TY - GEN
T1 - Risk management framework as technovigilance support at sterilization unit in the San Jose Hospital (Colombia)
AU - Rozo-Rojas, Ivanhoe
AU - Díaz-Piraquive, Flor Nancy
AU - de Jesús Muriel-Perea, Yasser
AU - Ordoñez-Díaz, Mayra Samara
AU - Ospina-Prieto, Liz Anyela
N1 - Publisher Copyright:
© 2018, Springer Nature Switzerland AG.
PY - 2018
Y1 - 2018
N2 - The article seeks to design a risk management framework at the Sterilization Unit in the San Jose Hospital according to the ISO 31000 guidelines as outcome of a research project between the Catholic University of Colombia and the Fundacion Universitaria de Ciencias de la Salud. This proposal can generate knowledge to improve the making-decisions into the medical processes to achieve the Patient Safety Policy. In addition, Risk Management is linked with the Patient Safety Policy, laws and normative in health sector, but in the literature review realized in Scopus, Science Direct and ISI Web of Knowledge databases risks and sterilization are not linked with Quality Management System and Knowledge Management in research publications. Furthermore, several research and review articles have a lot of information about technical information while the need on holistic approach is not appear in these databases. The methodological design was structured in accordance to the ISO 31000 guidelines and legal normative in a Colombian sterilization unit that realize sterilization by autoclave, hydrogen peroxide and ethylene oxide and it is processing 200 packages daily approximately. On the one hand, the risk management framework has seven foundations and five risk criteria to identify and evaluate them. On the other hand, the risk management framework had applied into sterilization processes and we identified and evaluated 15 risks on 14 sub-processes. Risk management began in washing and disinfection process and finalize in storage packets. In addition, sterilization risks have several impacts on organizational objectives and key indicators. Risks analysis tools must be included to generate scenarios and reports to take decisions. People who works in sterilization unit must use lessons learned to incorporate it in the risk management framework. Quality Management System for Medical Devices is an opportunity to improve the performance on the sterilization processes.
AB - The article seeks to design a risk management framework at the Sterilization Unit in the San Jose Hospital according to the ISO 31000 guidelines as outcome of a research project between the Catholic University of Colombia and the Fundacion Universitaria de Ciencias de la Salud. This proposal can generate knowledge to improve the making-decisions into the medical processes to achieve the Patient Safety Policy. In addition, Risk Management is linked with the Patient Safety Policy, laws and normative in health sector, but in the literature review realized in Scopus, Science Direct and ISI Web of Knowledge databases risks and sterilization are not linked with Quality Management System and Knowledge Management in research publications. Furthermore, several research and review articles have a lot of information about technical information while the need on holistic approach is not appear in these databases. The methodological design was structured in accordance to the ISO 31000 guidelines and legal normative in a Colombian sterilization unit that realize sterilization by autoclave, hydrogen peroxide and ethylene oxide and it is processing 200 packages daily approximately. On the one hand, the risk management framework has seven foundations and five risk criteria to identify and evaluate them. On the other hand, the risk management framework had applied into sterilization processes and we identified and evaluated 15 risks on 14 sub-processes. Risk management began in washing and disinfection process and finalize in storage packets. In addition, sterilization risks have several impacts on organizational objectives and key indicators. Risks analysis tools must be included to generate scenarios and reports to take decisions. People who works in sterilization unit must use lessons learned to incorporate it in the risk management framework. Quality Management System for Medical Devices is an opportunity to improve the performance on the sterilization processes.
UR - http://www.scopus.com/inward/record.url?scp=85051968901&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85051968901&partnerID=8YFLogxK
U2 - 10.1007/978-3-319-95204-8_37
DO - 10.1007/978-3-319-95204-8_37
M3 - Conference contribution
AN - SCOPUS:85051968901
SN - 9783319952031
T3 - Communications in Computer and Information Science
SP - 437
EP - 451
BT - Knowledge Management in Organizations - 13th International Conference, KMO 2018, Proceedings
A2 - Hadzima, Branislav
A2 - Uden, Lorna
A2 - Ting, I-Hsien
PB - Springer
T2 - 13th International Conference on Knowledge Management in Organizations, KMO 2018
Y2 - 6 August 2018 through 10 August 2018
ER -