Research – Out of warranty AT replacement | FOI document library

DOCUMENT 15 FOIFOI 24/25-015124/25-0889

Research – Out of warranty AT replacement

Is there a need to replace out of warranty assistive technology which is Brief currently well functioning to reduce the risk of catastrophic failure and potential harm to participants and responsibility risk to the agency?

Date May 17, 2021

Requester(s) [[s47F - personal privacy](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/)](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/) - Senior Technical Advisor (TAB)

Researcher s47F - personal privacy - Tactical Research Advisor (TAB/AAT)

Cleared s47F - personal privacy - Research Team Leader (TAB) – Cleared 18/05/21

Please note:

The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters they are to call the TAPS line for advice.

The Research Team are unable to ensure that the information listed below provides an accurate & up-to-date snapshot of these matters.

1 Contents

2 Related TAB Research ……………………………………………………………………………………………………… 2 3 Introduction …………………………………………………………………………………………………………………… 2 4 Terminology …………………………………………………………………………………………………………………… 4 4.1 What is Serviceable Life? ………………………………………………………………………………………….. 4 4.2 What is Catastrophic Failure? ……………………………………………………………………………………. 5 4.3 What is Lifecycle? …………………………………………………………………………………………………….. 5 4.4 What is Lifespan? …………………………………………………………………………………………………….. 5 4.5 What are Warranties? ………………………………………………………………………………………………. 5 5 TGA Requirements ………………………………………………………………………………………………………….. 6 5.1 Overview ………………………………………………………………………………………………………………… 6 5.2 TGA’s Pre-Market Responsibilities ……………………………………………………………………………… 6 5.3 TGA’s On-Market Responsibilities ……………………………………………………………………………… 8 5.4 TGA and Catastrophic Failure ……………………………………………………………………………………. 8 5.5 Manufacturer’s Responsibilities within the TGA Regulations…………………………………………. 9 5.5.1 The Therapeutic Goods (Medical Devices) Regulations ………………………………………….. 9

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5.5.2 Information provided by the manufacturer …………………………………………………………. 9 6 Considering ways of determining Life Span of a device ……………………………………………………… 10 6.1 Overview ………………………………………………………………………………………………………………. 10 6.2 Lifespan in terms of risk management in public health service medical equipment ……….. 11 6.3 Life Span examples using the GMDN ………………………………………………………………………… 12 7 Australian Government Safety Reforms for Medical Devices ……………………………………………… 13 8 Evidence that catastrophic failure of a prosthetic knee is likely to occur ……………………………… 14 9 Conclusions ………………………………………………………………………………………………………………….. 14 10 Appendix - Definitions ………………………………………………………………………………………………… 16 11 References ……………………………………………………………………………………………………………….. 17

2 Related TAB Research

NED21/73162 RES AT Lifespan of Communication Devices (Augmentative and Alternative Communication) 2021/0157

3 Introduction

The research brief for this paper originated from a TAB advice request (NED21/147873) surrounding a microprocessor-controlled prosthetic knee, which instigated discussion amongst the TAB Technical Practice and Resolution Team, where it became evident that the question exists across a range of assistive technology (AT).

For the purpose of exploring overarching themes for this research, components of the TAB Advice Request will be used as a case study throughout this paper. The Case The TAB advice involved a request for a replacement Ottobock Genium knee:

• The agency denied funding for replacement noting that “the Genium knee unit is not recommended to be serviced or replaced at this time.” The advice was later adjusted to “the Genium knee unit is not recommended to be serviced or replaced at this time unless the provider can submit evidence that catastrophic failure of the knee unit is likely to occur and poses injury risk for the participant by using a fully functioning unit that is out of warranty.” [TAB Advice 16/03/21, NED21/147873].

• The agency indicated the preferred course of action is for the participant to continue wearing a Genium knee unit that has reached the end of its serviceable life and is outside of the 6 year warranty period [Letter from Supplier 25/03/21].

• The supplier suggested that the agency’s position directly contradicted a statement made by the manufacturer (Ottobock) within its “Genium/X3 72 Month Service” documentation, which states that Ottobock recommends replacing these components once the warranty

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period has expired to ensure maximum safety and convenience for both prosthetic service provider and end user [Letter from Supplier 25/03/21].

• The supplier further states [Letter from Supplier 25/03/21]:

o For a Genium under warranty, a service is scheduled every 24 months and is required in order to keep the warranty valid.

o Once a device is out of warranty, the device is scheduled for maintenance at the same time interval but is not considered mandatory only because there is no longer a warranty to maintain.

o Ottobock says that all scheduled services are advised to ensure the prosthesis performs in a safe and predictable manner. If the knee unit is not serviced, Ottobock strongly recommends that the Genium unit should be replaced.

