What is it about?
The new ISO 80369-Small Bore Connectors will replace the present Luer-connectors to avoid misconnections. Unfortunately, the standard considers only the mechanical prevention of misconnections and not the possibility to optically distinguish between products with different connector types. This paper examines possible risks of a missing distinguishability and proposes measures to accomplish optical differentiation.
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Why is it important?
When introducing new medical devices, the risks for patients and the environment must always be taken into account. Indeed, the new ISO 80369-standard considers the greatest risks of mechanical misconnections, but doesn't considers new arising risks by a missing optical differentiation. But especially in time-dependent processes a fast selection of products with the correct connector type is important. A time lag can affect the treatment and provide risks with extensive harms for the patient.
Perspectives
The paper revealed several risks for the patient and the environment and proposes measures, subsequently. I definitely recommend implementing the measures to improve the patient safety and operational procedures.
Elisabeth Ibenthal
Fachhochschule Munster
Read the Original
This page is a summary of: Distinguishability and identifiability of products with small bore connectors according to ISO DIS 80369 series: risk analysis and summative evaluation, Current Directions in Biomedical Engineering, January 2017, De Gruyter,
DOI: 10.1515/cdbme-2017-0106.
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