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Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

Version 1.0, December 2019 - OBPR reference: 24680

21 February 2020

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Problem

The widespread application of emerging technologies to medical devices was not envisioned in the early 1990s when the GHTF began documenting[9] the principles that underpin device regulation in Australia and other comparable jurisdictions (such as the European Union (EU) and Canada).

Australia adopted the GHTF model as the basis for its medical devices regulatory framework in 2002. Changes since this time - rapid developments in advanced manufacturing and digital technologies, the expansion in the types of devices being produced in this way, and the increased availability of the technology - have meant that existing regulatory frameworks are not adequate to address these emerging technologies. This is not limited to personalised medical devices, and the TGA is also examining other emerging technology issues, such as software that is a medical device in its own right (including apps) and cyber security of medical devices.

The 2002 medical devices regulatory framework in Australia has not kept pace with how changes in technology and materials science has led to new types of personalised medical devices being made available.

Australia, and other jurisdictions, are now reviewing their legislative frameworks to ensure that the risks to patients associated with the emerging technologies and the personalisation of medical devices are appropriately mitigated, while still supporting the level of innovation and development that provides benefits to patients, the healthcare sector, industry, and the broader community.

Limitations with the framework in Australia

The TGA has undertaken a comprehensive review of the Australian medical devices framework as it applies to personalised medical devices and has identified a number of limitations:

  • devices which fall within the current definition of 'custom-made medical device' are not subject to regulation. This means that there is presently a large (and growing) proportion of the types of medical devices that are eligible for the custom-made exemption from regulation. This is far beyond the original intent which was, for largely lower class medical devices, to primarily shift to medical practitioners the burden of risk management of the quality, safety and performance of such devices.
  • insufficient mechanisms for the Australian Government to have effective oversight and visibility of the personalised medical device sector. In addition to the risk to patient health and safety this presents, the effect is an inconsistent regulatory burden on devices falling outside the 'custom-made' exemption. Given the rate of growth in these kinds of devices, the significance of this problem is predicted to also grow.
  • there are insufficient mechanisms for investigation or regulatory action following adverse events involving personalised (custom-made) medical devices. This is a result of the limited record-keeping requirements that currently exist.
  • the current personalised medical devices framework is misaligned with the regulatory schemes in other countries for material of human-origin, medical device combination products. This means that a global industry is currently subject to different regulatory regimes in Australia versus other countries resulting in unnecessary regulatory burden for industry.

These limitations are three dimensions (Figure 1) of a single problem.

Figure 1 - The three dimensions of the problem
The three dimensions of the problem

Dimension 1. Misalignment of regulatory oversight with level of risk

As outlined above, any device that is made for a particular patient at the request of a health professional is considered to be a custom-made medical device. The device is therefore exempt both from the requirement of being included in the ARTG and the range of conformity assessment requirements that applies to other medical devices, such as inspections of manufacturers' premises and the requirement for third-party certification.

This contrasts sharply with the regulatory requirements for non-custom-made medical devices, where strict controls are imposed on manufacturers, and also separately on Australian sponsors (importers, exporters and suppliers) to ensure that the devices do not pose unnecessary risks to patients or other users, and that they will perform the clinical functions for which they are intended. Sponsors (official suppliers) of non-custom-made medical devices also have a range of post-market monitoring requirements, while their inclusion on the ARTG enables a number of compliance and enforcement mechanisms to be used by the TGA, including cessation of supply if compliance or safety issues arise.

There are no limits in the Australian framework on the types of devices that can be supplied under the custom-made exemption pathway. The full spectrum of risk categories of medical devices are supplied this way, ranging from simple non-invasive devices such as orthotics for shoes to treat foot abnormalities, which are typically Class I devices, all the way to hip implants for treating bone loss due to cancer, which are Class III - the highest classification.

