Standards
The importance of standards to today's manufacturer of medical
devices has never been greater. Standards play an increasing role
in marketing, especially with the move towards global
harmonisation, and they are indispensable tools for establishing
state-of-the-art criteria in product liability and for maintaining
patient safety. Standards indicate what the benchmarks are to large
and small manufacturers alike.
ABHI keeps track of the various standards management activities
most relevant to our members, providing regular updates on latest
developments and concerns through the monthly Technical Update, the
Standards Management Advisory Group (SMAG) and the meetings of the
Technical and Environment Forum. Where relevant, positions on major
issues are pursued at all levels.
Working Groups, Special Interest Sections and Mirror Groups are
used to track and provide input to relevant standards work. At
present these groups cover quality systems,
sterilisation/microbiological issues, orthopaedics, sterilizers and
disinfectors, active medical devices and surgical instruments.
Close working relationships are maintained with the Medicines and Healthcare
products Regulatory Agency (MHRA), UK Notified Bodies, BSI and
Eucomed, to ensure effective consultation on
standards issues.
For those members interested in directly influencing the content
of standards, ABHI provides opportunities for nomination to the
relevant standards committees. Those who simply need information
will also find a network of people available to help.
Key activities and issues being addressed by the ABHI include:
- Quality management systems
- Sterilisation & microbiology
- Symbols and labelling of medical devices
- Development of new designs to replace Luer connectors for
medical devices (Small bore connectors)
- Nanotechnology
- Eucomed Standards Focus Group
- Electro-medical
- Orthopaedics - ABHI
Orthopaedics Special Interest Section