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 anaesthetists. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
Recent Medical Device Alerts relevant to radiologists
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25 Apr 2012 | Medical Device Alert: Dermal filler for breast augmentation Macrolane™ Volume Restoration Factor (VRF) manufactured by Q-Med AB (a Galderma division) (MDA/2012/022)
This Medical Device Alert has been issued regarding a problem when using Macrolane VRF20 and Macrolane VRF30 for breast augmentation which can make diagnosis of breast cancer more difficult, particularly with the use of mammography.
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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.
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23 May 2011 | Medical Device Alert: eXpert® DC Intraoral X-Ray systems manufactured by Gendex Dental Systems and supplied by KaVo Dental Ltd (MDA/2011/055)
This Medical Device Alert has been issued because the manufacturer has not had sufficient confirmation from users that they have received and acted on the information contained in the Field Safety Notice (FSN) for this device (dated 12 January 2011).
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17 May 2011 | Medical Device Alert: Powder free examination gloves manufactured by BM Polyco Ltd (MDA/2011/049)
This Medical Device Alert has been issued as gloves from the affected lots may have pinholes, which could increase the risk of cross infection and leakage.
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11 May 2011 | Medical Device Alert: Biogel Eclipse Reveal surgical gloves manufactured by Molnlycke Health Care (MDA/2011/043)
This Medical Device Alert has been issued as the company has received a small number of reports from customers overseas that pinholes have been found on the package seal of the Biogel Eclipse Reveal gloves. No reports have originated from the UK.
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19 Apr 2011 | Medical Device Alert: Eclipse treatment planning system manufactured by Varian Medical Systems Inc (MDA/2011/040)
This Medical Device Alert has been issued as when editing or changing the multi leaf collimator (MLC) using Eclipse, the dose plan may not recalculate automatically, as expected.
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12 Apr 2011 | Medical Device Alert: CT scanners manufactured by Philips Healthcare (MDA/2011/034)
This Medical Device Alert is being issued as the CT scanner table has the potential to collapse when a patient is on the table.
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17 Mar 2011 | Medical Device Alert: Microlance 30G x ½” sterile hypodermic needle manufactured by BD Medical (MDA/2011/028)
This Medical Device Alert has been issued as these needles, used for a variety of clinical procedures, may be blocked or partially blocked.
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03 Mar 2011 | Medical Device Alert: Alcohol skin preparation pads, swabs, and swabsticks manufactured by Triad Group Inc for H&W cv since 2007 (MDA/2011/023)
This Medical Device Alert has been issued because of a potential bacterial contamination of alcohol swabs which may lead to skin infection. This MDA updates MDA/2011/013R with details of additional manufacturers’ device packs and kits that contain the affected swabs.
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16 Feb 2011 | Medical Device Alert: All types, makes and models of breast implants (MDA/2011/017)
This Medical Device Alert has been issued because there is uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast. The MHRA has not received any adverse incident reports identifying ALCL in association with breast implants in the UK.
