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Gesundheitsökonomie & Qualitätsmanagement 2016; 21(02): 81-90
DOI: 10.1055/s-0042-104250
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

Anwendungssicherheit von Medizinprodukten: Menschliche Fehler im Fokus des BfArM

Safe Use of Medical Devices: The BfArM Focuses on Human Error
K. Lange
,
M. Nowak
,
W. Lauer
,
K. Broich
Further Information

Publication History

Publication Date:
25 April 2016 (online)

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Zusammenfassung

Fehler im Umgang mit Medizinprodukten stellen ein signifikantes Risiko für die Patientensicherheit dar. Im Rahmen der Forschung zur Anwendungssicherheit von Medizinprodukten untersucht das Bundesinstitut für Arzneimittel und Medizinprodukte daher, inwieweit Merkmale von Medizinprodukt, Anwender und Anwendungskontext (oder deren spezifische Kombination) einem sicheren Umgang des Anwenders mit dem Produkt entgegenstehen. Zwei Themenbereiche werden beispielhaft adressiert: der Umgang der Anwender mit Alarmierungen (als eine weit verbreitete und besonders kritische Gerätefunktion) sowie die Bedeutung von Informationen zur Sicherheit für den Umgang mit Medizinprodukten generell. Beide Themen werden in der Literatur zurzeit als problematisch diskutiert – systematische empirische Untersuchungen fehlen allerdings weitgehend. Die vorliegende Arbeit gibt einen Überblick über die (wenigen) jeweils existierenden Befunde und diskutiert offene Fragen, deren sich das BfArM in seiner laufenden Forschung zur Anwendungssicherheit von Medizinprodukten annimmt.

Abstract

Errors in the use of medical devices compromise patient safety. As part of its research on the safe use of medical devices, the Federal Institute for Drugs and Medical Devices therefore investigates, whether characteristics of the medical device, the user, and the use context (or a specific combination of these factors) interfere with a safe interaction of the user with the device. Two topics are specifically addressed: Users’ interactions with device alarms (as a particularly prevalent and critical function of medical devices) and the significance of safety information for interacting with medical devices in general. Both topics are deemed problematic in the current literature, but there are very few systematic empirical studies. The present work provides an overview of the (few) existing studies and discusses open issues that are addressed by the BfArM in its on-going research on the safe use of medical devices.

Schlüsselwörter

Medizinprodukt - Vorkommnis - menschlicher Fehler - Alarm - Gerätewissen

Key words

medical device - adverse event - human error - alarm - device knowledge
 

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