At the time of development of the current regulatory framework for medical devices in Australia (1990-2002), the state of technology relating to personalised medical devices was significantly less advanced, and the regulatory exemption put in place for custom-made medical devices was premised on a number of assumptions, many of which no longer hold true:

  • that the healthcare provider was taking on responsibility for the devices' performance, in the context of their clinical care for the patient;
  • that affected devices would largely comprise low-risk products such as glass eyes, prosthetic limbs, prescription lenses, or an occasional high-risk product; and
  • that the benefit of a patient being provided with a custom-made device rather than an inadequate mass-produced device, or not being provided with treatment at all, would outweigh the risk of no third-party oversight of the manufacturer of the device.

Present custom-made devices regulations only require a manufacturer to:

  • notify the TGA of the specific kind of custom-made device they are supplying.
    • This is a one-time notification for the category of the device, not an individual notification every time one is supplied.
  • complete a written statement about the device, including whether or not it complies with the essential principles.[10]
    • The information is not provided to the patient, which means that the patient may have no information about the device (unlike in the EU, where the manufacturer or authorised representative must also provide this information to the patient).

There is currently no requirement for any third-party assessment of custom-made devices or of their manufacture in Australia. The TGA may request information about the devices; however, the legislation does not provide the TGA with the power to enter and inspect manufacturing sites. Additionally, the manufacturer is only required to keep documentation about a custom-made device for five (5) years after supplying the device. This is considered to be an inadequate period of time for implantable devices due to their long expected lifetimes. Other jurisdictions, such as the EU, require that this documentation be kept for a period of fifteen (15) years.

Data limitations

The systemic risks presently presented by the uniform exemption of devices which meet the definition of 'custom-made medical device' from being regulated are clearly set out in this section.

The costs that changing this exemption to better manage patient safety risks are not possibly to quantify accurately. There is almost no data on the numbers of personalised devices that are proposed to be captured by any reform option such as manufacturing volumes and numbers of adverse events. That vacuum arises from the nature of the problem sought to be addressed by the proposed reforms - the exemption of custom-made medical devices from inclusion in the ARTG and third-party conformity assessment requirements.

TGA's power to request information is linked to ARTG inclusion or applications for such inclusion or conformity assessment certification (which do not cover custom-made medical devices). As a result, the TGA holds only very limited notification information on currently available custom-made manufacturers. It is also thought to be incomplete.

Other possible data sources were also investigated, but it was evident that none of the potential sources had information on types, volumes or costs of custom-made devices:

  • Inclusion on the Prostheses List, which prescribes reimbursement requirements of private health insurers for implantable prostheses (such as joint replacements, cardiac devices etc.). As listing on the Prostheses List requires inclusion of the device on the ARTG, there is no information on custom-made medical devices on this list.
  • The Medicare Benefits Schedule (MBS) is a list of health professional services subsidised by the Australian Government, but reporting on the MBS largely does not capture information on the medical devices used in those services.
  • Private and public hospitals hold information on procedures performed, but related medical device information, to the extent it is captured at all, is largely on individual patient records. Procurement systems also do not systematically collect information on custom-made medical devices procured
  • Healthcare sectors outside of hospitals may also use custom-made medical devices extensively, but data is unavailable on general use of medical devices, let alone custom-made medical devices. Dental, prosthetics, and orthotics health professionals are big users of custom-made medical devices, but other allied health sectors may also use custom-made medical devices, including physiotherapy and rehabilitation services, etc.
  • Custom-made medical devices also cover a broad scope of devices—some are used for individual patients (and where implanted may be detailed in the patient files) but some are individual healthcare practitioners, such as custom-made instruments and equipment, which are unlikely to be captured by existing reporting mechanisms.

Classification framework

Under the Australian regulatory framework, devices are categorised in a regulatory classification framework that applies increasing levels of regulatory requirements and oversight as the Class increases. Examples of medical devices and how they are categorised into regulatory class (from highest risk to lowest risk) are provided in the table overleaf.

Currently, regardless of a device's safety and intended performance, each is eligible for the custom-made medical device exemption (see the column 'potentially exempt'). In addition to the obvious risk of absence oversight otherwise applicable to such devices, it creates a serious gap in regulation between regulation of other medical devices of the same kind. Some regulation of personalised medical devices will address risks without unnecessarily increasing regulatory burden. The present landscape may create a perverse incentive for manufacturers and sponsors to fall within the terms of the exemption.

