Events

Alerte Ou Avis De Sécurité sur Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par manufacturer #17429.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2005/063
  • Numéro de l'événement
    CON2022643
  • Date
    2005-11-28
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2022643
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    These, and some other, lancing devices are intended for self-use by one patient only, to take blood samples for self-monitoring. the use of softclix and softclix ii lancing devices by healthcare and care workers to take blood samples from multiple patients has been implicated in the transmission of hepatitis b between patients. single patient lancing devices e.G. roche accu-chek softclix, softclix ii, softclix plus and multiclix are intended for self-use by one patient only, to take blood samples for self-monitoring. they are not intended for use by healthcare or care workers to obtain blood samples from multiple patients because there is a risk of cross infection and the transmission of blood borne viruses. the mhra is aware that the inappropriate use of the softclix and softclix ii devices by healthcare and care workers to obtain blood samples from multiple patients has been implicated in recent outbreaks of hepatitis b in care homes in england, in which two patients have died.
  • Action
    When testing multiple patients, healthcare and care workers should not use single patient lancing devices such as the Roche Accu-Chek Softclix, Softclix II, Softclix Plus or Multiclix lancing devices to obtain blood samples. When obtaining blood samples from more than one patient healthcare and care workers must ensure that the lancing device that they use is intended for this purpose. When obtaining blood samples from patients, healthcare and care workers must ensure that they use either a lancing device that is intended for use by healthcare and care workers to obtain blood samples, or a disposable single-use lancing device (Please see MDA/2004/044 - Lancing devices for obtaining blood samples). Healthcare and care workers should not use lancing devices intended for single patient use such as the Roche Accu-Chek Softclix, Softclix II, Softclix Plus or Multiclix lancing devices to obtain blood samples from multiple patients Lancing devices such as the Accu-Chek Softclix Pro have been developed for use by healthcare and care workers to obtain blood samples from multiple patients. Multiple patient lancing devices and disposable single-use lancing devices are also available from other manufacturers. Since August 2005 disposable single-use lancing devices have been available on prescription. ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix la...
  • Modèle / numéro de série
  • Description du dispositif
    Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429