MAKE LIKE A SUTURE AND LET GO, 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.
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
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
4. Ethicon, Inc. Ethilon Nylon Suture IFU. Ethicon Inc. a Johnson & Johnson Company. 2009. https://hostedvl106.quosavl. com/qb/
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.
6. US Food and Drug Administration. Step 3: Pathway to approval. Device Development Process. Updated February 9, 2018. https://www.fda.gov/patients/device-development- process/step-3-pathway-approval. Accessed October 10, 2018
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.
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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
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).
