TGA News Issue 38 (July 2002) - Medical devices
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
Animal selection criteria for medical devices
The criteria by which vertebrate animals are selected for use in the manufacture of medical devices was discussed at the 19 April 2002 meeting of the Therapeutic Device Evaluation Committee (TDEC). TDEC was advised that the TGA has not formally adopted a general guideline or standard setting out criteria to be observed when selecting vertebrate animals for use in medical device manufacture.
At present, the TGA is developing guidelines to address potential Transmissible Spongiform Encephalopathy (TSE) infectivity in low-risk (European Agency for the Evaluation of Medicine Products (EMEA) Category IV) materials. The scope of this document is limited and guidelines with broader application are required to ensure consistency in procedures for animal selection.
It is generally agreed that when selecting animals the sourcing and national controls are of primary importance. Nonetheless, within a national system, herd animals may be obtained from private sources or through the approved abattoir system where they have been subject to varying levels of scrutiny in both the pre-mortem and the post-mortem stage.
For biological materials intended for manufacture into medical devices, the primary focus must be directed to minimising the risks of using diseased or contaminated starting materials. In 1995, the Australian Code of Good Manufacturing Practice - Human Blood and Tissues was published to provide guidance on donor selection, donor exclusion and a quality system for human tissue processing and manufacture. The TGA considers that a similar approach should be adopted for animal tissue selection.
At the 19 April meeting, TDEC reviewed EN 12442:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices, in particular Clause 6.2 of Part 2: Controls on sourcing, collection and handling which reads:
| 6.2 |
Material of animal origin intended for utilization in medical devices shall have originated from animals confirmed by a veterinarian as being fit for human consumption. For species not usually consumed by humans a status equivalent to "fit for human consumption" is required. Records to demonstrate conformance with veterinary inspection criteria at the abattoir, certificate details and source shall be available. NOTE: Animals should be subject to ante-mortem veterinary inspection. Prior to certification, a post-mortem inspection should be performed immediately after slaughter and should include: (a) visual inspection; |
TDEC recommended that EN 12442:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices be adopted as a medical device standard under the new medical device legislation to assist in the selection of vertebrate animals and their tissues for medical device manufacture. TDEC also recommended that the standard be applied as a manufacturing principle under Part 4 of the current Therapeutic Goods Act.
Consultation with industry on the adoption of EN 12442 will be carried out in the near future.
New regulatory system for medical devices ready for implementation in 2002
The Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Charges) Amendment Bill 2002 were passed by both Houses of Parliament in March 2002. The Bills received Royal Assent on 4 April 2002 and the new internationally harmonised framework for the regulation of medical devices in Australia will be implemented on 5 October 2002.
The Therapeutic Goods (Medical Devices) Regulations 2001, which contain the detailed requirements for the new regulatory system, are being finalised. An initial draft of the Regulations (the Essential Principles and Classification Rules) is available. The third, and final, major platform of the regulations, the Conformity Assessment Procedures, will be released as soon as they are available.
In late-May and early-June 2002, the TGA, with assistance from the Medical Industries Association of Australia (MIAA), held a series of two day seminars on the new legislative requirements for medical devices. Feedback from participants at the seminars indicated that the seminars were very well received. Anyone who was unable to attend the seminars but would like a copy of the overheads provided obtain a copy by providing contact details by fax to 02 6232 8687.
In 2001, in consultation with MIAA, the TGA engaged Price Waterhouse Coopers (PWC) to develop a Fees & Charges Model for the new regulatory system for medical devices.
PWC have developed a fees and charges model that:
- aims to recover 62.5% from annual charges. This ensures stability and predictability are achieved for both industry and the TGA by retaining the emphasis that 62.5% of revenue from the medical devices industry comes from annual charges
- ensures revenue is generated from both the assessment activities and annual charges for ARTG entries expected under the new and current systems
- ensures a fair and equitable system for all sponsors, that apportions the fees and charges across the various groups according to the class of product and the amount of work required to assess a products suitability for supply in Australia.
The PWC Model provided four options for implementing the new fees and charges. Industry is currently reviewing the PWC Model with a view to providing comments by August 2002.
More information on the new regulatory system for medical devices: The Australian medical device regulatory system <http://www.tga.gov.au/devices/meddevreg.htm>.
Reuse of medical devices labelled single use
Medical devices can be labelled by the sponsor or manufacturer as "multi-use/reusable" or "single use only". A reusable device is intended to perform the same way, the first time it is reused and every time thereafter. The manufacturer validates the reusable device for reuse, and reprocessing instructions are provided with the device upon supply. A device that has been labelled "single use only" has not been validated for reuse by the manufacturer and any reuse of that device is considered "off label" use.
The Commonwealth does not condone the reuse of single use devices, however does recognise that it is conducted in State and Territory health care facilities for a small number of medical devices. The State and Territory health care facilities involved in reprocessing of single use devices recognise that reprocessing should only occur where it has been proven to be safe for the patient.
In July 2001, the Australian Health Ministers' Advisory Council (AHMAC) agreed that any reprocessing of single use devices is a manufacturing activity which requires regulation by the TGA and that the TGA should regulate to the same level as for the original manufacturer.
In May 2002, the TGA submitted a regulatory framework options paper to the National Coordinating Committee on Therapeutic Goods (NCCTG), a sub-committee of AHMAC. NCCTG have agreed that the regulatory framework for re-manufacture of a single use device for reuse must include the following regulatory requirements:
- GMP auditing and licensing of specified devices
- Patient consent
- Tracking
- Labelling and packaging
- Incident report and recalls
- A Technical File or Design dossier review.
The TGA is in the process of further developing the proposal and will be releasing a discussion paper in the near future.
TDEC 2002/1 meeting
The 2002/1 meeting of the Therapeutic Device Evaluation Committee (TDEC) was held on 19 April 2002. The main points of discussion included:
- The revision of new Committee processes for the expedient ratification of resolutions and the introduction of public release of key meeting outcomes on the TGA website
- The establishment of a process to regulate medical devices incorporating ancillary medicinal substances
- The evaluation of a polyurethane condom
- Problem report investigations including:
- reports of air embolism associated with a High Flow blood and fluid warmer
- uncoiling of the integral placement wire of a catheter
- kinking of the high pressure pump hose of a medical device steriliser
- reports of a substance collecting inside the tubing of an anaesthetic machine
- Review of the requirements for animal selection criteria for medical devices of animal origin
- Proposal to harmonise Australia's requirements for in-vitro diagnostic devices with international best practice
- The new medical devices legislation.
The recommendations of the Therapeutic Device Evaluation Committee are yet to be considered by the TGA.