Research Papers

Surface and Thermal Characteristics of Single-Use Electrosurgical Pencils After Clinical Reuse and In-Hospital Reprocessing

[+] Author and Article Information
Francesco Tessarolo

Department of Industrial Engineering,
University of Trento,
via delle Regole 101, Mattarello,
Trento I-38123, Italy;
Healthcare Research and
Innovation Program (IRCS-PAT-FBK),
Bruno Kessler Foundation,
Trento 38123, Italy
e-mail: tessaro@science.unitn.it

Sebastian Torres, Luis Miguel Ballesteros, Yesid Montoya

Department of Biomedical Engineering,
Antioquia School of
Engineering—CES University,
Sabaneta 055450, Colombia

Marta Rigoni

Healthcare Research and
Innovation Program (IRCS-PAT-FBK),
Bruno Kessler Foundation,
Trento 38123, Italy

Federico Piccoli, Iole Caola, Patrizio Caciagli

Department of Laboratory Medicine,
Azienda Provinciale per i Servizi Sanitari,
Trento 38123, Italy

Giandomenico Nollo

Department of Industrial Engineering,
University of Trento,
Trento I-38123, Italy;
Healthcare Research and
Innovation Program (IRCS-PAT-FBK),
Bruno Kessler Foundation,
Trento 38123, Italy

1Corresponding author.

Manuscript received February 17, 2017; final manuscript received August 28, 2017; published online October 20, 2017. Assoc. Editor: Matthew R. Myers.

J. Med. Devices 11(4), 041010 (Oct 20, 2017) (10 pages) Paper No: MED-17-1037; doi: 10.1115/1.4038145 History: Received February 17, 2017; Revised August 28, 2017

Safety and efficacy issues are associated with reprocessing of single-use electrosurgical pencils (EPs), requiring methods for assessing the reprocessing protocol before clinical reuse. This study aimed at monitoring the surface characteristics of single-use EPs subjected to multiple clinical use and in-hospital reprocessing. A total of 24 single-use-labeled EPs were divided in five test groups and one control group. The test groups were subjected to a different number of clinical uses, ranging from one to five. A multitechnique approach based on optical stereomicroscopy (OM), scanning electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDXS), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA) was applied. The silicon coating of the tip was significantly reduced, and foreign bodies were occasionally found on reprocessed EPs. The amount of biological debris and chemical residuals increased with the number of reprocessing cycles in critical areas. The degradation temperature of the EP handle polymer showed a progressive significant reduction. Cable cord showed no modification after reprocessing. EP tip could undergo major surface modifications that can affect functionality. The efficacy of the reprocessing protocol in removing debris from the EP handle should be carefully assessed. Surface and thermal characteristics have to be considered for validating a reprocessing protocol of single-use labeled EP.