• The Supplier stated that “When making this decision we must consider the risks associated with failure of the unit and the consequences of that failure. We also must accept that the question is not if the unit will fail but when.” Depriving the knee unit of a 72-month service means that it will no longer be well-maintained, and the possibility of catastrophic failure becomes greater and greater as the device is continued to be used. In our experience non- serviced knee units are highly unpredictable, and the potential consequences of failure are possibly extreme for this participant. The unpredictability of the knee not only relates to how the knee may fail, but also where and when it may fail.” [Letter from Supplier 25/03/21].

• The Supplier reiterated they “made the recommendation for the replacement of [the participants] microprocessor knee unit that is out of warranty, which is endorsed by the manufacturer and is an accepted industry practice. By denying this recommendation the NDIS, and its clinical advisors, are taking responsibility for the client’s safety until this issue is resolved.” [Letter from Supplier 25/03/21]

Dissecting the Case The research requester posed additional questions to be considered in this paper which are related to the specific advice (NED21/147873):

• What are the relevant Therapeutic Goods Administration (TGA) requirements in this scenario?

• Who do the TGA deem is responsible if the participant’s AT were to experience catastrophic failure once out of warranty and the provider has recommended replacement, NDIS say no but provider continues to enable use and attaches new parts to the part requiring replacement? That is, does enabling continued use assume the provider indicates it is safe to do so?

• What does the supplier Ottobock (and others across relevant AT) see as the risk associated with use beyond their warranty period? Can they clarify why they use warranty period and

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serviceable life terminology interchangeably? Do they consider them as the same thing?

• Are warranty period and serviceable life different concepts? Are there definitions around these terms and catastrophic failure we should be using in TAB when considering whether replacement of an item is R&N at a certain time?

• Is the provider right that a microprocessor knee has increased risk of use past warranty periods as compared to other prosthetic componentry because the provider themselves are not in a position to service the component as required? Is there different decision making to occur depending on the type of AT, the parts included, the risk to the participant if the AT is out of action, the ability for the provider to conduct maintenance and repairs themselves vs the supplier?

• How do these concepts apply across AT, not only to prosthetics?

4 Terminology

Terminology surrounding this subject can be confusing as some terms are used interchangeably by various organisations. Terms such as Life Cycle, Life Span, Effective Life, Physical Life, Useful Life, Serviceable Life, and Catastrophic Failure, are not easy to define as they can be used within different contexts.

Some of the more common interpretations of these terms are provided below. Additional terms referenced throughout this paper are defined and summarised in Appendix 1.

4.1 What is Serviceable Life?

A definition of “serviceable life” could not confidently be sourced. There are many definitions derived from the term “service life” mainly referring to the time a product may be in use (of service) to its owner in terms of an asset i.e. how long it will be useful [1-3].

There are interpretations, which cannot be quantified such as, “service life represents a commitment made by the item’s manufacturer and is usually specified as a median. It is the time that any manufactured item can be expected to be “serviceable” or supported by its manufacturer“ [4].

Given that the correspondence from the supplier to the Agency (dated 25/03/21), was written in the context of the manufacturer, it may be reasonable to suggest that this is related to the terms of the warranty: “Genium knee unit that has reached the end of its serviceable life and is outside of the 6 year warranty period”.

There may be justification to define “serviceable life” as the length of time that the manufacturer considers the item to be serviceable as reflected in their warranty.

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4.2 What is Catastrophic Failure?

Definitions for Catastrophic Failure can vary in terms of its reference to systems, equipment, events, or products. It can be broadly defined as “Changes in capability resulting in total loss of useful performance. Operating characteristics of a material, product, or system undergo sudden and drastic change [5].” Other legal oriented uses of the term can be found at the Law Insider [6].

4.3 What is Life cycle?

Life cycle is a broad term which can be used in many contexts such as, “a series of stages through which something (such as an individual, culture, or manufactured product) passes during its lifetime [7].” The Law Insider suggests a general legal definition, “all stages which are consecutive or interlinked, including research and development to be carried out, production, trading and its conditions, transport, use and maintenance, throughout the existence of the product or the works or the provision of the service, from raw material acquisition or generation of resources to disposal, clearance and end of service or utilisation [8].”

The above definitions appear to be in keeping with the way the TGA interprets the term for products (devices) undergoing the regulatory approval process, as well as post market monitoring and performance. It appears that the TGA use this term in the context of assessing and monitoring of a device while under their jurisdiction, however, no specific definition by the TGA could be located [9, 10].

4.4 What is Life span?

Life span of a device cannot be quantified. Various organisations use methods to apply a time value on devices and other medical equipment when assessing life span in terms of an asset [11-13].

