Taskforce established

Task Force members, from left: Linda Punyer, Jennifer Elijah,
Helen Kosmas, Denise Sofoulis, Mike Johnston,
Kelwant Dillon, Glenn Street

In recognition of the delays being experienced by sponsors, the National Manager has established a Task Force to tackle the backlog of applications for the listing of medical devices in the ARTG. The Task Force of eight people (led by Michael Johnston and Helen Kosmas) will process all applications received prior to 19 October 1997 and will also focus on codifying the decision making process to support the development of an Electronic Listing Facility (ELF) for medical devices.

Applications received after 19 October will be processed by the staff of the Medical Devices Section, who will be assisted by staff from the Task Force once the backlog has been removed. The dedication of these resources acknowledges the difficulties which have been experienced in achieving the agreed turn around time of 30 days for the processing of applications for listing of medical devices and the commitment of the TGA to ensuring timely access to safe and effective medical devices.

New home for the NRL

The closure of the Fairfield Hospital on 30 June 1996 has necessitated the relocation of the National Serology Reference Laboratory (NRL, formerly known as the National HIV Reference Laboratory). Following an Australia wide tender process the St Vincent's Institute of Medical Research (SMVIR) has been chosen to host the NRL.

The selection of St Vincent's Institute of Medical Research will allow the NRL to continue its important role in providing quality HIV testing. This will mean that Australia and the Asia-Pacific region will have access to the best quality tests available to diagnose and combat the spread of serious viral diseases. The Laboratory's role was expanded in 1995 to include Hepatitis C tests (HCV) to ensure the safety of blood and blood products, as well as tests used to monitor the effectiveness of drug treatment for these diseases.

The continued location of the National Serology Reference Laboratory in Melbourne will also allow it to develop an important working relationship with the Australian Red Cross Blood Service, which has recently established a national office in Victoria.

The NRL supports the Therapeutic Goods Administration (TGA) in the evaluation of HIV and HCV diagnostic tests prior to inclusion in the Australian Register of Therapeutic Goods (ARTG). The NRL also monitors post market performance of registered kits in Australia and coordinates a national laboratory quality assurance program.

The overall management of the Commonwealth contract with the host institution was transferred to the TGA from the Public Health Division in 1996.

Warning for imported mail order therapeutic goods

A number of overseas companies are now advertising catalogue lines of health care products that include therapeutic goods in international journals and on the Internet. There is concern that these companies may be encouraging the importation and illegal use of unlisted or unregistered therapeutic goods in Australia. The people who import these goods and use them on people other than themselves or their immediate family, are in breach of the Therapeutic Goods Act 1989.

TGA has discussed the situation with overseas mail order companies and agreed it is important to provide guidance to customers on the legal issues that need to be considered when purchasing goods.

The TGA recommends that entities operating outside Australia advertising direct mail therapeutic goods should include the following warning statement:

The warning should appear clearly in all promotional information and product information.

Publishers within Australia should note that under Regulation 6 (1) of the Therapeutic Goods Regulations, it is an offence for a person to publish an advertisement about goods for therapeutic use that are not listed or registered with the Therapeutic Goods Administration.

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Regulation of sterilants and disinfectants

The development and implementation of the regulatory framework for sterilants and disinfectants has proven a complex task and has required extensive stakeholder consultation to achieve a satisfactory outcome.

GMP licensing requirements

At a meeting on 4 September 1996 between industry representatives and TGA it was agreed that:

