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

Author:

Tessarolo Francesco12,Torres Sebastian3,Ballesteros Luis Miguel3,Rigoni Marta4,Piccoli Federico5,Caola Iole5,Caciagli Patrizio5,Montoya Yesid3,Nollo Giandomenico64

Affiliation:

1. Department of Industrial Engineering, University of Trento, via delle Regole 101, Mattarello, Trento I-38123, Italy;

2. Healthcare Research and Innovation Program (IRCS-PAT-FBK), Bruno Kessler Foundation, Trento 38123, Italy e-mail:

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

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

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

6. Department of Industrial Engineering, University of Trento, Trento I-38123, Italy;

Abstract

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.

Publisher

ASME International

Subject

Biomedical Engineering,Medicine (miscellaneous)

Reference34 articles.

1. Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology;M. A.,2011

2. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices;European Commission,,2017

3. Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals;U.S. FDA,2000

4. Reprocessing of Single-Use Medical Devices: A 2015 Update;CADTH,2015

5. What Is the Use? An International Look at Reuse of Single-Use Medical Devices;Int. J. Hyg. Environ. Health,2010

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