4.5 What are Warranties?

A warranty is a voluntary promise offered by the person or business who sold the product or service to the consumer. Once the consumer purchases the product or service, the promise becomes a right that can be enforced under the Australian Consumer Law (ACL) [14].

Warranties are separate from automatic consumer guarantees. The consumer guarantees which apply regardless of any warranties suppliers sell or give to the consumer, apply for a reasonable time depending on the nature of the goods or services. This means consumer guarantees may continue to apply after the time period for the warranty has expired [14].

With consumer guarantees, businesses must guarantee products and services they sell, hire or lease for under $40,000 and over $40,000 that are normally purchased for personal or household use [15].

Products must be of acceptable quality, that is [15]:

• Safe, lasting, with no faults

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• Look acceptable • Do all the things someone would normally expect them to do.

Services must [15]:

• Be provided with acceptable care and skill or technical knowledge and taking all necessary steps to avoid loss and damage. • Be fit for purpose or give the results that you and the business had agreed to. • Be delivered within a reasonable time when there is no agreed end date.

Consumer Guarantees are a provision under ACL, which is regulated by the Australian Competition and Consumer Commission (ACCC) [16].

5 Therapeutic Goods Administration Requirements

5.1 Overview

• The TGA’s regulatory requirements for medical devices is about manufacturing standards, and the manufacturer’s obligation to apply corrective action in relation to design or production of a device.

• It appears that the TGA does not have specific regulations with regard to obligations of warranty by the manufacturer, and that the TGA’s responsibilities finish with the monitoring of the ongoing obligations of the manufacturer.

• The TGA has no jurisdiction in matters where a participant’s device were to experience catastrophic failure.

• The Therapeutic Goods (Medical Devices) Regulations 2002 states that if applicable the manufacturer must provide with the device, a time period in which the device can be safely used, and that the device must be designed and produced in a way where it can be regularly maintained according to their instructions.

• NOTE: The TGA are currently in the process of reviewing and updating the Australian Regulatory Guidelines for Medical Devices (ARGMD) [17].

5.2 Pre-Market Responsibilities

To maintain public confidence in the safety, performance, benefits and risks associated with the use of medical devices on the Australian market, the TGA may conduct assessments [18]: • Before a device is able to be supplied to the market in Australia, and • While a medical device is available on the market.

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Before a new medical device can be supplied to the market in Australia, the TGA needs to be involved. The TGA’s regulatory requirements vary, depending on what the device is and how it is to be used. The TGA is involved in most of the stages in the life cycle of a medical device [18].

The risks associated with using medical devices can range from little or low potential risk to patients and users to significant potential risks. The level of assessment performed by the TGA before the device is able to be supplied in Australia directly relates to the level of potential risk as per the Risk vs Regulatory Requirements (Figure 1) [17].

Regulatory Requirements (Increasting)

Class | Classes Class lib Classes Is, Im, lla ivVAMD

Class of Device

® Quality System = Design/Type Control

@ Product

Figure 1: Level of regulatory assessment performed by the TGA based on class of device.

The TGA have a risk-based approach to regulation. It would be inefficient to regulate a tongue depressor with the same rigour as a pacemaker. The extent of regulation therefore depends on [19]:

e The intended purpose of the device.

e The degree of risk the device poses to the patient.

e The degree of risk the device poses to the user and those in the vicinity. e Whether the device is used internally or externally to the patient.

e The duration of use.

The level of scrutiny by the TGA of a device before it is placed on the Australian Register of Therapeutic Goods (ARTG) and supplied in Australia depends on the risk posed by the device. The TGA has adopted a classification system for devices, based on the level of risk [19].

Using the TGA’s classification tool (Figure 2) [20], the Genium knee would be classified as Class

1s/1m with a low potential of harm. Research — Out of warranty AT replacement Page 7 of 19

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FOI 24/25-0889 ndis Important considerations

Medical devices are classified according to the level of harm they may pose to users or patients. The following tool will assist in determining the classification of a medical device that is not an In Vitro Diagnostic device. There are separate classification rules for IVD devices.

Medical Device Classification Level of Potential Harm Class I Lowest

Class Is, Class Im Low

Class Ila Low to Moderate

Class IIb Moderate to High

Class III, AIMD High

Figure 2. TGA classifications.

5.3. On-Market Responsibilities

The TGA does not have specific regulations with regard to obligations of warranty by the manufacturer, and the TGA’s responsibilities finish with the monitoring of the ongoing obligations of the manufacturer.

