This chapter examines the role of the Therapeutic Goods Administration
(TGA) in the regulation of medical devices, including how issues of global harmonisation
and collaboration affect those regulatory processes. The chapter considers
whether the current mechanisms for pre-market assessment and post-market
surveillance of medical devices are appropriate for ensuring patient safety.
The chapter scrutinises a variety of current processes, as well as proposed
reforms, related to provision of clinical evidence; third party conformity
assessment; the classification and level of assessment of high risk medical
devices; adverse event reporting, clinical registries; remanufacturing of
medical devices; and the regulation of custom-made devices
This inquiry is being conducted in a dynamic policy and legal environment.
It is occurring at the same time as on-going implementation of the
recommendations of the Government's Review of Health Technology Assessment
(HTA) conducted in 2009. The Review made a number of recommendations
which 'impact on the...TGA, its interaction with other HTA agencies, and
improvement of post-market programs to better inform premarket regulatory
decision making'. The recommendations of the HTA review are contained in
In response to the HTA and other reviews, the TGA issued a discussion paper,
Reforms in the Medical Devices Regulatory Framework, in October 2010.
In addition, the final report of the TGA Transparency Review was released
on 20 July 2011. The report raised key issues regarding the
failure of the TGA to communicate adequately with stakeholders.
The 13 member review panel, chaired by Emeritus Professor Dennis Pearce AO,
made 21 recommendations. The recommendations sought to increase
stakeholder involvement in the TGA; improve information provision on the market
authorisation process; and facilitate reporting to the TGA, and provision of
information by the TGA, in relation to adverse events. The recommendations of
the Transparency Review are contained in appendix 4. The Government is yet
to respond to the recommendations of the panel.
Echoing the recommendations of the TGA Transparency Review, a consistent
theme of submissions to this inquiry is the need for the TGA to improve the way
that it communicates with stakeholders, and facilitates stakeholder opportunity
to communicate with the TGA. This issue is raised throughout this chapter and
is also addressed in chapter 4 in relation to identifying and acting upon high revision
rate medical devices.
It is also of note that this inquiry is being conducted at the same time
as representative class actions in the Federal Court of Australia in relation
to the DePuy ASR Hip and the DePuy LCS Duofix Femoral Component.
Related litigation is underway in other jurisdictions.
The role of the TGA in regulating quality of devices
The TGA is a division of the Department of Health and Ageing (DoHA). The
TGA stated its overall purpose is to 'protect public health and safety by
regulating therapeutic goods that are supplied in, or exported from, Australia'
as well as aiming 'to ensure that the Australian community has access, within a
reasonable timeframe, to new therapeutic goods'.
Therapeutic goods include medicines, medical devices and biological
products. Any product for which therapeutic claims are made (unless exempt)
must be entered in the Australian Register of Therapeutic Goods (ARTG) before it
can be supplied in Australia. The TGA carries out both pre-market assessment
and post-market surveillance.
In order to regulate medical devices, the TGA administers the following
- Therapeutic Goods Act 1989 (the Act);
- Therapeutic Goods Regulations 1990;
- Therapeutic Goods (Medical Devices) Regulations 2002 (the
- Therapeutic Goods (Charges) Act 1990.
Chapter 4 of the Therapeutic Goods Act 1989 provides for the
regulation of medical devices. The Act provides for various powers in relation
to the regulation of medical devices including the power to issue conformity
assessment certificates to manufacturers of a medical device; suspend or revoke
conformity assessment certificates in particular circumstances; include a
medical device in the ARTG; suspend or cancel entries of devices from the ARTG;
obtain information about medical devices; and require the recovery (recall) of
medical devices, or to inform the public about medical devices, where the
devices do not comply with the requirements of the legislation.
The regulation of medical devices in Australia includes the following
(a) A classification system for medical devices based on
different levels of potential risk to the patient.
(b) Manufacturers are required to demonstrate compliance with
a set of internationally agreed 'Essential Principles' for the quality, safety
and performance of the medical devices.
(c) A requirement that manufacturers implement and maintain a
suitable quality management system (QMS) for the design, production, release
and post market monitoring of medical devices.
(d) A requirement that medical devices be included in the
ARTG unless they are exempt.
(e) Medical devices available on the market are subject to
monitoring by the TGA. This monitoring includes a comprehensive incident
The TGA explained that as the regulator, it needed to achieve a balance
between safety and innovation. The TGA submitted that:
Consumers and health professionals expect medical devices to
be regulated to ensure an adequate level of safety and performance and that the
latest therapeutic technologies will be available in a timely manner.
Achieving this balance is becoming more involved due to advances in
technology. The TGA explained that 'Medical devices are becoming increasingly
complex, and can incorporate other therapeutic goods such as medicines and
The TGA went on to describe how this regulatory balance is achieved:
The TGA seeks to apply a risk-based regulatory system that
imposes sufficient regulatory controls, without imposing expensive and
unnecessary requirements on manufacturers, that might limit patients’ access to
effective therapeutic products.
Dr Rohan Hammett, National Manager, TGA, explained that it is not
possible to completely remove risk from this regulatory process:
It is a constant matter of balancing the challenges of
regulating the large number of products we regulate. One of the important
foundations of how we approach this is that we have an understanding that it
does not matter what amount of resources we have; it is not possible to create
a completely safe medical device, medicine or medical procedure. That just does
not exist. So in fact, despite the FDA's [United States Food and Drug
Administration] 17,000 staff, the ASR hip was approved and inserted in the US.
We would, I think, expect that, regardless of how many resources we had, there
would be some products that at some point in their life would result in adverse
events to consumers. That is the nature of health care, unfortunately: it is a
risky business. What we have to do is try to manage those risks.
The Australian Medical Association (AMA) observed that 'the arrangements
for assessing and regulating medical devices in Australia have served
Australians well'. However, the AMA noted that 'there will always be a tension
between introducing new products to the Australian market and being certain
that those products are safe and improve patient outcomes. This tension is
mitigated by rigorous pre and post-market assessment'.
Medibank Private noted that the TGA 'considers the technical performance
of a sponsor to consistently deliver the device as assessed through its
documentation processes' such as Australian code of good manufacturing practice
for medicinal products (GMP) and Independent Ethics Committee (IEC) compliance.
However, Medibank Private commented that the TGA does not assess quality on the
basis of clinical outcomes, 'rather, its primary role is as gatekeeper to ensure
no unsafe or non-efficacious devices are allowed to enter the Australian market'.
The Medical Technology Association of Australia (MTAA) emphasised the
importance of the HTA Review in considering the regulation of medical devices. It
The HTA Review provided a long-awaited opportunity for a
whole of system consideration of the assessment of non-pharmaceutical medical
technologies. The need for a review had been identified over several years by
the Productivity Commission. It was also supported by both political parties
during their time in government.
Global harmonisation and
The committee received evidence about the role the TGA plays in efforts
to align the regulation of medical devices through global harmonisation
processes. Evidence was also provided about how TGA regulation of medical
devices is affected by developments in harmonisation.
The committee also received evidence that the HTA Review considered how
harmonisation developments affected a number of pre-market assessment processes
including third party conformity assessment and the regulatory assessment of
higher risk medical devices.
These issues are discussed below.
The TGA has bilateral agreements in place with a number of countries 'ranging
from the recognition and acceptance of regulatory decisions on specific
products to sharing information about regulatory processes, such as what
pre-market assessments occur before a product is able to be supplied'.
By way of example, the Australia-European Union (EU) Mutual Recognition
Agreement (MRA) is a trade agreement between the Government of Australia and
the European Community (EC) which covers a range of industries including
medical devices. The MRA allows the TGA to issue European conformity assessment
certificates to Australian manufacturers to supply in Europe, and allows
specified European Notified Bodies to issue Australian conformity assessment
certificates to European manufacturers for supply in Australia.
The MRA excludes radioactive materials that are medical devices; devices
incorporating tissues of animal origin (with some exceptions); active
implantable devices; intra-uterine contraceptive devices; heart valves;
intra-ocular lenses; intra-ocular visco elastic fluids; powered drug infusion
pumps; implantable breast prostheses (except water/saline filled); barrier
contraceptives (excluding condoms); and instrument grade disinfectants.
The TGA is a founding member of the Global Harmonisation Task Force
(GHTF) for medical devices. The TGA explained the current role and function of
The GHTF is comprised of representatives from five founding
members: the EU, the USA, Canada, Australia and Japan. The GHTF has for 18
years worked on the development of a regulatory model and supporting documents
to underpin globally harmonised regulation of medical device technologies.
The purpose of the GHTF has been to encourage convergence in
regulatory practices related to ensuring the safety, effectiveness /
performance and quality of medical devices, promoting technological innovation
and facilitating international trade. This was primarily achieved through the
publication and dissemination of harmonised documents on basic regulatory
practices. These documents provide a model for the regulation of medical
devices that can then be adopted by national regulatory authorities.
