Regulatory Updates

Cynosure Lutronic reports patient burn incidents linked to spark and loud noise during DermaV laser vascular procedures.

Cynosure Lutronic reports an adverse trend of spark and loud noise complaints causing patient burns during vascular treatments with the DermaV laser system.

Draeger reports observed hose cracks in VentStar Resus Neo and Resuscitaire; no confirmed patient harm yet.

Draeger reports users have found visible hose cracks in VentStar® Resus Neo and Resuscitaire devices before use; no health impacts reported but risk cannot be excluded.

The August 2026 MHRA safety roundup highlights a ResMed ventilator PCBA leak risk, a Dräger anaesthesia workstation piston failure, and updated guidance on Belzer organ‑preservation solutions.

A new patient alert card warns men on finasteride of psychiatric side effects and persistent sexual dysfunction.

Edwards reports that mislabelled sensor cables on the ForeSight™ Oximeter may cause swapped left/right StO2 values, risking misdiagnosis.

MHRA releases new safety and educational resources to support regulatory measures from the 2023 Patient Safety Alert and 2024 Drug Safety Update.

The MHRA’s annual MedSafetyWeek runs 3‑9 Nov 2025, focusing on the theme ‘we can all help make medicines safer’.

The Pharmaceuticals and Medical Devices Agency (PMDA) issued a safety alert warning that using insulin‑specific syringes incorrectly may cause serious adverse health effects.

Using an IV infusion giving set instead of a blood transfusion set may cause serious patient harm.

ResMed issued a Field Safety Notice for Astral 100 and 150 ventilators and related PCB spare parts made before Oct 2024, citing a fault that could unexpectedly interrupt ventilation.