NOVEMBER 2019

Healthcare Technology Management &

Biomedical Engineering

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About ECRI Institute
 Independent, research-driven nonprofit focused
on:
 Patient safety, risk, and quality expertise
 Technology decision-making solutions
 Evidence-based medicine with objective research
 ECRI is 1 of only 13 Evidence-based Practice
Centers in all of North America
 Federally certified Patient Safety Organization
 47 years of laboratory-based medical device
evaluations Safety &
Quality
 25 years conducting Health Technology
assessment, forecasting and comparative-
effectiveness research
 Strict conflict-of-interest policy with
manufacturers Cost Evidence and
Effectiveness Outcomes

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Introduction

 Technology refers to equipment or devices and related

accessories/supplies

 “Healthcare Technology Management“ is concerned with equipment

used in direct patient care or equipment involved indirectly

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Picture: Courtesy of Varian Medical Systems
Lifecycle of Healthcare Technology

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A Healthcare Technology Management (HTM) Concept

Source: Association for the Advancement of Medical Instrumentation (AAMI)

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Medical Equipment Management Plan (HTM framework)

— Scope and Definition — IPM Procedures and schedule

— Principles — Repair program and service contract
— Objective/ Goals — Back up equipment
— Roles and Responsibilities of Multidisciplinary — Recalls and alerts
Staff — Incident reporting and investigation
— Polices and Procedures in areas such as : — Resources ( Staff, Budget, Space, Test equipment,
- Equipment selection and acquisition tools and supplies)
- Inventory management — User training
- Acceptance testing
— Education and training
— Decommissioning and disposal
— Performance improvement
— Infection control
— Emergency management

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Source: LinkedIn, People-Process-Technology in Management Consulting
Healthcare Technology Management by
Biomedical Engineering
 It costs money and requires resources, and can sometimes be seen as diverting
resources from direct patient care

 Is there a financial incentive or payer/funding scheme that drives safety?

 The main motivation is the duty of care

 In general, if investment is not put into asset management, income is lost. In

healthcare, quality is lost, but this only becomes visible after disaster strikes

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How Long Can You Ignore It?

Till:

 A CT scanner is down for 2 days?

 A service vendor demands a 10% increase?
 A patient is injured by medical equipment?
 There are non-compliances in the accreditation audit?

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Deficiencies from Poor Technology Management

 Wasting valuable time resources in managing the services providers

by the hospital clinical and administrative staff
 No uniform quality assurance in service delivery and standards
 Unstructured preventive maintenance
 Essentially a repair service with no technology resource to support the
users and hospital administrators for a lifecycle ownership of
equipment
 Uncertain and unpredictable costs (most times at the mercy of the
suppliers of services and parts)

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New Challenges for Biomedical Engineering Departments

1. More and more medical devices are “on the network”

2. With increased inventory comes increased preventive maintenance workload

3. Metrics for measuring the performance of biomedical engineering services are

ill-defined

 How does the biomedical engineering service handle these challenges?

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More Challenges for Biomedical Engineering Departments

 How does your biomedical engineering’s performance this year compare to that of the last three
years? (internal benchmarking)

 How does it stack up against biomedical engineering departments or contracted services in

similarly sized hospitals? (external benchmarking)

 The number of people the department requires based on inventory, work orders, beds, or adjusted
patient discharges

 The percentage of effort supporting project work such as wireless network management or
medical equipment planning

 The service cost to acquisition cost (S/A) ratio

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The Way Forward for Biomedical Engineering

Source: IETAM2013, J.P. McCarthy et. al.

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International Best Practices in
Biomedical Engineering

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I IINISNTSITTIUTTUET E
Medical Device Naming Conventions

 Any medical technology management program must begin with a standardized

naming convention for the devices and systems to be included

 Personnel at each facility in the system need to identify the same product by the
same name if the organizational leadership is to have an accurate understanding
of the devices in its inventory (and therefore an informed understanding of its
medical technology needs)

 More importantly, the use of a standardized naming convention across the entire
system better enables personnel at all facilities to comprehend and act upon safety
notices for specific types of devices

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Medical Device Naming Conventions

 These include items such as

surgical instruments, radiographic
equipment, clinical laboratory
instrumentation and in vitro
diagnostics, tests and reagents,
disposable products and supplies,
instruments used for clinical
equipment testing, and select
hospital furniture casework and
systems.

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Management of Hazards and Recalls

 There is a large volume of information for a health care organization to manage—

above and beyond the general hazards, warnings, and other safety information

 Internet-based automated alerts system for tracking hazard and recall information

 This system automatically documents actions by hospital staff to resolve reported

problems. It also allows hazard and recall coordinators to predetermine the
categories of alerts distributed to each staff member based on their
clinical/professional specialty

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Acquisition and Procurement of New Technology

 External independent product evaluations are important complements to the

procurement/contract bidding process

 Comparative evaluations include detailed descriptions of medical technology

devices, relevant performance criteria, test methods for verifying device
compliance with the criteria, test results, and comparative ratings derived from
the testing methodology

 Biomedical engineering uses the information on a number of different levels

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Acquisition and Procurement of New Technology

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Acquisition and Procurement of New Technology

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Comparative Evaluations

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Inspection and Preventive Maintenance

 Routine medical device inspections and preventive maintenance are key

 The procedures are performed before the devices are put into use for the first time
and then on a routine schedule throughout the life cycle of the device

 Each procedure includes background on the device’s use, risks typically

associated with the technology, detailed inspection procedures with pass-fail
criteria, lists of necessary test instruments, precautions to be taken when
performing inspections, and checklists and forms for completing the inspections.
The procedures include tests for electrical safety, alarm performance, output
measurements, mechanical integrity, and overall device quality and safety.

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Technology Replacement

 One of the most challenging aspects of managing a medical technology life cycle
is determining the time at which the technology should be replaced

 The hazard and recall and problem report databases can help identify trends and
known problems

 Data from inspection and preventive maintenance procedures are useful for
detecting abnormal device failure rates

 Information on new and emerging features designed to overcome the limitations

of existing technologies is factored in
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Predictive Replacement Planning (PRP)

Data Collection & Orientation Inventory Service Line 5-Year

Cleaning Meetings Analysis Reviews Replacement Plan

Unique Acquisition Criteria Key Prioritization Fiscal

Control # Manufacturer Model Date Dept Category Criteria Rationale Year

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 PREVIOUSLY
- REPAIRMAN -
BE focuses primarily on inspection, preventive maintenance, and repair of medical equipment only.

NOW
TECHNOLOGY MANAGERS
With new patient safety imperatives, greater scrutiny of services, and pressure to find cost savings
where possible, biomedical engineering is involved more in discussions and decisions that affect the
use of technology. Biomedical engineering professionals collaborating with senior management in:
a) capital equipment planning and purchasing
b) biomedical device integration with health IT systems planning and implementation
c) risk assessment
d) benchmarking of biomedical engineering’s performance.
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Questions?
Ir. Dharmesh R Doshi, P.Eng, ACPE, BBEng, MBA
[email protected]

Thank You

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