Australian medical device legislation is based on the regulatory system
recommended by the GHTF and is aligned with the EU medical device framework.
Dr Hammett, TGA, noted that the GHTF system has become the basis of regulation
of medical devices in most of the world. He explained that 'It has now been
picked up by a mirror body called the Asian Harmonisation Working Party, which
has adopted similar legislation throughout the Asia-Pacific region'.
However, Medtronics Australasia noted that the role of the GHTF does not
bind the member states of the organisation, who maintain independent control of
their regulatory systems. Medtronics explained:
The fact that Australia is a member of the GHTF and uses some
harmonised principles in the operation of the regulatory system does not, in
most cases, mean that there is automatic acceptance of products approved in
other jurisdictions. Depending on the risk class of the product TGA does
undertake its own assessments of the documents and clinical evidence presented
for registration in other jurisdictions. The exception to this is for some
products manufactured in the European Union and which fall under a specific
mutual recognition arrangement. In most cases TGA can, and regularly does,
question these assessments and from time to time rejects listings where it is
not satisfied with the evidence presented, even for products approved in other
The TGA has explained that the current GHTF will be disbanded and a new
regulatory forum established in order 'to better reflect the changing global
requirements of regulators of medical devices in 2011 and beyond'.
The Australian Dental Industry Association (ADIA), while describing TGA
commitment to international harmonisation of the regulatory framework for
medical devices as 'exemplary', has raised concerns that proposed restructuring
of the GHTF will disenfranchise industry input.
The ADIA submitted that the previous model that included industry input
was being replaced by a 'regulator driven model', something the ADIA described
as 'objectionable'. The ADIA argued that the TGA lacks the expertise to
properly assess the impacts of its proposals for regulatory reform. The ADIA
further submitted that:
...this approach is based on the flawed premise that
regulators have a detailed understanding of the needs of industry and the
effects of their decisions on the costs of supplying medical devices.
The TGA regulates medical devices differently, according to their
classification, based upon the device's intended purpose and level of risk. Dr
Rohan Hammett, TGA, explained to the committee how the TGA approaches risk
We do that with a stratified framework of assessment, so we
apply more assessment resources pre-market to high-risk devices than we do to
low-risk devices. Then we balance that with post-market monitoring.
There are five classes of medical devices, other than in vitro
diagnostic devices which have their own system of categorisation, as described
in Figure 1.
Figure 1: Medical Device Classes
Surgical retractors, tongue depressors
Hypodermic needles, suction unit
Lung ventilator, bone fixation plate
AIMD (Active Implantable Medical Devices)
Source: TGA, Submission 18, pp 19 – 20.
The level of pre-marketing assessment carried out by the TGA is
determined by these classes. There is no assessment by the TGA of most Class I
medical devices, although applicants must certify as to a range of matters.
Prior to making an application to include a Class IIa or IIb medical device the
TGA must have accepted the Manufacturer's Evidence,
which is compared with the device to ensure appropriate conformity assessment
certification. An administrative review of the application is conducted but no
further assessment is carried out unless it is an application required to be
audited under the regulations or the application is selected for a
non-mandatory application audit.
Applications for Class III and AIMD devices are also subject to
acceptance of Manufacturer's Evidence. They will also generally undergo a
Level 2 application audit assessment. This includes the requirements for a
Level 1 audit assessment
as well as a risk management report; clinical evaluation report; and efficacy
and performance data for medical devices that disinfect, including those that
sterilise other medical devices.
The AMA noted the importance that the medical profession places on the
TGA pre-market assessment processes for listing on the ARTG. In addition the
AMA observed that:
The medical profession's involvement in the TGA assessment
processes ensures they are guided by medical opinion. Consequently, medical
practitioners are able to confidently choose from a wide range of medical
devices on the ARTG to make decisions about the optimal treatment for the
patient, based on the patient’s particular clinical circumstances.
However, the Australian Orthopaedic Association (AOA) was critical of
the regulatory regime governing the introduction of prostheses and medical
devices into the Australian market. In particular, the AOA was concerned about
the number of 'gate-keepers' involved in the review process, a process they
described as 'cumbersome, repetitive, time consuming and expensive'.
The AOA explained further:
Prior to the HTA Review, there was in effect, three 'gatekeepers'.
Despite the HTA Review recommendations these three gatekeepers remain. The
gatekeepers are TGA, the Prostheses Listing Advisory Committee (PLAC - formerly
the Prostheses and Devices Committee (PDC)) and MSAC [Medical Services Advisory
The AOA went on to argue that despite apparent overlaps in the process
none of these regulatory bodies 'undertakes a total assessment of new
prostheses' with the result that 'serious and clinically unacceptable gaps
remain in the assessment process'. The AOA provided an example:
For instance, TGA will assess the biomechanical safety (for
issuing the Australian Register of Therapeutic Goods-ARTG number), but will not
look at efficacy, PLAC can comment on clinical safety, but only advise TGA and
MSAC. The HTA review agreed the CAGs [Clinical Advisory Groups] could raise
concerns related to safety but those concerns had to be referred to the TGA who
was the sole decision maker on safety. There is however considerable overlap
between safety and efficacy and while both should be assessed separately the
process would be streamlined if it was done all at once because in many
circumstances...the same information is used to assess both.
The AOA submitted that the development of a publicly available list of
approved devices on the ARTG is vital. They explained that currently it is
difficult for anyone to work out what has been approved as the TGA only
publishes limited information about what is available on the ARTG.
The following section considers evidence received by the committee that
describes the TGA's approach to clinical evidence, examines concerns about the
adequacy of clinical testing, discusses the difficulties of conducting clinical
trails with implantable devices, looks at whether the current approach provides
any clinical advantage, discusses the question of whose evidence should be
relied upon and briefly looks at other approaches.
The TGA approach
The TGA has noted that clinical evidence plays an important role in pre-
market assessment, with all medical devices 'required to have clinical evidence
to support the safety and performance of the device at the time the device is
placed on the market in Australia'.
The TGA commented that there are limitations on the coverage of the Act,
and the requirement to be included on the ARTG. These exceptions include
clinical trial exemptions; the Authorised Prescriber Scheme; the Special Access
Scheme (SAS); and personal importation.
The TGA explained that the clinical evidence for medical devices must
...an appraisal (evaluation) of the available clinical data
(including clinical trial data, post market surveillance and clinical experience
data) for that device (or similar/equivalent devices) with respect to both
performance of the device as intended by the manufacturer and the safety of the
The TGA went on to explain that usually the manufacturer is only
required to have signed a declaration that the device conforms to the Essential
Principles (noted previously at paragraph 2.10) and that the supporting
evidence of compliance, including clinical evidence, can be provided to the TGA
if requested. The TGA will usually only see the clinical evidence in certain
circumstances prescribed in the regulations. This includes:
(a) for medium to higher risk devices in relation to which
the TGA must undertake an application audit, to confirm that the declaration of
conformity is valid (these will be subject to a Level 2 audit); and
(b) for higher risk devices in relation to which the TGA is
required to issue a conformity assessment certificate following full review of
technical (including clinical) documentation for the device to confirm the
device performs as intended, does not pose any undue safety concerns and that
the benefits of using the device outweigh the risks; and
(c) irrespective of the risk level, under the circumstances
of a post-market review.
Concerns about adequacy of clinical
A number of submitters argued for improved clinical evidence prior to a
device being listed on the market. Dr Armitage, AHIA, made the salient point
that although there was a place for both pre-market assessment and post-market
surveillance, he believed that:
In the very first instance...if a more rigorous analysis of
independently determined clinical evidence were the criterion upon which the
TGA made its original decision many of the other problems would not occur.
The AOA also told the committee that current clinical evidence requirements
prior to devices being put on the market are not adequate.
It made a number of recommendations about improving clinical evidence including
...the clinical requirements pre-release be defined; two years
pre-release clinical testing for joint replacement devices; and that RSA [Radio
studies be undertaken in conjunction with
post-market surveillance. The AOA also emphasised the importance of international
collaboration on this issue.
Brandwood Biomedical compared the regulatory system for clinical trials
in Europe and Australia, and told the committee that:
[the] TGA undertakes no meaningful audit or supervision of
clinical trials – which is devolved entirely to local ethics committees,
whereas Clinical Trial Supervision is a key responsibility of Competent
Authorities and is extensively resourced in the larger agencies particularly of
the UK, Germany and France.
The Consumers Health Forum of Australia (CHF) raised concerns that 'many
of the devices that gain automatic entry on to the ARTG have a significant risk
of causing harm'. The CHF went on to observe that 'until recently, joint
replacements had been judged to be low risk despite the fact that many fail,
requiring re-operation and creating an increased risk of mortality for some
Ms Karen Carey, Board Director, CHF, questioned why untested medical devices
are being registered, and brought on to the market, when alternative devices
with a track record are already available. Ms Carey stated to the committee
The only circumstance in which there is justification to go
early to market—to give an early approval—is where there is no comparator
device in that category, and therefore the patient is making a decision between
a device that does not have a lot of evidence and no device at all. I think you
can justify that. In terms of bringing things to market early, where there is
already four, five, 10 or 20 similar devices, I just cannot see how you can
justify the risk.
