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One Liners Issue 35 - July 2005

Document details:

Type: Publication
Series No: 35
Audience: Healthcare professionals
Published: 01/07/2005
Format:
Size: A4
Pages: 1
Price: free
ISBN/ISSN:
Author: MHRA
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

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 equiment for granted...

Pad-antics
The MHRA is aware of issues involving defibrillation electrodes not being properly applied to the patient.

  • Do not open packs until ready to use. Check that electrode packaging is intact and the electrodes are in date. Prepare the chest area to achieve good skin contact, removing excess hair if necessary. If an adverse incident occurs, retain both electrodes and packaging.

Invisibly Intense
We have received reports of failure to locate radiopaque swabs left in the body following an operation using an image intensifier in theatre.

  • Users should be aware that, under these circumstances, a plain X-ray may be helpful.

Hubub?
We have received a number of reports of disconnection of detachable compression hubs from central venous and epidural catheters. This can result in leakage and catheter embolisation.

  • Always follow the manufacturers' instructions for assembly of compression hubs to ensure that the catheter is inserted to the appropriate depth and tightened appropriately. Regular checks on the security of the catheter to the hub should be performed.

Sit Tight
The MHRA has received a number of reports of death or serious injury to wheelchair users when a posture belt has been incorrectly fitted or adjusted.

  • Always fit posture belts in accordance with the wheelchair, the seating or the belt manufacturers' instructions and adjust the posture belt to suit the user. If appropriate, pass on guidance on how to maintain correct adjustment to the user or carer (MDA/2005/025).

Not a Wee Tube!
The MHRA is aware of an off-label practice where foley catheters are employed as enteral feeding tubes or to maintain the stoma when tubes are displaced. Unlike such tubes, foley catheters do not have an external fixation device and there is a risk of migration or displacement.

  • Ensure that medical devices are used in accordance with the manufacturers' instructions and for their intended purpose of use (MDA/2004/006).

Bedevil!
The MHRA has received a number of reports relating to risk of entrapment and crushing from accidental operation of foot controls on electrically operated beds.

  • If your organisation has electrically operated beds fitted with foot operated height controls, ensure lock-out functions are used in accordance with manufacturers' instructions for use. If no lock-out functions are fitted, alternative steps to reduce the risk of patient entrapment such as guarding, repositioning, permanently disabling, or removing the foot controls, should be considered.
 

Wrong Way Me Cock!
We have received a report where an unmarked two way stopcock was inadvertently left in the off position when pericardiocentesis was commenced. This prevented drainage and the patient developed cardiac tamponade.

  • Users should be aware of the on/off position, especially for unmarked stopcocks and ensure that the appropriate position is selected.
Published by the MHRA, an executive agency of the Department of Health. The MHRA was formed from a merger of the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) on 1 April 2003. 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: 10 October 2005