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Electronic medical equipment.

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Electronic medical equipment. Medical Engineering Perceptive devices Have action devices Technical Frequencies electromedical apparatus sensor, converter, Output ... – PowerPoint PPT presentation

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Title: Electronic medical equipment.


1
Electronic medical equipment.
2
Medical Engineering
medical facilities
Medical Apparatus
Medical instrument
By type use energy
electromedical apparatus
Mechanical electromedical apparatus
by direction energy flow
Have action devices
Perceptive devices
3
Perceptive devices
By type energy, perceptive
chemical energy
light energy
heat energy
electrical energy
Mechanical energy
4
Have action devices
by function
therapeutic
diagnostical
By type influence
mechanical energy
electrical energy
low frequency
X-ray
hydraulic
gas
light - optical
ultra sound
mechanical
high frequency
5
Electromagnetic Energy Exchange
is bidirectional
6
Technical Frequencies
7
electromedical apparatus
  • sensor,
  • converter,
  • Output device
  • Power sappy

8
(No Transcript)
9
Heinz-Eckhard Schmittendorf Safety and
Regulatory Affairs
1. Introduction 2. The Medical Devices
Directive 3. Conformity Assessment Procedure 4.
Exercise and Discussion
10
Safety and Regulatory Affairs / Introduction
  • What is the intended use of the device?
  • What potential risks do you see?
  • Assess these risks. Are they acceptable?
  • What can the manufacturer do
  • to reduce these risks?
  • How can the manufacturer prove that safety of
    the device is sufficient?

11
Safety and Regulatory Affairs / Introduction -
Risk Analysis According to EN 1441 -
12
Safety and Regulatory Affairs / Introduction -
Risk Analysis According to EN 1441 -
Failure Mode and Effect Analysis (FMEA)
S - severity of consequences (1..10)
P - probability of occurrence (1..10)
D - detectability (1..10) R - risk S
x P x D (1..1000), threshold of acceptability
50
13
Safety and Regulatory Affairs / Introduction -
Summary -
The use of medical devices involves specific risks
It is the manufacturer's responsability to -
identify potential risks, - evaluate the
acceptability - reduce risks to an
acceptable level
The application of standards helps to ensure a
high level of safety
Documentation is necessary to demonstate
appropriate risk management
14
Safety and Regulatory Affairs
2. The Medical Devices Directive
15
Medical Devices Directive - The New Approach -
In 1985 the European Union agreed on a "new
approach" to the regulation of technical aspects
of industrial products. Where harmonization of
legal requirements or administrative regulations
is necessary, the European Union develops
regulations, which are called Council Directives
or simply directives. Directives specify only the
essential requirements that are general and
mandatory. The detailed technical specifications
that may be used to demonstrate conformity with
the essential requirements are elaborated in
voluntary harmonized standards. If a product
complies with the requirements of a new approach
directive, the manufacturer marks it with the
CE-mark
16
Medical Devices Directive - The New Approach -
CE-marked goods are allowed free movement within
the internal market throughout the territory of
the European Economic Area (EEA). EEA EU
member states plus Norway, Iceland and
Liechtenstein Approach has been adopted by other
states (e.g. Hungary, Czechia) and is recognized
in many other countries.
17
Medical Devices Directive - MDD, standards, and
national legislation -
18
Medical Devices Directive - Articles and Annexes -
  • 23 articles (definitions, reference to
    standards, ...)
  • Annex I Essential Requirements
  • Annexes II-VIII Assessment Procedures
  • Annex IX Classification Criteria
  • Annex X Clinical Evaluation
  • Annex XI Notified Bodies
  • Annex XII CE Marking

19
Medical Devices Directive - Definition of a
Medical Device -
  • 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
    manu-facturer to be used for human beings for the
    purpose of
  • diagnosis, prevention, monitoring, treatment or
    alleviation of diseases, injuries, or
    handicaps,
  • investigation, replacement or modification of
    the anatomy or of a physiological process,
  • control of conception,
  • and which does not achieve its principal intended
    action in or on the human body by
    pharmacological, immunological or metabolic means.

20
Medical Devices Directive - Examples for Medical
Devices -
  • wheel chairs
  • patient beds
  • wound dressings
  • respiration tubes
  • products for transition of blood
  • blood pressure monitoring
  • endoscopes
  • x-ray
  • MRI
  • artificial joints
  • prosthetic heart valves
  • artificial joint
  • all accessories of medical devices (e.g.
    electrodes)

Note A medical device must have a proven
efficacy for specific medical purposes. Neither
Miracle Products nor general wellness products,
cosmetic products, fitness apparatus etc. (e.g.
muscle training apparatus, tooth whitener etc.)
are recognized as medical devices.
S19
21
Medical Devices Directive - Essential
Requirements -
  • General Requirements - state of the art
    safety of patients, operators and third
    persons - device must achieve intended
    performances
  • Chemical, physical and biological properties
  • Infektion and microbial contamination (incl.
    sterility)
  • Construction and environmental properties
  • Measuring function
  • Protection against radiation (incl. EMC)
  • Safetey of external or internal energy supply
    (electrical safety, software, alarm systems,
    etc.)
  • Information, labelling, instructions for use

