In my earlier April 15, 2019 Blog, I noted that the World Health Organization (WHO) states that “trained and qualified biomedical engineering professionals are required to design, evaluate, regulate, maintain and manage medical devices, and train on their safe use in health systems around the world.1” As we in IFMBE CED like to say, these “biomedical engineers-BE” as identified by WHO match our global job description for ‘clinical engineers-CE’, involved in Health Technology Management-HTM.
WHO has “conducted surveys and studies to have information on the academic programs, professional societies and status of biomedical (and clinical) engineers (BE/CE) worldwide, which will further enhance their involvement to increase access to safe, quality medical devices globally in order to provide better health care.1” From the results of surveys and studies conducted, a WHO publication about the role of BE/CE has been established.
The WHO on-line publication “Human resources for medical devices, the role of biomedical engineers, is part of the medical device technical series2, where WHO presents the different roles the BE/CE can have in the life cycle of a medical device, from conception to use. It is recognized that medical devices are becoming ever more indispensable in healthcare provision and among the key specialists responsible for their design, development, regulation, evaluation and training in their use – are biomedical (clinical) engineers.1” Health Technology (HT) defined by WHO: the application of organized knowledge & skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life.
Further, “WHO has compiled all information from the previous and current (2017-2018) surveys in order to apply for recognition of Biomedical Engineering as a discipline in the ILO (International Labor Organization) Standard Classification of Occupations, as biomedical engineers (currently) belong to Unit Group 2149 ‘Engineering Professionals Not Elsewhere Classified’.1" When ILO officially recognizes this discipline, the Ministries of Health (MOHs) in WHO’s Member States will be required to make annual measurements regarding plans to address capacity building for BE/CEs.
What is a pilot set of BE/CE performance Indicators that MOHs could use; has this question been well addressed before?
IFMBE CED is coming alongside WHO’s Medical Device Unit, led by Adriana Velazquez, to identify in 2019 a set of BE/CE performance indicators. There have been several prior studies, two are captured in References 3-5 below, eg, one from a WHO study in 2009, and another from Tobey Clark in 2015. Rationale of Indicators1 includes the following considerations: (1) relationship between the indicator and process or outcome; (2) benchmark or comparison; (3) definition of each indicator; and (4) results of empirical testing. The Group of indicators1 includes Impact of CE-HTM on: (1) Infrastructure; (2) Service quality; (3) Investment / use of resources; and (4) Clinical outcomes, or quality of care and patient safety. Example of these indicators are summarized below.
WHO 2009 Study
Clark 2015 Presentation
- Health Technology (HT) or HTM Policy present?
- HT or HTM strategy and implementation
- Influence on HT Decision Making - at MOH level
- Medical Devices regulation program in operation
Program Issues (Central Level)
- HTM Program present?
- Influence of HTM on Equipment Planning & Assessment
- HTM Staffing & Training Strategy
- Tools for HTM Program
- HTM Maintenance Management
Facility Issues (Local Level)
- Healthcare facilities accreditation?
- Facility status, eg, age, etc.
- HTM status, eg, under device asset management
- PM Completion
- High Risk (100%)
- Non-High Risk
- Tested before Patient
- Use/after repair (100%)
- Preventable Failures
- Use error, No problem found, Damaged, Maintenance
- Failure Rate/reliability
- Repeat Repairs
- Response time
- Cost of service
National Issues (Policies, Influence, Reporting)
- Annual Strategy/Plan to implement HT policy
- HTM Involvement in MOH Equipment
- HTM Program Issues (Central Level)
- HTM Program Evaluation
- Central HT Planning & Assessment
- Equipment Maintenance Management issues
- Influence on HT Decision-Making – Key Relationships
Facility Issues (Local Level)
- HTM Staffing
- Maintenance Management Issues
- HTM Training
- Equipment Operation
- Frequency of failures
- Time of first intervention
- Time to resolution
- Average downtime
- Distribution of failure types
- Maintenance costs
- Cost of spare parts
- Development of HT inventory and HT budget
- Development of Human Resources for HTM
- Expenses (waste) for the procurement of inappropriate equipment
- Development of expenses for the replacement of devices
- Process to reduce equipment down times (defects, missing supplies, lack of operator)
- Degree of equipment use to capacity
- Equipment life cycle in comparison to benchmarks
- Life cycle cost analysis
Source: United Kingdom
- Asset Management
- Analysis of inventory; Asset Register; Inventory compliance with database; Frequency (twice yearly)
- Measurement by quantity and value, and age profile
- Total assets; New assets; Decommissioned; Location change; Missing
- Wait time for specific clinical procedures due to equipment issues
- Rate of equipment incidents/events during surgery
- Infection rate due to devices, reprocessing multiple-use or reuse of SUDs
- Cardiac death cases due to malfunctioning defibrillator or use(r) error
- Adverse events due to malfunctioning or wrong equipment use
- Accident Trauma survival rates – equipment in place for rapid response
- Number/% of referrals to higher level facility due to equipment problems
- Priority clinical needs at various levels impact equipment HT decisions
- Clinical quality measurement connections for HTM
- Emerging technologies implemented, e.g. wireless, telehealth, EMRs
- Technical/Maintenance, Economic, Medical Equipment Acquisition, Criticality, Safety and Hospital measures
- 10 hospitals that cover different types of health care organizations
- Results - average gap of 67% between the CE Departments' performance and the ideal target
- World Health Organization (WHO) Biomedical Engineering Global Resources https://www.who.int/medical_devices/support/en/
- WHO Publications on medical devices https://www.who.int/medical_devices/publications/en/
- Luxembourg-WHO Project Technical Document: Strengthening Healthcare Infrastructure and Technology Management for Optimized Health Service Delivery - Indicators for evaluating and measuring the impact of healthcare infrastructure and technology management on investments, service delivery and quality of care, March 2009. Authors: Joachim Nagel, Antonio Hernandez, Tom Judd, Monika Nagel, Adriana Velazquez Berumen; copy available
- Tobey Clark, Are there Indicators to determine Best Practice in HTM programs? 1st ICEHTMC, China, October 2015.
- Antonio Hernandez and Tom Judd, Summary of CE-HTM Indicators, Clinical Engineering Handbook, 2019