Make Like a Suture and Let Go

Michelle L. Hawes, DNP, RN, CRNI, VA-BC™

Why do we hold on to the suture as a securement device when it was never intended to serve as one? I realize I may be preaching to the choir when it comes to the concept of avoiding sutures. The readers of IV Quarterly are leaders of best-practice in vascular access. The purpose of this article is to add weight to your argument to let sutures go for good.

The objective of sutures is wound closure. In manuals on sutures, including which type to use in specific locations, a brief section describes that the suture is not intended to secure external devices.1 How in the world did the suture become standard for securing a multitude of external devices? The answer in the early days of central vascular accesses devices (CVADs) was that the improvisation with sutures to secure the CVAD was considered the best practice.2 Other than first-generation tape, sutures were the only option in the early years and a perfectly acceptable off-label use.

As CVADs evolved, suture wings were a standard part of the design and still are. Practitioners placing CVADs would develop their technique for suturing the device. Today, articles discuss the best knots, methods, and suture characteristics that will force the CVAD to stay put.3 There remains the small print in the instructions for use (IFU) that sutures are for wound closure and not intended to secure external devices.4

If the suture is off-label, how can it be included in CVAD kits? Tradition. The suture is not just off-label; it is way-off-label. Using a device or medication offlabel is not illegal by learned intermediaries using current technology to fill a gap.5 The part of that statement that is extremely important is that there is a “gap.” The FDA states that if no other product on the market has been approved for use in the unique situation or treatment, an approved product for a different purpose may be utilized, applying current research and keeping patient safety a priority. When looking at the Food and Drug Administrations process for labeling medical devices and medication, there are two critical criteria: safety and efficacy.6 Safety must be proven before efficacy is assessed. Simply put, the evaluation of whether a device does what it states it should do can only be quantified after the patient’s safety is established.7

Every engineered securement device currently on the market had to go through the process of establishing safety and efficacy. Sutures have existed for thousands of years as an excellent means of wound closure but have never been labeled to secure external devices. Neither safety, nor efficacy, of sutures for CVAD securement has been assessed by the FDA.8 If presented to the FDA for labeling to secure CVADs, sutures would most likely fail the first step, safety. The practitioner’s risk of needle stick injury would shut down further assessment due to the availability of engineered securement devices with no chance of such injury.9

When an engineered securement devices like SecurAcath, Grip-Lok, Stat-Lock, SecurePort-IV, et al. fail to secure the CVAD or cause medical adhesiverelated skin injury (MARSI), a report is mandatory. The FDA completes follow-up for possible trends, benefitrisk assessments, and recalls. The manufacturer must file a report discussing the reason for failure and potential changes in the device, or education, to avoid a similar failure in the future.10

When a suture fails to secure a CVAD, causes the skin to erode, increases infection at the insertion site, no such report is made. Sutures are not labeled to secure CVADs; therefore, its failure to do so is not alarming to most healthcare professionals. A report

WHEN STICKING ISN’T AN OPTION, CONTINUED FROM PREVIOUS PAGE

may be made to the hospital’s risk management if there was a bad outcome, but otherwise, a suture letting go, tearing the skin, or causing a pressure wound is viewed as just what happens.

Looking at articles that include sutures used for securing CVADs, the primary endpoint is typically efficacy or how long the suture could secure the device.11 The noteworthy fact about considering sutures as a securement success violates two points on their own IFU. The first is using sutures for something other than wound closure, and the second is that non-absorbable sutures should be removed after 3-10 days, depending on the material.1

To conclude, sutures were an acceptable improvisation for securing CVADs when no other device was available on the market. The reasoning for using sutures off-label to fill the gap has not existed for decades. There are currently multiple engineered securement devices on the market with better outcomes, systems to report failures, and no risk of needlestick injury. Convenience of the suture in a CVAD kit is not a justification for decreasing patient safety, clinician safety, and device securement. Lastly, there is no need to enhance or create new tying techniques for suturing external devices; just LET GO.

I leave you with these missions:

1. Begin reporting the safety and efficacy issues of sutured CVADs to the same entity that you report engineered securement device failures. 2. Demand that sutures be removed from CVAD kits. 3. Request that CVAD kits include an engineered securement device approved by the FDA.

REFERENCES

1. Ethicon, Inc. Wound closure manual. Ethicon Inc. a Johnson & Johnson Company. 2005. http://www.uphs.upenn.edu/ surgery/education/facilities/measey/wound_closure_ manual.pdf. Accessed June 10, 2021 2. Kalso E. A short history of central venous catheterization. Anaesthesiologica Scandinavica. 1985:29(s81): 7-10. 3. Struck MF, Friedrich L, Schlelfenbaum S, Kirsten H, Schummer W, Winkler BE. Effectiveness of different central venous catheter fixation suture techniques: An in vitro crossover study. PLOS Open Access. http://doi. org/10.1371/journal.pone.0222463 4. Ethicon, Inc. Ethilon Nylon Suture IFU. Ethicon Inc. a Johnson & Johnson Company. 2009. https://hostedvl106.quosavl. com/qb/ 5. US Food and Drug Administration. Off-Label and investigational use of marketed drugs, biologics, and medical devices – information sheet. https://www.fda.gov/ regulatory-information/search-fda-guidance-documents/ label-and-investigational-use-marketed-drugs-biologicsand-medical-devices. Published September 12, 2018. Accessed October 10, 2018. https://www.fda.gov/ regulatoryingormation/guidances/ucm126486.htm 6. US Food and Drug Administration. Step 3: Pathway to approval. Device Development Process. Updated February 9, 2018. https://www.fda.gov/patients/device-developmentprocess/step-3-pathway-approval. Accessed October 10, 2018 7. Van Norman GA. Drugs, devices, and the FDA: Part 2. An overview of approval processes: FDA approval of medical devices. JACC: Basic to Translational Science. 2016;1(4):277278. https://doi.org/10.1016/j.jacbts.2016.03.009 8. US Food and Drug Administration. Surgical sutures – Class II special controls guidance document for industry and FDA staff. U.S. Department of Health and Human Services. Document issued on: June 3, s003, Updated July 2, 2018. https://www.fda.gov/medical-devices/ guidance-documents-medical-devices-and-radiationemitting-products/surgical-sutures-class-ii-special-controlsguidance-document-industry-and-fda-staff#10. Accessed June 10, 2021. 9. Occupational Safety and Health Administration. Bloodborne pathogens and needlestick prevention, engineering controls. US Department of Labor. nd. https://www.osha.gov/ bloodborne-pathogens/evaluating-controlling-exposure. Accessed October 15, 2021. 10. US Food and Drug Administration. Medical device reporting (MDR): How to report medical device problems. U.S. Department of Health and Human Services. Updated October 20, 2020. https://www.fda.gov/medical-devices/ medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems#howtoreport. Accessed October 15, 2021 11. Karpanen TJ, Casey AL, Whitehouse T, Timsit JF, Mimoz O, Palomar M, Elliott TSJ. A clinical evaluation of two central venous catheter stabilization systems. Annals of Intensive Care. 2019;9(49).