One Liners Issue 24 - October 2003

Cold Storage?
Defibrillator gel pads are temperature sensitive. MHRA continues to receive reports of incorrectly stored gel pads that have degraded and failed to function properly, resulting in poor conduction and possible patient burns.

• Always ensure that defibrillation gel pads are stored within the temperature range recommended by the manufacturer.

H to O?
Some oxygen therapy systems incorporate a bottle of sterile water to humidify the oxygen before it reaches the patient. Incidents have been reported where bottles have been over-pressurised, resulting in bursting.

• Always follow the manufacturer's instructions when assembling humidification systems for oxygen therapy devices.

Right Lines?
We have received several reports of inappropriate choice or over-insertion of central venous catheters, dilators or guidelines, leading to fatal consequences.

• Be aware of the range of devices available and select carefully, taking into account the size of the patient and intended route of insertion. A dilator should only be inserted far enough to open the puncture site, not pushed to its full length (MDA/2003/020).

Metal-work?
Recent reports have highlighted inadequate decontamination of reusable stainless steel vaginal specula. The consequences of this have, in some cases, led to patient recall and retesting.

• Wherever possible utilise single-use equipment or have your reusable devices reprocessed by a sterile services department (SSD). If this is not practicable or possible refer to Medical Device Alert MDA/2003/019 for guidance on re-processing stainless steel vaginal specula. General guidance on small steam sterilizers is given in Device Bulletin DB2002(06).

Rate Limiting?
The MHRA is aware of incidents where the infusion pumps were initially set at a fast delivery rate to purge the line but not reset to the desired rate for therapeutic infusion, resulting in over-infusion.

• Always check the delivery rate before pushing the 'start' button when any infusion is to be given.

Any Old Iron
A solid reamer fractured whilst being used to prepare a femur for hip replacement; part of the instrument was left in the patient. The fracture was the result of fatigue because the reamer was used beyond the end of its reasonable working life.

• In accordance with the guidance in Device Bulletin DB9801 and the Medical Devices Management Controls Assurance Standard, surgical instruments should be included in the planned replacement programme to reduce the likelihood of similar incidents.

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 involving a device, contact us on: 020 7972 8123 (medical), 8128 (nursing) or email: devices@mhra.gsi.gov.uk