Elements of risk assessment in medical equipment

Corciovă, Călin; Andriţoi, Doru; Ciorap, Radu

doi:10.1109/atee.2013.6563427

Cited by 12 publications

(7 citation statements)

References 1 publication

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“…They also suggested periodic inspection processes, maintenance guidelines and solutions, evaluation, and performance assessment for medical equipment. In their paper, they described a method that has five risk criteria in their scoring system concerning the patient, medical staff, and biomedical engineers in the healthcare system [11]. Tawfik et al (2013) developed a fuzzy logic model for medical equipment classification.…”

Section: Literature Reviewmentioning

confidence: 99%

Risk assessment of medical devices used for COVID-19 patients based on a Markovian-based Weighted Failure Mode Effects Analysis (WFMEA)

et al. 2022

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Medical devices are critical in the healthcare system and their failures can significantly impress the safety of patients, medical staff, and clinical engineers. With increasing COVID-19 pandemic in recent months, it is more necessary to assess the risks of the devices to avoid infection for patients, death, and severe hurts due to inactive and breakdown devices. The aim of this study is to assess medical device risks in general and pandemic situations with three main factors of the Failure Model Analysis Effect include occurrence, detection, and severity. Some sub-factors are defined and weighted using the Fuzzy DEMATEL and Fuzzy Best-Worst Method. Consequently, the weighted FMEA score of each failure is calculated as the Weighted Risk Priority Number. Finally, steady-state probabilities of very low and low failures are calculated to consider the changes during the time. Results show that near half of the failures are scored in very low and low levels but in the long term, most of them transfer to medium level risk. It can be concluded that some preventive maintenance plans for these kinds of failures to avoid occurring the higher risk level for them in the future is necessary and the results can help medical device managers.

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Section: Literature Reviewmentioning

confidence: 99%

Risk assessment of medical devices used for COVID-19 patients based on a Markovian-based Weighted Failure Mode Effects Analysis (WFMEA)

et al. 2022

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“…39 Corciova et al have summarized the main elements of risk treatment for medical equipment, including repair, equipment control, asset management, health care technology planning, and education. 120 As an extension to the smart healthcare system, the review will be mostly conducted on the studies about risk mitigation actions in system design, system operation and maintenance, as well as those in organization and in legislation.…”

Section: Risk Treatment and Mitigationmentioning

confidence: 99%

Risk management of smart healthcare systems: Delimitation, state-of-arts, process, and perspectives

Liu

2022

Journal of Patient Safety and Risk Management

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Sensing, communication, computation, and control technologies are facilitating smart healthcare to improve efficiency and effectiveness of medical treatment and care. This study focuses on the risk issues relevant with the adverse events where novel technical systems do not serve as expected. We discuss the unique challenges, define the scope of risk management in healthcare and review the state-of-art research on diverse topics under the framework widely used in risk management. Then, we present a systematic approach to identify the hazards to patients and other asset of interest in the perception, cyber communication, and execution of smart technologies and their operational contexts. We also investigate different methods for scenario, likelihood, and consequence analyses for specifying the risks of adverse events, and categorize the approaches of risk reduction, as the main strategy of treating risks of smart healthcare systems, into four groups of design, operation, organization, and legislation. At the last, the article proposes some research perspectives responding to the developing trend of smart healthcare.

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“…The final output should still be within 15% of the recommended setting and charge time should not exceed 15 seconds. The appraisal for functional assessment frequency would be twice a year (Table 2) [15].…”

Section: Classification and Prioritization Of Medical Equipment For Maintenance Activitiesmentioning

confidence: 99%

“…Before returning the equipment to medical personnel, it must be ensured that it has been adjusted to the original specific settings. Make sure that the volume of the audible alarms is loud enough to be heard under normal operating conditions [15].…”

Section: Total 13mentioning

confidence: 99%

A Modern Approach for Maintenance Prioritization of Medical Equipment

Corciovă¹,

Andriţoi²,

Luca³

2021

Operations Management - Emerging Trend in the Digital Era

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Maintenance is a crucial topic in the life cycle management of medical equipment. Evidence-based maintenance consists of continuous monitoring of equipment performance, starting from evidence—the current state from the point of view of fault history—and improving its efficiency through the necessary modifications. This process is very important for optimizing the use and allocation of the resources available by the clinical engineering departments. Maintenance of medical equipment consists of two basic activities: scheduled maintenance and corrective maintenance. The purpose of this chapter is to present document-based methods to evaluate every aspect of the medical equipment maintenance process and to provide a correct, objective and standardized approach that supports clinical engineering activities. Following the analysis, the results show that the combination of the use of the two methods provides an overview, in a periodic manner, of maintenance performance that indicates the use of the most appropriate procedures.

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Elements of risk assessment in medical equipment

Cited by 12 publications

References 1 publication

Risk assessment of medical devices used for COVID-19 patients based on a Markovian-based Weighted Failure Mode Effects Analysis (WFMEA)

Risk assessment of medical devices used for COVID-19 patients based on a Markovian-based Weighted Failure Mode Effects Analysis (WFMEA)

Risk management of smart healthcare systems: Delimitation, state-of-arts, process, and perspectives

A Modern Approach for Maintenance Prioritization of Medical Equipment

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