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FDA release draft report into pulse oximeters

The Food and Drug Administration have released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can be less accurate for people with darker skin pigmentation than people with lighter pigmentation.

Review of digital clinical safety standards: DCB0129 and DCB0160

NHS England has commenced a review of digital clinical safety standards DCB0129 and DCB0160 to ensure they remain up-to-date, practical and aligned with the latest advancements in healthcare technology and clinical practice. They are actively seeking input from a range of stakeholders, including NHS professionals, IT manufacturers and those involved in digital risk assessment. This will support them to …

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MHRA Consultation; Medical Devices Regulations: Routes to market and in vitro diagnostic devices. Closing date 5th January 2025

NAMDET members are asked to look at the latest MHRA consultation and make recommendations, suggestions etc. Closing date is January 5th 2024. Please feel free to share with colleagues working in medical device design and development too. The MHRA is inviting members of the public – including patients, medical device researchers, developers, manufacturers and suppliers, …

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Updated FAQ on Bed Rails Patient Safety Alert

Colleagues in the MDSO network have updated the Bed Rails FAQ resource to answer a few additional questions and add text to clarify the purpose of the document. Please follow this link to the MDSO page and see the latest v1.5 March 2024 version.

HSSIB share report about risks to medication delivery using ambulatory infusion pumps. (November 2023)

Colleagues at the HSSIB (Health Services Safety Investigation Body) have issued their final report all around ambulatory syringe pumps and their alarms, lack of monitoring and limitations. Despite having audio and visual warning alarms to notify when medication is not being delivered as it should be, there is a risk that alarms can go unnoticed, …

HSSIB share report about risks to medication delivery using ambulatory infusion pumps. (November 2023) Read More »

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