Failure mode, effects and criticality analysis (FMECA) for medical devices: does standardization foster improvements in the practice?

R Onofrio, F Piccagli, F Segato - Procedia Manufacturing, 2015 - Elsevier
failure modes determining. The team has investigated all the potential failure modes related
to PTA catheters starting from device … sources: medical device company complaints data …

Human reliability assessment for medical devices based on failure mode and effects analysis and fuzzy linguistic theory

QL Lin, DJ Wang, WG Lin, HC Liu - Safety science, 2014 - Elsevier
… for possible ways, in which failures (problems, errors, risks and … of medical devices to improve
the safety of medical devices. … reliability of medical devices, based on failure modes and …

[图书][B] Guidelines for failure modes and effects analysis for medical devices

D Press - 2018 - taylorfrancis.com
… application throughout the medical device’s life cycle. Other topics include regulatory
requirements relating to manufacturing of medical devices, risk management, Failure Mode, Effects …

[PDF][PDF] Using Failure Modes, Mechanisms, and Effects Analysis in Medical Device Adverse Event Investigations.

S Cheng, D Das, MG Pecht - ICBO, 2011 - ceur-ws.org
… evaluation process (eg, failing to identify the failure … for medical device evaluation by
using failure modes, mechanisms, and effects analysis to identify the root causes and failure

Failure modes in medical device software: an analysis of 15 years of recall data

DR Wallace, DR Kuhn - … Journal of Reliability, Quality and Safety …, 2001 - World Scientific
… of software-related failures of medical devices that caused no death or injury but led to
recalls by the manufacturers. The analysis categorizes the failures by their symptoms and faults, …

Failure analysis of medical devices

M Bowers, G Ganot, L Malito, B Kondori… - Journal of Failure …, 2022 - Springer
… This article first discusses failure modes of long-term orthopedic and cardiovascular implants.
It then … This section describes general types of devices and common failure modes. As with …

Risk assessment of medical devices used for COVID-19 patients based on a Markovian-based weighted failure mode effects analysis (WFMEA)

M Tavakoli, R Mesbahi, S Nayeri… - Scientia Iranica, 2022 - scientiairanica.sharif.edu
failure mode analysis approach to the 52 medical device prioritization risks. In this study, all
functional devices used for COVID-19 53 devices … general and pandemic failures. Then they …

Automated generation of failure modes and effects analysis for a medical device

M Hecht, E Nguyen, A Chuidian… - 2015 IEEE International …, 2015 - ieeexplore.ieee.org
failure propagations to generate the Failure Modes and Effects Analysis. The technique is
demonstrated on a microprocessorY controlled medical … addition of failure detection features, …

The failure of synthetic polymeric medical devices

PR Lewis - Durability and Reliability of Medical Polymers, 2012 - Elsevier
… failed medical devices are analysed for their failure modes … The analytical tools needed to
investigate failures of medical … features frequently allowing the failure mode to be identified …

Methodology to assess medical processes based on a Failure Mode and Effects Analysis (FMEA)

J Sobral, D Teixeira, H Morais… - 2017 IEEE 5th …, 2017 - ieeexplore.ieee.org
… [9] applied a FMEA to evaluate the potential failures in human reliability of medical devices
… for the risN assessment of medical devices (with focus on Failure Mode, Effects and criticality …