• GMP and licensing will apply to manufacturers of sterilant and instrument grade disinfectants only, and not to manufacturers of hospital grade disinfectants (the Therapeutic Goods Regulations are currently being amended to give effect to this decision).
• Manufacturers will be able to select EN46001, EN46002, ISO13485 or ISO13488 as the standard against which their manufacturing operations will be assessed by TGA for the purpose of obtaining a licence (this choice of standards is consistent with the approach in Europe).
• Applications for a licence to manufacture sterilants or instrument grade disinfectants must be lodged with TGA by 1 January 1998. Acompany lodging a licence application by this date may continue to manufacture until TGA makes a determination on the licence application (failure to lodge a licence application by the due date will result in a manufacturer being in breach of the Therapeutic Goods Act if it were to continue manufacture and supply).
• From 1 January 1998 to 1 January 1999, the manufacturer may nominate the date of the TGA audit. If a TGA audit has not taken place by 1 January 1999, TGA will specify an audit date.
• Manufacturers will be permitted 24 months, from 1 January 1998, to achieve compliance with the selected manufacturing standard, provided reasonable improvement is observed at each successive audit.
• A TGA licence will be issued when the manufacturer demonstrates compliance with all the elements of the relevant standard. A quality systems certificate will also be issued if requested.
• Therapeutic Goods Orders (TGOs) No.54 and No.54A will apply to the initial development studies, such as microbial efficacy, toxicity, compatibility, stability, labelling, etc. These studies should be undertaken prior to the GMP audits.

Sponsors of Overseas manufacturers of these products must provide, as part of the registration application, evidence that the overseas manufacturing site complies with an equivalent level of GMP.

Industry seminars

Seminars hosted jointly by the Proprietary Medicines Association of Australia (PMAA) and the Australian Chemical Specialties Manufacturers Association (ACSMA) targeting suppliers of hospital and household grade disinfectants were held in late June in Sydney and Melbourne. A seminar held late in 1996 targeted sponsors of the higher risk sterilants and instrument grade disinfectants.

Industry organisations have emphasised there is a need for TGA and the industry to continue the education program for both industry and healthcare professionals. As it currently is being suggested that hospital grade disinfectants are satisfactory for use on instruments, this would include dental and medical practitioners.

Applications and evaluations

At the closing date of 30 June 1997, approximately 80 applications for registration and 40 applications for listable products had been received. Evaluations for microbial efficacy, chemistry, toxicity and materials compatibility have commenced and additional scientific staff have been contracted to help undertake the task.

In general, the data supplied in support of the applications have been inadequate. The most common deficiency is the failure to provide adequate data to support the claims for the products, such as insufficient data on sporicidal activity, chemical stability, compatibility of materials, or risk analysis.

Timeframes

All sponsors are reminded that to support applications for listing on the ARTG for registrable disinfectants (that is instrument grade, hospital grade with specific claims) or household/commercial disinfectants with specific claims, should have been lodged with the TGA by 30 November 1997.

Sponsors who are unable to meet this deadline, should contact the Medical Devices Section of the TGA to discuss the timetable for lodgement of applications for particular products (Please quote the relevant TGAIN)

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US FDA introduces latex labelling requirements

In response to reports of allergic reactions to some medical devices, the United States Food and Drug Administration (FDA) is requiring all medical devices which contain natural rubber latex to be amended to include a statement on the label which states, "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions". Medical device packaging that contains latex will be required to carry a similar statement on the label. Products and packaging containing dry natural rubber will have to be identified as containing dry natural rubber.

The new requirements, published on 30 September 1997 in the Federal Register as a Final Regulation, will enable people who are allergic to latex to easily identify medical devices that contain latex.

Over the past decade, FDA has received more than 1,700 reports of severe allergic reactions, including 16 deaths, related to medical devices containing latex. The deaths were caused by a reaction to latex cuffs used on the tip of barium enema catheters which have been recalled from the market. The product supplied currently includes a silicone cuff.

Allergic reactions have been reported to a wide range of medical devices that contain latex, including latex surgical gloves, adhesive bandages, intravenous catheters, and anaesthesia equipment. FDA sponsored an international conference on latex sensitivity in 1992 to determine the cause and extent of the problem and explore ways to address it.

While the risk of an allergic reaction to latex for the general public is estimated to be less than 1 percent - health care workers and patients with conditions involving multiple surgical procedures are at greater risk due to frequent exposure.

FDA is also requiring that all "hypoallergenic" claims on medical devices be removed because of the potential to mislead people sensitive to latex. Such claims are currently found on many medical devices that contain reduced levels of latex protein. However, these products may still cause allergic reactions in people who are latex sensitive. While manufacturers may not use the term "hypoallergenic" the labelling may include a claim reduced incidence of sensitivity.

