THERAPEUTIC GOODS ACT 1989
THERAPEUTIC GOODS ORDER No. 59
Polymer Urethral Catheters for General Medical use
I, John Cable, delegate of the Minister for Health and Family Services for the purposes of the exercise of the Minister’s powers under Section 10 of the Therapeutic Goods Act 1989, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the said Act, HEREBY:
REVOKE, on and from the date this Order is gazetted, Therapeutic Goods Order No, 38, “Single-Use Urethral Catheters (Sterile) for General Medical Use” which commenced to operate on 16 May 1991; and
DETERMINE that the matters specified in clauses 1 to 10 inclusive and Appendix A and B in the document titled “AS/NSZ 2696:1996 Australian/New Zealand Standard, Medical devices – Polymer urethral catheters for general medical use”, published by Standards Australia on 5 July 1996 (“the Standard”) and as modified below, shall constitute standards for all polymer urethral catheters for general medical use.
MODIFICATIONS TO THE STANDARD
(a) CLAUSE 2 “REFERENCED DOCUMENTS”
Add to the top of the list of referenced documents in Clause 2 the Australian Standard:
“1199 Sampling procedures and tables for inspection by attributes (AS 1199-1988)”;
(b) NEW CLAUSE 11
Insert after Clause 10 the following new Clause:
“11 The table below sets out the acceptable quality levels to be applied to the tests described in the standard, as set out in “Table 1 - Sample size code letters” and “Table 2-A - Single sampling plans for normal inspection (Master table)” in AS 1199.”;
AS/NZS 2696:1996 Clause No. | Inspection Level | Acceptable Quality Level |
6.4.2 | A minimum of 3 replicates shall be used for the test samples and controls used to test for cytotoxicity, refer to Appendix B | |
6.4.4 | As defined in TGO 11 | As defined in TGO 11 |
7.2.1. | S-2 | 4.0 |
7.2.2 | S-2 | 4.0 |
7.3 | S-2 | 4.0 |
8.1.2 | S-2 | 4.0 |
8.1.4 | S-2 | 4.0 |
8.1.5 | S-2 | 1.5 |
8.2.2 | S-2 | 4.0 |
8.2.5 | S-2 | 1.5 |
8.2.6 | S-2 | 4.0 |
8.2.7 | S-2 | 1.5 |
8.2.8 | S-2 | 4.0 |
8.2.9 | S-2 | 1.5 |
9.1 | S-2 | 1.5 |
10.1 | S-2 | 1.5 |
10.2 | S-2 | 1.5 |
10.3 | S-2 | 1.5 |
(c) NEW CLAUSE 12
Insert after Clause 11 the following new Clause:
“12 A reference in this Order to another document is taken to be a reference to the document as in force on the date this Order is gazetted.”.
This Order commences on the date this Order is gazetted.
Dated on this 7th day of April 1997.
John Cable
Delegate of the Minister for Health and Family Services
Overview
The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the quality, safety, efficacy, and timely availability of therapeutic goods. This Act was introduced to address the need for a comprehensive legal framework to ensure that therapeutic goods available in the Australian market meet necessary standards. The Therapeutic Goods Order No. 59, issued in 1997, revokes the previous standards for single-use urethral catheters and adopts new standards for polymer urethral catheters for general medical use. These changes were made to align with the latest Australian and New Zealand Standards, ensuring that the safety and quality of these medical devices are up to date. The policy objective of this Order is to protect public health by ensuring that the therapeutic goods supplied in Australia are of acceptable quality and safety.
Scope and Application
The Therapeutic Goods Order No. 59, made under the Therapeutic Goods Act 1989, applies to all polymer urethral catheters intended for general medical use within Australia. This legislative instrument revokes the previous Therapeutic Goods Order No. 38 concerning single-use urethral catheters and sets new standards for polymer urethral catheters, aligning with the AS/NZS 2696:1996 Standard. The application of this order is national, as it pertains to the regulation of therapeutic goods across Australia. The order modifies the referenced documents and includes new clauses that establish acceptable quality levels for the tests described in the standard, ensuring that manufacturers and suppliers comply with the specified requirements to maintain safety and efficacy standards for these medical devices. The order does not specify exclusions or exemptions but relies on the overarching provisions of the Therapeutic Goods Act 1989 for enforcement and compliance.
Key Provisions
The Therapeutic Goods Order No. 59 (TGO No. 59) under the Therapeutic Goods Act 1989 revokes the previous order (TGO No. 38) and establishes new standards for all polymer urethral catheters intended for general medical use. The new standards are based on the Australian/New Zealand Standard AS/NZS 2696:1996, with modifications to Clause 2 and the addition of Clauses 11 and 12 (sections 1 to 10 inclusive, along with Appendices A and B). Clause 2 now includes the Australian Standard "Sampling procedures and tables for inspection by attributes (AS 1199-1988)" in its list of referenced documents. Clause 11 outlines acceptable quality levels for the tests described in the standard, using tables from AS 1199. Clause 12 clarifies that references to other documents are to be understood as references to those documents as in force on the date this Order is gazetted.
Under this Order, manufacturers and suppliers of polymer urethral catheters must comply with the specified standards, including the acceptable quality levels detailed in Clause 11. They must ensure that the products meet the requirements for cytotoxicity and other specified tests. This involves conducting tests using a minimum of three replicates for samples and controls and adhering to the standards set out in AS/NZS 2696:1996 and AS 1199. The modifications and additional clauses impose obligations on these parties to maintain up-to-date records and documentation to demonstrate compliance with the Order.
Breach of the requirements set out in this Order may lead to significant consequences. The Therapeutic Goods Act 1989 provides for both civil and criminal penalties for non-compliance. Civil penalties may include fines and other monetary penalties as determined by the court. Criminal offences under the Act may result in substantial fines and imprisonment, with the maximum penalties varying depending on the severity and nature of the breach. For example, individuals and corporations can face fines of up to $1.65 million and imprisonment for up to 10 years for serious offences. These stringent measures underscore the importance of adhering to the standards set forth in TGO No. 59.