Flexible endoscopes - avoid placing device in storage and drying cabinets where ultraviolet light shines on them

(Olympus) outer sheath and light guide tube of endoscopes may be damaged if directly exposed to ultraviolet (UV) light used in some endoscope storage and drying cabinets. (MDA/2007/034)

10 May 2007 at 11:00

Ref: MDA/2007/034

Action deadlines for the Safety Alert Broadcast System (SABS)

Deadline (action underway): 11 June 2007, Deadline (action complete): 10 August 2007

Device

Flexible endoscopes manufactured by Olympus, distributed in the UK by KeyMed Limited.

Problem

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.

Action

  • 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.

Action by

Lead staff involved in: * the reprocessing and use of flexible endoscopes * the procurement of flexible endoscopes and associated storage and drying cabinets * trust risk management, health and safety and decontamination

Distribution

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

Trusts to:

SABS liaison officers for onward distribution to all relevant staff including:

  • Chest physicians
  • Clinical governance leads
  • Day surgery units
  • Gastrointestinal surgeons and physicians (upper and lower)
  • General surgeons
  • Gynaecological surgeons
  • Health and safety managers
  • Infection control departments
  • Infection control nurses
  • Infection prevention and control directors
  • In-house maintenance staff
  • Medical directors
  • Neurological surgeons
  • Outpatient clinics
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Purchasing managers
  • Risk managers
  • Sterile services departments
  • Supplies managers
  • Theatre managers
  • Thoracic surgeons
  • Urological surgeons

Healthcare Commission (CHAI) to:Headquarters for onward distribution to:

  • Hospitals in the independent sector
  • Independent treatment centres

Primary care trusts to:

SABS liaison officers for onward distribution to all relevant staff including:

  • Community hospitals
  • Infection control nurses
  • Medical directors
  • Nursing directors
  • Purchasing managers
  • Supplies managers

Contacts

Enquiries to the manufacturer should be addressed to:

Roger Gray
General Manager - QA/RA
KeyMed Ltd
KeyMed House
Stock Road
Southend-on-Sea
SS2 5QH

Tel: 01702 444 276 (direct line)
Fax: 01702 445 112

E-mail: Roger.Gray@keymed.co.uk

Enquiries to the MHRA should quote reference number 2007/003/022/081/012 and be addressed to:

Technical aspects

Ian Smith or Allan Hidderley
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3306 / 3172
Fax: 020 7084 3106

E-mail: ian.smith@mhra.gsi.gov.uk & allan.hidderley@mhra.gsi.gov.uk

Clinical aspects

Nevil Batra
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

E-mail: nevil.batra@mhra.gsi.gov.uk

Change of address or removal from address list for Healthcare Commission:

Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG

Tel: 020 7448 0842

E-mail: contacts@healthcarecommission.org.uk

How to report adverse incidents

Incidents relating to medical devices must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as soon as possible.

Further information about reporting incidents; online incident reporting facilities; and downloadable report forms are available from MHRA’s website (http://www.mhra.gov.uk).

Alternatively, further information and printed incident report forms are available from:

MHRA Adverse Incident Centre
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

Telephone 020 7084 3080 or Fax 020 7084 3109 or e-mail: aic@mhra.gsi.gov.uk(An answerphone service operates outside normal officer hours)

Medical Device Alerts are available in full text on the MHRA website:http://www.mhra.gov.uk

Further information about SABS can be found at www.info.doh.gov.uk/sar2/cmopatie.nsf

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