Publications

Publications section

We produce a range of publications, most of which are aimed at healthcare professionals or people working in the device or pharmaceutical industries. Some are available in full-text as pdf documents.

Latest Publications

• 24 Jul 2008| MDA/2008/056 - Laboratory analysers and their associated assays - ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems, manufactured by Siemens Healthcare Diagnostics, serial numbers 078-A001-XX and XP 078-A010-XX

  This Medical Device Alert highlights an issue with the ADVIA Centaur and ADVIA Centaur XP systems which may fail to alert the user when the wash 1 bottle is nearly empty. This may lead to incorrect test results in high risk biomarkers.

• 24 Jul 2008| MDA/2008/055 - Homecare, intensive care and transport ventilators - Pulmonetic Systems (Cardinal Health) LTV1000, LTV950, LTV900, service agents Carina VT

  This Medical Device Alert has been issued due to affected ventilators that may fail in use without appropriate alarms.

• 24 Jul 2008| One Liners issue 60 - July 2008

  This news sheet is aimed at healthcare professionals and highlights problems with the use of medical devices. This issue covers topics including multi-lumen IV extension lines, tracheostomy tubes, laryngoscopes, resuscitation bags and vascular closure devices.

• 23 Jul 2008| Class 4 Drug Alert (Caution in Use): Baxter Healthcare Ltd - Accusol 35 Solution, Accusol 35 Potassium 2 mmol/l and Accusol 35 Potassium 4 mmol/l - EL(08)A/9

  We have been informed that some batches of Accusol 35 Solution, Accusol 35 Potassium 2 mmol/l and Accusol 35 Potassium 4 mmol/l have formed visible white precipitate during haemofiltration in Continuous Renal Replacement Therapy (CRRT).

• 23 Jul 2008| Public consultation (MLX 353): Consultation on advanced therapy medicinal products

  This consultation seeks your views on proposals for the UK’s exemption scheme for advanced therapy medicinal products (ATMPs) under Article 28 (2) of Regulation EC No 1394/2007 (“the ATMP Regulation”).

• 22 Jul 2008| MDA/2008/054 - Smiths Medical Portex™ Blue Line Ultra tracheostomy kits, lot no 499265

  This Medical Device Alert highlights that mislabelling of the device may result in the use of a fenestrated suction tube, reducing both suction and ventilation.

• 22 Jul 2008| MDA/2008/053 - Unomedical OP suction tubing lot 182281 only

  This Medical Device Alert has been issued after the manufacturer identified a manufacturing error with the potential for the tubing to collapse whilst in use, preventing suction.

• 21 Jul 2008| MDA/2008/052 - Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare

  This Medical Device Alert has been issued due to some variants of the Puma and Beatle being too heavy for the standard four point webbing tie-down system available for use in a vehicle.

• 21 Jul 2008| MDA/2008/051 - Kimal safety fistula needle (all product codes and lots)

  This Medical Device Alert has been issued after Kimal identified the potential for the unintentional retraction of the cannula into the protection sheath.

• 16 Jul 2008| Medicines & Medical Devices Regulations: What you need to know

  This short brochure provides an overview of what the MHRA does and how we do it.