Introduction

Husam Yahya Naser

2022
 Health Care System
Health care: is the maintenance or improvement of health via
the prevention, diagnosis, treatment, amelioration, or cure of
disease, illness, injury, and other physical and mental
impairments in people.

Health care systems are organizations established to meet the

health needs of targeted populations according to well-studied
scientific policies and plans adopted by the World Health
Organization (WHO).
 Healthcare Providers
1- Medicine, dentistry, pharmacy, midwifery, nursing, optometry,
audiology, psychology, occupational therapy, physical therapy,
athletic training, and other Supportive health and nursing
specialties.

2- In cooperation with the disciplines of bio/medical engineering

with its branches and the disciplines of biological, chemical and
physical sciences.

3- In addition to other engineering disciplines, administrative

and service disciplines that support.
 Types (levels) of health services
Health care works for providing:

1- Primary Healthcare.
2- Secondary Healthcare.
3- Tertiary Healthcare.
4- Public healthcare.
 Primary Healthcare
The International Classification of Primary Care (ICPC) is a
standardized tool for understanding and analyzing information
on interventions in primary care based on the reason for the
patient's visit.

Primary care: refers to the work of health professionals who act

as a first point of consultation for all patients within the health
care system and providing the public health programs and
services. So, at this level it can be give a full services to patients
or may be referred for secondary or tertiary care.
 Primary Healthcare

Such a professional would usually be a physician, such as a

general practitioner or family physician. Another professional
would be a licensed independent practitioner such as a
physiotherapist, or a non-physician primary care provider such as
a physician assistant or nurse practitioner.

Primary care can be provided in different settings, such as

Primary Healthcare Centers or Urgent Care Centers.
 Secondary Healthcare
Secondary care includes acute care: necessary treatment for a
short period of time for a brief but serious illness, injury, or other
health condition.

This care is often found in a hospital emergency department.

Secondary care also includes skilled attendance during
childbirth, intensive care, and medical imaging services which we
can see this services together in general or teaching hospitals.

Some primary care services are delivered within hospitals,

patients may be required to see a primary care provider for a
referral before they can access secondary care.
 Secondary Healthcare
Secondary health care services are provided in public or
educational hospitals by doctors of all levels, general
practitioner, as well as specialist doctors with their different
educational and professional degrees, in cooperation with health
professionals, such as physical therapists, respiratory therapists,
occupational therapists, speech therapists, and dietitians.
 Tertiary Healthcare
Tertiary care is specialized consultative health care, usually for
inpatients and on referral from a primary or secondary health
professional, in a facility that has personnel and facilities for
advanced medical investigation and treatment, such as a tertiary
referral hospital.

Examples of tertiary care services are cancer management,

neurosurgery, cardiac surgery, plastic surgery, treatment for
severe burns, advanced neonatology services, and other
complex medical and surgical interventions.

These services are provided by all the medical, health and

support groups mentioned in the previous two levels, but the
presence of doctors with a precise specialization is required.
 Public healthcare
(Home and community care)
Public health: has been defined as the science and art of
preventing disease, prolonging life and promoting health.

Many types of health care interventions are delivered outside of

healthcare sites. They include many interventions of public
health interest, such as food safety surveillance, school health,
pregnancy care, immunization, health visitor program, support
of self-care and periodic vaccination programs.

These services are provided by units located in primary health

care centers under the management of health staff, and
physicians with specializations in family medicine and
community medicine.
 Medical Engineering and Health Care
The role and tasks of the medical engineer depend on the level
and type of health care, as it is closely related to the devices,
equipment, tools and medical supplies that help medical and
health personnel in the processes of diagnosis, monitoring,
treatment and rehabilitation.

These tasks are:

1- Technical Duties
2- Techno Administrative Duties
 Technical Duties
1- Design
2- Manufacturing
3- Marketing
4- Sales
5- Installation
6- Applications Specialist
7- Operator (sometimes)
8- Maintenance
9- Spatial distribution of medical devices
10- Participation in the clinical decision (sometimes)
11- Hospitals design
 TechnoAdministrative Duties
1-Planning (development and create of medical units)
2- Estimation of need
3- Preparing technical specifications
4- Training and development
5- Preparing studies to improve and develop work and
optimal use of medical devices.
6- Work in committees related to the activity of medical
devices.
7-Participation in the analysis of bids for medical
devices
What is a Medical Device?
 What is a Medical Device?
"Any instrument, apparatus, appliance, software, material or
other article, whether used alone or in combination, including
the software intended by its manufacturer to be used specifically
for diagnostic and/or therapeutic purposes and necessary for its
proper application, intended by the manufacturer to be used for
human beings or animal for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of
disease, or compensation for an injury or handicap.
- investigation, replacement or modification of the anatomcal
part or of a physiological process
- control of conception, and which does not achieve its principal
intended action in or on the life body by pharmacological,
immunological or metabolic means, but which may be assisted in
its function by such means.”
 Classifications
of
Medical Devices
 Genral Classifications
Medical devices can be generally grouped according to the three
areas of medicine:
1- Diagnosis
Diagnostic devices

2- Therapy
Therapeutic devices

3-Rehabilitation Application of Assisting

Orthotic and Prosthetic devices
 Diagnostic Devices
Types of diagnostic devices:
1- Recording and Monitoring Devices.
2- Measurement and Analysis Devices.
3- imaging devices.

