Incorporation of safety, health and environmental aspects for medical devices in Malaysia / Dinesh Murgis
Generally the life expectancy of Malaysian population has increased over the years. This is partly due to availability of medicines and medical devices. However, the medical devices can pose direct and indirect risks and hazards associated to safety, health and environment. Therefore in this study,...
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| Format: | Thesis |
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2018
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| Online Access: | http://studentsrepo.um.edu.my/9019/ http://studentsrepo.um.edu.my/9019/7/dinesh.pdf |
| Summary: | Generally the life expectancy of Malaysian population has increased over the years. This is partly due to availability of medicines and medical devices. However, the medical devices can pose direct and indirect risks and hazards associated to safety, health and environment. Therefore in this study, risk and hazards associated to safety, health and environment are generally assessed by visit to a medical device establishment. The study was conducted to identify possible risk and hazards from the application and usage of common medical device. Data acquisition related to the possible risk and hazards were identified using a set of standard methodology. Personnel from the medical device establishment was interviewed with a set of question, observation during site visit and walk about in the manufacturing line also contributed in the data collection. Apart from that, review and verification of the medical device technical file was also conducted. The risk assessment was done using a standard risk evaluation matrix. Six main groups of risks were recognized and a total of 28 possible risks were identified under the main group. With reference to the risk and hazards identified, approximately 25 strategies that can be used to minimize or eliminate these risks are also presented accordingly and evaluated in terms of applicability and ease of implementation. Subsequently, a standard medical device checklist based on the technical and legal requirement was developed and proposed to be used to assess a medical device prior to usage in order to minimize or eliminate any possible risk and hazard that might arise.
Keywords: Medical device, Risk and hazards, Strategies |
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