Manufacturers have one year - until September 30, 1998 to comply with the new law. The regulation does not apply to latex containing medical devices that do not come in contact with people.

Proposed new standards for condoms

The Therapeutic Goods Order (TGO) 39, which was gazetted on 30 May 1991, specifies the mandatory standards for rubber condoms based on ISO 4074:1990 - Rubber Condoms. Since 1991 nearly all of the parts of ISO 4074 have been revised.

The TGA recommended to the 20 November 1997 meeting of the Therapeutic Goods Committee (TGC) to adopt new mandatory requirements for rubber condoms based on the amended international standards.

The following table indicates the parts of ISO 4074 that are referenced in TGO 39 and the publication date of the revisions to be adopted byreference in a new TGO.

ISO 4074 "Rubber Condoms" Part name	TGO 39 referenced part	Revised proposed in TGO
Part 1: Requirements	1990	1996
Part 2: Determination of length	1980	1994
Part 3: Determination of width	1980	1994
Part 4: Determination of colour fastness	1980	None
Part 5: Testing for holes	1984	1996
Part 6: Determination of bursting volume and pressure	1984	1996
Part 7: Oven conditioning	1986	1996
Part 9: Determination of tensile properties	1980	None
Part 10: Packaging and labelling Condoms in consumer packages	1990	1990

The effect of these changes is to align the requirements for leakage, and bursting volume and pressure, with international requirements. Requirements that did not relate to the safety of condoms, namely colourfastness and tensile strength, have been deleted from the revised standards. Technical details of the changes are set out below.

• The requirements, inspection level and AQL (acceptable quality level) for dimensions.
• The requirements and AQL for bursting volume and pressure have been modified. The minimum burst pressure has been increased from 0.9 kPa to 1.0 kPa. There is a slight (approximately 4%) increase in the minimum burst volume requirement. The AQL is modified to allow 1.0% defectives (previously 1.5%).
• The requirements and AQLfor oven treated condoms are now the same as for untreated condoms. The inspection level is reduced to S-4. The ageing period has been increased from 48 hours to 168 hours.
• The requirements, inspection level and AQL for freedom from holes have been modified. The rolling technique previously unique to TGO 39 is now incorporated in ISO 4074. The inspection level remains at G-1, but the minimum sample size is 315 (previously 125). The AQL is modified to allow 0.25% defectives (previously 0.4%)
• The requirement for colourfastness has been deleted.
• The requirement for tensile properties has been deleted.
• The requirements and inspection level for packaging and labelling are unchanged. The AQL is modified to allow 4.0% defectives (previously 1.0%).

Sponsors of rubber condoms in Australia should check that their supplying manufacturers are aware of the requirements specified in the new international standard and determine whether their products are able to comply.

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Harmonisations with the European Union

What is it all about?

The Therapeutic Goods Administration (TGA) and the Government are committed to harmonising the Australian requirements for the regulation of medical devices with those of the European Union (EU).

What is the TGA doing

The TGA has established a team dedicated to the development of Regulation Impact Statement (RIS) exploring various options to harmonise the Australian requirements for the regulation of medical devices with that of the EU. This comprises an analysis of the costs and benefits for stakeholders for each option. A survey of sponsors in 1996 provided an assessment of the overall reaction to the proposal. An implementation strategy and a new structure of fees and charges, reflecting the proposed options, are now being developed. Following further consultation with device sponsors, industry associations and consumer groups, the draft fees and charges will be submitted together with the RIS for consideration by the government.

After enactment of the legislation and introduction of the preferred option for a new regulatory system for medical devices, the TGA will provide guidelines and conduct information sessions to assist the industry.

When would the changes take effect?

It is anticipated that the new legislation will be considered by Parliament during the 1998 Spring sitting.

