What question did this study set out to answer?

To examine why medical-device safety surveillance systems systematically fail to capture adverse events arising at the interface of individually compliant devices used in combination.

August 16, 2026Expert Review of Medical Devices

When the interface fails: a patient-safety hazard hidden by the assumption of human error

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Authors

AAAmar AlwitryRoyal College of Ophthalmologists

Discussion

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Implication

Surveillance review reveals underreported device interface failures in surgical settings, indicating misattribution to clinician error masks critical patient safety risks.

Key Points

To examine why medical-device safety surveillance systems systematically fail to capture adverse events arising at the interface of individually compliant devices used in combination.
Searched PubMed/MEDLINE and Google Scholar from database inception to July 2026, alongside the US FDA MAUDE adverse-event database and professional safety publications.
Synthesized data from surveys, case series, health-economic and litigation analyses, and ISO 80369 small-bore connector standards, utilizing the syringe-cannula junction in intraocular surgery as a primary exemplar.
Interface failures between individually compliant devices are routinely misattributed to clinician error rather than mechanical or design incompatibility at the junction.
Existing safety and incident-reporting systems lack dedicated surveillance categories for combination device failures, resulting in substantial under-reporting and unrecognized costs to patients and clinical staff.

Cite This Study

Amar Alwitry (2026) studied this question.

synapsesocial.com/papers/6a817a91f2fb91fc834ae8c9 https://doi.org/10.1080/17434440.2026.2720197

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August 16, 2026Expert Review of Medical Devices

When the interface fails: a patient-safety hazard hidden by the assumption of human error

View Full Paper

Ask AI

Bookmark

Authors

AAAmar AlwitryRoyal College of Ophthalmologists

Discussion

Member takes

Implication

Surveillance review reveals underreported device interface failures in surgical settings, indicating misattribution to clinician error masks critical patient safety risks.

Key Points

To examine why medical-device safety surveillance systems systematically fail to capture adverse events arising at the interface of individually compliant devices used in combination.
Searched PubMed/MEDLINE and Google Scholar from database inception to July 2026, alongside the US FDA MAUDE adverse-event database and professional safety publications.
Synthesized data from surveys, case series, health-economic and litigation analyses, and ISO 80369 small-bore connector standards, utilizing the syringe-cannula junction in intraocular surgery as a primary exemplar.
Interface failures between individually compliant devices are routinely misattributed to clinician error rather than mechanical or design incompatibility at the junction.
Existing safety and incident-reporting systems lack dedicated surveillance categories for combination device failures, resulting in substantial under-reporting and unrecognized costs to patients and clinical staff.

Cite This Study

Amar Alwitry (2026) studied this question.

synapsesocial.com/papers/6a817a91f2fb91fc834ae8c9 https://doi.org/10.1080/17434440.2026.2720197

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