Manufacturers have ongoing legal obligations for medical devices that they manufacture. One is that [17]:

e They implement appropriate means to apply any necessary corrective action in relation to the design or production of a device as soon as practicable after becoming aware of information relating to:

o Any malfunction or deterioration in the characteristics or performance of the device.

fe)

Any inadequacy in the design, production, labelling or instructions for use of the device. o Any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device that might lead, or might have led, to the death of a patient or a user of

the device in Australia, or to a serious deterioration or serious injury to his or her state of health.

5.4 Catastrophic Failure

Current information suggests that the TGA has no jurisdiction in matters where a participant’s device were to experience catastrophic failure.

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5.5 Manufacturer’s Responsibilities within the Therapeutic Goods Administration Regulations

5.5.1 The Therapeutic Goods (Medical Devices) Regulations

The Therapeutic Goods (Medical Devices) Regulations 2002 (“the regulations”) clearly states that manufacturers are required to indicate a time period in which a device can safely be used, and that the device must be designed and produced in a way where it can be regularly maintained according to their instructions. [21].

5.5.1.1 Time period in which the device can safely be used The regulations state that if applicable the manufacturer must provide with the device, a time period in which the device can be safely used, and if the information with the device does not include such, a statement of the date of manufacture of the device (Schedule 1, Part 1, 13.3, Items 12 & 13) [17, 21].

5.5.1.2 Long Term Safety and Maintenance Schedule 1, Part1 ,4 of the regulations state that [17, 21]:

A medical device must be designed and produced in a way that ensures that if:

a. the device is used within the period, indicated by the manufacturer, in which the device can be safely used; and b. the device is not subjected to stresses that are outside the stresses that can occur during normal conditions of use; and c. The device is regularly maintained and calibrated in accordance with the manufacturer’s instructions; the characteristics and performances mentioned in clauses 1, 2 and 3 are not adversely affected.

5.5.2 Information provided by the manufacturer

In the case of Otto Bock’s Genium X3 device, the warranty [22], instructions for use [23], and general information [24] documents were sourced from the internet.

No specific time period were given for which it might be safe to use the device in any of the documents. However, this information may have been provided in other documentation to the participant. The instructions for use document clearly indicates that:

• “Regular service inspections are recommended in the interest of the patient’s safety and in order to maintain operating reliability and protect the warranty.” (This was also mentioned in the warranty). • “The duration of use can be individually extended depending on the intensity of use by performing regular service inspections.”

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Although clearly stating that service inspections are required to maintain the warranty, it appears that Otto Bock are also stating that the duration of use of the device can go beyond the warranty period, as long as service inspections are maintained, which would potentially identify defects.

Interpreting the TGA regulations and the Otto Bock instructions for use of the Genium X3, it would appear that the device is safe to use after expiry of the warranty, providing that it is serviced regularly as recommended by the manufacturer. Where as a result of the service, the manufacturer recommends replacement of certain components or indeed of the device itself, it could be deemed that following through with the recommendations of the manufacturer, or the manufacturer’s agent, is doing so based on expert advice.

6 Considering ways of determining life span of a device

6.1 Overview

Many organisations refer to the “life span” of a device or product. The lifespan of AT cannot be precisely determined. No research could be sourced which might indicate precise lifespan, other than general articles indicating that lifespan may be longer or shorter depending on a number of factors. In a recent TAB research paper looking at the lifespan of AT communication device, three manufacturers were contacted asking for the lifespan of their devices, all three indicated that they could not determine lifespan as it depends on a number of factors.

In Australia, the Biomedical Engineering Advisory Group (BEAG) is an industry advisory group where its members provide a link to their broad network and advises on ways to strengthen teaching and research activities through industry engagement [25]. A BEAG guidance paper on the lifespan of biomedical devices suggested that in some cases the life of a biomedical device may be longer or shorter depending on a number of factors [11]. They also reiterate that lifespan estimates provided in their guidance are a guide only and do not always indicate an age after which biomedical devices should not be used. Factors include:

• Frequency of use. • Nature of use. • Environment of use. • Experience and knowledge of the user. • Care and attention paid to use and operator maintenance. • Existence, capability and cost of maintenance support. • Stage in product life cycle. • Management of scheduled and unscheduled maintenance. • Availability and cost of consumables and spare parts. • Availability and cost of replacement devices. • Relative efficacy and effectiveness of the alternative methods and devices. • Business and safety risks associated with continued or discontinued use. • Strategic and political risks associated with continued or discontinued use. • Compliance with current codes and standards. • Technological or clinical redundancy. • Funding availability.

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The BEAG recommends that a risk management approach is taken when developing a replacement program for biomedical devices and that risk factors, including those above, are considered together with the age/lifespan ratio [11].

6.2 Life span in terms of risk management in public health service medical equipment

The Medical Equipment Asset Management Framework (MEAMF) has been developed to improve medical equipment asset management in Victoria and, in particular, to help individual health services meet their risk responsibilities [26]. Other states such as Queensland have similar frameworks [12]. The MEAMF involves a broad range of stakeholders across health services and industry groups [26].

