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 orthopaedic practitioners. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
Recent Medical Device Alerts relating to orthopaedics
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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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27 Feb 2012 | Medical Device Alert: All metal-on-metal (MoM) hip replacements (MDA/2012/008)
The MHRA is issuing updated information and advice about the management and monitoring of patients implanted with metal-on-metal (MoM) hip replacements.
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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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20 May 2011 | Medical Device Alert: Wound dressing. PremierPore VP Island Dressing. Manufactured by Shermond. Specific lot numbers (MDA/2011/053)
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 issued on 16 March 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: Oxygen masks and face tent masks manufactured by Unomedical a/s (MDA/2011/038)
This Medical Device Alert has been issued as degradation of the plastic within six to eight months of manufacture can result in a sticky substance appearing inside and/or outside the mask.
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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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11 Feb 2011 | Medical Device Alert: Alco-Prep® alcohol skin preparation pads, swabs and swabsticks manufactured by H&W cv since 2007 (MDA/2011/013R)
This Medical Device Alert has been issued because this product has been recalled due to potential bacterial contamination of alcohol swabs which may lead to skin infection. Immunocompromised individuals are at greater risk of serious infection.
