Medical Device: Legal Definition

“any instrument, apparatus, appliance, material or other article,

whether used alone or in combination, including the software
necessary for its proper application intended by the manufacturer to
be used on human beings for the purpose of:
Medical Devices – An Overview – diagnosis, prevention, monitoring, treatment or alleviation of
disease,
– diagnosis, monitoring, treatment, or alleviation of or
compensation for an injury or handicap,
– investigation, replacement or modification of the anatomy or of a
physiological process,
Carmel J. Caruana – control of conception
Prof. and Head of Medical Physics and which does not achieve its principal intended action in or on the
Faculty of Health Sciences, University of Malta human body by pharmacological, immunological or metabolic means,
[email protected]
but which may be assisted in its function by such means.”
(93/42/EEC, OJ L169 p0001-0043)

The EU Medical Device Directives Software

• The Medical Devices Directive (MDD) (93/42/EEC, OJ L169 p0001-0043) : covers all
medical devices from bandages, tongue depressors, thermometers to contact lenses,
stethoscopes, splints, first-aid kits, breathalysers, heart valves and imaging equipment. • Many devices include software which is often
• The In-Vitro Diagnostic Medical Devices Directive (IVDD) (98/79/EC OJ L331 p01-37):
equipment, reagents, control standards, test-kits etc intended for the in-vitro
essential for the proper functioning or the
examination of human specimens e.g., blood glucose strips and meters, pregnancy test effective use of the device
kits, medical microscopes, spectrophotometers, blood grouping reagents, HIV test kits,
microscope cell counting chambers, control materials to verify analyser performance. • Such software is itself legally considered as a
• The Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC OJ L189 p17-
36): active (i.e., include an energy source) implants or partial implants e.g., implantable medical device in its own right and must go
cardiac pacemaker, Implantable defibrillators, implantable nerve stimulators, bladder
stimulators, cochlear implants, implantable active drug administration device. through all the rigorous testing procedures as
• Amendments to the original directives: Directive 2007/47/EC amending Council a hardware medical device.
Directive 90/385/EEC on the approximation of the laws of the Member States relating
to active implantable medical devices, Council Directive 93/42/EEC concerning medical
devices and Directive 98/8/EC concerning the placing of biocidal products on the
market (OJ L 247 p21-55).
• Some countries have transposed these directives into a single legislation

Carmel J. Caruana,BioMedical Physics, FHS, UoM 1

 EC Medical Devices Site
(https://ec.europa.eu/growth/sectors/medical-devices_en)

Brief Survey of Medical Devices

(about 500,000 types at present and increasing daily!)

5 6

In vivo Diagnosis: Physiological Measurement Devices Patient

Monitoring
• Basic: Thermometers, blood pressure
monitors Devices in
• Cardiac: ECG (EKG), Doppler flowmeters,
pulsed Doppler ultrasound, exercise stress
testing …
Intensive Care
• Neurophysiology: EEG, EMG Can you spot the baby
• Gastrointestinal: electrogastrography, among the devices? That
naso-gastric sensors (measure pH to assess baby would not be alive today
gastro-oesophageal reflux)
if it weren’t for those devices.
• Audiology
• Ophthalmic, optometry
• Respiratory (including sleep) physiology:
spirometers, pulse oximetry, impedance
pneumograph
• Urodynamics: uroflowmeter measures the
amount of urine and flow rate,
cystometrogram (CMG, measures bladder
capacity, bladder pressure, how full
bladder is before you feel the urge to
urinate) ECG (aka EKG)

Carmel J. Caruana,BioMedical Physics, FHS, UoM 2

 in vivo Diagnosis: Diagnostic Radiology
(aka Medical Imaging) in vivo Diagnosis: Endoscopy
• X-ray projection
imaging (XRI)
• Computerised
Tomography (CT)
• Ultrasound
• Magnetic resonance
imaging (MRI)
• Thermography etc
• Medical image
processing software

Therapy: Drug Delivery Devices Therapy: Physiotherapy Devices

• Infusion • UV and IR therapy Ultrasound
therapy unit
pumps
• Shortwave diathermy
• syringe driver
or syringe • Ultrasound therapy
pump (a small • Laser therapy (wound treatment: faster
infusion pump) healing, pain relief)
Laser
therapy unit

Muscle stimulator

Carmel J. Caruana,BioMedical Physics, FHS, UoM 3

 Therapy: Radiation Oncology Devices Nuclear Medicine: Diagnosis and Therapy
• X-ray and charged particle beams from
accelerators (linacs)
• Brachytherapy
• Treatment planning systems and software

http://news.stanford.edu/news/2007/april18/gifs/
accelerator3.jpg

14

Prosthetic Devices: Spare Parts for the

Surgery: Surgical Theatre Devices
Human machine

anaethesia

Carmel J. Caruana,BioMedical Physics, FHS, UoM 4

 Devices for Quality Controlling Medical
Disposable Medical Devices
Devices
• devices to test whether medical devices are
functioning properly are also considered as medical
Suction catheter
devices!

