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KMID : 1040120150010020071
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Evidence and Values in Healthcare
2015 Volume.1 No. 2 p.71 ~ p.80
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Structured literature review to identify patient safety issues related to medical device
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Choi Mi-Young
Kim Sun-Kyung
Park Jeong-Su
Kim Min-Jeong
Baek Young-Gi
Kim Su-Kyeong
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Abstract
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Objectives: In healthcare environments, especially hospitals, many providers and practitioners work using various medical devices. There are concerns about patient safety in relation to these medical devices. Recently, new medical devices based on high technology development have been more rapidly introduced to hospitals. Even though we do not know the exact incidence and magnitude of adverse events related to medical devices, it is important to know the general safety
issues related to medical devices worldwide for patient safety improvement. We intended to identify patient safety issues related to medical devices using a structured literature review (SLR).
Methods: A SLR was performed focusing on patient safety issues related to medical devices. Based on protocols of SLR, reviewers have searched databases such as MEDLINE, EMBASE, Cochrane Library and CINAHL including domestic databases. Data extraction was performed independently in pairs and qualitative data synthesis was performed.
Results: A total 34 studies were selected. The study design was classified as survey (70%), retrospective cohort design (18%) and prospective cohort design (12%). Issues were classified as type of adverse event, place of event occurrence and type of medical devices. We summarized the issues as 9 topics. The most frequent topics were related to the use of invasive medical devices. Malfunction of operation devices, infusion pump error, adverse events associated pediatric patients, false alarm, inappropriate layout, information system, remained devices/materials and infection related to medical devices were followed.
Conclusion: The patient safety issues related to medical devices would be used as base evidence for hospitals and healthcare policy makers. Structuring a comprehensive patient safety management system is needed for ensuring the safety of medical devices.
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KEYWORD
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Equipment and supplies, Equipment safety, Patient safety
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