Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care.
Below are the MDAs we have published that are of particular relevance to obstetrics and gynaecology staff. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
Obstetrics and gynaecology-related Medical Device Alerts
-
09 May 2012 | Medical Device Alert: Endoscope accessory holder, all manufacturers (MDA/2012/024)
This Medical Device Alert has been issued as the MHRA has been informed that the use of inappropriate accessory holders within automated endoscope reprocessors (AER) may lead to contamination of devices, equipment and processing media by retained soil and corroded material from the endoscope accessory holder.
-
08 May 2012 | Medical Device Alert: Alaris® IVAC® 590 series blood set manufactured by CareFusion (MDA/2012/023)
This Medical Device Alert has been issued as the MHRA has been informed that the manufacturer has received reports of leakage between the sleeve tubing and the drip chamber joint of the blood set when using Alaris® IVAC® 590 series blood sets.
-
09 Feb 2012 | Medical Device Alert: Reagents requiring manual handling for use in combination with Cobas c501/502 analyser manufactured by Hitachi (MDA/2012/004)
This Medical Device Alert has been issued because the use of insufficient volumes of reagent may lead to a false negative result leading to patient harm.
-
01 Feb 2012 | Medical Device Alert: Catheter valve manufactured by Coloplast (MDA/2012/003)
This Medical Device Alert has been issued as Coloplast are recalling this product due to a sterility issue associated with the catheter valve.
-
03 Nov 2011 | Medical Device Alert: Laboratory based syphilis test: Mercia Syphilis M kit manufactured by Microgen Bioproducts Limited (MDA/2011/104)
This Medical Device Alert has been issued as higher level of non-specific cross-reactivity leading to false positive syphilis IgM results there may be misdiagnosis of early acute infection.
-
20 Jun 2011 | Medical Device Alert: Pelispec vaginal specula (MDA/2011/069)
This Medical Device Alert has been issued because the peel pouch of approximately 1% of the products may be damaged and the sterility compromised.
-
07 Jun 2011 | Medical Device Alert: Alcohol skin preparation pads, swabs and swabsticks manufactured by Triad Group Inc since 2007 (MDA/2011/065)
This Medical Device Alert has been issued because the manufacturers published Field Safety Notices (FSN) for these devices in April 2011, but have not had sufficient confirmation from users that they have received and acted on this information.
-
06 Jun 2011 | Medical Device Alert: Neonatal resuscitation systems manufactured by Intersurgical Ltd (MDA/2011/063)
This Medical Device Alert has been issued in support of the Field Safety Notice (FSN) for this device on 19 May 2011 that was published by the manufacturer.
-
06 Jun 2011 | Medical Device Alert: Various products. Manufactured by Boston Scientific (MDA/2011/062)
This Medical Device Alert has been issued because the manufacturer published a Field Safety Notice (FSN) on 10 May 2011 for these devices that were stolen before they were sterilized, although labelled as ‘sterile’.
-
26 May 2011 | Medical Device Alert: BLAKE® and J-VAC™ products. Manufactured by Ethicon (MDA/2011/057)
The manufacturer issued a Field Safety Notice (FSN) for these devices on 24 March 2011. However the MHRA cannot be confident that the recall action has been effective and that users have received and acted on this information.
