Transilluminators used with neonates - ensure you follow the instructions and that the device can be used with neonates

(All) use of an inappropriate light source for transillumination can result in burns. (MDA/2003/044)


Issued: 2 December 2003


Transilluminators used with neonates


Use of an inappropriate light source as a transilluminator can result in burns to the patient.

A neonate recently received a serious burn when a new light source was used as a transilluminator. Additionally, the hospital had an identical unit with a filter fitted, which had been used for some time without injury. The manufacturer subsequently stated that these devices were not intended to be used for this purpose, with or without a filter. There was no mention of use of this light source as a transilluminator in the instructions for use.


  1. Before purchasing a light source, verify that its intended purpose meets your requirements.
  2. Before use, ensure that the transilluminator is used:
    • for its intended purpose
    • in accordance with the manufacturer’s instructions for use, paying particular attention to recommendations regarding light intensity.
  3. Be aware of the risks if the device is used for a purpose not described within the manufacturer’s instructions for use.

  4. For pilot sites of SABS, an implementation plan should be in place within 30 days, to ensure that all staff have undertaken the actions described in this alert and the actions are incorporated into training plans for new staff.


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


  • Liaison officers (for onward distribution)
  • Directors of anaesthetics
  • Medical directors
  • Nursing executive directors
  • Anaesthetists
  • Paediatricians
  • Theatre managers
  • Paediatric intensive care units
  • Special care baby units
  • Accident & emergency departments
  • Health & safety officers
  • Risk managers
  • IV therapy nurse specialists
  • Clinical governance lead
  • Paediatric out-patient departments


  • Hospitals in the independent sector


Technical aspects:

Michael Pearman or Louise Mulroy
Hannibal House
Elephant and Castle
London SE1 6TQ

Tel: 020 7972 8177 / 8113
Fax: 020 7972 8209


Clinical aspects:

Jonathan Plumb
Hannibal House
Elephant and Castle
London SE1 6TQ

Tel: 020 7972 8128
Fax: 020 7972 8111


Enquiries to the MHRA should quote reference number 20021105.030-26 and be addressed to:

Change of address or removal from list for services registered under the Care Standards Act 2000

NCSC Customer Service Unit
St Nicholas Building
St Nicholas Street

Tel: 0191 233 3556


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MDA/2003/044 - Transilluminators used with neonates

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