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

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.