A major component of applying the framework is to define what effective life is, and how to estimate the effective life of medical equipment. Knowing the effective life of equipment shows the health service when the equipment may need to be replaced [13].

The framework defines ‘effective life’ in relation to other terms such as physical life and useful life [13]:

Effective life - the period over which an item of medical equipment can provide the required clinical function or service for a health service. The Department of Health expects that an asset will complete its effective life before being considered for replacement.

Physical life – the total expected number of productive years for an item of medical equipment. The physical life of an item of medical equipment has ended once it has physically deteriorated to an extent that it is no longer capable of being repaired or used for its intended purpose.

Useful life – the period over which an item of medical equipment may be available for productive use by the health service or the number of units of use (for example, hours, procedures, exposures) expected to be achieved by the item of medical equipment by the health service.

Common criteria for determining effective life are [13]:

• technological obsolescence • an item’s fitness for purpose • maintenance • support and parts availability • legislation • frequency of maintenance • Use and cost.

Factors that affect the effective life of an individual asset include [13]:

• The frequency, environment and nature of use. • The care and attention paid to use and operator maintenance. • The existence, capability and cost of maintenance support. • The availability of consumables and spare parts. • The availability of upgrades and renewals. • Changes in legislative and regulatory requirements. • Changes in industry or professional standards.

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• Variation between manufacturers. • Poor manufacturing quality. • Technological or clinical redundancies.

Determining Effective Life

The framework’s preferred method for determining the effective life of an item of medical equipment is the MEAMF baseline. The baseline tabulates the effective life for each common GMDN category of medical equipment, using an average value for all makes and models of that category [13].

The Global Medical Device Nomenclature (GMDN) is a comprehensive system of internationally agreed coded descriptors used to identify medical device products. The GMDN enables the standardised naming and categorisation of medical devices, accessories and systems, as well as other healthcare-related products (including technical aids, hospital and home care products). The GMDN specifically includes the original coding given to the Emergency Care Research Institute’s Universal Medical Device Nomenclature System (UMDNS) terms. This enables the direct mapping of existing UMDNS-coded medical devices to GMDN coding where the UMDNS descriptor has been adopted unchanged in the GMDN [13].

The Therapeutic Goods Administration (TGA) in Australia is one of more than 20 regulatory bodies worldwide that have adopted GMDN. Others include the Food and Drug Administration (United States) and the Medicines and Healthcare products Regulation Agency (United Kingdom). TGA requires that the GMDN code be included as part of the registration of medical devices on the Australian Register of Therapeutic Goods (ARTG) [13, 18, 27].

The GMDN Device Categories are [28] :

01 Active implantable devices 02 Anaesthetic and respiratory devices 03 Dental devices 04 Electro mechanical medical devices 05 Hospital hardware 06 In vitro diagnostic devices 07 Non-active implantable devices 08 Ophthalmic and optical devices 09 Reusable devices 10 Single use devices 11 Assistive products for persons with disability 12 Diagnostic and therapeutic radiation devices 13 Complementary therapy devices 14 Biological-derived devices 15 Healthcare facility products and adaptations 16 Laboratory equipment

6.3 Life Span examples using the Global Medical Device Nomenclature

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The BEAG guidance paper on the life span of biomedical devices gives an extensive list of expected life spans using the GMDN device category codes together with the UMDNS device groups and descriptions. Several examples of the extensive list is below (Table 1) [11]. (NOTE: The document was last updated in 2004. A more recent update to the document could not be sourced).

Table 1. Examples of GMDM device category codes and UMDNS devices groups

avkce UMDNS Life Device UMDNS Description Expectancy caeory Grou (years)

Code id ¥

4 17159 INFUSION PUMPS, AMBULATORY, INSULIN 10

10 13168 PROSTHESES, JOINT, WRIST 4

2 15613 VENTILATORS 7

4 16214 WHEELCHAIRS, POWERED 5

4 10385 EXERCISERS, BICYCLE 10

4 17187 COMMUNICATION AIDS, VOICE SYNTHESISER 10

13 50038 TELEPHONES, CELLULAR 5

7 Australian Government Safety Reforms for Medical Devices

Regulation reforms are being called for in Australia after the catastrophic failure of various medical devices such as breast implants, surgical mesh, hip implants, and heart valves [29, 30]. The TGA has delayed the commencement of regulatory changes until late 2021 for the following [31]:

e 25 November 2021 for reclassification of certain devices, including

oO spinal implantable medical devices

Oo active implantable medical devices

e 25 February 2021 for medical device software

e 25 February 2021 for personalised medical devices (including 3D printed devices) and e 25 November 2021 for systems or procedure packs.

