Is it a legal requirement for manufacturers to provide?
It is not a legal requirement for autoclave manufacturers to provide a Written Scheme of Examination (WSoE). We, Photon Surgical Systems now offer this documentation for the Newmed/Midmark autoclaves we sell.
Three defined but separate considerations…
- SERVICE – Service of the Autoclave to the Manufactures protocol – we call this the SERVICE BULLETIN, a comprehensive document provided by Midmark Newmed, periodically updated, explaining the method of service and service components required every 1000 cycles by a trained Engineer
- VALIDATION to HTM20-10 (Quarterly)/HTM01-05 (Annual) – Validation of the performance of the Autoclave using independent calibrated equipment Temperature/Pressure/Time, this is relevant in a Medical/Dental environment (but not a requirement in a Veterinary environment) – City & Guilds qualifications through Eastwood Park (Non-Vacuum Autoclaves. STM1 & Vacuum Autoclaves. STM4)
- PSSR 2000 – Pressure System Safety Regulation – This is a UK Regulation relating to all pressure vessel systems Autoclaves/ Air Compressors etc. An Inspection of the chamber/autoclave systems by a “competent person” to the “Written Scheme of Examination” is required every “time period defined in the WSoE” (e.g. per annum). See UKAS RG2 Document
Our objective is to achieve accreditation to provide Pressure Vessel Examinations to the WSE within 6-12 months. However, it is up to the practice themselves to source a company to fulfil this (I believe there is currently 5 companies in the country, most of the insurance companies).
Who’s responsibility is it to get a WSoE in place?
Please click here to view a copy of HSE L122 (Second edition) Published 2014. Pressure Systems Safety Regulations 2000 (PSSR 2000). It is the responsibility of the User/Owner of the system to ensure there is a WSoE in place (see PSSR regulation 8). There is no obligation on the supplier of the equipment to provide one. In the vast majority of cases, they are supplied by the inspection body contracted by the user.
The importers are the ISO9001:2015 accredited UK agents for Midmark Newmed Sterilization Equipment. They provide engineer training to the manufactures Service Bulletin, technical support and Validation to HTM20-10/HTM01-05. They have employed a “Pressure Vessel Consultant” for advice as compliance to PSSR 2000, as it is such a grey and confusing area within the Industry. Many companies provide WSoE, many provide Pressure Vessel Examination to the WSoE, but to what level of “competence”?. Ultimately it is your (the user/owners) responsibility to ensure the Inspector is a competent person, it is you we are endeavouring to protect.
Who can carry out the WSoE at the moment?
We can now provide an approved written Scheme of Examination for the Newmed/Midmark Autoclave range (the method of examination) approved by our Pressure Vessel Consultant. There will be a small charge for this document.
What do we need from you to can carry out the WSoE?
To provide a WSoE (Written Scheme of Examination) on Newmed / Kronos Autoclaves (any we sell from new). We will need the following details from you:
- Name Of Practice
- Address Of Practice
- Name Of Main User
- Location Of Autoclave
- Autoclave Serial Number
- Pressure Relief Valve Serial Number (this is located on the pressure relief valve – you will need to take the cover off to access this) We can provide this service free of charge however you will have to wait until we have an engineer is in the area to get the relief valve serial number or if you are in a rush there will be a call out fee in order for an engineer to come out to site.