Whose evidence should be relied
Dr Armitage, AHIA, raised concerns about the reliance of the TGA on the
clinical evidence provided by the manufacturer of a device:
In Australia a device can be inserted into what in this
instance would be an unsuspecting Australian patient and the only clinical
evidence of that device's success which the TGA takes into account is
information provided by the manufacturer of that device. They clearly have a
financial conflict of interest and that ought to be stopped.
Dr Armitage went on to argue that there are avoidable risks associated
with accepting clinical evidence from overseas:
If in fact one of the bodies with which the TGA is globally
harmonised—in other words, similar bodies overseas—have authorised the use of a
particular device the TGA is comfortable with accepting that recommendation
and/or clinical evidence from the people who wish to sell the device. Unless
there can be rigorous evidence that the overseas processes have had appropriate
clinical testing there will always be an element of risk. I think it can be
Dr Armitage, submitted that Australia should become far more engaged
with clinical testing. He told the committee that:
I believe that there would be university departments that
would be thrilled to set themselves up as centres of excellence in doing
clinical trials. You would not have to have many of them around Australia, but
it would be quite an easy way. There would be a financial commitment. I accept
that. But I think that is better than subjecting people to the failure of the
device. But you would have to set up a system whereby if somebody wanted to
bring a device into Australia they would actually have to...submit it to
appropriate clinical testing.
Difficulties of conducting trials
of implantable devices
Other submitters noted the difficulties of conducting clinical trials
with implantable devices. Medtronics Australasia noted that:
The risk management models adopted globally for assessment of
medical devices acknowledge the differences between pharmaceuticals and
devices, and the impractical nature of pharmaceutical type trials in the
Similarly, Ms Anne Trimmer, Chief Executive Officer, MTAA, argued that
the standards of clinical evidence that are applied for pharmaceuticals cannot
realistically be applied in the same way to medical devices. She explained
The regulation of safety and efficacy of medicines is based
on pharmacology and chemistry where the properties and action of active
ingredients can be determined in preclinical and clinical studies. The clinical
evidence was obtained mostly pre-market from large, double-blind, randomised
controlled trials. In contrast, randomised, double-blind placebo controlled
trial designs are very difficult and often unethical to implement as part of
the evaluation of a device or a surgical procedure. That is for the obvious
reason that it would not be ethical to put into a patient a device that is a
placebo. Therefore, so much more of the assessment of a medical device happens
after the device has been in use with the patient and the patient experience
becomes a very critical part of assessment in an ongoing way.
Ms Trimmer went on to argue that there are further differences in
assessing drugs and devices that need to be understood, namely that the
development cycle is very different. Ms Trimmer explained that:
Medical devices are developed in a framework of continuous
innovation and iterative improvements which can be based on advances in
science, technology and materials. If you look at, for example, very early
pacemakers, they were large, boxlike devices that were attached in some way to
the outside of the patient. These days they are very small and implantable. In
comparison, pharmaceuticals are developed following extensive research and development
of a specific molecule or compound with the result that it can take many years
for a new drug to enter the pipeline.
Does the current approach provide
Professor Stephen Graves, Director, National Joint Replacement Registry (NJRR),
also addressed the issue of whether registering and placing untested new
devices on the market provides any clinical advantage. He provided evidence to
the committee that it may produce exactly the opposite effect. Professor Graves
argued that many new devices were performing no better than, or in some cases
worse than, existing devices. He explained to the committee:
We have just had an article accepted for publication in the
Journal of Bone and Joint Surgery in America, which is the premier orthopaedic
journal, looking at new devices that came onto the market in the five-year
period between 2003 and 2007. There were over 260 new devices, hips and knees,
that came onto the market in that time, the vast majority of which were used
only in a very small number of procedures, 75 per cent, less than 100 procedures,
so it was very difficult to know whether or not they were going to work. Of the
25 per cent that were used in a large number of procedures the registry found
that none performed better than the established prosthesis we already had on
the market and that 30 per cent performed significantly worse. It is that 30
per cent that performed significantly worse that we do have concerns with.
The difficulty in assessing a large number of devices that are each only
used in a small number of procedures was also mentioned as a matter of concern
by other submitters. Dr Armitage, AHIA, noted that there are thousands of
devices available in Australia, something he believed has come about 'because
the opportunity to have devices listed is too loose—it is being tightened, but
we would say that is well overdue'.
Mr Robert Lugton expressed great disquiet at the current proliferation
of hip device combinations that are being used by surgeons. Mr Lugton drew
attention to the NJRR annual report for 2011, noting that:
This year the report identified 330 new femoral cup and
acetabular cup combinations than last year. An over 20% increase in one year.
This makes assertions that we operate a 'choice' based system laughable.
The committee heard from Mr Richard Bartlett, First Assistant Secretary,
Medical Benefits Division, Department of Health and Ageing, who confirmed that
there is no requirement to prove that a device performs better than those
already available, before it is listed. He stated that in Australia the
criterion is 'essentially about maximising choice for both doctors and
consumers'. Mr Bartlett went on to argue that:
A device that may not perform in a superior way across the
board may well perform in a superior way with an individual patient. We have a
system that in effect allows doctors to make those choices with patients.
The committee is of the view that the current perception that there is an
increasing number of medical devices that perform no better than, and often
worse than, those already available is concerning. The committee is unconvinced
by Mr Bartlett's assertion that new devices may perform better in an individual,
although not across the board. There appears to be no process to collect
evidence to support this assertion.
The committee believes that Recommendation 8c of the HTA Review should
be implemented in order to increase the rigour of regulatory assessment of
higher-risk medical devices. An appropriate level of evidential review should
be undertaken over an adequate period of time. The committee is also of the
view that the requirements of the clinical evidence should be defined. The
committee notes the AOA's recommendation for a minimum of two year's clinical evidence.
The committee received evidence from submitters about the way that
France regulates its medical devices. Dr Armitage informed the committee that
in France there is a predetermined number of devices. Dr Armitage went on to
If someone wishes to have a new device listed for
reimbursement they must prove that their device performs better than the one
that is already allowed for reimbursement.
Dr Armitage supported this approach and commented:
That seems, to me, completely reasonable. Why would anybody
want to authorise the use of a device which potentially has dramatic
consequences if it goes wrong unless it can be proven to give a better clinical
outcome than the device that is already being used safely?
However, Medtronics Australasia submitted that, in many respects, there
is not much difference between the system for reimbursement of medical devices
in Australia and France. Medtronics Australasia was of the view that:
...the French system, whilst it has some different nuances
reflecting the different structure of their healthcare systems, in many
respects parallels the Australian system, and has quite similar tests for the
reimbursement of medical technology.
Regulatory entry is governed by the French Competent
Authority AFSSAPS which ensures that products entering the market in France
have been assessed as meeting the Essential Principles required to gain a CE mark.
In most respects these Essential Principles are the same as those required
under Australian Law and regulation and applied by the TGA.
The CHF suggested a number of ways that consumers could be engaged in
the approval of medical devices. They submitted that the committee might
...the development of mechanisms to take into account
consumer experience in the approval of devices. This may include: consumer
representatives on committees, the use of consumer impact statements, public
reporting of consumer experiences with devices and technologies [and] other
models that have been effective internationally.
TGA Medical Device Regulation
The TGA has released a number of discussion papers that address the
regulation of medical devices. In December 2008 the TGA released Use of
Third Party Conformity Assessment Bodies for Medical Devices Supplied in
Australia. The issue of third party conformity assessment is discussed
below at paragraph 2.67. In October 2009 the TGA released A Proposal for the
Reclassification of Joint Replacement Implants. The reclassification of
joint replacements is discussed below at paragraph 2.87.
Additionally, in October 2010 the TGA released Reforms in the Medical
Devices Regulatory Framework: Discussion Paper. This contained nine
proposals, including a package of reforms that responded to
Recommendations 8b and 8c of the HTA Review:
- Proposal 2A proposed amending regulations so that Australian
medical device manufacturers would no longer be required to hold TGA conformity
assessment certification but could, in the alternative, use 'equivalent
certification issued by third party assessment bodies to support medical device
entries in the ARTG, as is currently available to overseas manufacturers'. This
is discussed below at paragraph 2.67.
- Proposal 2B proposed increasing pre-market scrutiny for
implantable devices and is discussed below at paragraph 2.96.
Proposal 2C goes to recognition of third party assessment
bodies through undertaking formal confidence building of those European
Notified Bodies designated under the MRA between Australia and the European
Commission, and setting up a system to enable assessment bodies based in
Australia to operate as a third party for the purpose of issuing certification
under the Australian legislation.
