1. 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

2. 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

3. 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’?

4. “ 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. ”

5. Implications for Physiotherapists  PTs supply and manufacture items that could be classified as Class 1 medical devices:

6. Terminology  A clinician needs to comply with the TGA regulations if they are considered to be the manufacturer of a medical device

7. 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.”

8. 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

9. 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

10. 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

11. Classify the Device Guidance 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?

12. Apply Conformity Procedure Guidance 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

13. Comply with Essential Principles Guidance 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…

14. Document Technical Information Guidance 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

15. Complete Declaration of Conformity  Indicates that you have completed all compliance procedures

16. 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

17. 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?

18. 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

19. 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