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hossein hassanzadeh

on 6 January 2015

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Transcript of Management

Management of Medical equipment
presented by
sayyid Hossein hassanzadeh

Department of biomedical physics and engineering
Shiraz university of medical Science
The problem is the ineffective use and subsequent poor operational performance of medical equipments
The Problem Statement
Results from previous studies showed that in low- and medium-income economies, indicate that
as much as half of the equipment
in urban and rural medical institutions is
inoperable and not in use
despite of development in past few decades, the fact remains that a large proportion of the population in those countries does not have access to adequate health care.
Some of the Aims and Objectives
(Medical Devices Agency: Health Equipment information, Issue 98:28)
An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means
The International Medical Device Market
The international medical equipment industry is extremely diverse also cost governments a substantial amount of money
espicom estimates that one and a half million different medical devices available on the market represented over 327 billion US dollar ,excluding in vitro diagnostics
World trade in medical equipment is dominated by three countries; Germany, the USA and Japan, who combined account for over half of total exports of both medical instruments and electromedical equipment
Major Problems about medical equipments in developing countries
What we learn ?
Poor performance of the existing equipment is an important contributor to the health crisis in developing countries.

Estimating the proportion of equipment in developing countries which is not functioning is vary considerably.

Health technology is one of the weakest components of the national
health system, and the absence of suitable health technology policies is at the root of the problem

There seems to be some association between certain hospital-characteristics-related variables and equipment performance.

Making appropriate medical devices available and affordable in health care settings is linked to health equity, and service delivery that is more responsive to the needs of patients.

Effective and efficient technical management of medical devices
remains a concern in most low-income countries and middle-income countries despite the existence of dedicated responsible units at the national level.

Factors that can promote or limit access to medical devices include:
market availability, cost, the decision making process, infrastructure and environmental factors, capacity to utilize the devices, timely
replacement, cost recovery or systems for reimbursement, and transparency in the medical devices market
The limited total volume of equipment

The unequal distribution of the stock of equipment

The poor performance of the installed stock of equipment
Policy and context related
Suggested Reasons for Poor performances
Hospital Characteristics
The Technology
Management process
Infrastructure &
Foreign Aid

Technical Services

Healthcare Technical Services (HCTS) Components
The Cyclical Management System
Equipment Utilisation
Equipment Acquisition
Availability of comprehensive and up-to date information
The policy documents and associated implementation strategy
Understanding the importance of the discrepancy between
'what is'
'what ought to


is very crucial and must be consider in policy outlines and needs assessment.
The population targeted by the health service

Current and future health needs of the population

The health service functions required to meet those needs

The health care equipment required to perform those functions

The current stock of functioning equipment (i.e. effective available stock)

The current stock of non-functioning equipment, which can be restored

Current staff competences (operators and service personnel)

Available financial resources

Certain criteria must have to be taken into consideration
What would
we like to
have and what
can we
What do we have
What do we
Health Policy
Functions at
all Levels of
Health Care
(Donor Aid)
(Operators &
Health Care
(Generic List)
Available Stock
of Health Care
Discussing Requirements

defining needs for new equipment, a selection from the available products from the local and/or international market will have to be made.

The selection of suitable equipment requires


thought and investment of time
and resources.

The specification of requirements

should involve the user

of the equipment
as well as senior qualified staff of the
Health Care Technical Service (McKie, 1987).
We should note that....
factors to be taken into consideration
when selecting equipment
technical support from the supplier
technical features of the equipment
the quality and completeness of equipment documentation
installation procedures
commissioning of the equipment
price criteria
length of the warranty period
delivery time
Procurement can be regarded as the process by which an item of equipment, which has already been selected, is purchased by the user
It's an a predominantly administrative exercise
The right equipment.... in working order
The usual procedure for equipment procurement is to invite firms to submit tenders
Installation and Commissioning
In the context of this study, the installation of medical devices refers to the process of simply putting the hardware in place
Brief Notes
Commissioning of health care facilities has been described as: "...the process of speedily and efficiently bringing those facilities into use and ensuring that each facility operates to the desired standards and makes the best use of the resources available" (Steele et al., 1983:297).
Planned installation and commissioning procedures are to be in place, stipulating a number of tests to be performed
Incorrect installation of medical devices is said to be a
major cause
for equipment ineffectiveness also it's important to note that Except for the simple and robust items of equipment, most medical equipment
requires planned installation
To deliver intended services for equipment , it is necessary that personnel operating the equipment are adequately trained in using the devices confidently while observing appropriate safety procedures
Operation and Maintenance
No staff should be expected or allowed to use equipment unless training has been given appropriate to the degree of sophistication. This will normally involve the manufacturer or supplier initially and the in-house technical service thereafter (McKie, 1987)
Previous studies in developing countries show that a high percentage of equipment malfunction is caused by operator mishandling
about maintenance keep in mind that
In situations where there is a lack of service capacity
(poor conservation culture), it frequently happens that

