A critical risk that may go unnoticed without appropriate safeguards
—Circuit misconnections in anaesthesia systems are a well‑recognised clinical safety risk. If not identified promptly, such misconnections may impair oxygenation or ventilation and can contribute to serious patient harm, including life‑threatening outcomes1.
International incident reports have documented serious adverse events associated with ventilation circuit misconnections under earlier industry standards, including cases involving severe patient injury and fatal outcomes. These reports underline the importance of design‑driven risk mitigation, appropriate training and adherence to applicable standards1,2.
While rare, these events may also be associated with increased resource utilisation, including longer hospital stays and additional treatments. As such, they represent a preventable hazard that should be addressed through system design, clinical protocols, and compliance with relevant standards.
Identical ports, misconnection risk
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Under earlier editions of ISO 80601-2-13:2011, the inspiratory, expiratory and breathing-bag ports were designed with identical connectors. This configuration increases the possibility of inadvertent misconnections, particularly in high pressure or emergency clinical environments.
This means accessories can fit on any port, creating three possible misconnection scenarios—all of which can lead to inadequate patient ventilation.
3 possible misconnections can occur
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New ISO standard: No deadly mix-ups, no adaptors
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ISO 80601-2-13:2022 introduces connector design changes intended to reduce the likelihood of certain misconnection scenarios by preventing incompatible components from being directly connected.
The use of adaptors with connectors designed under ISO 80601‑2‑13:2022 may undermine the safety intent of the standard and, depending on configuration and jurisdiction, could result in non‑compliance with applicable regulatory requirements. Healthcare providers should assess equipment configurations in accordance with local laws, regulations and clinical governance processes.
The new ISO 80601-2-13 explained
Watch the animation video to learn more about the technical changes implemented by ISO 80601-2-13.
A potentially fatal but avoidable error
This resource offers in-depth analysis of real-world incidents, the latest ISO safety standard - including ISO 80601-2-13.
This whitepaper provides valuable guidance to help you protect your patients, safeguard your team and minimise the costly applications.
Download our breathing circuit chart
Designed to support risk reduction for specific breathing circuit misconnection scenarios when used in accordance with applicable standards and instructions for use.
Explore our circuit portfolio to support the reduction of misconnection risks and consider transitioning to systems aligned with ISO 80601-2-12:2022 as part of your patient safety and risk management approach.
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—Reference list
—1. Prien T, Brinker A, Pfeiffer K, Van Aken HK. Equipment Problems. Preventable Anesthetic Deaths: Is ‘PaF’ the Magic Dragon? Anesth Analg (2019), 129, 1439–1441
2. Brinker A, Pfeiffer K, Lange, K. Anästhesie: Zwischenfälle vermeiden. Dtsch Arztebl (2019), 116(33-34): A-1500 / B-1236 / C-1216
Disclaimer
Product availability, regulatory classification and compliance obligations may vary by country. This information is provided for general educational purposes and does not replace local regulatory guidance or clinical judgement.