Objective of diagnostic devices:

1- Enhance and extend the five human senses to improve to
collect data from the patient for diagnosis.
2- the perception of the physician can be improved by diagnostic
instrumentation in many ways:
A: Amplify human senses.
B: Place the observer's senses in inaccessible environments.
 Therapeutic devices
Types of Therapeutic devices:
1- Devices used to treat disorders.
2- Devices to assist or control the physiological functions

Objective of therapeutic devices:

- Deliver physical substances to the body to treat disease.

-Physical substances:
1- Voltage, current
2- Pressure, Heat
3- Flow, Force.
4- Electromagnetic radiation
 Assistive or Rehabilitative Devices
Types of rehabilitative devices:
1- Orthopedic devices: is an appliance that aids an existing
function
2- Prosthetic device: provides a substitute of body part.

Objective of rehabilitative devices:

- Assist individuals with a disability.

The disability can be connected to the following troubles to

perform activities of daily living, such as:
1- Limitations in mobility.
2- Communications disorders.
3- Sensory disabilities.
 Importance of Classification
Knowing how your medical device is classified matters for the
following reasons:

1- Classification is important because it organizes objects and the

sciences associated with them and simplifies their understanding

2- Classification is important in learning, prediction, inference

and decision making

3- Classification also helps us understand how devices relate to

each other.
 Importance of Classification
4- Classification will determine what you have to do before you
can sell your product.

5- Classification will help you establish requirements during the

product development phase, specifically design controls.

6- Product classification is an important component in

determining how much it will cost to bring your device to market
and give you some idea of how long it will take.
Criteria of Medical Device Classification
Generally, medical device legislation is a risk-based system taking into
account the vulnerability of the human body and the potential risks
associated with the devices, the medical devices are classified as per
their risk level and intended use.

This approach uses a set of criteria that can be combined in various

ways in order to determine classification, which are:

1- Duration of contact with the body.

2- Degree of invasiveness.
3- Local vs. systemic effect.
4- Potential toxicity.
5- The part of the body affected by the use of the device.
6- If the device depends on a source of energy.
 General Classification of Medical “Device”
((per their risk level and intended use))

1- Class-I : Devices involving low risk levels

(Thermometer, Elastic bandages , Examination Glove)

2- Class-IIa : Devices involving low to medium risk

(Hypodermic Needle, Infusion Pumps)

3- Class-Ilb :Devices involving moderate to high risk

(Lung ventilator , Bone fixation screw)

4- Class-III : Devices involving high risk. (Heart valve,

Pacemakers, Dental Lasers)
 Specific Medical Purpose

Duration of Use
1- Transient
Normally intended for continuous use for less than 60 minutes.

2- Short term
Normally intended for continuous use for between 60
minutes and 30 days.

3- Long term
Normally intended for continuous use for more than 30 days.
 Specific Medical Purpose
Surgically invasive device

An invasive device which penetrates inside the body through the surface of
the body, including through mucous membranes of body orifices with the aid
or in the context of a surgical operation, and a device which produces
penetration other than through a body orifice.

Reusable surgical instrument

An instrument intended for surgical use in cutting, drilling, sawing, scratching,

scraping, clamping, retracting, clipping or similar procedures, without a
connection to an active device and which is intended by the manufacturer to
be reused after appropriate procedures such as cleaning, disinfection and
sterilization have been carried
out.
 Specific Medical Purpose

Active medical devices

Active device means any device, the operation of which
depends on a source of energy other than that generated
by the human body for that purpose and which acts by
changing the density of or converting that energy.

The application of energy from the human body for the

purpose of operating a device does not make the device
‘active’ unless that energy is stored within the device for
subsequent release, such as elastomeric pumps, where the
energy from the human body is stored in the stretched
elastomer layer.
 Specific Medical Purpose

Implantable Device

Any device, including those that are partially or wholly absorbed,

which is intended:
— to be totally introduced into the human body
— to replace an epithelial surface or the surface of the eye, by
clinical intervention and which is intended to remain in place
after the procedure.
Thank You