Copyright © 2017 by ASME
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Tessarolo, F. , Caola, I. , and Nollo, G. , 2011, “ Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology,” Biomedical Engineering, Trends, Research and Technologies, M. A. Komrowska and S. Olsztynska-Janus , eds., InTech, Rijeka, Croatia, pp. 619–644. [CrossRef]
European Commission, 2017, “ Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices,” European Commission, Bruxelles, Belgium, accessed July 17, 2017, https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en
U.S. FDA, 2000, “ Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals,” U.S. Food and Drug Administration, Silver Spring, MD, accessed Dec. 7, 2016, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107172.pdf
CADTH, 2015, “ Reprocessing of Single-Use Medical Devices: A 2015 Update,” Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada, accessed Dec. 7, 2016, https://www.cadth.ca/reprocessing-single-use-medical-devices-2015-update
Popp, W. , Rasslan, O. , Unahalekhaka, A. , Brenner, P. , Fischnaller, E. , Fathy, M. , Goldman, C. , and Gillespie, E. , 2010, “ What Is the Use? An International Look at Reuse of Single-Use Medical Devices,” Int. J. Hyg. Environ. Health, 213(4), pp. 302–307. [CrossRef] [PubMed]
Quian, Z. , and Castaneda, W. R. , 2002, “ Can Labelled Single Use Devices Be Reused? An Old Question in the New Era,” J. Vasc. Interventional Radiol., 13(12), pp. 1183–1186. [CrossRef]
Mahapatra, S. , and Rengarajan, N. , 2017, “ Use of Recycled External Fixators in Management of Compound Injuries,” Expert Rev. Med. Devices, 14(1), pp. 83–85. [CrossRef] [PubMed]
Tessarolo, F. , Disertori, M. , Guarrera, G. M. , Capri, S. , and Nollo, G. , 2009, “ Reprocessing Single-Use Cardiac Catheters for Interventional Cardiology. A Cost-Minimization Model for Estimating Potential Saving at Departmental Scale and National Level,” Int. J. Public Health, 6(2), pp. 38–47.
Ruffy, R. , 1995, “ Catheter Ablation in a Less Privileged Country: The Importance of Spreading the Goods,” Pacing Clin. Electrophysiol., 18(7), pp. 1463–1464. [CrossRef] [PubMed]
Arora, P. , Kumari, S. , Sodhi, J. , Talati, S. , and Gupta, A. K. , 2015, “ Gloves Reprocessing: Does It Really Save Money?,” Indian J. Surg., 77, pp. 1291–1294. [CrossRef] [PubMed]
Arévalo, L. C. , and Carrillo-Martínez, C. M. , 2007, “ Reuse and Recycling Practices in a Colombian Hospital,” AORN J., 86(5), pp. 791–797. [CrossRef] [PubMed]
Batista Neto, S. , Graziano, K. U. , Padoveze, M. C. , and Kawagoe, J. Y. , 2010, “ The Sterilization Efficacy of Reprocessed Single Use Diathermy Pencils,” Rev. Lat. Am. Enfermagem, 18, pp. 81–86. [CrossRef] [PubMed]
Torres, S. , Montoya, Y. , Echeverri, C. E. , Giraldo, P. , and Tapias, L. , 2014, “ Topographical and Structural Evaluation of Diathermy Pencils Employed on Aesthetic Surgery Subjected to Four Reprocessing Cycles Using the EIA/CES ‘QUALY’ Approach,” Rev. Ing. Bioméd., 8(16), pp. 13–18.
Tessarolo, F. , Torres, S. , Ballesteros, L. , Rigoni, M. , Picoli, F. , Caola, I. , Montoya, Y. , and Nollo, G. A. , 2015, “ Multi-Techniques Approach to Assess Reprocessing of Single-Use Electrosurgical Pencils,” 37th IEEE Annual International Conference on Engineering in Medicine and Biology Society (EMBC), Milan, Italy, Aug. 25–29, pp. 6876–6879.
U.S. FDA, 2015, “ Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” U.S. Food and Drug Administration, Silver Spring, MD, accessed Dec. 7, 2016, https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf
Holm, S. , 1979, “ A Simple Sequentially Rejective Multiple Test Procedure,” Scand. J. Stat., 6(2), pp. 65–70.
Pruneda, F. , Suñol, J. J. , Andreu-Mateu, F. , and Colom, X. , 2005, “ Thermal Characterization of Nitrile Butadiene Rubber (NBR)/PVC Blends,” J. Therm. Anal. Calorim., 80(1), pp. 187–190. [CrossRef]
Tessarolo, F. , Caola, I. , Fedel, M. , Caciagli, P. , Guarrera, G. M. , Motta, A. , and Nollo, G. , 2007, “ Different Experimental Protocols for Decontamination Affect Cleaning of Medical Devices. A Preliminary Electron Microscopy Analysis,” J. Hosp. Infect., 65(4), pp. 326–333. [CrossRef] [PubMed]
Klasz, K. , 2008, “ Quality Management for the Processing of Medical Devices,” GMS Krankenhaushygiene Interdisziplinär, 3(3), pp. 1–15.
Massarweh, N. N. , Cosgriff, N. , and Slakey, D. P. , 2006, “ Electrosurgery: History, Principles, and Current and Future Uses,” J. Am. Coll. Surg., 202(3), pp. 520–530. [CrossRef] [PubMed]
AORN, 2005, “ Recommended Practice for Electrosurgery,” AORN J., 81(3), pp. 616–642. [CrossRef] [PubMed]
ECRI, 1998, “ Ignition of Debris on Active Electrosurgical Electrodes,” Health Devices, 27(9–10), pp. 367–370. [PubMed]
Jones, E. L. , Overbey, D. M. , Chapman, B. C. , Jones, T. S. , Hilton, S. A. , Moore, J. T. , and Robinson, T. N. , 2017, “ Operating Room Fires and Surgical Skin Preparation,” J. Am. Coll. Surg., 225(1), pp. 160–165. [CrossRef] [PubMed]
Dale, M. , lane, J. , and Crawford, D. C. , 2008, “ Electrosurgical Tip Cleaners,” Centre for Evidence-Based Purchasing, London, Report No. CEP 08006.
Weld, K. J. , Dryer, S. , Hruby, G. , Ames, C. D. , Venkatesh, R. , Matthews, B. D. , and Landman, J. , 2006, “ Comparison of Mechanical and In Vivo Performance of New and Reprocessed Harmonic Scalpels,” Urology, 67(5), pp. 898–903. [CrossRef] [PubMed]
DesCôteaux, J. G. , Poulin, E. C. , Lortie, M. , Murray, G. , and Gingras, S. , 1995, “ Reuse of Disposable Laparoscopic Instruments: A Study of Related Surgical Complications,” Can. J. Surg., 38(6), pp. 497–500. [PubMed]
Fedel, M. , Tessarolo, F. , Ferrari, P. , Lösche, C. , Ghassemieh, N. , Guarrera, G. M. , and Nollo, G. , 2006, “ Functional Properties and Performance of New and Reprocessed Coronary Angioplasty Balloon Catheters,” J. Biomed. Mater. Res., Part B, 78(2), pp. 364–372. [CrossRef]
Tessarolo, F. , Ferrari, P. , Nollo, G. , Motta, A. , Migliaresi, C. , Zennaro, L. , Rigo, A. , and Guarrera, G. M. , 2004, “ Evaluation and Quantification of Reprocessing Modification in Single Use Devices in Interventional Cardiology,” Appl. Surf. Sci., 238(1–4), pp. 341–346. [CrossRef]
Lucas, T. C. , Oréfice, R. L. , Pinotti, M. , and Huebner, R. , 2009, “ Surface Evaluation of Cardiac Angiographic Catheters After Simulated Use and Reprocessing,” Appl. Surf. Sci., 256(5), pp. 1419–1425. [CrossRef]
Li, H. , Wang, L. , Song, G. , Gu, Z. , Li, P. , Zhang, C. , and Gao, L. , 2010, “ Study of NBR/PVC/OMMT Nanocomposites Prepared by Mechanical Blending,” Iran. Polym. J., 19(1), pp. 39–46.
Wu, J. , Chen, T. , Luo, X. , Han, D. , Wang, Z. , and Wu, J. , 2014, “ TG/FTIR Analysis on Co-Pyrolysis Behaviour of PE, PVC and PS,” Waste Manage., 34(3), pp. 676–682. [CrossRef]
Pappa, K. , Mikedi, A. , Agapiou, S. , Karma, G. , Pallis, C. , Statheropoulos, M. , and Burke, M. , 2011, “ TG–MS Analysis of Nitrile Butadiene Rubber Blends (NBR/PVC),” J. Anal. Appl. Pyrolysis, 92(1), pp. 106–110. [CrossRef]
Zilberstein, B. , Silva, R. C. , Valim, S. G. , Yukui, K. T. , and Valentim, R. , 2013, “ High-Resolution Tweezers for Cutting and Coagulation Reprocessing,” Arq. Bras. Cir. Dig., 26, pp. 230–233. [CrossRef] [PubMed]
Loftus, T. J. , 2015, “ A Comparison of the Defect Rate Between Original Equipment Manufacturer and Reprocessed Single-Use Bipolar and Ultrasound Diathermy Devices,” ASME J. Med. Devices, 9(4), p. 044501. [CrossRef]


