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Current status of medical device malfunction reporting: using end user experience to identify current problems.
Arkeliana Tase1, Melody Z Ni2, Peter W Buckle2
1Surgery and Cancer, Imperial College, London, UK a.tase@imperial.ac.uk.
BMJ Open Quality
|May 27, 2022
Summary
Under-reporting of medical device issues hinders patient safety improvements. This study highlights barriers and proposes solutions, emphasizing end-user experience for better medical device performance data and risk management.
Area of Science:
- Biomedical Engineering
- Health Services Research
- Patient Safety
Background:
- Current medical device malfunction reporting systems suffer from under-reporting and lack of continuous data.
- This deficiency prevents effective data interrogation and trend recognition for evolving issues.
- Consequently, medical device use relies on personal experience rather than robust evidence.
Purpose of the Study:
- To investigate the causes of insufficient data on medical device performance and associated patient risks.
- To identify existing barriers to comprehensive reporting and explore methods for improvement.
- To leverage end-user experiences for enhanced medical device safety and efficacy.
Main Methods:
- A qualitative study employing semistructured interviews and surveys with clinicians and manufacturers.
- Thematic analysis of collected data, with interview findings informing survey design.
- Adherence to Standards for Reporting Qualitative Research (SRQR) guidelines.
Main Results:
- Multiple barriers to reporting were identified, encompassing patient safety and system-related aspects.
- Variable acceptable error levels and normalized workarounds for device issues were observed.
- Clinicians and manufacturers identified needs for greater system transparency, feedback, efficient reporting, and improved communication.
Conclusions:
- Complex issues in medical device performance reporting significantly impact patient safety and clinical staff.
- A focus on incidents limits learning; end-user experience is crucial for identifying system weaknesses.
- Enhanced communication between healthcare providers and the MedTech industry is essential for improvement.
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