Regulatory class/level Example devices Potentially exempt?
Class AIMD

Pacemakers

Artificial hearts

Y
Class III

Prosthetic heart valves

Absorbable surgical sutures

Y
Class IIb

Surgical lasers

Diagnostic X-ray

Y

Class IIa

Class I(s)

Class I(m)

Dental drills or ultrasound machines

Sterile surgical gloves

Clinical thermometer measuring body temperature

Y
Class I

Crutches

Hospital beds

Y

Therefore, the existing requirements for custom-made medical devices do not distinguish between the quality, safety, and intended performance of the devices, and they are noticeably lighter than the requirements placed on manufacturers for medium and higher class mass-produced devices. Their application takes no account of the quality, safety and intended performance of the relevant device.

Regulatory requirement Mass-produced Custom-made
Current regulatory requirements for custom-made devices N/A

Notify the TGA of the specific kind of device being supplied (one-time notification for the category of device)

Create and retain (internal) a written statement about the device including whether it complies with each of the TGA's Essential Principles

TGA may request information about the devices

Routine inspection of manufacturing sites Yes No
TGA inspection of manufacturing sites Yes Limited - only where there is an immediate public health risk and within Australia only
Information provided to patient Yes None
Nominated individual/organisation that is legally responsible under the Act for ensuring devices do not pose unnecessary risks to patients or other users, and that they will perform the clinical functions for which they are intended Yes No
Device must meet specific criteria related to its intended purpose, and be included on the ARTG before it can be supplied in the Australian market Yes No
Marketing approval of non-compliant devices can be removed from the market (suspended or cancelled from the ARTG) Yes No
Criminal and civil penalties can apply for non-compliance Yes No

Dimension 2. Misalignment with international norms

Australia, and its system of regulation of medical devices, does not operate in isolation. With just two percent of the world medical devices market, it is important for Australia to harmonise with international regulators, as it facilitates a viable domestic manufacturing base including for supply to international markets. It also makes Australia a more attractive market into which overseas manufacturers may supply their devices. The latter is critical for ensuring that the most appropriate medical devices are available to Australian patients.

Globally harmonised approaches to address the regulatory challenges associated with emerging technologies assist the delivery of standards and regulatory practices related to the safety, performance, and quality of medical devices; promote innovation; facilitate international trade; and reduce regulatory burden. Failure to so align creates a regulatory disjunct for Australia leaving both the domestic medical device market and Australians disadvantaged in the likely reduced pool of devices to which they may have access.

There exists an opportunity for Australia to adopt a strategic long-term regulatory position on personalised medical devices, by aligning its regulatory framework to that of the best-practice model advocated internationally by the IMDRF personalised medical devices working group. The beneficiaries are domestic medical device manufacturers and Australian patients.

Dimension 3. Need to balance risk with regulatory burden

The government's approach to regulating therapeutic goods is designed to ensure that regulation is only used where absolutely needed and, then, only to the extent needed to protect and advance public health. In practice, this means that the level of regulation - and the TGA's regulation and compliance efforts - is (in general) commensurate with the risks posed by particular therapeutic goods or types of technology, process, or material.

Personalised medical devices offer significant benefits to patients, the health system, and industry, but, as ever, there is a need to balance the benefits against the risks.

The Australian medical devices regulatory framework currently provides for the regulation of custom-made devices, which are devices intended to address an individual's needs where no other suitable device is available on the market. Oversight of custom-made medical devices for the most part lies with healthcare professionals who commission their manufacture. In this way, the risk associated with the custom-made device is managed, at least in part, by the health professional in exercising their clinical judgement. In comparison, manufacturers of mass-produced medical devices are the primary parties responsible for meeting safety, performance, and quality requirements when designing and manufacturing their medical devices.

