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Hospital Beds / Cots
Notice type:
Advisory
Date:
10/06/2010
Product name or type:
Hospital Beds / Cots
Target Audience:
Hospital Managers / CEOs
Clinical Directors
Risk Managers
Purchasing Managers
Nursing Managers
Paediatric Ward Sisters
Health Services Executive (HSE)
Public and Private Nursing Homes
Problem Or Issue:
There is a risk that occupants may become entrapped in the side rails/mattresses of hospital beds/cots potentially resulting in harm, including death.
Background Information Or Related Documents:
Following a number of fatal incidents in Europe, including where a child became entrapped in the side rails of adult size hospital beds, the Irish Medicines Board (IMB) issued Safety Notice SN2006(01) relating to Hospital Beds in Paediatric Wards in January 2006.
As the prevalence of such incidents across Europe has continued in recent years, the IMB is providing further recommendations for healthcare institutions and emphasising that heightened vigilance and monitoring of this issue is required to ensure patient safety. The IMB also wishes to highlight that this issue may not be limited to children and consideration should also be given to other vulnerable bed occupants (e.g. elderly patients).
Hospital Beds / Cots Document
Actions To Be Taken:
1) Ensure that the appropriate staff members are advised of this notice.
2) Review the current practice in your institution and initiate the appropriate measures to reduce the likelihood of a similar incident occurring.
3) When conducting a risk assessment of patient beds/cots, relevant staff should consider that each bed occupant, mattress, bed and side rail combination is unique and therefore a comprehensive risk assessment is required to ensure patient safety. As part of such an assessment, relevant staff should pay particular attention to the following seven areas in the bed system where there is a potential for entrapment. (See Diagram on page 2 of attached pdf document. Source: US Food and Drug Administration).
4) Paediatric beds should be used for children. If paediatric beds are not available, ensure that appropriate risk mitigation measures are taken to ensure patient safety.
5) Staff should ensure that occupants of hospital cots are appropriately monitored.
Further Information:
All adverse incidents relating to a medical device should be reported to the:
Health Products Regulatory Authority
Human Products Safety Monitoring
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail:
vigilance@imb.ie
Website:
www.hpra.ie
Click
here
to Download a PDF version of the Safety Notice
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Date Printed: 20/04/2024