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 …
The first ever meeting of NAMDET North East has been arranged for January 4th 2017. Venue: Education Centre, Hexham Hospital, Corbridge Rd, Hexham, NE46 1QJ Time: 10:00 – 14:00 Agenda 10:00-10:15 Welcome from organisers 10:15-10:45 Introduction from all attendees. 10:45-11:30 Introduction to NAMDET from national rep. 11:30-12:00 Formal group roles 12:00-12:30 Lunch break ( lunch …
NAMDET North East Inaugural Meeting Jan 4th 2017 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 …
Our colleagues at IPEM are arranging a 1 day event focussing on Human Factors and Medical Devices. With reference to the recent Guidance document on “Human Factors and Usability Engineering” produced recently by MHRA, this meeting aims to bring together researchers from all relevant disciplines active in the field, including medical device users, clinical/biomedical engineers, …
NAMDET is pleased to announce that the final programme and speakers have been agreed for this year’s conference being held in Birmingham on 3rd November. Delegate bookings have exceeded all expectations and our exhibitors will not be disappointed with turnout. Our Gala evening meal on the 2nd November has also proved very popular for those who are travelling and …
Conference 2016 final agenda and speakers confirmed 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 …
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 …