Advances in the Standards & Applied Sciences

Advances in the Standards & Applied Sciences

Cytotoxicity study of different disposable medical devices extract using MTT assay

Document Type : Original Article

Author
Department of Food Toxicology, Food Technology and Agricultural Products Research Center, Standard Research Institute, Karaj, Iran
Abstract
A large number of disposable medical devices (DMD) are being used every day. In this regard, one of the most important issues is the safety of these tools for patients. In this study, the cytotoxicity of different DMD from different brands was investigated. We studied the cytotoxicity of extracts of DMD including intravenous transfusion sets (IVTS), intravenous infusion set (Microset) and syringe using L-929 cells. Alterations in cell morphology and viability were evaluated using light microscopy and the MTT assay, respectively. Findings of the study demonstrated that 20 percent of IVTS samples, 10 percent of microset samples and 5 percent of syringe samples were cytotoxic. In this regard, four cytotoxic IVTS induced about 95%, 88%, 84% and 79% lethality in treated L929 cells. Also, two cytotoxic microset samples induced 74% and 65% lethality in treated L929 cells and a cytotoxic syringe sample induced 71% lethality in treated cells. Microscopic evaluation showed that treated cells with the toxic samples were damaged and there were no normal morphology and cell growth. We conclude that some DMD are toxic and as a result they could be hazardous for human health. We strongly believe that before clinical use of these medical devices, their biocompatibility must be evaluated by certified laboratories.
Keywords
Subjects

[1]          Liu X, Rodeheaver DP, White JC, Wright AM, Walker LM, Zhang F, et al. A comparison of in vitro cytotoxicity assays in medical device regulatory studies. Regulatory Toxicology and Pharmacology. 2018;97:24-32.
[2]          Pant AB, Agarwal AK, Sharma VP, Seth PK. In vitro cytotoxicity evaluation of plastic biomedical devices. Human & experimental toxicology. 2001;20(8):412-7.
[3]          Bernard M, Jubeli E, Pungente MD, Yagoubi N. Biocompatibility of polymer-based biomaterials and medical devices - regulations, in vitro screening a
 
nd risk-management. Biomaterials science. 2018;6(8):2025-53.
[4]          Schumacher I, Tsiperman E, Tarnopolsky A, Raskin A, Sigler E, Domb AJ. Quality and stability evaluation of disposable medical equipment. Polymers for Advanced Technologies. 2007;18(3):207-12.
[5]          Hill SS, Shaw BR, Wu AH. Plasticizers, antioxidants, and other contaminants found in air delivered by PVC tubing used in respiratory therapy. Biomedical chromatography : BMC. 2003;17(4):250-62.
[6]          Lay JO, Jr., Miller BJ. Plasticizers in pacifiers: direct determination by FAB-MS. Analytical Chemistry. 1987;59(22):1323A-5A.
[7]          Schuh JCL, Funk KA. Compilation of International Standards and Regulatory Guidance Documents for Evaluation of Biomaterials, Medical Devices, and 3-D Printed and Regenerative Medicine Products. Toxicologic pathology. 2019;47(3):344-57.
[8]          10993-5 I. Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. 2009.
[9]          10993-12 I. Biological evaluation of medical devices — Part 12: Sample preparation and reference materials. 2021.
[10]        10993-1 I. Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. 2018.
[11]        Gruber-Bzura BM. [Cytotoxicity in vitro as the principal parameter for evaluation of biocompatibility of medical devices]. Wiadomosci lekarskie (Warsaw, Poland : 1960). 2017;70(5):977-81.
[12]        Müller U. In vitro biocompatibility testing of biomaterials and medical devices. Medical device technology. 2008;19(2):30, 2-4.
[13]        Berridge MV, Herst PM, Tan AS. Tetrazolium dyes as tools in cell biology: New insights into their cellular reduction.  Biotechnology Annual Review. 11: Elsevier; 2005. p. 127-52.
[14]        Gimeno P, Thomas S, Bousquet C, Maggio AF, Civade C, Brenier C, et al. Identification and quantification of 14 phthalates and 5 non-phthalate plasticizers in PVC medical devices by GC-MS. Journal of chromatography B, Analytical technologies in the biomedical and life sciences. 2014;949-950:99-108.
[15]        De Jong WH, Geertsma RE, Tinkler JJ. Medical devices manufactured from latex: European regulatory initiatives. Methods (San Diego, Calif). 2002;27(1):93-8.
[16]        Ratner BD, Bryant SJ. Biomaterials: where we have been and where we are going. Annual review of biomedical engineering. 2004;6:41-75.
[17]        Brehler R, Rütter A, Kütting B. Allergenicity of natural rubber latex gloves. Contact dermatitis. 2002;46(2):65-71.
[18]        Drewa T, Wolski Z, Gałazka P, Wozniak A, Olszewska-Słonina D, Sir J. [Silicone and latex urinary catheters cytotoxicity on primary cultured rabbit urothelial cells]. Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego. 2004;16(93):228-31.
[19]        Cormio L, Turjanmaa K, Talja M, Andersson LC, Ruutu M. Toxicity and immediate allergenicity of latex gloves. Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology. 1993;23(7):618-23.
[20]        Williams DF. On the mechanisms of biocompatibility. Biomaterials. 2008;29(20):2941-53.