This is also discussed below at paragraph 2.67.
However, on 23 September 2011 the TGA announced, in relation
to Proposal 2, that these proposals remain under consideration and further
consultation will occur on amended versions of these proposals.
Third party conformity assessment
As noted above, in December 2008, the TGA released a discussion
paper Use of Third Party Conformity Assessment Bodies for Medical Devices
Supplied in Australia, seeking the views of stakeholders on a number of
proposals. The discussion paper canvassed issues regarding the appropriate role
of the TGA, and the appropriate role and requirements of third party assessment
bodies, in issuing conformity assessment certificates.
The HTA Review, noting the above consultation, made the following
Recommendation 8: That the Therapeutic Goods Administration
(TGA), in the context of international harmonisation:
(a) continue its role as the independent national regulator
solely responsible for assessing the safety, quality and efficacy of therapeutic
goods for entry on The Australian Register of Therapeutic Goods (ARTG) and
marketing in Australia;
(b) respond to the issues raised in consultations regarding
third party conformity assessment by July 2010, with a view to implementing
changes agreed by government by 2011;
(c) increase the rigour of regulatory assessment of higher
risk medical devices by 2011, to ensure an appropriate level of evidential
review is undertaken to ensure safety, quality and efficacy of these devices
prior to entry on the ARTG and to provide a sound evidence basis for Australian
Government HTA processes.
(d) develop protocols by July 2010 for sharing information
with other HTA agencies through the SEP (subject to commercial-in-confidence
constraints) on the outcomes of its safety assessments.
In addition to evidence provided to the committee regarding the
appropriate level of clinical evidence for higher risk medical devices, many
submitters also addressed issues around third party conformity assessment. These
issues have previously been, and continue to be, the subject of a number of government
consultations and reviews as detailed below.
Inclusion of a medical device in the ARTG allows it to be supplied in,
or exported from, Australia. For a medical device to be included in the ARTG,
the TGA requires evidence that the conformity assessment procedures applied by
the manufacturer of the device conform with the Essential Principles, including
that the manufacturer's quality system is accredited to an acceptable standard.
This evidence is provided as a conformity assessment certificate, and the body
issuing the certificate is referred to as a Conformity Assessment Body (CAB).
If a medical device is made in Australia, only the TGA may issue a
conformity assessment certificate. If a medical device is not made in Australia,
and does not contain a designated material, then bodies other than the TGA may
issue conformity assessment certificates.
There are three main interrelated issues related to third party
conformity assessment. The first issue goes to concerns, discussed previously,
that unsafe medical devices approved in other jurisdictions, may be included on
the ARTG. The second issue is that the requirements on Australian medical device
manufacturers are currently more onerous than the requirements placed upon
overseas medical device manufacturers. The third issue is whether, in
Australia, bodies other than the TGA should be able to carry out third party
In the previous section on clinical evidence the case for and against
accepting the assessment of non-Australian evidence to fulfil the requirements
of registration on the ARTG was discussed. Submitters, including Dr Armitage
from the AHIA, expressed concern that devices assessed overseas may be
introducing an unacceptable and avoidable risk into Australia's regulatory
framework. Dr Armitage stated that there was a risk of 'a race to the bottom'.
Other submitters argued that Europe's regulatory system is sufficiently
strong and well aligned to Australia's regulatory system that if a product has
been assessed by a notified body in Europe it should be accepted for approval.
A number of submitters supported the TGA proposal to allow the use of
accredited third party conformity assessment bodies, as an alternative to the
TGA, for issuing conformity assessment certificates for Australian
manufacturers. It is clear that Australian medical device manufacturers
consider that they are disadvantaged in relation to their international
Max Boccardo Associates explained how the TGA applies more stringent
requirements on Australian manufacturers:
The Therapeutic Goods (Medical Devices) Regulations 2002
follow closely, but not totally, the European Union Medical Device Directive
93/42/EEC (MDD). Under this Directive, Medical Device manufacturers need to
obtain Conformity Assessment Certification from certain accredited third party
inspection bodies, known as "Notified Bodies" in the European Union.
TGA accepts readily such EU Certificates for the approval of
Medical Devices in Australia from all manufacturers except those from
Australia, which instead can only obtain their Certificates directly from TGA.
The Department of Innovation, Industry, Science and Research (DIISR)
Use of third party assessment has the potential to save
considerable time and money for Australian medical devices manufacturers and
their customers and could provide a choice of conformity assessment pathways as
is the case in larger markets such as the European Union (EU).
A number of submitters were critical of the time and cost involved in
current TGA conformity assessment.
DIISR went on to explain that:
...assessment in larger markets, such as for a European CE
mark, is often quicker (around 90 days for the European market versus around
nine months for the Australian market - 255 days plus clock stops in Australia);
and cheaper (around AUD 5000 for the European market versus around AUD 100,000
for the Australian market) for identical products.
The Medical Technology Association of Australia also supported the use
of third party conformity assessment, noting that proposals for compulsory
conformity assessment by the TGA of higher risk devices:
...removes the inequity between Australian and overseas
manufacturers but subjects all to a much more expensive assessment process
which in almost all cases will duplicate very rigorous assessments already
undertaken by a European Notified Body.
The committee also heard that efficiencies could be achieved by lifting
international regulatory standards to allow greater use of third party
conformity assessment for the purposes of listing on the ARTG. Boston
Scientific Australia New Zealand argued that as Australia has a small population
and represents only 2.6 per cent of global medical device sales, use of third
party conformity assessment would facilitate 'a balancing act between ensuring
safety and quality requirements and ensuring access'.
Similarly, Ms Robyn Chu, Director, Health Outcomes, Johnson &
Johnson Medical (JJM), told the committee that:
...one of the issues we have is that the notified bodies in
Europe are quite well resourced. If the product has already been assessed
through these notified bodies and been given EC certification, we see that, in
order for Australians to get access to innovative technologies, our regulatory
system should adopt EC certification as approval.
Brandwood Biomedical noted the already close alignment of Australian and
European technical requirements and standards. It explained that although the
technical standards and assessment processes in Australia and Europe are
essentially identical, the European system divides the administration of
regulation into two parts:
1. Notified Bodies conduct premarket assessments of
manufacturers and issue CE certifications resulting in the so-called “CE
marking” of medical devices. These are almost always private sector
2. Competent Authorities accredit and supervise the Notified
Bodies. These are almost always national government departments or agencies.
Competent Authorities are also responsible for the approval and audit of clinical
Brandwood Biomedical went on to submit that the TGA could relinquish
direct assessment of medical devices and instead adopt the role of Competent
Authority 'as has been done by larger medical device regulatory agencies in the
UK, Germany and France'. Addressing concerns about 'more recently established
smaller Notified Bodies', Brandwood Biomedical suggested that 'the TGA would be
in a position to restrict accreditation to only those larger Notified Bodies
which are adequately resourced and competent for the role'.
Similarly, JJM submitted that the TGA should 'adopt the role of a
designating authority for Conformity Assessment Bodies which can demonstrate
competence to evaluate all devices', as well as:
...retain its role as a Competent Authority in determining
which applications for inclusion in the Australian Register of Therapeutic
Goods are accepted based on the conformity assessment evidence issued by third
party Conformity Assessment bodies.
JJM went on to argue that in order to enable third party conformity
assessment to be implemented, the TGA should not only seek 'complete alignment
of classification rules between the Australian regulations and the European
Medical Device Directive assessment to be implemented', but that the TGA should
also 'broaden existing and establish new mutual recognition agreements with other
highly regulated countries such as Canada and Japan as well as Europe'.
JJM submitted that this would allow the TGA:
...to approve products based on the third party conformity
assessments such as provided by European Notified Bodies (EU NB), for all
classes of medical devices supplied in Australia where there are no unique
risks or differences in clinical practice can be identified.
The committee is of the view that there is some merit in a country like
Australia, with a small market share and finite resources, using some third
party conformity assessment conducted overseas. However, the committee considers
that a dilemma remains regarding the most effective way to monitor the quality
of work performed by conformity assessment bodies in other jurisdictions, in
order to remain assured of the quality and safety of medical devices in
Proposal to reclassify joint
replacement implants from Class IIb to Class III
As noted above, in October 2009, the TGA released a Consultation Paper
proposing reforms to the classification of implantable hip, knee and shoulder
joints through 'upclassifying' joint replacement implants from Class IIb to
The paper noted that:
Recent data has shown that there appears to be a higher than
average revision (failure) rate for some orthopaedic joint replacement implants
than others which is a cause for concern.
As discussed above, in February 2010 the HTA Review also recommended (Recommendation
8c) increasing the rigour of regulatory assessment of higher risk medical
devices by 2011.
