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MDA/2007/065 - Hospital beds: Hill-Rom TotalCare Duo 2

Document details:

Type: Medical Device Alert
Series No: MDA/2007/065
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 22 July 2007 at 14:30
Ref: MDA/2007/065
 Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Hospital beds: Hill-Rom TotalCare Duo 2.

 

Problem:
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.

>Page 2

Action by:
All those using and managing pressure relieving hospital beds, in particular: bed managers, nurses, care staff, maintenance staff and contractors.

 

Action:

  • 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.

 

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
Social services in England - Directors*

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

>Pages 2-3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 30 August 2007
Deadline (action complete): 12 September 2007


Page last modified: 22 August 2007