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 theatre practitioners. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
Medical Device Alerts related to theatre practitioners
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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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04 Apr 2012 | Medical Device Alert: AlboGraft polyester vascular graft manufactured by LeMaitre (MDA/2012/018)
This Medical Device Alert has been issued as there is the potential for blood leakage (or other adverse incidents) with these grafts. The reported leaks have occurred at implantation.
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29 Mar 2012 | Medical Device Alert: Sterile indigo carmin manufactured by Derm Tech (MDA/2012/015)
This Medical Device Alert has been issued after the manufacturer identified that indigo carmin dye manufactured sterile may change to an unexpected colour and/or exhibit a weak colour.
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15 Mar 2012 | Medical Device Alert: LigaSure Dolphin Tip sealer/divider manufactured by Covidien (MDA/2012/013)
This Medical Device Alert has been issued as the handle pins may disengage, possibly compromising the removal of tissue from between the jaws.
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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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07 Mar 2012 | Medical Device Alert: AlboGraft Polyester Vascular Graft manufactured by LeMaitre (MDA/2012/010)
This Medical Device Alert has been issued as there is the potential for profuse bleeding (or other adverse incidents) with these grafts.
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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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16 Feb 2012 | Medical Device Alert: Stapler Duet TRS™ universal straight and articulating single use loading units (SULU) manufactured by Covidien (MDA/2012/005)
This Medical Device Alert has been issued following reports of serious injuries that have occurred following the use of Stapler Duet TRS™ loading units manufactured by Covidien in the thoracic cavity.
