Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations

Pazart, Lionel; Pelayo, Sylvia; Chevallier, Tiphaine; Gruionu, Gabriel; Mabo, Philippe; Bayon, Yves; Barbot, Frédéric; Lihoreau, Thomas; Roussel, Catherine; Maglaveras, Nicos; Lekka, Eirini; Ferreira, H. A.; Rocha, Isabel; Geris, Liesbet; Lavet, C.

doi:10.5220/0010382902740284

Cited by 2 publications

(1 citation statement)

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“…In addition, it must use effective maintenance programs that assist the device operators or users in repairing if it breaks down while providing health services. Which have been considered to have complex automation characteristics based on their design, and they need to provide accurate information about their operation and repair [1]. As a result, this assessment must address the economics of the life cycle of each medical device.…”

Section: Introductionmentioning

confidence: 99%

Application the Risk-Based Maintenance for Optimizing the Overall Medical Devices Safety

Mkalaf

2022

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The purpose of this study was to identify risks to patients as a result of sudden device failure during the delivery of medical treatment services. Which, can affect the reputation of hospitals following the exposure of patients' lives to various risks like death, injury, and misdiagnosis. Furthermore, a sudden failure will lead to increased economic losses as a result of increased maintenance costs. Of (20) medical devices, (6) high-risk devices were selected, such as a ventilator, diathermy, anesthesia, BiPAP, oxygen concentrator, and electrosurgical devices. A quantitative statistical analysis based on risk-based maintenance is used to evaluate the effectiveness of the reliability of the medical device and its risks to patient lives. The results show that the reliability of the chosen medical device has declined, with higher maintenance costs due to excessive maintenance or the type of maintenance policy used. Therefore, this study provides evidence that hospitals must adopt a risk-based maintenance approach to prevent sudden failure while in service. In addition, these medical devices have various complex parts that must adopt a combination of maintenance schedules. Based on Risk-Based Maintenance's experience in improving patient safety in public hospitals in the 20 most successful OECD countries.

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Section: Introductionmentioning

confidence: 99%

Application the Risk-Based Maintenance for Optimizing the Overall Medical Devices Safety

Mkalaf

2022

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Clinical Investigation as an Iteration Tool for the Design of Low-Risk Medical Devices: A Case Study of an IV Drip Monitoring System

Venkatesh¹,

Karia²,

Arora³

2021

2021 IEEE Global Humanitarian Technology Conference (GHTC)

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Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations

Cited by 2 publications

References 0 publications

Application the Risk-Based Maintenance for Optimizing the Overall Medical Devices Safety

Application the Risk-Based Maintenance for Optimizing the Overall Medical Devices Safety

Clinical Investigation as an Iteration Tool for the Design of Low-Risk Medical Devices: A Case Study of an IV Drip Monitoring System

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