Value-based Procurement Of Medical Equipment

Leveraging Health Technology Management SystemsMedical equipment planning and procurementare conducted as part of a national healthtechnology management (HTM) system. Asdefined by WHO, the proper management anduse of health care technologies begins with astrong understanding of the needs of the country,region, community, and facility, and ends withfinal equipment decommissioning and disposal.HTM includes planning and procurement,appropriate donation solicitation and provision,effective equipment delivery and installation,asset inventory management, maintenance,and end-user training on correct operation.HTM is conducted alongside health technologyassessments (HTAs) and health technologyregulatory and performance compliance.9Recognizing the important role of healthtechnologies, the 60th World Health Assemblyreinforced the need to establish priorities in theselection and management of health technologiesin resolution WHA60.29.10 This resolutionrecommends that to reduce wasted resources,ministries of health develop national strategiesto support HTM, including the development ofsystems to assess, plan, procure, and managehealth technologies.HTM systems will vary by country and healthsystem level. Some countries will need to investin additional advocacy and analysis activities tounderscore for decision-makers the importantrole that HTM plays in an efficient health system.Value-based procurement of medical equipmentFigure 2 illustrates some of the links of HTM to policy,regulation, financing, and public health researchprocesses, and shows the various stakeholders thatcontribute to and benefit from an HTM system.Ministries of health will need to work withstakeholders to identify practical and feasible HTMindicators to monitor and use for performancemanagement systems. Procurement teams canincorporate these HTM indicators into contracts andservice level agreements as appropriate.Figure 2. HTM linkages to a national health systemHealth Policiesinclude procurement and HTM policiesEnablingsystems andinformationHealth Technology ManagementRegulatorySystemStakeholdersPLANNING AND REQUIREMENTSHealth systemstrengtheningstrategiesACQUISITION (PROCUREMENT OR DONATION)INSTALLATION AND ACCEPTANCEHealth MANAGEMENT AND MAINTENANCEEpidemiologicaland implementationresearchDECOMMISSIONING AND DISPOSALAdapted from Global Health Tech Equity, How Emerging CE-HTM Can Help (webinar). American College of ClinicalEngineering, April 2017. https://youtu.be/jZZPySot8hU. 4 ALENGINEERS

HTM processes and activitiesMedical equipment planning and procurementare HTM processes in the acquisitionstage. The acquisition stage is followed bythe utilization stage of HTM. Examples ofactivities that occur during the acquisitionand utilization stages of HTM are shown inTable 1. This guide focuses on the equipmentacquisition stage of HTM.Table 1. Examples of stages, processes, and activities for HTM acquisition and utilizationMEDICAL EQUIPMENT ACQUISITION STAGEProcessActivity examples Needs assessmentEquipment planning Health technology assessments Health system strengthening Budgeting/financing for TCO Feasibility appraisal Value for money appraisalHTM requirementsIdentifying, analyzing, and planning toaddress the life cycle requirements of medicalequipment not only helps procurement teamsmaximize VFM and patient outcomes, but alsoinforms accurate technical specifications thatrepresent national, subnational, and facilitylevel needs.Public procurement teams must have activeparticipation from a multidisciplinary teamof HTM stakeholders, including healthfacility staff, clinical and laboratory experts,biomedical engineers, health programmanagers, health system strategists, healthfinancing agencies, and—in some cases—patients to fully understand equipmentrequirements. Some of the required inputsfrom HTM representatives are listed in Table 2. Market analysis Technical requirement identificationEquipment procurement Procurement specifications Tender/purchase/lease Delivery and installation Commissioning and acceptance Initial training of users and techniciansMEDICAL EQUIPMENT UTILIZATION STAGEProcessActivity examplesEquipment management Contact management Supplier management Equipment inventory/audits Performance monitoring Maintenance/spare part tracking Routine training of users and technicians Evidence-based replacement planning Decommissioning and disposal Post-market surveillanceRisk management Inspection and calibration Adverse event monitoringValue-based procurement of medical equipment 5

