Medicine feeders including spoons, syringes and soothers are classified as medical devices. Such devices can be categorised as (1) Medicine feeders with volumetric markings or specifications and (2) Medicine feeders without volumetric marking or specifications.
Medicine feeders without volumetric markings are not intended to provide a measuring function or to accurately measure medicine doses.
The Medicines Board issued a safety notice on the 27th of June 2011 to the general public, pharmacies, hospital personnel and retailers concerning the use of medicine feeders.
They warned companies who wished to place medicine feeders on the Irish market that they must be in compliance with the Medical Devices Directive 93/42/EEC and S.I. No. 252 of 1994. These regulations provide that the devices and their labelling are required to bare a CE mark.
The IMB has become aware of number of non-compliance medicine feeders including spoons, droppers, syringes and pacifiers that have been provided to pharmacy outlets, retail outlets and hospitals. Non conformances have varied from inadequacies in the labelling to products that have not been assessed by a notified body.
They have directed that pharmacists, hospital personnel and retailers ensure that their staff are made aware of the advisory notice and also aware of the differences between the products. In incidences where a device is not supplied to the consumer with its original packaging they have been warned to ensure that the use, accuracy and cleaning of the device is clearly outlined to the customer.
Consumers have also been warned by the IMB that before using the medicines, particularly oral liquids, that they have ensured that they have confirmed with their pharmacist how it should be administered and that they understand the dosage required and how best to measure it. Any consumer with concerns or questions should consult with their pharmacist or general practitioner as a matter of urgency.
If any of these issues affect you, you should immediately contact Liam Moloney, Solicitor in Naas, on 045 898000 to find out your rights.