Legal and ethical issues with respect to biomaterials Flashcards
Why regulate? (3)
Until the late 1980’s there was almost no regulation of biomaterials and medical devices in the UK.
The need for European standards (ENs) to assist the free market.
The desire to produce medical products that were safe and good for their intended use.
EU/ EEC legislation (2)
Directive on Active Implantable Medical Devices (90/385/EEC)
Directive on Medical Devices (93/42/EEC)
A Directive may be considered as a piece of Community legislation. When adopted, members are obliged to transpose these into national law
What is a medical device in Europe?
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 ……
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, prevention, monitoring, treatment or alleviation of or compensation for an injury or handicap
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, but which may be assisted in its function by such means”
Active implantable medical devices directive (2)
Covers all powered implants (e.g. cardiac pacemaker).
Medical Devices Directive
Covers most other implants
The CE marking that appears on any device or its packaging means that the device satisfies the requirements essential for it to be fit for its intended purpose. Obligatory from 1.1.99.
The CE marking on a product does what (6)
Indicates to governments that the product can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA),
Ensures the product can move freely throughout the European Single Market,
Indicates to customers that the product meets designated minimum safety standards and therefore a minimum level of quality,
Promotes public health and safety
The award of a CE mark enables goods to be sold throughout the EEA.
It is the result of a risk management exercise
However, “no amount of experimental study can guarantee the absolute safety of any substance”
Who awards a CE mark? (2)
The competent Authority
Each Member State has a “competent authority who ensures compliance with the MDD and evaluates adverse incidents.
In the UK this is the Secretary of State for Health who acts through the DoH Medicines & Healthcare products Regulatory Agency (MHRA).
Who checks compliance? (2)
A Notified Body
The Competent Body authorises independent agencies who check and prove that medium and high risk devices meet the essential requirements so that manufacturers may apply the CE mark to their devices.
A “Notified Body” has been nominated by an EU member government.
Examples include BSI, Lloyd’s Register Quality Assurance Ltd., SATRA Quality Assurance Ltd., and Amtac Certification Services Ltd.
The classification rules (4)
Class I. Low risk. Manufacturer declares conformity.
Class IIa. Medium risk. Manufacturer declares conformity and Notified Body confirms.
Class IIb. Medium risk. Notified Body carries out and audit and/or testing.
Class III. High risk. As IIb but require submission of a design dossier to Notified Body
What tests are applied? (3)
European standardisation started in 1989 and followed US closely.
The most important document re: the biological testing of medical devices is ISO10993 (EN 30993).
Part 1 of which gives guidelines on selection of tests
Global Medical Devices Regulation (2)
All developed countries have a national regulatory framework and body:
USA = US Food & Drug Administration (FDA)
Europe = Each country has a competent authority
World Health Organization provide a global atlas of medical status of different countries
What is a hazard? (2)
A potential source of harm, where harm is any physical injury and/or damage to health or property (EN1441).
Modern biological safety is based on the principles laid down by Paracelsus (1493-1541) who noted that all materials are poisonous at a sufficiently high dose.
Regulation and the management of risk (3)
Risk might be defined as the possibility of more than one outcome occurring from a given set of circumstances.
Imposition of legal controls is a form of risk management
Biological safety assessment combines aspects of risk analysis, assessment and control
Tianjie Dental Falcon x-ray (4)
Hand held x-ray machine available on internet for as little as £200.
Reported to give a x10 x-ray dose above recommended maximum.
Wide x-ray beam.
Plug not wired to UK standards
