EIGA Position Paper 26/18 – Filling of customer owned medical gas cylinders
Throughout Europe there are a number of customers that own medical gas cylinders and request that they are filled by a third party. These can include healthcare institutions, fire services, military services, home care service providers and homecare patients.
Dependant on the position taken by the national Regulatory Authorities in each Member State, this may require these cylinders to be filled under a Manufacturer's Licence (ML) and supplied under a Marketing Authorisation (MA).
Irrespective of the regulatory requirements, extreme care is needed to ensure that the specification and condition of the cylinder package does not jeopardise either patient safety or the safety of the person filling the cylinder.
This Position Paper covers both the specification of the valve and cylinder shell and the internal and external condition of the package. There should be a formal approach to the filling of these customer owned cylinders to ensure that the package is safe for the service for which it is intended.
13 December 2018