EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDERS NUMBER 52 & 53
GLOVES FOR MEDICAL AND DENTAL USE and SURGICAL GLOVES
(Section 10, Therapeutic Goods Act 1989)
The Therapeutic Goods Act 1989 (the Act), which was enacted on January 17, 1990, regulates the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods which are used in humans. The Act came into effect on February 15, 1991.
Section 10 of the Act empowers the Minister, or an Officer of the Commonwealth with the appropriate delegation, by Order published in the Commonwealth of Australia Gazette to determine, as required, standards for therapeutic goods.
Part 2 of the Act, in sections 10-15, contains provisions dealing with the standards which may be applied to therapeutic goods. This Part covers matters such as the determination of standards
(s. 10), date of effect of standards (s. 11), special standards (s. 14) and consent being subject to conditions etc…. in certain circumstances (s. 15).
Section 10(1) of the Act states that “The Minister may, by order published in the Commonwealth of Australia Gazette, determine that matters specified in the order specify a standard for therapeutic goods or a class of therapeutic goods identified in the order (whether or not those goods are the subject of a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary)”.
Surgical and examination gloves (medical gloves) are a high use item, used in a situation where exposure to infection to viruses such as HIV and Hepatitis is high. The users expectation that the device will provide protection is also high as medical gloves are specifically sold and used for the prevention of infection. Like condoms, the quality of both surgical and examination (medical) gloves is considered a critical aspect of the National Aids program and infection control procedures in all health care facilities. There are well known cases of the transmission of infection, including HIV and Hepatitis, from doctors to patients and vice versa and there is strong expectation among health workers and patients that medical gloves are of sufficiently high quality to protect them.
The Therapeutic Goods Committee (TGC), which is the committee that advises the Minister on matters relating to standards for therapeutic goods agreed at their meeting of 19 April 1996, that
ISO 11193:1994 International Standard – Single-use rubber examination gloves – Specification and ISO 10282:1994 International Standard – Single-use sterile surgical rubber gloves – Specification should, subject to consultation, be adopted as Therapeutic Goods Orders (TGO’s). Standards Australia has since published new standards for both surgical and examination gloves which clone these International Standards. As the Australian Standards now duplicate the requirements of the International Standards TGO’s 52 & 53 have therefore been made to reference Australian/New Zealand Standard 4011:1997 – Single-use examination gloves – Specification and Australian/New Zealand Standard 4179:1997 – Single-use sterile surgical rubber gloves – Specification, respectively.
The proposal to adopt these standards as new TGO’s has been circulated widely to users and industry and all comments have been considered.
The Orders were was signed by the delegate of the Minister on 24 May 1997 for the purpose of establishing standards for medical gloves under section 10(1) of the Act.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the quality, safety, and efficacy of therapeutic goods used in humans, thereby establishing a national system of controls. Enacted by the Parliament of Australia, the Act aims to ensure that therapeutic goods available to the public meet necessary safety standards, thereby protecting public health. Section 10 of the Act allows the Minister for Health or a designated officer to establish standards for therapeutic goods via orders, which are to be published in the Commonwealth of Australia Gazette. These Therapeutic Goods Orders (TGOs) include TGO 52 and TGO 53, which were introduced to address the high-stakes nature of medical and dental gloves used in healthcare settings, where the risk of infection transmission is significant. These orders reference Australian/New Zealand standards to ensure that gloves provide the necessary protection against infections such as HIV and Hepatitis, aligning with the high expectations of both healthcare workers and patients.
Scope and Application
The Therapeutic Goods Act 1989, which commenced on February 15, 1991, establishes a national framework to control the quality, safety, and efficacy of therapeutic goods used in humans. The Act empowers the Minister or a designated officer to determine standards for therapeutic goods through Orders published in the Commonwealth of Australia Gazette, as specified in Section 10 of the Act. Therapeutic Goods Orders (TGO) 52 and 53, established under this section, specifically set standards for medical and dental gloves, including surgical gloves. These Orders were designed to ensure the quality of gloves used in high-risk environments where protection against infections such as HIV and Hepatitis is crucial. The Orders reference Australian/New Zealand Standards AS/NZS 4011:1997 and AS/NZS 4179:1997, which were developed to mirror the international standards ISO 11193:1994 and ISO 10282:1994, respectively. The Orders apply to all entities manufacturing, supplying, or importing these gloves within Australia, ensuring compliance with the specified standards to maintain public health safety. The scope of these Orders extends to the entire nation, encompassing all states and territories, and they are subject to further regulation through subordinate instruments as needed.
Key Provisions
Section 10 of the Therapeutic Goods Act 1989 provides the primary mechanism by which the Minister or an authorised officer can establish standards for therapeutic goods, including medical and dental gloves. Section 10(1) specifically allows the Minister to determine standards for therapeutic goods or classes of therapeutic goods through orders published in the Commonwealth of Australia Gazette. These standards must specify the matters that define the quality, safety, and efficacy of the goods. In the context of the legislation, Orders 52 and 53 were established to address the standards for gloves used in medical and dental procedures.
The obligations imposed by these Orders require manufacturers, importers, and suppliers of medical and dental gloves to ensure that their products meet the specified standards. Specifically, these standards mandate that gloves must comply with the Australian/New Zealand Standard 4011:1997 for examination gloves and Australian/New Zealand Standard 4179:1997 for sterile surgical gloves. Compliance entails adhering to the specifications regarding material composition, manufacturing processes, and performance criteria designed to ensure the gloves' protective capabilities against infections such as HIV and Hepatitis.
Failure to comply with these standards can result in significant legal and financial repercussions. Under the Act, non-compliance can be considered an offence, potentially leading to criminal charges. The penalties for such offences can be substantial, including fines that may reach up to $330,000 for individuals and $1.65 million for corporations, as stipulated in the Therapeutic Goods Act. Additionally, non-compliant goods may be subject to seizure and prosecution, further underscoring the importance of adhering to the established standards to avoid these severe consequences.