Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2005/063

CON2022643

2005-11-28

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2022643

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.

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