SN 2002(30) - Ureteric stent degradation by light

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December 2002

MANUFACTURER/SUPPLIER
Cook Urological

PROBLEM
The Cook Sof-Flex® Multi-Length ureteric stent may degrade and become unfit for use before the indicated expiry date, if it has not been stored in the dark.

For the attention of:

NHS Trusts (England) - Chief Executives
National Care Standards Commission - Headquarters
Primary Care Trusts (England) - Chief Executives

ACTION

• Do not use Cook Sof-Flex® Multi-Length ureteric stents that have not been stored away from artificial light as well as daylight.
• Store medical devices under the conditions indicated on the label.
• Ensure that appropriate storage facilities are available at relevant sites (wards, operating theatres, storage rooms, etc.

DISTRIBUTION REQUIRED
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:

TRUSTS to:

• Liaison Officers (for onward distribution)
• All Healthcare Managers and Professionals
• Distribution Managers
• Medical Directors
• Urologists
• Gynaecologists
• Nursing Executive Directors
• Sterile Services Managers
• Supplies Managers
• Theatre Managers
• All staff involved in the storage of devices

NATIONAL CARE STANDARDS COMMISSION to:

• Headquarters (for onward distribution)
• Hospitals in the Independent Sector

PRIMARY CARE TRUSTS to:

• Liaison Officers (for onward distribution)
• All PCT based urology theatres

BACKGROUND
Recently a case has come to MDA's attention where two polymeric ureteric stents became friable within the stated shelf life of the product. One stent crumbled upon explantation, two weeks after insertion into the patient. A nephrostomy was needed to remove the stent parts. A second (unimplanted) stent from the same hospital was examined and also found unsuitable for use. It appears that storage of these devices in glass cabinets with exposure to artificial lighting had caused the materials to degrade. The individual products were packaged in transparent foil. Product labelling indicated that the devices should have been stored in the dark.

MDA is currently discussing packaging changes with the stent manufacturer to afford improved protection from light. However, polymeric materials are generally susceptible to ageing and this phenomenon may cause them to become brittle over time. The Medical Device Regulations require that manufacturers should state the expiry date on the label of their devices. This is the date until which the device can be safely stored in accordance with the product labelling. If the recommended storage conditions have not been observed, the effective lifetime of the device could be less than that stated on the label.

ENQUIRIES
Enquiries to the MHRA should quote reference number 20020308.999-046

© Crown Copyright 2002