The TGA's Reforms in the Medical Devices Regulatory Framework: Discussion
Paper, discussed above, also contained a proposal that addressed the
reclassification of joint replacements. Proposal 1 formed part of the response
to Recommendation 8c of the HTA Review, proposing a reclassification of all
hip, knee and shoulder joint replacement implants from Class IIb to Class III
medical devices. The proposal was substantially similar to that introduced into
European legislation by Commission Directive 2005/50/EC. However, the
European legislation appears to only address total joint replacements whereas
the TGA proposal covers both partial and total joint replacements.
On 23 September 2011, following receipt of submissions and
consultations the TGA released a statement outlining their proposed course of
action in relation to the nine proposals contained in the discussion paper. In
relation to Proposal 1 the TGA announced its intention to implement the
proposal to reclassify joint replacement devices included in the ARTG from
Class IIb to Class III 'through an amendment to the Therapeutic Goods (Medical Devices)
Regulations 2002 with a two year transition period commencing from
1 July 2012'. 
Dr Hammett, TGA, told the committee that the TGA was not only trying to
effect reforms to the way medical devices are regulated in Australia but also
at an international level. Dr Hammett explained:
...we are trying to work with our international regulatory
partners to effect that change globally. We are mindful that we are only two
per cent of the world's market and, if we want to see improvements in the
safety of products on the market, as we all do, we need to impact on the global
regulatory system for medical devices. That is what Australia is actively
engaged in doing currently.
A number of submitters supported the TGA's proposed change of
classification of joint replacement implants from Class IIb to Class III.
The AMA noted that 'this will ensure that these devices, which are constantly
utilising new materials and construction techniques, undergo a more rigorous
assessment before they are listed on the ARTG'.
The AOA supported the change of classification but cautioned that this 'does
not necessarily mean that there will be increased or defined clinical requirements
in that assessment process'. The AOA submitted that 'what is required is movement
to class III and standardised clinical assessment using internationally agreed
JJM also supported the reclassification from Class IIb to Class III,
noting they understood 'the TGA's position to align Australia's regulatory
system with equivalent international regulations such as the European Union
(EU) Medical Device Directive 93/42/EEC (MDD)'. However, it submitted that the
extra regulatory burden imposed by the reclassification means that a two year
transition period is insufficient.
JJM also raised specific concerns about additional requirements
associated with ARTG inclusion and Unique Product Identifiers (UPI). JJM noted
that although Australia and the EU have similar regulatory frameworks, the TGA has
requirements additional to the EU regulatory system. It explained that in
Australia there is a requirement for medical devices to be listed on the ARTG
before supply and the devices must be listed at the level of UPI. JJM submitted
While JJM supports the TGA's intent to increase visibility
and traceability of high risk Class III devices, we have concerns regarding the
TGA's interpretation and ruling on acceptable UPIs which we would submit has,
at times, been inconsistently applied. JJM recommends that the TGA work with
industry to clarify the UPI requirements for orthopaedic implants before
introduction of the amended Regulations.
Proposal to increase the level of
assessment of Class III devices
The October 2010 Reforms in the Medical Devices Regulatory Framework:
Discussion Paper also responded to HTA Recommendation 8c. Proposal 2B
addressed increasing pre-market scrutiny for implantable medical devices. This proposal
had two parts: the first required a TGA conformity assessment to be issued for
the highest risk (Class III/AIMD) implantable medical devices; and the second
required medical device applications to be selected for auditing for the lower
risk (Class IIb) implantable devices.
However, on 23 September 2011 the TGA announced that this proposal
remained under consideration and that further consultation would occur on an
As part of the evidence provided to the committee a number of submitters
addressed the issue of the appropriate level of pre-market scrutiny for higher
risk medical devices.
In a general sense many consumers supported the proposal to increase the
level of assessment of high risk devices, as discussed in the section on
clinical evidence. However, a number of medical device companies questioned
whether this was necessary or possible given the resource constraints of the
St Jude Medical Australia submitted that the full conformity assessment
proposed by the TGA for all Class III and AIMD products 'represents a costly
and inefficient duplication of quality system and product evaluations that have
previously been completed by a competent overseas Notified Body'. St Jude
Medical went on to submit that:
...the TGA has failed to provide evidence to demonstrate how
the current process of reliance on overseas evaluations for Class III and AIMD
medical devices does not provide an appropriate level of protection for the
Australian public or how duplicating this process in Australia will provide any
additional level of assurance.
Brandwood Biomedical and Medtronic Australasia raised concerns that the
TGA does not have sufficient resources or technical personnel to undertake this
increased level of regulatory review. They go on to argue that a combination of
high assessment costs and time delays could lead to industry reducing the range
of products supplied in Australia and a reluctance to introduce new devices.
Dr Hammett, TGA, told the committee, albeit in relation to the proposal
up-classify joint replacement implants from Class IIb to Class III, that they
believed the TGA had adequate resources to carry out its role. Dr Hammett
stated 'we think we can manage this process adequately and have developed an
implementation plan to do that'.
The committee is of the view that reclassifying joint replacement
devices from Class IIb to Class III, as proposed by the TGA, is a sound
approach. However, the committee is of the view that this should be
supplemented by a higher level of assessment of Class III medical devices.
The TGA's regulatory framework for medical devices includes provision
for post-market monitoring. The TGA explained that this includes:
...checking evidence of conformity; conducting periodic
inspections of manufacturer’s quality management systems and technical
documentation, including documentation held by a sponsor; and imposing specific
requirements for manufacturers and sponsors to report, within specified
timeframes, adverse incidents involving their medical devices.
The TGA went on to comment on the HTA Review's findings regarding
Feedback from stakeholders as part of the HTA Review
identified that there was room for further improvement in post-market
surveillance and in the ongoing monitoring of devices. This includes ensuring
there is a continuing process of performance assessment over the 'life-cycle'
of a device.
Recommendations 13, 14 and 15 of the HTA Transparency Review address the
issue of post-market surveillance. These recommendations addressed the need to
improve adverse event reporting; increase the collection and use of post-market
surveillance data; and establish, and expand participation in, clinical
registers for high-risk implantable devices:
Recommendation 13: That, in order to improve the
post-market surveillance to patient safety, the TGA take steps to increase the
rate of reporting of adverse events, including by health service providers and
Recommendation 14: That, in order to improve the
post-market surveillance to the sustainability of the health system and the
longer-term regulatory efficiency of HTA processes, DoHA explore options for
consideration by government in 2011 to facilitate the expansion and use of
post-market surveillance data to inform safety, effectiveness and reimbursement
decisions for devices and procedures.
Recommendation 15: That registers for high-risk
implantable medical devices and/or procedures be established, with:
(a) key stakeholders such as clinicians, health consumers and
industry to participate in governance of and contribution to registries;
(b) establishment of mechanisms to apply data from the
register to future HTA;
(c) the feasibility, benefits and methodologies for data
linkage to be explored in a pilot project in regard to a particular device
identified by the high-risk implantable devices register;
(d) consideration of how developments in e-health and data
linkage could improve the efficiency of the post-market surveillance of medical
technology more generally; and
(e) the development of criteria, the identification of
opportunities and the consideration of strategies for improvements in public
investment in medical devices.
As noted above, while the Government has accepted all of the other
thirteen recommendations made by the HTA Review, Recommendations 13-15 have not
yet been accepted and are subject to further consideration due to the costs
involved in their implementation.
A number of submitters told the committee that these recommendations
should be implemented. By way of example AusBiotech stated that:
...many of the issues addressed by the terms of reference of
this Inquiry are well-addressed in the recommendations of the HTA Review and in
their implementation and [Biotech] suggests that an outcome of the Senate
Inquiry be the provision of opportunity for the HTA recommendations to be fully
implemented and their effectiveness and impact on the regulatory standards
associated with medical devices monitored.
Similarly, the AHIA supported the implementation of the recommendations
and noted that although DoHA has delayed these recommendations based on the
cost implications, there has been 'no cost benefit analysis flagged to allow
the issue to progress'. AHIA also informed the committee that 'a number of the
industry bodies including the AHIA have flagged a willingness to financially
support their establishment'.
The committee received evidence that there is 'currently limited
reporting and visibility by the TGA in relation to post-market surveillance'.
Medibank Private explained that 'due to resource limitations, the TGA tends to
be more reactive rather than proactive in post-market surveillance activities'.
It submitted that this is 'a situation which could be addressed by prioritising
implementation of HTA recommendations 13, 14 and 15' regarding post-market
The CHF noted that identifying prostheses with high revision rates
relies on the post-market capture of information from consumers, health
professionals and manufacturers. Drawing on consumer consultations, they emphasised
the 'importance of ensuring that many avenues are available for the capture of
such information, and then for its aggregation, public reporting and feedback
into the review process'.
Adverse event reporting
In addition to the HTA's consideration of adverse event reporting, the
TGA Transparency Review identified a number of issues with the process:
- The current reporting system for adverse events is complex.
Timely advice and the distribution of information regarding
adverse drug reactions appear to be lacking.