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The Health Issues Centre (HIC) is an Australian peak consumer health advocacy working with consumers to identify poor practice, policy, and regulation within the health sector [32]. The HIC claim that since recent device failures have been brought to light, they have been alerted to other device malfunction including [32]:

• Hernia and bowel mesh • Cochlear implants • Metal hip replacements • Total knee replacements • Inter uterine devices • Insulin pumps • Pain pumps • Resuscitation devices • Ventilators • The “green whistle” used by paramedics for pain • Breast implants – not just PIP and cereform • Shoulder replacements • Obesity surgery devices • Stents • Intraocular lenses

8 Evidence that catastrophic failure of a prosthetic knee is likely to occur

Given that there are regulations in place by the TGA to ensure that safety within the manufacturing of the device, and the monitoring of the safety of the device while it’s in use, the consumer can only trust that these measures are reliable. Catastrophic failures are usually interpreted as “unexpected”, in that there was no intention for the failure or event to occur. If the TGA regulations safeguard the consumer in the safety of devices, then it would be expected that the consumer would trust those regulations. Given the unexpected nature of a catastrophic failure, it’s difficult to obtain evidence which might indicate that a catastrophic failure is likely to occur.

9 Conclusions

• It may not be necessary to replace out of warranty AT which is currently well functioning in an attempt to reduce the risk of catastrophic failure and potential harm to participants, and risk to the agency.

• Certain operations of manufacturers are regulated by the TGA. It appears that the manufacturer Otto Bock, has adhered to relevant TGA regulations. In interpreting the TGA regulations and the Otto Bock instructions for use of the Genium X3, it would appear that the device is safe to use after expiry of the warranty, providing that it is serviced regularly as recommended by the manufacturer. Where as a result of the service, the manufacturer recommends replacement of certain components or indeed of the device itself, it could be

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deemed that following through with the recommendations of the manufacturer, or the manufacturer’s agent, is doing so based on expert advice.

• It appears the TGA does not have capacity to deem responsibility to a party where a participants AT were to experience catastrophic failure. The TGA’s role is to assess devices for safety prior to reaching the market, and to monitor the manufacturer’s responsibility in applying any necessary corrective action in relation to the design or production while the device is on the market. The TGA has no other jurisdiction in matters where the manufacturer’s role within a warranty is concerned.

• The TGA regulations exist to safeguard the consumer in the safety of devices. It would be expected that the consumer would place trust in those regulations. Given the unexpected nature of a catastrophic failure, it’s difficult to obtain evidence which might indicate that failure is likely to occur.

• In the case presented in this paper, if the manufacturer is recommending that a component be replaced, and the supplier continues to attach new parts to the part recommended for replacement, then it could be determined that the supplier is at risk by not following the advice of the manufacturer, who is giving that advice based on their regulatory requirements.

• Warranty periods and serviceable life are not necessarily different concepts, they are directly related in that the serviceable life is the length of time that the manufacturer considers the item to be serviceable as reflected in their warranty period. Serviceable life can extend beyond the warranty period as per that advised by the manufacturer under regulations of the TGA. For example, provided that the device is serviced at time periods indicated by the manufacturer, which may potentially identify defects.

• In the case presented in this paper, it appears that where the TAB is considering whether replacement of an item is R&N, that time would be when the manufacturer deems the device should be replaced. For example, if the device is out of warranty and is still receiving servicing at intervals recommended by the manufacturer, including the replacement of certain components, where the manufacturer identifies that the device can no longer support the replacement of components and requires complete replacement.

• In the case presented in this paper, the provider is correct when they suggest that there is an increased risk when the microprocessor knee is used past the warranty period (as compared to other prosthetic componentry) because they are not in a position to service the component as required. The reason there is increased risk is because the device is not undergoing the service recommended by the manufacturer which is supported by TGA regulation. The manufacturer is advising regularity of maintenance at certain intervals after the warranty expiry - “If the knee unit is not serviced, Ottobock strongly recommends that the Genium unit should be replaced” (Letter from Supplier 25/03/21). If the provider is not in a position to service the device, that raises the question of who can? This has not been investigated.

•

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e Life span of a medical device is determined using various methods across different organisations, and are mainly in relation to asset management. What they determine as life span is the time period they continue to use the device before it’s replaced. The methods applied to determine this include maintenance frequency and type of use.

e If the TAB were to introduce a term to support discussion surrounding the subject of device warranty and life span - that could be ‘effective life’. Where the manufacturer has responsibility to adhere to TGA regulations, it could be considered that they are recommending the “effective life”, which can extend beyond a warranty period, as based on their determination of the time period the device can safely be used, and taking into account the frequency of maintenance.

e The supplier Otto Bock or other suppliers have not been approached with regard to their opinion of risk associated with the use of a device beyond their warranty period.

e Currently in Australia, there is controversy surrounding catastrophic failures in medical devices where reform to regulation of devices is being called for, and where the TGA will commence regulatory changes in late 2021. It is recommended that the TAB monitor and keep abreast of these changes.

