Please note that contact names and/or numbers may have changed since this notice was published. If you need to contact us about a particular notice, please call on 020 7084 3272 or e-mail dts@mhra.gsi.gov.uk quoting the reference number and title of the notice.
_________________________________
December 2002
MANUFACTURER/SUPPLIER
Various
PROBLEM
There is a risk of ineffective ventilation to the patient if breathing filters, heat and moisture exchangers (HMEs) or heat and moisture exchanging filters (HMEFs) incorporated into breathing circuits become occluded due to inappropriate use.
For the attention of:
NHS Trusts (England) - Chief Executives
National Care Standards Commission - Headquarters
Primary Care Trusts (England) - Chief Executives
ACTION
Ensure that filters, HMEs and HMEFs are correctly positioned in the breathing system by appropriately trained staff following the manufacturer's instructions for use.
Staff should be aware that occlusion of the filter, HME or HMEF increases the resistance to airflow, resulting in increased airway pressures. Airway pressures should be monitored during use and the filter, HME or HMEF changed as necessary.
Staff should check the manufacturer's instructions for use:
-
before any drugs are to be administered via the breathing system to ensure that nebulisation is not contra-indicated. Also check with the manufacturer of the drug that it is suitable for nebulisation. Ensure that the filter, HME or HMEF is correctly positioned and closely monitored airway pressures during and after nebulisation.
-
before using active humidification (i.e. heated water bath humidifiers)
-
for other contra-indications, such as use with patients who exhibit excessive respiratory tract secretions.
DISTRIBUTION REQUIRED
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:
TRUSTS to:
-
Liaison Officers (for onward distribution)
-
Directors of Anaesthetics
-
Medical Directors
-
Theatre Managers
-
Operating Department Practitioners
-
Accident and Emergency Departments
-
Intensive Therapy Units (Adults and Paediatric)
-
Special Care Baby Units
-
Maternity Departments
-
Dental practitioners
-
All wards
NATIONAL CARE STANDARDS COMMISSION to:
-
Headquarters (for onward distribution)
-
Care Homes providing nursing care
-
Care Homes providing personal care
-
Domiciliary Care providers
-
Hospices
-
Hospitals in the Independent Sector
-
Dental practitioners in the Independent Sector
PRIMARY CARE TRUSTS to:
-
Liaison Officers (for onward distribution)
-
Consultants in Communicable Disease Control
-
Directors of Public Health
-
General Dental Practitioners
-
General Practitioners
-
Health Visitors
BACKGROUND
The Medical Devices Agency (MDA) has received several reports of increased resistance to airflow of breathing filters, HMEs and HMEFs resulting in ineffective patient ventilation. One incident resulted in a patient developing a pneumothorax.
Reports indicate that the manufactuers' instructions for use are not being followed and that the devices are being used when contra-indicated. These have included use on patients with excessive respiratory tract secretions, incorrectly positioned devices and lack of monitoring of resistance to airflow during use, all of which have resulted in ineffective patient ventilation.
The Medical Devices Controls Assurance Standard, requires that all staff are provided with training in the safe use of equipment. Current standards can be downloaded from the standards link on the Controls Assurance website at www.casu.org.uk.
ENQUIRIES
Enquiries to the MHRA should quote reference number 20010911.012-3
© Crown Copyright 2002