The regular provision of information to keep health
practitioners, consumers and the media informed of the TGA's management of
adverse events is needed.
The lack of transparency regarding information on adverse events
including events following immunisation.
The TGA Transparency Review also made several recommendations regarding
adverse event reporting:
Recommendation 19: The TGA more effectively facilitate
the recognition and reporting of adverse events by health practitioners and
consumers, and promote the adverse event reporting system.
Recommendation 20: The TGA make its Adverse Events
Database available to, and searchable by, the public in a manner that supports
the quality use of therapeutic goods.
Recommendation 21: The TGA work with State and
Territory governments, stakeholders, and other relevant agencies, to improve
the visible management of adverse event reporting in support of consumer safety
and consistent with the findings of the Horvath Review into Immunisation.
Submitters raised a number of issues in relation to adverse event
reporting including that the Therapeutic Goods Regulations require a
manufacturer to report adverse events to the TGA yet reporting of adverse
events is optional for medical device users. The TGA encourages the reporting
of adverse events and its website includes forms for 'medical device users
(clinicians, patients or their relatives, etc) to report any suspected problems
with a medical device which has or may present a health hazard' as well as a
form for 'medical device manufacturers or authorised representatives for
mandatory reporting of adverse events associated with a medical device'.
Submitters also noted the importance of encouraging adverse event
reporting by health practitioners and consumers.
The Cancer Council WA commented that:
...currently there is limited stakeholder access to post-market surveillance
reporting systems, which provide vital information for monitoring of the safety
and efficacy of devices. Consumers, patients and clinicians are a rich source
of information as end-users
of therapeutic products, and so should be encouraged to participate in the post-market surveillance
The CHF further commented that 'consumers often report an adverse event
to their doctor rather than the manufacturer or sponsor of a device' and 'often
the sponsor is not aware of adverse events'. Yet, whereas the Act requires
sponsors to report adverse events there is no requirement for doctors to do so.
A number of submitters indicated that greater clarity is required
regarding what events need to be notified to the TGA. By way of example, the
CHF submitted that regulations need to be strengthened 'so that sponsor
judgement is not a factor in determining what is to be reported'.
Similarly, the Australian Private Hospitals Association (APHA) proposed that 'there
should be clear criteria established around...what constitutes a notifiable
issue and what does not'.
The AMA provided suggestions about how to better facilitate reporting by
Medical software companies could incorporate the ability for
medical practitioners to compile the adverse event report using their medical
practice software. Relevant information could be electronically incorporated
into the TGA form and emailed directly to the TGA. This would reduce the time for
completing and dispatching the form, which in turn would encourage more
reporting to the TGA. Further, it is important that medical practitioners can
see the value of reporting adverse events to the TGA by receiving information
directly from the TGA about the quantity of reports of the same nature and what
action has been taken in respect of the product that has been reported as being
associated with adverse events.
Other submitters provided similar comments on the need for the TGA to
provide feedback to stakeholders. The CHF suggested that the TGA make
information on adverse event reports available in real time and provide formal
feedback on the TGA response to stakeholders involved in adverse event
Similarly, Cancer Council WA submitted that:
...regular, public reporting on the nature of adverse events
associated with therapeutic devices is essential. We recommend the TGA publically
reports on adverse events associated with therapeutic devices, detailing
associated TGA action. We submit that such a system would enhance the manner in
which the general public is notified of potentially risky devices.
The CHF submitted that initiatives need to be developed 'to build and
support increased awareness of the Incident Report and Investigations Scheme
[IRIS] and other post-market surveillance processes'.
The CHF noted that when they carried out consultations for the HTA Review
consumers expressed a strong view that:
...the post-market surveillance function should be the responsibility
of an agency separate from the one that conducts the original assessment of
However, in the event that the TGA remains responsible for post-market
surveillance as well as assessment, the CHF submitted that 'consumers argued
that a separate division of the TGA should be created to conduct reviews,
ensuring greater separation of assessment and review functions'.
A number of submitters expressed specific concerns about adverse
reporting as it relates to remanufactured devices. Further discussion of
remanufactured devices is found below. Medtronic Australasia explained its concerns
about this issue:
Medical device manufacturers are required to keep records of,
and report to regulatory authorities, all adverse events and complaints
regarding their products. Medtronic has significant concerns about the ability
of healthcare practitioners, consumers and companies to effectively identify
original products from those that are likely to still bear the original manufacturers
logos and model numbers but which have been reprocessed whether or not
additional labelling is applied. Accurate recording of complaints, failures and
adverse events is essential as a part of post-market surveillance and internal
quality systems to ensure that the trending and reporting processes are not
contaminated and skewed by inclusion of reprocessed devices. Similarly, where
the original manufacturer identifies a quality issue with the original product and
issues recalls and field actions to customers and consumers, it may not be possible
to identify where reprocessed products have been supplied and thus to notify
users. This potentially raises issues of concern with respect to ongoing patient
In the context of this inquiry, issues of post-market surveillance
assume a particular importance for patients who experienced problems associated
with implantation with the DePuy hip or hip resurfacing system. This is
discussed further in chapter 4.
The Centre of Research Excellence in Patient Safety (CREPS) explained
that clinical registries are databases that systematically collect health-related
information on specified groups of individuals. This includes those treated
with a particular surgical procedure, device or drug (e.g. joint replacement); diagnosed
with a particular illness (e.g. stroke); or managed via a specific healthcare resource
(e.g. treated in an intensive care unit).
In November 2010 the Australian Health Ministers’ Conference (AHMC)
endorsed principles for clinical registries, which had been drafted by CREPS
and the National E-Health Transition Authority (NEHTA). Following this, the Australian
Commission on Safety and Quality in Health Care (ACSQHC) announced that it
Draft national arrangements, including data and clinical
governance, for Australian clinical quality registries.
Prepare a costed technical infrastructure plan to be provided
to Health Ministers in 2011.
The TGA submitted that there are a range of considerations in
establishing and managing clinical registries:
- adequacy and reliability of funding–funding needs to cover
infrastructure/core costs, data collection, analysis and reporting, operational
requirements and the ability to support growth and innovation;
agreement on the funding obligation – amongst beneficiaries of
the data and information produced by the registry;
definition of role and role clarity – the extent to which
different stakeholders can access data and information and engage in registry
governance and operations;
the elements of central registry functions – data management,
quality control, reporting and governance;
the elements of peripheral registry functions – data collection
and patient follow up which occur at a hospital level and rely upon the
engagement and support of health service providers; and
requirements for information technology and other infrastructure
to support registry operations and governance.
A number of submitters supported the role that clinical registries can
play in post-market assessment.
The AMA observed that:
Clinical registers allow medical practitioners to identify
problems early, respond appropriately and support clinical decisions about
which devices are delivering the best patient outcomes in particular clinical
The AOA argued that clinical registries provide a superior mechanism to
'reactive post-market surveillance driven by reports of adverse outcomes from
sponsors' in ensuring that products continue to meet Australian standards.
The National Joint Replacement Registry (NJRR), which is administered by
the AOA, and has been collecting data on the revision of orthopaedic procedures
since 1 September 1999, was singled out for praise by a number of submitters.
The AMA described the NJRR as a 'premium example of a clinical registry
that collects and provides high quality data on the performance of joint
prostheses'. The AMA explained further that:
The NJRR allows the Australian Orthopaedic Association to
monitor the performance of surgeons against their peers. The NJRR information
also assists the TGA to remove unsafe and non-performing devices from the ARTG.
The AOA claimed that the NJRR has been very successful in changing the
behaviour of orthopaedic surgeons, evidenced by a decline in the proportion of
revision hip replacements and revision knee procedures. The AOA went on to
state that the NJRR:
...has proven to be a world benchmark in the establishment
and maintenance of rigorous post-market surveillance. It is pro-active,
centrally driven, government funded, conflict free with professional ownership
of the data and protected under Quality Assurance legislation for compliance.
The AOA noted that the NJRR 'was the first to identify that the ASR was
a prostheses that was associated with a higher than anticipated revision rate
and this lead to the prostheses being withdrawn in Australia in 2009 almost a
year earlier than the worldwide withdrawal'. AOA provided further information
about the operation of the NJRR:
Currently AOA NJRR reports regularly to TGA and to other
government bodies regarding demographics, trends in prostheses usage and
prostheses with a higher than anticipated revision rate. It has also provided
TGA with secure internet access to its database that enables the TGA to obtain
preliminary outcomes data on any joint replacement prostheses being used within
the country. This data is updated daily and reflects the national situation as
of six weeks earlier. The AOA NJRR also provides the TGA with ad hoc reports on
request. These are sometimes requested if TGA have received adverse event
notifications and want more in depth information on a particular prosthesis.