In the context of the increasing technological complexity of, and higher risks of many custom-made medical devices, it is not appropriate that medical practitioners bear the primary risk of managing the quality, safety and performance of the device itself. This does not absolve the practitioner of responsibility for delivery of a high standard of care including to choose the medical device most suitable to meet the patient's needs. It is not, however, appropriate risk management, for example, for a medical practitioner to assume responsibility for assessment of the design and manufacture of a high-risk custom-made joint replacement made in a specialist and remote manufacturing facility, or a custom-made tooth crown made by a dental technician in a dental laboratory associated with their practice.

Implications for patients and management of the health system

Devices not performing as intended

No device is risk free, and complications and adverse events relating to failures in design or manufacturing can have significant implications both for individuals and for the health sector more broadly. This applies equally to personalised medical devices.

There have been a number of recent well-publicised issues with medical devices in recent years, with Senate Inquiries on ASR metal on metal hip replacement implants,[11] PIP breast implants[12] and vaginal mesh implants.[13] These relate to mass-produced medical devices, but exemplify the potential harms associated with devices that do not perform as they should. The experiences of individuals can vary greatly, and can be life altering, or life ending. For example:

  • Chapter 3 of the Senate Inquiry report on the ASR metal on metal hip replacements notes that in addition to the failure and need for revision of the hip replacement, complications included severe pain, loss of mobility and a complex of physical and psychological effects due to shedding of cobalt and chromium ions from the implanted device.
  • Chapter 4 of the Senate Inquiry report on the PIP breast implants notes not only the physical complications experienced by patients who received these implants, but also the impacts of the associated anxiety and mental stress.
  • Chapter 2 of the Senate Inquiry report on vaginal mesh implants also details the severely adverse outcomes those women who have experienced complications following their surgery, and a list of urogynaecological (vaginal) surgical mesh complications was also published on the TGA's website. Complications include ongoing pelvic soft tissue trauma and infection, acute and/or chronic pain, extensive scarring, and in many of these cases the initial complaint (such as stress urinary incontinence or pelvic organ prolapse) has also recurred.

While the numbers of patients affected by failures of mass-produced devices will, at present, be higher than that for custom-made medical devices, the potential adverse effects resulting from personalised medical devices can be just as significant and costly on an individual basis. With increasing personalisation, the occurrence of these issues where personalised medical devices are involved will increase over time.

There can be significant individual harm and costs to the healthcare system when there is a failure of a medical device, including:

  • the need for additional surgeries that may include explanting the device, followed by other surgery to address both the original problem and any problems caused by the faulty device;
  • the cost of associated psychological impact of the failure of a device and steps required to remediate the failure;
  • increased hospital stays, which puts additional strain on health systems and divert resources from other patients;
  • inability to return to the previous employment, affecting potential future income and impacting the employer; and
  • cost of litigation.

In addition to protecting patients from medical devices not performing as intended, a robust regulatory framework also assists the devices sector to manage risks.

Assurance of regulatory oversight

Regulatory oversight provides evidence-based assurance around the safety, quality and performance of medical devices. In addition to the fundamental role in ensuring devices perform as intended, this assurance is also relied upon across the health sector and by the broader community.

As outlined above, for custom-made devices, the clinical judgement exercised by the prescribing health professional is a key factor in managing the risks associated with the medical device. However, the increasing complexity and technology involved in producing these devices is changing the balance around the role for health professionals in this context. While health professionals continue to be best placed to identify the specific requirements for their individual patients, it is inappropriate risk management to require them to assume responsibility for ensuring the device is designed and manufactured appropriately. This is particularly so as the technological complexity of both the manufacturing process and the devices themselves becomes increasingly specialised.

The broader health sector also relies on the assurance provided by the medical device regulatory framework. While no medical device is without risk, approval of medical devices is relied upon as assurance of the safety, quality and performance of the device.

There are also broad effects at a more systemic level, such as for procurement (e.g., hospitals sourcing medical devices) and reimbursement (e.g., inclusion of a medical device on the ARTG is a requirement for all listings on the Prostheses List described above). While custom-made devices are currently prevalent in some sectors (such as dentistry), as the number of increasingly complex custom-made medical devices grows and becomes widely available in different specialities, health sector concerns about the regulation of custom-made medical devices is expected to grow.

