Introduction to Medical Devices, Physical Agents and Safety Culture

Health Technology definition

An intervention developed to prevent, diagnose or treat medical conditions; promote health; provide rehabilitation; or organize healthcare delivery

Intervention definition

a medical test, medical device, pharmaceutical, biologic (e.g., vaccine), procedure, program or system

Biology

Biologics - vaccines

Chemistry

Pharmaceuticals

Physics

Medical Devices

Physical Agents example

sources of energy such as x-rays, magnetic fields, laser, UV sources, electricity etc.

medical device role

Protection from deleterious effects of associated Physical Agents

Medical Physicists role

act as a knowledge transfer bridge between medical device providers / medical device research literature and the medical and healthcare professions

Medical device definition

any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes

specific medical purposes (7)!!

- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations
- which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices

Regulations definition

binding legal force throughout every Member State and enter into force on a set date in all the Member States

Directives definition

lay down certain results that must be achieved but each Member State is free to decide how to transpose directives into national laws.

Decisions definition (2)

- EU laws relating to specific cases and directed to individual or several Member States, companies or private individuals.
- binding upon those to whom they are directed

Recommendation definition (2)

- not binding
- allows the institutions to make their views known and to suggest a line of action without imposing any legal obligation on those to whom it is addressed.

Opinion definition (2)

- not binding
- instrument that allows the institutions to make a statement without imposing any legal obligation on those to whom it is addressed.

type of EU Legal Acts (5)

- regulation
- directive
- decision
- recommendation
- opinion

active device definition

any device, the operation of which depends on a source of energy other than that generated by the human body

implantable device definition (2/4)

1. any device (also 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
2. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days

invasive device definition

any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body

in vitro diagnostic medical device definition

any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information

in vitro purpose of providing information about:

- concerning a physiological or pathological process or state
- concerning congenital physical or mental impairments
- concerning the predisposition to a medical condition or a disease
- to determine the safety and compatibility with potential recipients
- to predict treatment response or reactions
- to define or monitoring therapeutic measures
- Specimen receptacles

Specimen receptacles definition

a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination

Basic Devices (In vivo Diagnosis - physiological med. dev.) (2)

- Thermometers
- blood pressure monitors

Cardiology Devices (In vivo Diagnosis - physiological med. dev.) (4)

ECG (electrocardiograph)
Doppler flowmeters
Doppler ultrasound
exercise stress testing

Neurophysiology Devices (In vivo Diagnosis - physiological med. dev.) (2)

EEG (electroencephalograph)
EMG (electromyograph)

Gastrointestinal Devices (In vivo Diagnosis - physiological med. dev.) (2)

electrogastrograph (an ECG for the stomach!)
naso-gastric sensors

naso-gastric sensors role

measure pH to assess gastro-oesophageal reflux

Audiometry Devices (In vivo Diagnosis - physiological med. dev.)

measurements of hearing

Optometry Devices (In vivo Diagnosis- physiological med. dev.)

measurements of vision

Respiratory physiology Devices (In vivo Diagnosis- physiological med. dev.) (2)

spirometers
pulse oximetry

Urodynamics Devices (In vivo Diagnosis - physiological med. dev.) (2)

uroflowmeter
cystometrograph

cystometrograph role (CMG)

measures bladder capacity, bladder pressure, how full bladder is before you feel the urge to urinate

uroflowmeter role

measures the amount of urine and flow rate

Diagnostic Radiology (in vivo Diagnosis) (6)

X-ray projection imaging (XRI)
Computerised Tomography (CT)
Ultrasound
Magnetic resonance imaging (MRI)
Thermography
Medical image processing software

endoscopy definition

visual examination of a body cavity or canal using a specialized lighted instrument (endoscope)

capsule endoscopy definition

examination of the small intestine made by a tiny video camera placed in a capsule and then swallowed as traditional endoscopy cannot completely access the small intestine because of its length and complexity

Spectrophotometers (UV, VIS, IR) definition

measurement of concentrations (fx.: blood to see the amount of bilirubin, haemoglobin, and glucose in the serum of blood)

Electrophoresis definition

a technique by which molecules are separated and measured (fx.: proteins, DNA, or RNA fragments)

Flow cytometry definition

a technique for counting cells suspended in fluid as they flow past a light beam

pH / ISE meters definition

ion selective electrode for measuring ion concentrations

Medical Laboratory Devices (5)

- Spectrophotometers
- Electrophoresis
- Flow cytometry
- pH / ISE meters
- Medical microscopes

Drug Delivery Devices (Therapy)

Infusion pumps
syringe driver (a small infusion pump)

Physiotherapy Devices (Therapy) (5)

UV and IR therapy
Shortwave diathermy
Ultrasound therapy
Laser therapy (wound treatment: faster healing, pain relief)
Muscle stimulator

laser therapy

wound treatment: faster healing, pain relief

Shortwave diathermy

SWD

Ultrasound therapy

Muscle stimulator

creates steady electric impulses that stimulate muscle contractions

syringe driver

a motorized device that injects medication/drugs into the body

Infusion pumps

regulate the flow of medication into a patient

Surgical Theatre Devices

devices used in surgical field - clamp, light etc

Prosthetic Devices

artificial replacements for human machine

Disposable Medical Devices examples (3)

Suction catheter
I.V. cannula
Umbilical cord clamp

Suction catheter

IV cannula

Umbilical cord clamp

Pacemaker

delivers electrical impulses to heart to regulate heart rate
- lead fed through vein to right atrium
- detect missed heartbeat

cardiac defibrillator

An external or implantable device that provides an electric shock to the heart to restore a normal sinus rhythm.

Nuclear Medicine

Uses radioactive materials either to image a patient's body or to destroy diseased cells

Thyroid gland location and structure

made up of two halves (2 tyroid cell) on the side of the trachea

function of thyroid gland

combine iodine and the amino acid tyrosine to make thyroid hormones
- only cells in the body which can absorb iodine

Thyroid hormones (T3 and T4)

thyroxine (T4) and triiodothyronine (T3)

I-123

used for diagnosis

I-131

used for therapy

Self-testing 'home' Devices (3)

-thermometers
-pressure measuring instruments
-test kits (pregnancy test kits, glucose levels in blood)

Point-of-care devices definition (POC)

allows for patient testing and analysis near the patient (at the bedside)

POC Devices: Miniaturization examples

Blood analysis system
ultrasound system
Pulse oximeter

Blood analysis system

ultrasound system

Pulse oximeter

shows blood oxygenation level, pulse rate

CE Mark

A product safety standard of the European Union

Classes of devices order

increasing order of increasing risk

Device Classification

according to risk level and level of regulatory control proportionate to the level of risk

Class I (5)

-Urine collection bottles
-Cervical collars
-Walking aids and wheelchairs
-Non-invasive electrodes
-Medical imaging monitors

Class IIA (7)

Tubing used with infusion pumps
Dental bridges and crowns
Muscle stimulators
TENS (Transcutaneous Electrical Nerve Stimulation) devices MRI,
Gamma cameras ECG,
EEG

Class IIB (7)

X-ray sources
gas-machine
Anaesthesia machines
Dialysis machines
Insulin pens
Infusion pumps
External pacemakers and defibrillators

Class III (5)

pacemaker
artificial-heart
implanted neuromuscular stimulator kit
transducer
electrode