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 critical care staff. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
Critical care-related Medical Device Alerts
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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.
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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.
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12 Apr 2012 | Medical Device Alert: Oral swabs with a foam head, all manufacturers (MDA/2012/020)
This Medical Device Alert has been issued as foam heads of oral swabs may detach from the stick during use. This may present a choking hazard for patients.
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15 Mar 2012 | Medical Device Alert: Patient vital signs monitor manufactured by Philips Healthcare (MDA/2012/012)
This Medical Device Alert has been issued as patient vital signs monitors may not visually or audibly alarm to alert users at the central station.
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01 Mar 2012 | Medical Device Alert: Level 1® Normothermic IV fluid administration sets, specific lots of model numbers D-60 HL and DI-60HL manufactured by Smiths Medical (MDA/2012/009)
This Medical Device Alert has been issued as Smiths Medical has become aware of an increase in the number of reports of disconnections of the Luer lock connector at the patient end of the tubing for these fluid warming sets which can lead to a risk of fluid/ blood loss or delay in therapy.
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23 Feb 2012 | Medical Device Alert: Aquarius haemofiltration machine using software version 6.01 manufactured by Nikkiso Europe (previously Edwards Lifesciences Ltd) (MDA/2012/007)
This Medical Device Alert has been issued because the revised software upgrade version 6.02.06, replacing software version 6.01, has been postponed pending further validation by the manufacturer.
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18 Jan 2012 | Medical Device Alert: Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend manufactured by Smiths Medical (MDA/2012/002)
This Medical Device Alert has been issued as incorrectly connected accessories may be difficult to remove, requiring excessive force to disconnect. This may cause the tube to dislodge, requiring it to be changed.
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17 Jan 2012 | Medical Device Alert: Rüsch Flexislip/Flexi-Slip™ endotracheal tube stylet with soft distal tip, 6F manufactured by Teleflex (MDA/2012/001)
This Medical Device Alert has been issued as Teleflex is undertaking a recall following complaints received about two problems - difficulty removing the stylet from the endotracheal tube after intubation and separation of the PVC sheath from the stylet.
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22 Dec 2011 | Medical Device Alert: Octopus 3 extension set with anti-reflux valves and clamps manufactured by Vygon (MDA/2011/113)
This Medical Device Alert has been issued as there is a possible failure to deliver therapy under gravity infusion, as these sets may be fitted with anti-syphon valves instead of anti-reflux valves.
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13 Dec 2011 | Medical Device Alert: All Plum A+ infusion pumps manufactured by Hospira Inc (MDA/2011/110)
This Medical Device Alert has been issued due to a possible delay in therapy due to continuous recycling and/or rebooting, if the LED display settings are adjusted from the original default settings when using Plum A+ infusion pumps manufactured by Hospira Inc.