Table 2. Stakeholder inputs to equipment planning and procurement HTM processesHealth facilitypersonnelClinicians andlaboratory managersBiomedicalengineers Health need characterization Health need characterization Maintenance requirements Usability criteria Usability criteria Quality standards Background on pastequipment performance Patient needs Power quality andavailability Past local supplierperformance Existing annual or multi-yearfacility plans Environmental factors Facility accessibility Training needs Transport Infrastructure status Assessments Installation Power quantity and quality Existing HTA outputs Maintenance Training needs TCO input data Spare part management TCO input data Risk identification Inspection Consumables Risk identification Water and waste systems CalibrationPolicy andfinancial personnelProcurementstaff Relevant strategicinitiatives Bidding documents Legal requirements Contract management Budgets formaintenance Supplier performancemonitoring Contract documents Budgets for operationand disposal Timeline andconstraints Partnershipmanagement Donor management TCO input dataHTM regulations and standardsHTM should be supported at the national, subnational, and facility levels with regulations,standards, and funding.HTM regulations or standards must outline: Roles and responsibilities for medical device(including medical equipment) management. Importance of HTM that includes selection,acquisition, acceptance, maintenance, repair,monitoring, and disposal of equipment.Value-based procurement of medical equipment Requirements for risk management, includingadverse incident reporting.Examples of existing HTM policies or standardsinclude: Training requirements and access to themanufacturer’s instructions.UK Health and Social Care Act (RegulatedActivities) Regulations 2014: Regulation 15 Record keeping, including asset inventories andmaintenance tracking requirements.This UK Government regulation includes therequirement that medical equipment used to delivercare and treatment must be clean, suitable for theintended purpose, maintained, stored securely, andused properly. Conditions for outsourcing of maintenance. Standard protocols for equipment deployment,tracking, and utilization. Equipment acquisition and utilization financing. Decontamination requirements, when needed. 6 Available at https://bit.ly/UK HCSA regulations.

ANSI/AAMI EQ56: 2013, Recommended Practicefor a Medical Equipment Management ProgramThis recommended practice from the AmericanNational Standard Institute’s Association for theAdvancement of Medical Instrumentation specifiesminimum criteria for a management programdesigned to minimize certain risks associated withequipment that is used during the routine care ofpatients in a health care organization.Available at https://bit.ly/EQ56 1303 preview.US Joint Commission Revised EquipmentMaintenance Standards for Critical Access HospitalsThese maintenance standards, developed by theUnited States Centers for Medicare & MedicaidServices (CMS), require that health care facilitiesmaintain, inspect, and test all inventoried medicalequipment in accordance with manufacturers’recommendations or with strategies of an alternativeequipment maintenance (AEM) program.Available at https://bit.ly/Joint CommissionMaintenance.CASE STUDYMedical Equipment Uptime Project in ZambiaIn 2017, the Zambian Ministry of Health requested that the Tropical Health and Education Trust(THET) study the impact of biomedical engineering technologists (BMETs) on medical equipmentperformance in reference hospitals.At the conclusion of the Medical Equipment Uptime Project, a systematic approach toprocurement of new medical equipment was recommended to diminish the large differences inequipment availability at various hospitals. This approach would also make access to health carethroughout Zambia more equitable and would support the goal of universal health coverage.Financial analysis at the end of the project concluded that medical equipment procurementwithout an equipment maintenance plan is wasteful. Analysis also indicated that: Cost of Service Ratio (COSR), defined as the yearly cost of providing maintenance dividedby the initial procurement cost of the equipment, was estimated as 2.8% for “in-house”maintenance. COSR of 5% should be budgeted for outsourced maintenance contracts. Maintenance budgets should not be assumed to be available. Equipment lifetime will be reduced by a factor of 2 if maintenance costs are not addressed. Priorities of the health departments did not correspond with equipmentprocured centrally. Standard Equipment Lists (SEL) focused primarily on needsof higher-level hospitals. New equipment procurement often replaced availableequipment that could instead be repaired. Procurement of spare parts was needed in 30% ofrepair cases; however, procurement of spare partsfrom international suppliers was not successfulin the project timeframe.Adapted from: THET, Medical Equipment Uptime ProjectFinal Report.11 Photo: PATH/Gabe Bienczycki.Value-based procurement of medical equipment 7

HTM RESOURCESWHO publications on medical devicesAvailable at https://www.who.int/medical devices/publications/.“How to Manage” Series for Healthcare TechnologyZiken International. St. Albans, UK: TALC; 2005. https://bit.ly/How to Manage Series.This series is designed to contribute to improved health care technology management (HTM).The series includes: Guide 1: How to Organise a System of Healthcare Technology Management Guide 2: How to Plan and Budget for your Healthcare Technology Guide 3: How to Procure and Commission your Healthcare Technology Guide 4: How to Operate your Healthcare Technology Effectively and Safely Guide 5: How to Organise the Maintenance of your Healthcare Technology Guide 6: How to Manage the Finances of your Healthcare Technology Management TeamsManaging the Lifecycle of Medical EquipmentTropical Health and Education Trust (THET). London: THET; 2017. https://bit.ly/THET Managing Lifecycle.International Federation for Medical and Biological Engineering (IFMBE) websitehttps://ced.ifmbe.org/. Accessed March 31, 2020.The IFMBE supports the United Nations and WHO to promote information on biomedical and clinicalengineering and advancing safe and effective medical technology design, deployment, and managementprograms.EBME websitehttps://www.ebme.co.uk/articles/management. Accessed March 31, 2020.This medical engineering portal operated in the United Kingdom includes many articles and aggregatesstandards and guidelines for medical equipment management and maintenance.Operating room at the Uganda CancerInstitute. Photo: PATH/Lynn Heinisch.HTM support materialsThe Biomedical Equipment Management and Maintenance Program of the National Health Systems ResourceCentre, Ministry of Health and Family Welfare, Government of India, has produced the following: Biomedical Equipment Management and Maintenance Program. New Delhi: Government of India; 2018.https://bit.ly/NHSRC HTM Guide. Technical Guidance Document for In-House Support and Monitoring of Public Private Partnerships. NewDelhi: Government of India; 2019. https://bit.ly/NHSRC Outsourcing.Value-based procurement of medical equipment 8

