changes to the therapeutic goods act and its implications
DESCRIPTION
Changes to the Therapeutic Goods Act and its implications. Prepared by: Anna Frazer Prosthetist Hunter Prosthetics & Orthotics Service 10 th November 2006. Information derived from work of the AOPA TGA working party. What is the TGA?. Therapeutic Goods Administration regulates the: - PowerPoint PPT PresentationTRANSCRIPT
Changes to the Therapeutic Goods Act and its implications
Prepared by: Anna FrazerProsthetist
Hunter Prosthetics& Orthotics Service
10th November 2006
Information derived from work of the AOPA TGA working party
What is the TGA? Therapeutic Goods Administration regulates the:
Therapeutic Goods Act 1989
Therapeutic Goods (medical devices) Regulations 2002
– Exemption on low risk items lifted in 2004
– Low risk items include orthoses, prostheses and medical aids
Background Why do PTs need to comply with TGA
regulations?
– A physiotherapist may be supplying devices that are considered Class I medical devices under changes to the Act
– Although ‘low risk’ devices, they must meet safety standards
– Risk of fines
• http://www.tga.gov.au/devices/fs_offencesdr.htm
– How do you classify something as a ‘medical device’?
“ A medical device is used for: diagnosis, prevention, monitoring, treatment or alleviation of
disease;
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
investigation, replacement or modification of the anatomy or of a physiological process; or
control of conception,
and that 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; or
an accessory to such an instrument, apparatus, appliance, material or other article. ”
Implications for Physiotherapists PTs supply and manufacture items that could be
classified as Class 1 medical devices:
Terminology
A clinician needs to comply with the TGA regulations if they are considered to be the manufacturer of a medical device
A manufacturer is… “The person who, with a view to supplying the device under the
person's name, does one or more of the following using ready made products:
1. assembles the device
2. packages the device
3. processes the device
4. fully refurbishes the device
5. labels the device
6. assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following
– the labelling of the device
– the instructions for using the device
– any advertising material relating to the device.”
So, what if you… supply something straight out of its packet and
only perform modifications specified by the larger manufacturer?
– = not a manufacturer
supply something out a packet but modify it significantly?
– = manufacturer
make or assemble something from raw materials or components?
– = manufacturer
Terminology Custom-made
– From scratch or assembled, may include some prefab components
• Example: interim prosthesis, hand splint
Customised
– Modifications made to prefab device for a specific patient
• Example: heat mouldable foot orthoses, wheelchair modifications
Steps in complying with TGA Classify medical device
Apply appropriate conformity procedure
Demonstrate compliance with applicable essential principles
Document technical information
– Risk management procedures
– Clinical evidence
Complete declaration of conformity
Classify the DeviceGuidance Document 25: Classification of medical
devices
Is it a medical device under the description provided by the TGA?
• 22 rules of classification
Do you need to comply with the TGA?
If so, are you considered a manufacturer or sponsor?
Apply Conformity ProcedureGuidance Document 25: Classification of medical
devices
Procedure depends upon status
– Manufacturer
• In-house procedure
• Industry standards may be used
– Sponsor
• Mandatory to register device on the Australian Register of Therapeutic Goods (ARTG)
• More rigorous standards and detailed information required
• Fee applicable
Comply with Essential PrinciplesGuidance Document 22: Essential Principles for
Medical Devices
Essential Principles
– “set out the requirements relating to the safety and performance characteristics of medical devices”
Cover risks associated with use
– Heat, mechanical failure, cross-contamination, patient education, documentation…
Document Technical InformationGuidance Document 22: Essential Principles for
Medical Devices
Provide clinical evidence for all compliance statements
– Critical literature reviews
– Bench testing results, MSDS, etc
– Clinical evaluation
Document risk analyses
Document planned review procedure
Complete Declaration of Conformity
Indicates that you have completed all compliance procedures
Post Production Activities Manufacturers must
– systematically review experience gained post-production
– Institute processes for corrective action
– Notify TGA of adverse events
Post-market vigilance
– Recall of devices must be easily achieved
– Maintenance procedures must be implemented
– Satisfaction reviews should be part of a quality improvement system
Grey Areas Use of raw materials to make a device according
to supplier instructions
– If followed to the letter, are you still a manufacturer?
Re-use and second-hand components
– How do you ensure that they meet the safety and performance criteria of the essential principles?
– Infection control, mechanical failure risk…
– How do you track their source and manufacture date?
Other Considerations Patient information and education
– Essential principles relating specifically to
• Content, style and form (eg. lettering at least 1mm high, manufacturer’s details)
• Requirements (date of manufacture, individual patient use, intended purpose, care of device, sterile status, etc)
• Location of the information (on device if possible)
• Instructions for use
Recommended Reading:
www.tga.gov.au
www.tga.gov.au/devices/presentations.htm
Guidance Document Number 25:Classification of medical devices
Guidance Document Number 22:The essential principles for medical
devices