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The risk-based operational safety strategy for Perkin-Elmer/Cetus DNA Thermal Cycler PCR systems

By
Julio Cesar Pino Tarragó ,
Julio Cesar Pino Tarragó

Universidad Estatal del Sur de Manabí. Carrera de Ingeniería Civil. Jipijapa. Manabí. Ecuador

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Leider Inocencio Saraiba Núñez ,
Leider Inocencio Saraiba Núñez

Universidad de Holguín, Departamento de Estudios Biomédicos. Holguín, Cuba

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Maira Rosario Moreno Pino ,
Maira Rosario Moreno Pino

Universidad de Holguín, Departamento de Ingeniería Industrial. Holguín, Cuba

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Yorley Arbella Feliciano ,
Yorley Arbella Feliciano

Universidad de Holguín, Departamento de Ingeniería Mecánica. Holguín, Cuba

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Abstract

Introduction: this article was conducted in the field of polymerase chain reaction (PCR) test safety, where it is essential to understand the contribution and impact of risk analysis methods to improve test safety medical diagnosis at the institutional level. In this context, the current study focuses on failure modes and effects analysis (FMEA) applied to the Perkin-Elmer/Cetus deoxyribonucleic acid (DNA) thermocycler.
Objective: the objective of this study is to provide practitioners with a comprehensive overview of the application of FMEA to improve the operational safety of Perkin-Elmer/Cetus DNA thermocyclers used in medical diagnostics in ataxic patients.
Methods: to carry out this study, a methodology based on an exhaustive review of the scientific literature available in academic databases and relevant sources was used. Previous studies on FMEA analysis of DNA thermocyclers in common and expanded forms were collected and analyzed.
Results: the results obtained demonstrated that FMEA is an effective tool to identify and evaluate possible failure modes of Perkin-Elmer/Cetus DNA thermal cyclers. Several defects were identified and their consequences, causes and classification based on their severity and frequency were determined. Likewise, corrective actions are proposed to reduce the identified risks.
Conclusions: early identification of possible failure modes and implementation of corrective actions can reduce risk and guarantee the quality of the diagnoses carried out and therefore improve operational safety.

How to Cite

1.
Pino Tarragó JC, Saraiba Núñez LI, Moreno Pino MR, Arbella Feliciano Y. The risk-based operational safety strategy for Perkin-Elmer/Cetus DNA Thermal Cycler PCR systems. Salud, Ciencia y Tecnología [Internet]. 2024 Apr. 14 [cited 2024 May 28];4:789. Available from: https://revista.saludcyt.ar/ojs/index.php/sct/article/view/789

The article is distributed under the Creative Commons Attribution 4.0 License. Unless otherwise stated, associated published material is distributed under the same licence.

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