Grahic Jump Location
Fig. 2

Characterization of the cutting surface of the tip (ROI#1) by optical microscopy (a) and (b), scanning electron microscopy (c) and (d), and energy dispersive X-ray spectroscopy (e) and (f). Representative images are reported for a new (left column) and a reprocessed (right column) EP. Brownish residuals were detected by optical microscopy (b), and scanning electron microscopy (d). According to EDXS spectra, dark gray areas in the SEM images are, respectively, due to the silicon coating in new devices (c) and (e), and tissue residual in reprocessed EPs (d) and (f).

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Fig. 3

Representative images of areas that showed differences in surface characteristics between new (left column) and reprocessed (right column) under optical microscopy investigation. EPs (a)–(d): ROI#2 (metal–polymer junction of the tip); (e) and (f): ROI#3 (proximal portion of the handle); (g) and (h): ROI#4 (external surface of the handle). Original magnification is 10×.

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Fig. 1

Electrosurgical pencil assessed in the study. In the right column are presented the six ROIs subjected to the multitechnique evaluation after sectioning the device: #1, cutting surface of the tip; #2, metal–polymer junction of the tip; #3, proximal portion of the handle; #4, external surface of the handle; #5, surface of the cut function button; #6, proximal portion of the cable cord. Device portions are mounted on aluminum stub for scanning electron microscopy and energy dispersive X-ray spectroscopy.

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Fig. 4

Representative images of areas that showed differences in surface characteristics between new (left column) and reprocessed (right column) EPs under scanning electron microscopy observation. (a) and (b): ROI#3; (c) and (d): ROI #4 (longitudinal groove of the handle); (e) and (f): ROI#5 (top surface of the cut button); (g) and (h): ROI#5 (basement of the cut button). Original magnification is 100× ((a), (b), (e), (f), (g), (h)) or 150× ((c) and (d)).

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Fig. 5

TGA analysis of the handle polymer. Curves obtained from one representative sample for each study group are superimposed for ease of comparison. Number of clinical uses and reprocessing cycles are reported in the color legend. (a) Full temperature range (24–600 °C) curves showing minimal weight loss below 220 °C. (b) Detail of the weight versus temperature curves in the 380–450 °C range showing major weight loss. (c) Derivative of the weight loss versus temperature in the 380–450 °C range, showing the decrease of the degradation temperature (peak maximum) according to the number of reuses and reprocessing cycles.

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Fig. 6

Changes of surface and thermal properties according to the number of clinical uses and reprocessing sustained by the device (0: new unused devices). (a) Bar chart summarizing the score obtained with SEM for the variable “debris at the button base” in ROI#5 from each tested EP. The increase of the debris amount (higher scores) with the number of reprocessing cycle is shown by the median values (in red). (b) Degradation temperatures (Td) of the polymeric handle (ROI#4) obtained with TGA from each tested EPs. The decrease of the degradation temperature with the number of reprocessing cycle is evident. Mean values are reported in red.



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