Compliance with a robust regulatory framework also provides assurance to the medical device industry that they are appropriately managing their obligations to patients, medical practitioners, the health sector, and the community. It also provides a framework for internal assurance, including for governance (such as for company boards and shareholders).

Scale and scope of the problem

The following figures help to provide as much insight as is available into the potential scale and scope:

  • the size of the 3D printing market; and
  • the number of health practitioners/businesses in the market likely to already be using personalised medical devices

3D-printing in healthcare

In 2017, the global 3D printing in healthcare market was valued at $797.7 million, and is estimated to grow at 18.3% compound annual growth rate from 2018-2023.[14] North America is the leading market in the 3D-printing in healthcare market with 39.7% of the total share followed by Europe. 3D-printing in the healthcare market in the Asia Pacific region (APAC) is growing at a significant pace and the share of Europe and the APAC[15] combined was 37% of the global market.

Some sources predict that between 2019-2024, the compound annual growth rate for the 3D-printing market will grow 12.8% and that the APAC region will be the fastest growing market.[16]

While 3D-printing technology is not the only manufacturing technique for custom-made medical devices, the emergence of this technology is instrumental in a shift from bespoke custom-made medical devices to large-scale production of personalised devices. 3D-printing has the potential to shift some types of medical interventions from custom-made medical devices being an exception, to personalised medical devices being routine. Detailed analysis of medical device sectors utilising 3D (and 4D[17]) printing technologies shows:[18]

  • Medical devices: 3D printing of medical devices is at different stages of development, with the technology quite mature for prototyping (which has been in use for several decades by some manufacturers) and is being actively embraced by some non-implantable sectors where personalisation is the norm (external prosthetics, hearing aids and dental implants). It is early mainstream use for low volume medical devices, and in 'adolescent' development for custom-made medical devices and pre-surgical planning. It is estimated that there is around five (5) percent to twenty (20) percent market penetration for medical devices which might utilise 3D printing technology.
  • Surgical implants: While still largely in the domain of top clinical research institutions (with an estimated 1% market penetration) the use of 3D technologies in this sector is expected to be among the faster-paced adoptions of medical technology. This is due to the potential impact on quality of life for patients given precision 3D printed implants and related items (such as personalised anatomical models, instruments and surgical plans), and the large market for surgical implants (e.g. there were 122,500 joint replacement procedure in Australian in 2018[19]).
  • Dental devices: Dental devices (from more straight-forward caps, crowns, braces, and implants, to reconstructive implants) are ideally suited to 3D-printing as these are personalised, unique items which cannot be mass-produced (and likely to already be produced as custom-made medical devices). 3D-printing has been used to create dental appliances for several years, primarily by laboratories that serve dentists. A transition is beginning to shift the technology directly into dentists' offices, but this is slow given the high investment costs and design and technological skills needed to master the technology. Current use of 3D technology is estimated at around 5% to 20%, and expected to continue to grow steadily.

Healthcare practitioners

The TGA employed an independent firm—Noetic[20] - to undertake its regulatory costings in support of this RIS. In terms of the scale of businesses potentially using personalised medical devices (now or in the future), Noetic estimated that there are currently approximately 8,503 business, including:

  • 7,500 dental practices
  • 600 prosthetists/laboratories
  • 116 orthotic/prosthetic practices
  • 287 private hospitals

Each of these sectors already makes extensive use of custom-made medical devices. Although (as discussed above) data on the full range and number supplied is not available, custom-made medical devices in common use in these sectors include:

  • dental practices: custom-made crowns, dentures, braces, implants
  • prosthetists/laboratories: custom made prosthetics such as limbs
  • orthotic/prosthetic practices: generally custom-made orthotics
  • private hospitals: may make quite bespoke custom-made medical devices in in-hospital engineering labs, or source custom-made medical devices (including high-risk devices) from the device sector, including endovascular grafts, maxillofacial implants (for reconstruction of the face, skull, jaw, etc.) and patient-matched joint replacements.

Footnotes

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