One Liners issue 64 - February 2009

Still or sparkling?
MHRA has received reports of erroneous results on laboratory tests where the reagent has not been aspirated because of bubble formation on the surface of the reagent liquid.

• Always follow the manufacturer’s instructions for use to minimise bubble formation and removal of air bubbles that form on the liquid surface of the reagent.

YOU’RE fragMEANT to retrieve it..
MHRA has become aware of a number of instances where fragments of vascular catheters and guidewires left in the patient’s body have caused death or serious injury.

• Minimise the likelihood of device breakage by not using too much force on insertion or withdrawal or by bending the device. If the device does break, ensure that this is recorded in the patient’s notes and the patient is made aware.

Radio inactive
MHRA is aware of a small number of reports in which X-rays emitted during CT exams may cause active implantable medical devices to malfunction, eg, unintended shocks from neuro stimulators.

• Ensure a system is in place to check whether the patient has such a device and if so, that there are procedures to minimise x-ray exposure by keeping equipment out of the primary beam and to deal with emergencies.

Keep practicing…….
MHRA has recently updated and published “Devices in Practice” a practical guide to medical devices for all health and social care professionals working in acute, primary care and social care sectors.

• It contains checklists for procuring and using medical devices safely, together with advice on record keeping, maintenance and repair, training and reporting adverse events.
• “Devices in Practice” is available on the MHRA website or a hard copy can be obtained by emailing; michael.peel@mhra.gsi.gov.uk

The curse of inflation
MHRA has received reports of overinflation of the balloons of foley urethral catheters for paediatric use which are supplied with pre-filled syringes containing a volume of fluid that exceeds the inflation volume of the balloon. This has resulted in balloon bursting and the need for recatheterisation.

• Always ensure that the manufacturer’s maximum inflation volume is not exceeded.

Don't cross lines…
MHRA is aware of an incident during a phaco procedure where the irrigation and vacuum lines were incorrectly connected leading to a collapse of the lens bag.

• Always test the hand piece prior to use to ensure its correct function.

The One Liners Editions are published by the MHRA, an executive agency of the Department of Health.
Adverse incidents should be reported at the earliest opportunity. We prefer to receive reports via the online reporting system on our website www.mhra.gov.uk
You may also use this online system to send an e-mail copy of your report to your medical device liaison officer.
We also have an adverse incident hotline: 020 7084 3080. You can find detailed reporting guidance on our website.