常是许多外科手术中唯一可用的医疗设备,在这些情况下,工作实践控制是限制不可避免地暴露于利器所带来的风险的唯一选择。然而,在VAD固定的情况下,缝合违反了NSPA,增加了对临床医生和患者的伤害风险。自20世纪90年代末以来,esd已经可用,并且不断发展和改进。一些临床医生故意不遵守规定,忽视现有的更安全的安全选择,这是不能再容忍的。传统和方便的缝合线使用是不可接受的,应该报告给你的风险管理人员,以提高临床医生和患者的安全性。第3部分,冬季社论:无效:缝合失败作为临时固定选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
JAVA - Journal of the Association for Vascular Access
JAVA - Journal of the Association for Vascular Access Medicine-Medicine (miscellaneous)
CiteScore
1.10
自引率
0.00%
发文量
22
期刊介绍: The Association for Vascular Access (AVA) is an association of healthcare professionals founded in 1985 to promote the emerging vascular access specialty. Today, its multidisciplinary membership advances research, professional and public education to shape practice and enhance patient outcomes, and partners with the device manufacturing community to bring about evidence-based innovations in vascular access.
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