Umbilical cord clamp

I.V. cannulae

Active Implantable Medical Devices In vitro Diagnosis - Medical Laboratory Devices

• Spectrophotometers (UV, VIS,
• Active medical device: “any IR)
medical device relying for its
functioning on a source of electrical
• pH / ISE (ion selective
energy or any source of power electrode) meters
other than that directly generated • Electrophoresis: a technique by
by the human body or gravity” which molecules e.g., proteins,
(90/385/EEC OJ L189 p0017-0036).
DNA, or RNA fragments are
• Active implantable medical device:
“any active medical device which is
separated and measured
intended to be totally or partially • Flow cytometry: a technique
introduced, surgically or medically, Cardiac stimulator and pacemaker. Frontal chest X-ray of a 57-
year-old man with cardiac insufficiency (heart failure), who has for counting cells suspended in
into the human body or by medical been fitted with a pacemaker (upper left) coupled with a cardiac
defibrillator (upper right). Wires from the devices lead to the
fluid as they flow past a light
intervention into a natural orifice, heart (lower centre). Heart failure can be caused by several

and which is intended to remain

conditions, and is a general term used when the heart is not
functioning sufficiently for the body's needs. Pacemakers and beam
defibrillators are devices used to maintain the normal rhythm of

after the procedure” the heart by delivering electrical

impulses.(http://www.sciencephoto.com/media/81839/enlarge) • Medical microscopes (including
19 virtual microscopy)

Carmel J. Caruana,BioMedical Physics, FHS, UoM 5

 Self-testing ‘home’ Devices POC (Point of Care) Devices: Miniaturization

• 'device for self-

testing`: e.g.,
thermometers,
pressure measuring
instruments, test
kits (pregnancy, Blood analysis
system
glucose levels in Blood
pressure,
blood used by oxygenation
diabetes patients
etc) Blood glucose
meter
ultrasound system

Nanowires: Brain studies and therapy

• Bunch of nanowires being guided through the
circulatory system to the brain. Once there,
the nanowires would spread out branching
into tinier and tinier blood vessels. Each
nanowire would then be used to record the
electrical activity of a single neuron, or small
And the Future? groups of neurons (better than PET or fMRI!)
giving the ability to pinpoint damage from

Nanodevices and Nanomaterials injury and stroke, localize the cause of

seizures etc.

• People with Parkinson's disease can

experience significant improvement from
direct stimulation of the affected area of the
brain with electrical pulses. But the
stimulation is currently carried out by
inserting wires through the skull and into the
brain, a process that causes scarring of brain
tissue. The hope is, by stimulating the brain
with nanowires threaded through pre-existing
blood vessels, doctors could give patients the
benefits of the treatment without the
damaging side effects.

Carmel J. Caruana,BioMedical Physics, FHS, UoM 6

 Medical Nanorobots Artificial RBC
(‘respirocyte’) • Can transport 236
times more O2 / than
natural RBCs
Drug
delivery • Filled with these
robots
respirocytes an adult
human could hold
breath underwater for
four hours!!

Reading List (updated 2016)

• Recommended Text
– Jacobson B., & Murray A. (1st Edition, no more recent edition available), 2007, Medical Devices: Use
and Safety. Churchill Livingstone : Oxford (ISBN 9780443102592; available at FHS library)

• Further Reading
– Medicines and Healthcare products Regulatory Agency (MHRA, UK) (2014) Devices in Practice -
Checklists for using medical devices (to be read thoroughly).
https://www.gov.uk/government/publications/devices-in-practice-checklists-for-using-medical-
devices
– ILO. Exposure to physical agents (for healthcare workers) http://www.iloencyclopaedia.org/part-xvii-
65263/health-care-facilities-and-services/163-the-physical-environment-and-health-care/exposure-
to-physical-agents
– Hunter T. B., & Taljanovic MS. (2003). Glossary of Medical Devices and Procedures - Abbreviations
Acronyms and Definitions. RadioGraphics, 23, 195–213. Download from:
http://radiographics.rsna.org/content/23/1/195.full.pdf
– EC. Directive 1993/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the
European Communities L 169, 12/07/1993, pp. 01 - 43. (pdf available from EU site)
– EC. The In-Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC Official Journal of the
European Communities L331 p01-37 (pdf available from EU site)

27

Carmel J. Caruana,BioMedical Physics, FHS, UoM 7