Flexible endoscopes 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2007/034

CON2031041

2007-05-10

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031041

The outer sheath and light guide tube of olympus flexible endoscopes may be damaged by direct exposure to ultraviolet (uv) light, as used in some endoscope storage and drying cabinets. keymed has informed the mhra of the increase in olympus flexible endoscopes being returned to them for repair due to damage to the outer sheath of the insertion tube and light guide tube. olympus believes that this damage is caused by prolonged exposure to uv light, as used in some endoscope storage and drying cabinets and causes significant deterioration in the outer coating of all olympus flexible endoscopes. this type of damage to the outer sheath of the flexible endoscope insertion tube and light guide tube may: cause trauma to the patient affect the functionality of the endoscope allow ingress of fluids into the endoscope inhibit effective decontamination of the endoscope by allowing micro-organisms to be retained in the damaged area of the endoscope reduce the number of endoscopes available for use in the unit whilst the affected endoscope is being repaired.

Avoid placing Olympus flexible endoscopes in storage and drying cabinets where UV light shines directly onto the endoscope. If no other suitable storage or drying cabinet is available carry out a risk assessment for the continued use of these cabinets for storing and drying Olympus flexible endoscopes. Before purchasing a new endoscope ensure that it is compatible with local endoscope storage and drying cabinets. Be aware of MHRA advice given in MDA/2007/035.