10 Appendix 1 - Definitions Definitions referenced throughout this paper.

Term Definition Reference(s)

Warranty A voluntary promise offered by the person or ACCC [14] business who sold the product or service to the consumer. Once the consumer purchases the product or service, the promise becomes a right that can be enforced under the Australian Consumer Law.

Consumer Guarantee A law provisioned by Australian Consumer Law, ACCC [15] which is regulated by the Australian Competition and | Consumer Law [16] Consumer Commission (ACCC), where businesses must guarantee products and services they sell, hire or lease for under $40,000 and over $40,000 that are normally bought for personal or household use, apply regardless of any warranties suppliers sell or give to the consumer, and apply for a reasonable time depending on the nature of the goods or

services. Serviceable life The length of time that the manufacturer considers Various [1-4] the item to be serviceable as reflected in their warranty Catastrophic Failure Changes in capability resulting in total loss of useful The Law Dictionary [5]

performance. Operating characteristics of a material, product, or system undergo Sudden and drastic change.

Research — Out of warranty AT replacement Page 16 of 19

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Term

Life cycle

Life span

Effective life (Medical Equipment)

Physical life (Medical Equipment)

Useful life (Medical Equipment)

11 References

FOI 24/25-0889

Definition

All stages which are consecutive or interlinked, including research and development to be carried out, production, trading and its conditions, transport, use and maintenance, throughout the existence of the product or the works or the provision of the service, from raw material acquisition or generation of resources to disposal, clearance and end of service or utilisation.

Life span of a device cannot be quantified. Various organisations use methods to apply a time value on devices and other medical equipment when assessing life span in terms of an asset.

The period over which an item of medical equipment can provide the required clinical function or service for a health service.

The total expected number of productive years for an item of medical equipment. The physical life of an item of medical equipment has ended once it has physically deteriorated to an extent that it is no longer capable of being repaired or used for its intended purpose.

The period over which an item of medical equipment may be available for productive use by the health service or the number of units of use (for example, hours, procedures, exposures) expected to be achieved by the item of medical equipment by the health service.

Reference(s)

Law Insider [8]

The Biomedical Engineering Advisory Group (BEAG) [11]

State of Victoria [13]

Queensland Health [12]

State of Victoria (Department of Health). Medical equipment asset management framework - Part C 2012 [13]

Blanchard S. The Major Difference Between the Service Life of an Asset and Its Physical Life.

Chron. not date.

Pa Organisation for Economic Co-operation and Development. Service Life (of an asset) 2003 [Available from: https://stats.oecd.org/glossary/detail.asp?ID=2430. 3. T. Cooper. Beyond Recycling: the longer life option London: New Economics Foundation;

1994 [Available from:

https://www.academia.edu/31425579/Cooper T 1994 Beyond Recycling the longer life option

London New Economics Foundation?auto=download.

Wikipedia. Service Life 2021 [Available from: https://en.wikipedia.org/wiki/Service life.

53 The Law Dictionary. What is catastrophic failure? no date [Available from: https://thelawdictionary.org/catastrophic-

failure/#:~:text=Changes%20in%20capability%20resulting%20in, undergo%20Sudden%20and%20dra

stic%20change.

Law Insider. Catastrophic Failure definition no date [Available from:

https:

www.lawinsider.com/dictiona

catastrophic-failure.

Research — Out of warranty AT replacement

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Merriam-Webster. Life cycle no date. [Available from: https://www.merriam-

webster.com/dictionary/life%20cycle. 8. Law Insider. Life cycle definition no date. [Available from: https://www.lawinsider.com/dictionary/life-cycle. 9. Australian Government - Department of Heath - Therapeutic Goods Administration (TGA). Safety first! How a risk based, life-cycle approach to medical device design improves patient safety 2019 [Available from: https://www.tga.gov.au/sites/default/files/tga-presentation-termis-ap- abmc7-2019-congress-14-17-october-2019.pdf. 10. Australian Government - Department of Heath - Therapeutic Goods Administration (TGA). Researcher considerations 2020 [Available from: https://www.tga.gov.au/researcher-considerations. 11. Biomedical Engineering Advisory Group (BEAG). Life span of Biomedical Devices 2004 [Available from: http://cedglobal.org/download/Life%20Span%20of%20Biomedical%20Devices%20- %20Guidance%20Paper%20Final.pdf. 12. Queensland Health. Medical equipment asset class - Categories and useful life guidelines 2020 [Available from: https://www.health.qld.gov.au/ data/assets/pdf file/0008/1022201/qh-gdl- 483.pdf. 13. State of Victoria (Department of Health). Medical equipment asset management framework

Part C 2012 [Available from: https://crm.hfma.org.au/sites/default/files/uploaded- content/website-content/medical equipment asset.pdf.