The committee heard that although the ASR hip was withdrawn from the
market in 2009, it continued to be sold in other parts of the world until
August 2010. Professor Graves, NJRR, used this example to make a case for much
greater international collaboration:
There are now 20 or so registries around the world, and I
think that there needs to be much more international collaboration. If we look
at the ASR, in Australia we identified that it was an issue and it was
withdrawn from the Australian market in 2009. It continued to be sold in other
parts of the world until August 2010. The reason that the company gave for
withdrawing it worldwide in 2010 was, they said, that the English and Wales
registry had identified that there was a higher than anticipated rate of
revision for these devices. Now, we had been identifying it for quite a few
years at that point of time. But what that message really says is that two
registries identifying an issue suddenly adds a lot more strength to the idea
that there may be an issue with the device.
Professor Graves, NJRR, provided further information on advantages that
accrue in being able to link a number of similar registries at the
international level. Professor Graves informed the committee that the US Food
and Drug Administration (FDA) have formed a new organisation called the
International Consortium of Orthopaedic Registries (ICOR). Professor Graves,
who will chair ICOR, explained what the organisation will do:
What they are doing is providing funding for registries to
work together in a collaborative manner to identify issues with respect to
joint replacement. We have talked about issues related to individual devices;
however, there are classes of devices which are now being identified as an
issue. The metal-on-metal group as a whole, particularly in conventional hip
replacements and large-head metal on metal, is an issue of great concern
worldwide. The Australian registry has been identifying another class where
there have been devices that use what we refer to as exchangeable necks which
appear to have over twice the risk of revision compared to devices that do not
have those exchangeable necks. So there are a whole range of issues coming up
that registries, if they work in collaboration, will identify very quickly and
on which they will be able to provide very strong advice to regulatory bodies
A number of submitters proposed that more clinical registries need to be
with the CHF suggesting that the NJRR should be used as a model for further
The AMA described clinical registries as 'a valuable and cost-effective way to
undertake post-market assessment', and submitted that:
If we are to improve post-market assessment of medical
devices and patient safety in Australia, it is essential that more clinical
registries be established for a broader range of devices, such as neurological
shunts and cardiac devices...The benefits to the Australian community, both in
terms of individual health outcomes and overall health expenditure, and the
public interest in guaranteeing independent governance of clinical registries,
justifies Government funding for clinical registries.
The MTAA supported the development of further clinical registries for
higher risk devices but stressed that these should be 'developed in accordance
with public health priority areas to ensure that the cost of the registry
delivers maximum benefit to the healthcare system'.
Noting the success of the NJRR, the AOA suggested 'the establishment of
additional registries for things such as Anterior Cruciate Ligament (ACL) reconstructions,
hip fractures, cardiac/cardio/thoracic devices and trauma registries',
submitting that these registries should be 'established, funded and supported
by similar professionally independent mechanisms as the AOA NJRR'.
JJM submitted that clinical registries could benefit from a broader
range of stakeholder involvement. They acknowledged that a consultative committee
to the NJRR has been formed including stakeholders from the industry. However, JJM
went on to comment that 'we would like to see broader implementation (including
patients, administrators and industry) in the governance of the registry itself'.
The AMA provided comment on the funding of clinical registries:
We note that while the Commonwealth's costs of the NJRR are
met by a levy on device suppliers, these costs are passed on to patients. The
role of the TGA in post-market regulation will be sufficiently strengthened by
the introduction of more clinical registries. We believe this is a cost that
the Australian community is willing to share, rather than imposing it on the
individuals whose lives have been saved or improved by medical devices.
Other post-market mechanisms
The committee received information from submitters about how the billing
code, in conjunction with other coding and identification processes, could be
utilised to flag when a problem was occurring with a particular device. The
AHIA submitted that:
There is no flag or indicator to a billing code identified as
being subject to an alert or recall and benefits are not adjusted based on
industry feedback as to the device’s performance. If this option were to be pursued,
there is considerable scope for improvement, via the coding and identification
processes between the TGA, PL and any patient data registers that would
potentially pick up on these points.
The way that these coding and identification processes could be better
aligned was described by the AOA. The AOA submitted that there should be:
...simultaneous allocation of ARTG numbers, Private Health
Insurance prostheses listing, and allocation of billing codes, catalogue
numbers and [Medicare Benefits Schedule] CMBS item numbers for each device
In addition to the post-market surveillance mechanisms already detailed,
the TGA draws on advice from clinical and technical experts. The TGA provided details
of the three expert committees that assist with pre- and post-market functions
in the medical devices area of the TGA.
The Advisory Committee on Medical Devices (ACMD) 'provides
independent medical and scientific advice to the Minister for Health and Ageing
and the TGA on safety, quality and performance of medical devices supplied in
Australia including issues relating to premarket conformity assessment and post-market
- The Medical Devices Incident Review Committee (MDIRC) 'is
established as a sub-committee of the ACMD. The major function of MDIRC is to
advise the TGA and the ACMD on matters relating to the safety performance of
medical devices supplied in Australia. It does this by reviewing reports
received by the TGA through its medical device Incident Reporting and
- The Orthopaedic Expert Working Group (OEWG) 'is established as a
sub-committee of the ACMD. This group consists of orthopaedic surgeons with
expertise in joint replacement surgery. It has a crucial role to play in advising
the TGA on appropriate actions to take in the regulation of orthopaedic
devices. It is called upon to review available clinical data and other relevant
information and provide advice to the TGA on whether an early revision
(replacement) rate for orthopaedic devices is acceptable for the identified
implant of concern'.
In addition to operating the NJRR, the AOA explained that it has also
recently established a system of web-based linkages for early notification of
hazard alerts, enabling early and rapid dissemination to AOA surgeons. The AOA
explained that 'this expediency precludes further devices being implanted
during any ‘lag’ period of notification'.
The committee notes that Recommendations 13, 14 and 15 of the HTA Review
go to improved post-market surveillance by increasing the rate of reporting of
adverse events, including by health service providers and consumers;
facilitating the expansion and use of post-market surveillance data to inform
safety, effectiveness and reimbursement decisions; and establishing further
clinical registers for high risk implantable devices and procedures. The
committee is of the view that implementing these recommendations will make an
important, and timely, contribution to improved post-market surveillance.
The committee is of the view that implementing the recommendations of
the TGA Transparency Review will also make an important, and necessary
contribution to post-market monitoring and surveillance. Recommendations 15-21
of the TGA Transparency Review go to substantially improving the way that the
TGA communicates with stakeholders in relation to post-market monitoring and
compliance, and the way that it manages adverse events. Recommendations 1-14 of
the TGA Review are also pertinent as they address the need for improved
communication and information provision by the TGA for the benefit of, and with
greater involvement by, stakeholders.
Safety standards and approval processes for devices that are remanufactured
for multiple use
Single-use medical devices are medical devices 'intended to be used on
an individual patient during a single procedure and then discarded...not
intended to be reprocessed and used on another patient'. When a single-use
device is 'remanufactured' a single-use device is either assembled, packaged,
processed, fully refurbished, labelled or assigned a new intended purpose to
supply for reuse.
The TGA explained that the Australian Health Ministers’ Advisory Council
(AHMAC) had decided in 2001 that if reprocessing of single-use devices was to
occur in Australia, it would be regulated as a manufacturing activity by TGA to
the same requirements as the original manufacturer.
The TGA outlined the regulatory framework for reprocessed single-use
medical devices (SUD) and noted that under current therapeutic goods
legislation, reprocessed SUDs are 'treated as new distinct medical devices,
with the new manufacturer (the reprocessor) responsible for ensuring the
reprocessed single-use devices are of acceptable safety, and perform as
The TGA went on to explain the conformity assessment approval process,
noting however that 'to date, the TGA has not issued a conformity assessment
certificate to any manufacturer of reprocessed single-use medical devices'. The
TGA stated that:
...[the approval process] requires a review of the
information provided by the manufacturer to ensure that the manufacturer
employs a QMS [Quality Management System] suitable for the class of device
being manufactured, and the manufacturer holds adequate evidence to demonstrate
the safety and performance of the reprocessed devices. Manufacturers assessed
as meeting these regulatory requirements would be issued with a conformity
assessment certificate, enabling the reprocessed medical devices to be included
on the ARTG.
Submitters provided a range of opinions to the committee on the
acceptability of remanufacturing single-use devices for multiple use. A number
of submitters supported the remanufacture of medical devices in certain
circumstances. The AOA argued that many items that could be safely used more
than once are disposed of as they are labelled single-use.
Sportsmed-SA contended that 'there is a financial incentive for a manufacturer
to label all devices an SUD irrespective of whether it still is fit for
purpose for subsequent use'.
Stryker Australia submitted that 'the remanufacturing of specific and
appropriate expensive medical devices that are marked for single-use only, can
contribute to relieving costs in an overburdened health system'.
Stryker Australia distinguished between devices that can genuinely only be used
once and those that have only been validated for a single-use, arguing that:
...there is a large range of products that can genuinely only
be used once, there is also a significant number of products that the original
equipment manufacturers (OEMs) have only validated for a single use, and that
with the correct and validated remanufacturing processes in place, could be
validated as safe and effective for an additional use.
