Hill-Rom TotalCare Duo 2 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2007/065

CON2032088

2007-07-22

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032088

The manufacturer has omitted to provide suitable decontamination instructions with this pressure relieving hospital bed. the mhra has received two reports of damaged mattress covers that allowed body fluids to soak into the mattress. no instruction was provided on how to check the condition of the mattress and cover. this presents a risk of cross infection. the manufacturer has omitted to provide customers with information on how to undertake suitable checks and decontamination procedures. the manufacturer does not include full decontamination details with the instructions for use, due to different requirements in different countries. in the uk they are covered in a separate document, w13001uks rev2. two nhs trusts have reported a risk of cross infection with this bed. residues of body fluids from previous occupants have been found under mattress covers. many of these beds are used by intensive care units. the mhra has not received any adverse incident reports of cross infection occurring due to this problem.

Trace all Hill-Rom TotalCare Duo 2 beds in use and in storage. Contact Hill-Rom on 01530 562167 for copies of the cleaning and disinfection instructions. Unzip the mattress covers and check for signs of fluid contamination on the mattress and damage or holes in the mattress covers. Dispose of damaged covers. If replacement or spare mattresses and mattress covers are required, contact Hill-Rom on 01530 411000 Between each patient use check whether any fluids have penetrated the cover and follow Hill-Rom’s cleaning, disinfection and laundry advice for the covers and mattresses.