Australian Competition & Consumer Commission (ACCC). Warranties 2021 [Available from:

https://www.accc.gov.au/consumers/consumer-rights-guarantees/warranties#warranty-against- defects. 15. Australian Competition & Consumer Commission (ACCC). Consumer guarantees 2021 [Available from: https://www.accc.gov.au/consumers/consumer-rights-guarantees/consumer- guarantees. 16. Consumer Law. Consumer guarantees 2006 [Available from: https://consumerlaw.gov.au/sites/consumer/files/2016/05/0553FT ACL- guides Guarantees web.pdf. 17. Australian Government - Department of Heath - Therapeutic Goods Administration (TGA). Australian regulatory guidelines for medical devices (ARGMD) 2020 [Available from: https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd. 18. Australian Government - Department of Heath - Therapeutic Goods Administration (TGA). Australian regulatory guidelines for medical devices (ARGMD) 2011 [Available from: https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd. 19. Australian Government - Department of Heath - Therapeutic Goods Administration (TGA). The regulation of medical devices 2011 [Available from: https://www.tga.gov.au/behind- news/regulation-medical-devices. 20. Australian Government - Department of Heath - Therapeutic Goods Administration (TGA). What classification is my medical device? 2021 [Available from: https://www.tga.gov.au/sme- assist/what-classification-my-medical-device#107. 21. Australian Government. Therapeutic Goods (Medical Devices) Regulations 2002 2002 [Available from: https://www.legislation.gov.au/Details/F2020C00822. 22. Ottobock. Genium X3 Service pass no date [Available from: https://shop.ottobock.us/store/medias/46D875-EN-05- 1810.pdf?context=bWFzdGVyfHJvb3R8MTkzNDczfGFwcGxpY2F0aW9uL3BkZnxoZTgvaGFiLzg4OTI2M zQyMzQ5MTAucGRmfDMyNTk2OWY5MzBhYWFmOGI2ZjdmYjYwODM2ZTBiN2QyNTdiZDFiZDgxOW M0ODk4NmVjNjlkNmUzYzgwNzEwOTE&attachment=true#:~:text=Ottobock%20offers%20two%20w arranty%20packages,and%20a%20six%2Dyear%20warranty.&text=This%20service%20pass%20gives %20you,it%20is%20due%20for%20servicing. 23. Ottobock. Genium X3 3B5-2/3B5-2=ST - Instructions for Use no date [Available from: https://shop.ottobock.us/media/pdf/647G1149-INT-05-1703w en 2018.pdf.

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Ottobock. Genium Reclaim your strength no date [Available from: https://professionals.ottobock.com.au/document?mediaPK=8923931836446&attachment=true.

University of Melbourne (Faculty of Engineering and Information Technology). Industry

Advisory Groups no date [Available from: https://eng.unimelb.edu.au/about/advisory-groups. 26. State of Victoria (Department of Health). Medical equipment asset management framework

Part A & B 2012 [Available from: https://www2.health.vic.gov.au/about/publications/policiesandguidelines/medical-equipment- asset-management-framework-part-a-b.

Department of Health (TGA). Global Medical Device Nomenclature - GMDN. 2013.
World Health Organisation (WH). GMDN User Guide: A comprehensive guide to the Global Medical Device Nomenclature (Version 2010) 2008 [Available from: https://www.who.int/medical devices/innovation/GMDN Agency User Guide v120810.pdf.
ABC News. Rules designed to protect patients from faulty medical devices delayed until next year 2020 [Available from: https://www.abc.net.au/news/2020-06-21/tga-rules-to-provide-more- oversight-medical-devices-delayed/12373290.
ABC News. Warnings of more “catastrophic failures” of medical devices without serious reform 2018 [Available from: https://www.abc.net.au/radio/programs/am/warnings-catastrophic- failures-medical-devices-without-reform/10146304.

Australian Government - Department of Heath - Therapeutic Goods Administration (TGA).

Delays to the commencement of certain medical device regulatory changes 2020 [Available from: https://www.tga.gov.au/delays-commencement-certain-medical-device-regulatory-changes. 32. Health Issues Centre. Medical Device and Implant Failure 2020 [Available from: https://hic.org.au/medical-device-and-implant-failure/.

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