However, JJM contested the assertion that reprocessing of single-use
medical devices provides economic benefits. JJM acknowledged that 'various
studies show that reprocessing single-use devices is cheaper than using a single-use
device'. Nevertheless, they submitted that:
...the analysis of economic benefits is often inadequate as it
is based upon a comparison of the cost of reprocessing versus the price of a
new single use device. This type of analysis does not take into account other
significant costs to hospitals such as internal costs, regulatory compliance costs
and the penalty costs of adverse events such as device failure or
JJM noted that the regulatory approach to reprocessing single-use
devices differs in different jurisdictions, and provided a summary of the
differences. The United Kingdom prohibits the reprocessing of single-use
devices due to fears of cross contamination with Creutzfeld-Jacob Disease (CJD)
and variant CJD. However in the EU there is no uniform policy, with some
countries not approving or prohibiting reprocessing of single-use devices.
While the United States allows commercial reprocessing under the regulatory
control of the United States Food and Drug Administration (FDA), Canada has no
guidelines at a national level.
St Jude Medical noted 'ongoing concerns about significant gaps in the Australian
Regulatory Guidelines for Medical Devices (ARGMD) on the Reuse of Single Use
Devices'. They noted that 'Australia has a regulatory system for medical
devices that is harmonised with the European Medical Device Directives', yet submitted
that 'remanufactured devices are not considered suitable for CE marking in
A number of submitters raised the prospect that post-market surveillance
will be compromised if remanufactured devices are unable to be traced.
For example, JJM noted that:
...it is problematic that many devices bear the CE mark
directly on the device (in compliance with regulatory requirements). Unless the
CE mark is physically removed (a process which may in itself damage the device)
the reprocessed single use medical device is effectively misbranded.
St Jude Medical explained further its concerns that the TGA is
'currently considering an application to ‘remanufacture’ products that the
original manufacturer has designed to be used only once', arguing that a
remanufacturer should not be able to supply a device, still bearing the
original manufacturers branding, for a use for which it is not intended:
Under the Australian regulatory system for medical devices,
it is the responsibility of the designing manufacturer to determine the
intended use of a device based on a thorough understanding of the design,
materials, manufacturing processes and risk analysis. If the device cannot be
guaranteed by the manufacturer to perform according to specification more than
once, then it must be labelled as "Single Use Only"...It appears that
the TGA is contemplating condoning 'off label' use.
Several submitters raised concerns that remanufactured devices pose
threats to patient health. AusBioTech noted risks from remanufactured devices including
risks of contamination, material degradation and mechanical failure of the
medical device, as well as that remanufacturers do not have 'access to the original
design specifications which makes validating the safety and effectiveness of
the reprocessed device difficult'.
Similarly, St Jude Medical listed potential risks to patients from
remanufactured devices including cross-infection from failure to remove
micro-organisms (including prions), accumulation of unsafe levels of
sterilisation chemicals, damage to the integrity of the materials and potential
for mechanical failure.
Medtronic Australasia raised concerns about 'whether a device designed
for single-use can be effectively decontaminated and re-used whilst maintaining
the same safety profile' as the original device. Medtronic Australia provided
evidence of its experience with remanufactured devices:
Results from Medtronic testing of US market sourced reprocessed/remanufactured
Medtronic Octopus® tissue stabilisation product, used for beating heart
surgery, in the US market, showed that all of the 14 reprocessed units tested
were contaminated with unknown material, showed DNA and protein positive
bio-contamination and exhibited physical defects.
Stryker South Pacific provided additional information to the committee
to clarify the difference between validated remanufacturing and other kinds of
reuse. They explained:
Remanufacturing devices using a validated remanufacturing
process should not be confused with any other practice of reusing devices.
There are many health care settings in which devices are reused without
undergoing a validated remanufacturing process, for example a hospital may
decide to clean and reuse devices without any external validation. This was
common in Australian hospitals before being banned in 2003/04 and is still
reportedly common in hospitals in some parts of the world. This ban stopped
risky reuse practices but led to hospitals discarding many devices that could with
appropriate and validated remanufacturing – be used safely more than once.
Stryker South Pacific also sought to dispute the claims that
remanufactured devices are unsafe. They informed the committee that:
Comprehensive evidence from the USA supports the safety and
quality of remanufactured devices and has identified no additional problems associated
with validated remanufacturing processes over and above those recognized by the
original manufacturer. The overwhelming majority of reports to the Food and
Drug Administration (FDA) of adverse events associated with medical devices
relate to the first use of ‘single use’ devices and the FDA has stated that it
has not identified ‘any adverse events that were actually related to the
reprocessing of the SUD (single use device).’
Furthermore, FDA’s adverse event database contains over 6,500
reports of patient deaths associated with original (un-reprocessed) medical devices since 2004.
According to the same database, no deaths have been associated with the use of
reprocessed ‘single use’ medical devices.
Issues of informed patient consent were raised by a number of submitters.
St Jude Medical argued that patients 'need to be fully informed that
a reprocessed medical device may be used during the procedure' as remanufacturing
of devices elevates risks to patients.
Similarly, JJM argued that:
...typically patients are not informed that reprocessed
devices are to be used or their consent requested. Surgeons and other
clinicians also are not normally aware if a device they are about to use is
AusBiotech recommended consideration of an inquiry to address the safety
concerns associated with the reprocessing of single-use medical devices in
Stryker South Pacific recommended 'that the TGA (or appropriate body) conduct
an inquiry into the un-validated
reprocessing of medical devices in Australian hospitals and health care
The committee received a variety of evidence about whether
remanufactured devices are safe, but was concerned by risks of contamination,
material degradation and mechanical failure of medical devices. While the
committee is aware of arguments that remanufacturing medical devices may
contribute to reducing hospital's costs and waste, they note that these
benefits may not be as substantial as claimed.
The committee notes that a prudent approach was taken by the Australian
Health Ministers' Advisory Council in 2001 when it decided that, if
reprocessing of single-use devices was to occur in Australia, it should be
regulated to the same requirements as the original manufacture. The committee
supports the prudent approach taken by the TGA to date, which has seen no conformity
assessment certificate issued to any manufacturer of reprocessed single-use
The regulation of custom made
Although the placement of therapeutic goods on the ARTG is regulated by
the TGA, there are limitations on the coverage of the Act and exceptions to the
requirements that medical devices be placed on the ARTG. 
The ADIA has raised the issue of how internet imports circumvent the
protections put in place by the Therapeutic Goods Act 1989. The ADIA
It is possible to purchase from overseas sources (via
websites such as eBay) most products that appear on the ARTG. There is evidence
that healthcare professionals are buying dental product[s] from overseas
sources and using [these] in their practices...
Similar concerns were expressed by Logic Appeal who informed the
committee that up to 50 per cent of custom made dental prostheses
such as crowns, bridges, dentures and some implants are sourced from overseas
markets such as China, India and Vietnam. Logic Appeal stated that these
medical devices are not validated by the TGA at the source of manufacture.
Logic Appeal went on to explain that while 'the onus is on the
practitioner using them to verify they that they are of an adequate standard',
the practitioner is frequently unaware of the source of the prostheses, as they
may have ordered the item from an Australian address. Logic Appeal also told
the committee that 'Patients are similarly unaware of where their dental device
Logic Appeal informed the committee that in the United Kingdom patients
receiving a dental appliance are offered a statement of manufacture. Logic
Appeal explained that 'Practitioners are obligated to retain this statement for
the lifetime of the prosthesis and record whether this was provided to the
patient or not'.
Both Logic Appeal and the ADIA submitted that legislative reform is
required in relation to the importation of dental prostheses. Logic Appeal
submitted that legislation is required to hold dentists and dental care
professionals accountable if they sub-contract manufacture of a medical device
overseas, with a statement of manufacture serving as proof to both patients and
practitioners of where the device originated.
The ADIA suggested that 'the medical devices personal importation
provisions contained in the Therapeutic Goods Act (Cth) 1989 be removed',
and 'the Australian Government provide a budget appropriation to the TGA to
fund activities associated with awareness of, and compliance with, regulatory
standards for the importation of medical devices'.
The committee notes that custom made dental devices appear to escape TGA
scrutiny, with dental professionals and patients alike unaware that up to 50
per cent of custom made dental prostheses are manufactured overseas, with no
validation at the source of manufacture. The model employed in the United
Kingdom, whereby patients are offered a statement of manufacture, and
practitioners are obliged to retain this statement for the lifetime of the
prosthesis, and must record whether the statement was provided to the patient
or not, appears to have merit.
The committee is also concerned that the issue of unregulated
importation of dental devices via the internet may indicate a much broader
problem of inadequate regulation of other medical devices purchased through the
internet. The committee is of the view that this requires further investigation
and assessment by the TGA.
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