Third WHO Global Forum on Medical Devices Geneva May 2017

Transcription

1 Third WHO Global Forum on Medical Devices Geneva May 2017 Key elements of medical imaging equipment procurement and equipment specifications Stewart Whitley, Treasurer, International Society of Radiographers

2 ISRRT s Identity Was founded in 1962 Has 94 Member Societies Has over 500,000 Society members and Is in excess of 5000 Associate Members. Has Officially recognized as Non-Government Organisation by the WHO. Is the only organization representing all disciplines of Radiographers and Radiological Technologists internationally.

3 Medical imaging equipment specifications key considerations Scope of the project - minor or major Operational context and requirements Specific specification requirements Pre-purchase questionnaire to confirm compliance with safety standards Associated building work Maintenance options Business plan approved with agreed budget

4 Medical imaging equipment specifications key considerations Tendering process local system or National - OJEC or NHS Supply Chain using National Framework (UK and European Economic Community) Expressions of interest via a Pre-Qualification Questionnaire (PQQ) Agreed selection criteria and scoring systems Invitation to Tender Equipment evaluation technical and costs including life time costs Final selection process Award of contract/business traditional purchase, lease or managed equipment service, adherence with National regulations i.e. NHS conditions of contract for the purchase of goods (September 2010) and other relevant regulations i.e. CE mark and electrical safety standards etc. (uk) PACS & RIS connectivity issues

5 Pre-Qualification Questionnaire (PQQ) Pre-Qualification Questionnaire A Pre-Qualification Questionnaire (PQQ) is a document to be completed at the beginning of the tendering process. The PQQ makes sure only suppliers who meet the our minimum requirements are invited to a tender. The PQQ document The PQQ document will give: an overview of the contract, including contract length and value an explanation on how the questionnaire will be evaluated the companies who will be invited to the next stage, which is the Invitation to Tender (ITT) he deadline by which to return the questionnaire

6 Invitation to Tender (ITT) An Invitation to Tender (ITT) is an invitation for a potential supplier to bid on a particular contract. The ITT contains: instructions on how to complete the response criteria against which the tender will be evaluated, for example price and quality certificates to be signed confirming agreement with the purchaser's policies and terms a specification providing details of the contract requirement contract terms and conditions between the purchaser and successful company pricing schedule where the provider enter prices in a standard format so they can be compared with other bids quality or technical questions

7 Medical imaging equipment specifications operational context and requirement narrative Location and nature/type of work undertaken Clinical Type of patients Volume/throughput of work Equipment configuration room layout DICOM and PACS/RIS connections QA aspects expected Installation requirements minimum room dimensions, weight, supporting cabinets dimensions, air conditioning requirements/ventilation, pre-installation work, power supply, lead time to delivery and installation time, guaranteed uptime etc...

8 Medical imaging equipment specifications specific core specifications (e.g. DDR system) X-ray generator Exposure control X-ray tube and housing X-ray table, Bucky mechanism and Vertical Bucky Detector(s) and housing requirements Ceiling tube suspension system Light beam diaphragm review workstation and post processing PACS/RIS links Data storage General Safety Accessories Radiation safety dose saving features

9 Medical imaging equipment specifications Pre-purchase questionnaire (PPQ) Equipment description generic device type, country of origin, model number, supplier details CE marking complacence with Medical Devices Directive, EMC Directive and Low Voltage Directive Management Systems Standards e.g. ISO9001:2008, ISO13485:2003, SGS Safety Standards Service/Spares/Installation information Ionizing Radiation information Decontamination/Reprocessing information Warranty Declaration

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11 Medical imaging equipment specifications sources of help National Guidelines UK: NHS Supply Chain (National Framework Agreement) Medical Physics Departments Existing specifications National Evaluation reports UK; The Centre for Evidence based Purchasing (CEP), MHRA s Device Evaluation Service, 6 Diagnostic Imaging Centres

12 Medical imaging equipment procurement process for sourcing, evaluating and purchasing Agreed equipment specification Associated building work Maintenance options Business plan approved with agreed budget Tendering process UK: OJEC or NHS Supply Chain using National Framework, Local system Agreed selection criteria and scoring systems Equipment evaluation technical and costs including life time costs Final selection process Award of business traditional purchase, lease or managed equipment service PACS & RIS connectivity issues

13 Medical imaging equipment procurement Key points for installation planning, overview of the process, planning things to consider etc. Identification of who is the client for signing off agreed plans Identification of project team Appointment of consultant? Identification of building and engineering requirements Room data sheets Room plans with sign off Appointment of sub contractors for pre-installation work turnkey or traditional Commissioning meeting to include identification of legal and statuary requirements and H&E issues, rules and codes of conduct including stop and start procedures etc Agreed Project Plan using Microsoft Project

14 Medical imaging equipment procurement Key points for installation planning, overview of the process, planning things to consider etc. Progress meetings Procurement of associated equipment furniture Method statement for delivery of equipment Risk assessments Equipment Handover including O&M manual (Operation and Maintenance) Commissioning and Mobilisation stage including Critical exam, MEGAN checks and Medical Physics IT issues connection with PACS & RIS Staff training Payment schedules

15 Key elements of medical imaging equipment procurement and equipment specifications