Documenting Medical Equipment RequirementsMedical equipment requirements document thefunctions, performance, and features necessary tomeet the end user’s needs and deliver the desiredhealth outcomes at the facility in which equipmentwill be utilized and maintained. Requirements shouldcommunicate what is needed over the completeequipment life cycle, from installation to theoperational and decommissioning stages.Incomplete or inaccurate medical equipmentrequirements will result in equipment that: Does not meet a health need. Cannot be correctly installed or commissioned. Will not have access to the required quantity orquality of energy. Will be broken by untrained users or technicians.How are medical equipmentrequirements documented?There are three different documents used tocommunicate medical equipment requirements:1. Procurement product profiles2. Technical specifications Will not be decommissioned or disposed of properlyat the end of its economically viable lifetime.Requirements should be written in simple, precise,and brand-agnostic language to support active, fair,and transparent competition in the tendering process.Requirement documentation should be a collaborativeactivity that engages all relevant HTM members.Requirements are specified in three documents whichwill be developed sequentially and are detailed here.Value-based procurement of medical equipmentThese three documents—the procurement productprofiles, technical specifications, and procurementspecifications—are developed sequentially, asshown in Figure 3 on the next page.3. Procurement specifications (also known asbidding or tender documents)Table 3. Description, purpose, and key contributors to medical equipment requirement documentsDocument typePurposeProcurementproduct profilePreliminary documentation that provides a high-leveldescription of what is needed, including accurateinformation from a facility perspective. This documentalso highlights urgent constraints that must beaddressed in the technical specifications document. End usersTechnicalspecificationsThe technical specifications document is a commonformat that specifies functional, performance, anddesign requirements for medical equipment. It alsooutlines what will be needed for delivery, installation,commissioning, and acceptance of equipment. Biomedical engineersProcurementspecificationsAlso known as bidding or tender documents,procurement specifications will include technicalspecifications and information on the procurementprocess, dates of bid submission and opening,evaluation criteria and methods, and contract termsand conditions. Procurement staff Cannot be calibrated or maintained according tomanufacturer’s recommendations. Is not sustainable for operation in the facility’sexisting budget.These documents will be used for differentpurposes and with varying levels of detail, asdescribed in Table 3. 9 Contributors Program staff Biomedical engineers Technical experts Technical experts Technical experts

Figure 3. Sequential steps to profile, specify, and prepare procurement LSPECIFICATIONSPROCUREMENTSPECIFICATIONS Facility focused Biomedical engineering led Characterizes health need Finalizes functional,performance, and designspecifications Includes environmental data Usability factors identified Patient needs included Technical requirementsdrafted Required accommodationsare noted Informed by market analysisand supplier evaluation Used by procurement teamsto prepare procurementspecifications Also known as bidding ortendering documents Technical specifications area component Also communicatestendering/bid process,timeline, evauation methods,contracting terms, andconditionsAdditional information on implementing each of these steps is provided in the following text.Value-based procurement of medical equipment 10 1. Procurement product profileThe procurement product profile is a highlevel description of basic medical equipmentrequirements, specifically focused onmeeting the needs of patients and end users,recognizing what is appropriate for a specificfacility context, and planning for how theequipment will need to be supported by thehealth technology management system.The procurement product profile will bedeveloped and coordinated by the procurementteam, with input from facility managers,intended equipment end users, clinical andlaboratory experts, biomedical engineers, andother members of the HTM team.Table 4 lists examples of procurement productprofile content from facilities that characterizethe health, user, and facility needs.Clinical, laboratory, biomedical engineering, andother technical experts will review the facilityand end-user information to help procurementteams draft functional, performan

procurement processes—but also the potential benefits to patients, providers, and national health and HTM systems. As part of VBP, a VFM analysis . role that HTM plays in an efficient health system. Leveraging Health Technology Management Systems Figure 2 illustrates some of the links of HTM to policy,