Stewart Whitley, Treasurer, International Society of Radiographers

Third WHO Global Forum on Medical Devices Geneva – 10-12 May 2017

Key elements of medical imaging equipment procurement and equipment specifications

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.

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

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

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

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

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.…..

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

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

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

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

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

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

Key elements of medical imaging equipment procurement and equipment specifications