6/3/2016 Crew

MCA Safety Bulletin NO. 7

By Notices

Inflatable life rafts intended for commercial and pleasure vessels have been found to contain medical kits from non-authorized suppliers. Some UK service stations, manufacturers and distributors of life rafts have imported and supplied medical kits that contain Chinese medicines and medical devices. These are not authorized for use in the UK.

The kits contain non-compliant medicines and medical devices that do not carry a CE (European Conformity) mark. Non-compliant medicines include those without a Distribution Authorization (unlicensed), those meant for prescription–only or pharmacy–only distribution. Seasickness pills stored in the life raft, but separate from the medical kit, are also suspect.

In addition, it is believed that some medical kit suppliers without authorization for United Kingdom (UK) distribution are marketing kits for sale on the internet. Medical kits supplied to another EEA state or other flag states must comply with the national regulations for that state.

Life raft suppliers and distributors have been given direction to inspect all life rafts imported to the UK. Instructions on customer contact are included with the bulletin.

The bulletin advises mariners and vessel owners to:

  • Contact the life raft supplier or service station that serviced, sold or rented the life raft for advice
  • Address immediate concerns about the medications or devices to the MHRA (Medicines and Healthcare products Regulatory Agency)
  • Be vigilant for unauthorized imported medical kits when you are buying life rafts or replacing kits for use by crew and guests on your vessel

Any kits from deployed life rafts or seasickness pills that appear suspect should be returned to the supplier for disposal under approved guidelines.

The full content of the bulletin is available.