EFHSS Questions and Answers - Question Q00269

We are in the process of putting out an RFP for a tunnel washer and have utilised many aspects of HTM 2030 as the basis for the performance specification

Several of the firms have come back with comment that this HTM will add significantly to the cost of the initial unit and the operating costs.

Their advice is that we should be specifying appropriate International/European Standards as the basis of our RFP

I would appreciate others experiences with specifying tunnel washers

Thanks
Tony Blackler
Manager Sterile Services
Christchurch, N.Z.

Tony

Implementation of HTM 2030 will indeed add to the cost of a machine. However, there is no other current standard for a washer-disinfector. The European standard is currently under comment but its requirements are roughly the same as HTM 2030. Thus, if you wait until EN ISO 15883 is finally published and you specify that for compliance then you will end up with a machine similar to one that complies now to HTM 2030. You must remember that HTM 2030 is a document that does not only cover machine design, intruemntation and validation. It also covers aspects of operation and management and thus refelcts a systematic approach to the decontamination of medical devices. HTM 2030 is used for specification and compliance of all washer-disinfectors being installed within the UK and reflects what any future standard will require. If you do not use 2030 for purchasing then you have no other option.

Best wishes - Peter Hooper