22
Medical Devices Directive - Compliance with
Essential Requirements -
Presumption of conformity for the aspects that
are covered by the standard. Application of
harmonized standards is optional.
23
Medical Devices Directive - Compliance with
Essential Requirements -
requirement
applicable?
ensured by
application of EN 60601-1 Medical electrical
equipment. Part 1 General requirements for
safety
12.6
Protection against electrial risks ... avoid the
risk of accidental electris shocks during normal
use and in single fault condition ...
yes
S13
24
Medical Devices Directive - Declaration of
Conformity -
This Product complies with the Essential
Requirements of the Directive 93/42/EEC.
The Manufacturer
25
Medical Devices Directive - Technical
Documentation -
  • Product Description
  • intended use / application scope / contra
    indications
  • variations and approved accessories
  • instructions for use / operation manual
  • advertising materials / brochures / leaflets
  • Product Specification
  • construction drawings, manufacturing plans,
    part lists
  • essential requirements / list of applied
    standards
  • manufacturing and sterilisation specifications
  • QS specifications (SOP, testing plans)
  • labelling and user information (EN 1041)
  • Product Verification
  • risk analysis (EN 1441)
  • test and inspection records, certificates
  • clinical data / clinical assessment
  • Conformity Declaration

26
Medical Devices Directive - Summary -
New approach Essential Requirements and
harmonized standards
MDD
Definition medical device
Technical Documentation
27
Safety and Regulatory Affairs
3. Conformity Assessment
28
Conformity Assessment - Introduction -
  • If a product complies with the requirements of a
    new approach directive, the manufacturer signs a
    conformity declaration.
  • Depending on the potential risk of the device
    certification by a Notified Body may be
    required.
  • If certification is a requirement as part of the
    conformity assessment procedure, the manufacturer
    has the option to choose any of the Notified
    Bodies in any of the Member States of the EU.
  • Products which require certification by a
    Notified Body carry the CE-marking in combination
    with the number of the Notified Body, for example

29
Conformity Assessment - Risk Classes -
18 classification rules (Annex IX)
I
III
IIb
IIa
low Risk high
S17
30
Conformity Assessment - Criteria for Risk
Classification -
  • invasive / non-invasive
  • surgically invasive / non-surgically invasive
  • implantable / non-implantable
  • active / non-active
  • short-term / long-term use
  • application on critical organs (central
    nervous system, central blood circulation system)

31
Conformity Assessment - Examples for Risk
Classification -
  • Class I wheel chairs, patient beds,
    non-invasive electrodes
  • Class I sterile wound dressings, thermometer
  • Class IIa ultrasound diagnostic device,
    respiration tubes, blood pressure monitoring
    devices, products for transition of blood
  • Class IIb artificial joints, lithotripthers
  • Class III prosthetic heart valves, neurologic
    catheters

S19
32
Conformity Assessment - Procedures -
manufacturer
Annex VII
I
III
IIb
IIa
I
Ann. II with design examination
Annex VII Annex IV, V or VI
sterile or with a measuring functionAnnex V
notified body
Annex II without design examinationor Ann.
III Ann. IV, V or VI
Ann. III Ann. IV or V)
S20
33
Conformity Assessment - Procedures -
34
Conformity Assessment - Type Examination
Verification -
  • EC-Type Examination Notified Body examins
    technical documentation and performs tests on a
    prototype to ensure conformity with essential
    requirements
  • EC - Verification Notified Body performs tests
    on every device or samples from current
    production to ensure conformity with technical
    documentation and essential requirements

S19
35
Conformity Assessment - Quality Assurance -
  • Notified Body performs audit of the manufacturers
    quality assurance system.
  • QA-system has to apply to EN 9001 (general QA)
    and EN 46001 (additional requirements to medical
    devices).

ISO 9001/2
20/19 standard elements
EN 46001/2
additional requirements
S19
36
Conformity Assessment - Quality Assurance -
Additional Requirements acc. to EN 46001
Element
set up a product file
2. Quality system
include safety requirements in design input
data document design verification incl.
clinical investications
4. Design control
establish procedures for traceability to
facilitate corrective action
8. Identification and traceability
documented feedback system for early warning
and corrective actions document and
investigate all feedback incl. complaints
maintain procedures for recall actions
14. Corrective and preventive action
retain quality records for a time period at
least equivalent to the life-time of a
product, but not less than 2 years
16. Quality records
S19
37
Conformity Assessment - Quality Assurance -
General Requirements acc. to EN 9001 (excerpt)
1. Management responsability 2. Quality
system 3. Contract Review 4. Design
control 6. Purchasing 7. Control of
custumer-supplied product 8. Identification
and traceability 9. Process Control 10.
Inspection and testing 11. Control of
inspection, measurement and test equipment 14.
Corrective and preventive action 18.
Training 20. Statistical techniques
S19
38
Conformity Assessment - Steps to CE-Marking -
  • define intended use of the device
  • set up and maintain the technical documentation
    incl. risk analysis
  • classify the device
  • choose a conformity assessment procedure
  • perform conformity assessment (if required
    with Notified Body)
  • issue the declaration of conformity and affix
    the CE marking

39
Conformity Assessment - Summary -
Possible conformity assessment procedure depends
on risk classification.
Procedures with / without involvement of
Notified Body.
Procedures based on product testing or audit of
quality assurance system.
Manufacturer chooses procedure and procedure.
CE-mark with / without number of Notified Body.
40
Safety and Regulatory Affairs
4. exercise discussion
41
Safety and Regulatory Affairs - Exercise -
42
Safety and Regulatory Affairs - Discussion -
Is a medical device that bears the CE-mark save?
Why?
Do you see any weak spots in the current
regulatory system?
Any other questions?
43
Heinz-Eckhard Schmittendorf Safety and
Regulatory Affairs
1. Introduction 2. The Medical Devices
Directive 3. Conformity Assessment Procedure 4.
Exercise and Discussion
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