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Primary care One Liners issue 01

Document details:

Type: Publication
Series No: PC01
Audience: Healthcare professionals
Published: 01/04/2005
Format:
Size: A4
Pages: 1
Price: free
ISBN/ISSN:
Author: MHRA
Copyright: Crown
   

ALL medical devices can fail but an increasing number of incidents that result in significant morbidity or mortality arise out of user/device interface problems or because of poor practices. The aim of this news sheet is to detail briefly some of these problems in an attempt to make users more aware of what can go wrong - it is all too easy to take equipment for granted...

Concentration Conflagration
MHRA has received several reports where patients have caused serious fires because they have been smoking cigarettes whilst using an oxygen concentrator in their homes.

  • Those issuing oxygen concentrators to domiciliary patients should ensure that they are fully aware about the dangers of smoking in the vicinity of the machine.

Steam Train
MHRA has become aware of vacuum (forced air removal) bench top sterilizers being used to processed wrapped, textile, hollow or tubular medical devices without being aware that a daily steam penetration test is necessary to assist in the demonstration of effectiveness of sterilizing such products.

  • Ensure that a daily steam penetration test is carried out in accordance with manufacturers instructions. If there is no test available, do not use the sterilizers for processing any of the above medical devices but use only for non-wrapped, solid devices.

False Track
MHRA received reports of false positive results in chlamydia immuno-assay testing due to the use of swabs not intended or validated for such use.

  • Ensure that all swabs used take into account the swab and test kit manufacturers' recommendations. In the absence of any recommendations, the suitability of swabs for the intended use should be established.

Plasma Screen
There are many different blood glucose meters available that use test strips which are either whole blood or plasma calibrated. Using plasma calibrated strips in a meter intended for whole blood calibrated strips can give results approximately 12% too high.

  • Make sure you know which type of meter is in use and employ the correct type of test strip.

Steamed Up!
MHRA has received a number of reports of patients who have been recalled for vaginal examination because vaginal specula have not been adequately sterilized following cleaning.

  • MHRA recommends the use of steam sterilization at 134-137° C for 3 minutes, rather than dry heat sterilization (hot air ovens) because it is quicker, more effective and more controllable.

Foot Sore?
MHRA has been made aware that wheelchair users who have diabetes are vulnerable to injuries or pressure ulcers of the feet, in addition to the more obvious load-bearing areas such as ischial tuberosities.

  • Risk to the feet should always be checked, especially if the patient cannot wear normal footwear. The appropriate foot support or padding should be provided.

Published by the MHRA, an executive agency of the Department of Health. If you would like to discuss or report an incident, including 'near misses' involving a device, either contact your trust's medical device liaison officer or contact us on: 020 7084 3123 (medical), 3128 (nursing) or email: devices@mhra.gsi.gov.uk



Page last modified: 13 August 2005