is replaced
without considering the
of restoring existing assets to good working
Equipment maintenance has been described as any action or combination of actions carried out to retain an item in, or restore to, an acceptable
condition (Metha, 1983:151)
we must have a good perceive about the difference between
preventive maintenance
The equipment operator, therefore, functions as an important
in the managerial chain
Traditionally equipment maintenance and repair has been regarded as the most important function of a HCTS
Operation and Maintenance (contd)
Cancellation and Disposal
The extent of equipment malfunction and down-time increases with the age of the equipment
A technical report for the United Kingdom's health service suggests that the mean life of equipment is between 6 and 10 years (Health Service Supply
Council, 1984)
A good Engineer needs to consider the
issue of equipment obsoletion due to
technological and medical
advances in this sector.
The Medical Devices Agency reasons which equipments may have to be replaced
Worn out beyond economic repair
Damaged beyond economic repair
Clinically or technically obsolete
Spare parts no longer available
More cost-effective equipment
or clinical service is available
Some of the key issues related to equipment replacement
Presence of a Replacement Policy
Budget for Equipment Replacement
Equipment Replacement Planning
Inventory of Equipment
Equipment Disposal
Ensure improved access, quality and use of medical products and technologies in health sector

Obtain a clear understanding of factors contributing to differences in equipment effectiveness in the health sector of countries

Develop a comprehensive and coherent framework for analysis, with the objective of contributing to the development of policies and strategies in management of medical equipment.
Conceptual Framework for effective management
Health technology
The application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life.
Medical device
Medical devices

requiring calibration, maintenance, repair, user training
, and
. this activities usually managed by clinical engineers also it excludes implantable, disposable or single-use medical devices
Medical equipment
(Needs assessment for medical devices, 2011)
(Needs assessment for medical devices, 2011)
(Espicom, The World Medical Market Book 2013)
(Espicom, The World Medical Market Book 2013)
National health policies, strategies, and plans must articulate in a comprehensive, balanced, and coherent fashion.
The word ‘
’ is defined to include a vision, strategies, action plans, indicators, and a monitoring and evaluation system to measure implementation.
Vision, values, goals, targets, and intersectoral policy alignment

A robust situation analysis

The possible scenarios and policy directions

A comprehensive strategy to respond to the challenges and implement the policy directions

The leadership and governance arrangements for implementing the strategy
Policy and context related
Comprehensive policy must covering
Absence of public and private sector policies
Poor equipment conservation culture
Weak infrastructure and organization
Lack of trained maintenance staff
Lack of trained equipment operator
Weak technical support system
Inadequate finances for equipment management
Poor logistics support (transport, information)
Poor donor practices
Geographical location and size

Type of ownership
the inherent complexity of medical devices

the lack of equipment standardization

the degree of equipment obsolescence
technology-related variables
Technology Alone Cannot Solve Health Problems
Seeking Explanations for the Variations in Performance
Poor equipment acquisition procedures
Poor maintenance and repair procedures
Poor equipment replacement procedures
Poor management of human resources development
Poor equipment performance evaluation procedures
Poor management of foreign aid
Management-process related Suggested Reasons

WHO Organization.Needs assessment on medical equipment. Switzerland :World Health Organization;2011

WHO Organization.Development of medical device policies. Switzerland :World Health Organization;2011

WHO Organization.medical equipment maintenance porgramme overview. Switzerland :World Health Organization;2011

WHO Organization.Medical device regulation,global overview and guiding principles :World Health Organization;2003

Bastiaan L Remmelzwaal. The Effective Management of Medical Equipment in Developing Countries. A Series of Five Papers
. FAKT Report number 390,1997
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