Auditing workshop

The TGA collaborated with the UK Medical Devices Agency to hold a four day workshop on "Auditing Sterile Device Manufacturers". The workshop provided a detailed insight into the harmonised standards for sterilisation adopted under the European Medical Device Directive. Twenty six delegates attended the course including staff from TGA, the device industry and hospital sterilisation units, with two overseas delegates from the Singapore Ministry of Health and TUV in Japan.

Mutual Recognition Agreement with Europe

It is anticipated that the Mutual Recognition Agreement (MRA) on Standards and Conformity assessment negotiated between Australia and the European Union will be signed in February 1998.

The delay from the previously advised date of November 1997 relates to consideration of a request by the EU for an amendment to the decreditation procedures for determining the competence of Conformity assessment Bodies.

The Department of Industry, Science and Technology, the National Association of Testing Authorities, Australia (NATA) and the Council of the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) will hold discussions in November with the EC regarding the proposed changes.

Implementation of the MRA is scheduled to occur one month after signing.

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Device labelling

While device manufacturers appear to be enthusiastically taking up the use of labelling symbols, it would appear more needs to be done by manufacturers or sponsors to educate Australian customers and users as to the meaning of the symbols. TGA has received many calls from health care workers seeking an explanation of the various symbols and in relation to the mandatory labelling requirements of TGO 37. Of particular concern are reports that the European Standard EN980 symbol for 'Do Not Reuse' is being used as the exclusive means of communicating that a medical device is intended for single use.

While TGO 37 is under review, the use of the EN980 symbol for 'Do Not Reuse' as the sole means of indicating that the product is intended for single use does not presently comply. Words such as "do not reuse", "single use" or "use only once" should also appear on the product label or on the information provided within the packaging. It is preferable that the explanatory words are printed near the appropriate symbol as this will expedite the education of users.

Sponsors should also be aware that changes to labelling made after products are entered on the ARTG are required to be notified or approved by the TGA. Attention is drawn to part VA of the Trade Practices Act which requires that goods are supplied free from defects and that they provide a level of safety that persons are generally entitled to expect. This requirement extends to the provision of adequate instructions and warnings and suppliers of any goods should not rely exclusively on symbols to convey important safety information when there is widespread ignorance of the meaning of these symbols.

To assist in the education of users the following symbols from EN980 are reproduced.

	Serial Number
	Catalogue Number
	Batch Code
	Do Not Reuse
	Sterilization by Irradiation
	See Instructions for Use
	Sterilization by Steam or Dry Heat
	Use By
	Sterile
	Sterilization by Ethylene Oxide

Display of unauthorised goods

Schedule 5 of the Therapeutic Goods Regulations exempts certain goods from registration or listing in the ARTG. Item 3 specifically exempts;

samples of therapeutic goods imported, exported, manufactured, or supplied for:

1. submission to a regulatory authority; or
2. subjection to developmental or quality control procedures; or
3. examination, demonstration or display; or
4. subjection to analysis or laboratory testing; but not for supply for therapeutic use in humans"

This means sponsors may import and display therapeutic goods at conferences, trade fairs and other events prior to the entry of these goods on the ARTG, provided certain conditions are met. In the past, TGA issued conditional written authorisations to display unauthorised therapeutic devices for specific products and events. This practice has been discontinued.

However sponsors displaying unauthorised devices must ensure these goods are displayed in a manner that makes it clear the devices are currently unauthorised and not available for supply. This means the display must include a clearly legible sign stating the goods are not entered on the Australian Register of Therapeutic Goods [ARTG] and their safety, quality and efficacy has not been established by the Therapeutic Goods Administration [TGA]. Any promotional material about these products distributed at the meeting should include a similar statement. There are additional trade display guidelines for unregistered drugs. These are included in the Australian Pharmaceutical Manufacturers Association (APMA) Code of Conduct.

The sponsor may hold these devices under the direct control for up to 12 months but must maintain records relating to the source and supply of the devices and provide this information to TGA if requested. The products must be destroyed or returned to the consignor of the devices within 1 month of the end of that period, unless the goods have been approved for entry onto the ARTG.