MHRA Ophthalmic Website

In December 2007 a doctor was undertaking a routine pupil examination in the Accident and Emergency Department. Asking the patient to open her eyes wide, he moved the pen torch close up and turned it on. Suddenly, the bulb blew and broken glass was scattered into the patient's eye; fortunately, the patient was unharmed. After finishing his examination, he reported the incident to the Medicines and Healthcare products Regulatory Agency (MHRA). Subsequently, a colleague informed him that she had experienced an identical problem with another pen torch earlier that week; at that time the patient was on high flow oxygen and the incident almost caused a fire. She had initially thought it was probably just a one-off so had not informed anyone, but after discussion with her colleague, she also reported the incident.

All incidents received by the MHRA are investigated in conjunction with the manufacturer and the more reports that are made, the faster the issue can be resolved; every individual report is thus extremely important. On this occasion, the manufacturer discovered that a processing fault had resulted in the bulb being incorrectly positioned and was thus more prone to exploding. The manufacturer, in collaboration with the MHRA, issued an immediate recall and a Medical Device Alert was issued (MDA/2008/028) to ensure that all of the affected pen torches were taken out of supply, quarantined and returned to the manufacturer for disposal. This factual sequence of events shows how collaboration between clinicians and the MHRA, via the reporting of adverse incidents, can increase the safety and safe use of medical devices.

Presently, the MHRA is working on making the reporting of Adverse Incidents easier by launching a series of specialty specific webpages. Ophthalmology is the first, and has been developed in collaborating with the Royal College of Ophthalmologists. Other aims of the page are to inform ophthalmologists about important safety information regarding medical devices and medicines specific to ophthalmology, and more general information which all medical practitioners should be aware of. As this webpage has been created specifically for ophthalmologists, the MHRA would encourage any feedback regarding its content and usability to susanne.ludgate@mhra.gsi.gov.uk

http://www.mhra.gov.uk/ophthalmology

Dr Susanne Ludgate, Clinical Director, MHRA

Mr Timothy Rimmer, Quality & Safety Sub-committee

Ophthalmology leads the way on safety
Do you know how to report adverse reactions to medicines or problems with medical devices? Do you know how to find out if anyone else has reported a problem with a drug or device you are using? Check out the MHRA website's new ophthalmology area www.mhra.gov.uk/ophthalmology

Updated 8 April 2010 (BB)