Adoption of ISO14971
To: The Chief Medical Officer
From: The Chief Information Officer
Subject: Adoption of ISO14971
Date: June 16, 2021
ISO14971 is a global standard for medical device risk management that aims at defining a standard process for determining risks related to medical devices at all phases in their life cycle. The life cycle of the medical devices usually ranges from designing the product to procurement to production and post-market use. The primary goal is to analyze, evaluate, control, and monitor the risks that are associated with every life cycle stage (Teferra, 2017). ISO14971:2019 is the most recent version that was published by ISO and replaced ISO14971:2007.
Adoption of this standard is indeed in the best interest of the entire hospital due to the benefits that it will present in our daily operations. It will also play a fundamental role in maintaining the security and privacy linked with the increasing use of medical devices in the hospital. The ISO14971 clearly describes the steps which can be followed to ensure that risks are managed in our health facility. Clause 3 in ISO14971 states that during the risk management process, the top management should review the risks for medical devices at planned intervals, come up with a policy and the acceptance criteria for risk and show commitment to managing risks of every medical device (Chan, & Tong, 2018). Similar to other management principles, ISO14971 maintains that individuals who carry out risk assessment must be competent and knowledgeable.
ISO14971 contains the major steps that are followed during the process of risk management, and if implemented effectively in our hospital, it will result in positive outcomes. The risk management process involves analysis of the risk, evaluation of the risks, risk control, residual risk control, developing a risk management report, and information from production and post-production. Risk analysis should be performed on every medical device and identify potential hazards. After determining the possible hazards, the risk for every hazardous situation is estimated and list the features that can foreseeably affect the safety of the medical devices. Risk analysis should be incorporated with hazardous events that may lead to a hazardous situation while the reasonably foreseeable combinations of those events are analyzed separately.
Evaluation of the risk involves examining every hazardous situation and then use the organization’s risk acceptability method to confirm if risk reduction is required for the hazard or not. The outcomes of risk evaluation activities are normally recorded in the file. Evaluation of the risk can be calculated by multiplying the severity of the hazard by the possibility of its occurrence. Risk control is a process of reducing risk by minimizing an unacceptable risk. The efficiency of the control is determined through reevaluation of the residual risk and it is chosen based on certain factors like its economic feasibility, simplicity and practicality (Lueddemann, et al., 2016). Residual risk evaluation is carried out after all controls have been obtained and are considered to be effective. A file is then maintained with the risk management register after all the risks have been controlled appropriately and are records are maintained. In a risk management report, reviews are planned for the risk management system and before a medical device gets into the commercial market, a review should be performed. Relying on the review, a report is then developed and it must comprise the results of the review and be integrated into the risk management file. In order to acquire information from production and post production, a system for monitoring the performance of the medical device must be created and be maintained properly. Some of the information that would be obtained from production include any failures in clinical trials while from post production the information might be in regard to customer complaints or failure of the product.
In conclusion, I believe that if we incorporate and adopt the ISO14971 standard in our hospital, it will significantly to manage our risks. We will be able to manage those risks by implementing all the steps that have been outlined and eventually lead to provision of high quality services in our health facility.
Reference
Chan, T., & Tong, R. K. (2018). ISO 14971: Application of Risk Management to Medical Devices. In Handbook of Medical Device Regulatory Affairs in Asia (pp. 175-191). Jenny Stanford Publishing.
Lueddemann, T., Sahin, S., Pfeiffer, J., & Lueth, T. C. (2016, December). Experimental evaluation of a novel ISO 14971 risk management software for medical devices. In 2016 IEEE/SICE International Symposium on System Integration (SII) (pp. 162-167). IEEE.
Teferra, M. N. (2017). ISO 14971-Medical Device Risk Management Standard. International Journal of Latest Research in Engineering and Technology (IJLRET), 3(3), 83-87.
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