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