News

NAMDET has expanded to Facebook. Just go to Facebook and type in search: NAMDET. There are many photographs already uploaded

Our Engineering colleagues across the NHS have been collaborating to develop a new standard PAQ (Pre-Aquisition Questionnaire) and a new agreed one is available. Please note this original 2016 version has been replaced with th enew 2018 version linked above. NAMDET is pleased to see ‘training’ listed as key requirements and we are always keen …

New PAQ For: Pre-Aquisition Questionnaire for new medical devices Read More »

Our colleagues at CME have issued some new advice around covering up the screen on syringe drivers if used in direct sunlight as this may affect its use. Please see their safety bulletin and share the information with your colleagues in EBME,  Medical Equipment Management etc. cme-medical-ambulatory-pump-safety-notice-fsn-2016-004 Many thanks website team @ namdet

NAMDET has been invited to participate in helping to draft document guidelines into definitions and classifications of Medical Device Adverse Incidents reports. This work will help harmonise reporting, phrases and terminology. The MHRA are key members of a working group; IMDRF (International Medical Devices Regulators Forum) and are engaging in key stakeholder input. The current documents can …

MHRA Consultation and Feedback required (IMDRF) Read More »

Our colleagues at the MHRA have issued an alert about leaking TIVA (Total Intravenous Anaesthesia) giving sets supplied by Global Components Medical Ltd. If propofol leaks from the ‘check valve’ Luer lock connector patients could become aware during surgery The list of products affected are attached to the alert. Please feel free to pass onto …

MHRA Alert: Leaking TIVA sets… MDA/2016/021 Read More »

Our colleagues at the MHRA have issued an alert for lifepack defbrillators and issues around failure to deliver a shock. LIFEPAK CR Plus AEDs or LIFEPAK EXPRESS AEDs may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened. The problem is due to an internal component (reed switch) …

MHRA Alert : Lifepack CR plus, and Express defibrillator Read More »

This year’s conference will hopefully be opened with a montage of photographs from our members; carrying out training, delivering teaching sessions, attending namdet meetings, training events and conferences throughout 2016. However, we need YOU to send them in so we can put this montage together to share at the conference. If you have any suitable …

Photo montage for conference 2016 Read More »

The MHRA have issued updated advice (Aug 2016) on apps as medcial devices. How users can spot if their app is a medical device and what to look for. Developers are also given advice on complying with the regulations. A new twitter feeed @MHRAgovuk is also being used to promote the new guidance You can read the …

MHRA advice on software apps as medical devices Read More »

NAMDET’s Chairman Paul Lee has just finished a short presentation entitled ‘Medical Device Training’ on this month’s MDSO webex. The Medical Device Safety Officer’s (MDSO) network hold a monthly webex meeting to share issues of significance and share important alerts and key messages about medical device safety. The slide show (MDSO webinar Sept 2016) highlights …

Medical Device Training: MDSO webex slides Read More »

NAMDET are a registered contributor to NICE clinical guidelines and have been asked if we could like to contribute to a review and update of new and recent guidelines. Please see if there is anything that you (and or your colleagues) are able to contribute towards and get back to your regional chair, who will …

NICE guidelines updates Read More »