Manufacturing and supplying surgical loan kits to Australian hospitals

Surgical loan kits typically include reusable surgical instruments, implantable medical devices, or single-use medical devices that are supplied on loan or long-term consignment to hospitals for specific surgical procedures. They can be customised for the hospital, procedure, surgeon, or patient. 

Surgical loan kits are assembled by a manufacturer using medical devices, also known as component medical devices, that were manufactured by component manufacturers and included in the Australian Register of Therapeutic Goods (ARTG) by component sponsors. 

As such, surgical loan kits do not need to be included in the ARTG as a whole; however, each component medical device in the surgical loan kit must be included in the ARTG and comply with labelling, instructions for use (IFU), and safety and performance requirements. 

Roles

Component manufacturers, component sponsors, and surgical loan kit manufacturers all play a role in maintaining the safety and quality of surgical loan kits. 

Component manufacturer

The component manufacturer is the entity that manufactures the individual component medical devices included in a surgical loan kit. They are responsible for design, production, packaging, labelling, and assigning the intended purpose to the component medical device. 

They must create technical documentation to show the device is safe, performs as intended, and meets Australian regulatory requirements before supply. 

Component sponsor

The component sponsor is the entity that includes the component medical device in the ARTG for supply in the Australian market. 

They are responsible for post-market surveillance and vigilance obligations, including but not limited to adverse event reporting. 

Surgical loan kit manufacturer

The surgical loan kit manufacturer is the entity that assembles, packages, or labels the kit using ready-made component medical devices from component manufacturers and arranges distribution to hospitals. They must: 

• ensure each component medical device in the surgical loan kit is included in the ARTG, and
• supply each component medical device in a way that is consistent with the component medical device labelling and corresponding ARTG entries.

They also have obligations for adverse event reporting and recordkeeping. 

An entity may hold several roles. For example, an entity may be both the component sponsor and the surgical loan kit manufacturer.

Surgical loan kits are usually supplied to Australian hospitals as follows, noting that practices may vary between manufacturers and hospitals: 

• Hospitals follow policies or contractual agreements to select and procure medical devices for specific surgical procedures.
• The surgical loan kit manufacturer, upon receipt of a purchase order or request from a hospital, assembles the surgical loan kit according to the hospital’s specifications or the specific surgical procedure.
• Each set of surgical instruments and other medical devices in the surgical loan kit is specific to the models of implants or other devices that are used in a particular surgical procedure or as requested by the surgeon or hospital.
• The surgical loan kit manufacturer makes all necessary documentation available to the hospital, such as:
  • Instructions for Use (IFU) that include applicable cleaning, sterilisation instructions, and processing instructions for component medical devices
  • detailed content lists of the surgical loan kit
  • any patient materials that accompany component medical devices such as Patient Information Leaflets (PILs) and Patient Implant Cards (PICs)
  • Unique Device Identifiers (UDI) for each component medical device in the surgical loan kit, where applicable.
• A courier delivers the surgical loan kit to the hospital or, if required, to the hospital’s central sterilising supply department (CSSD). The hospital or CSSD:
  • unpacks the surgical loan kit
  • checks delivery against the contents list and instrument checklist for completeness
  • visually inspects items
  • decontaminates items, if required
  • sterilises both reusable medical devices and any other medical devices that require sterilisation prior to use according to the component manufacturer’s IFU.
• Following surgery, the CSSD cleans, decontaminates, and sterilises applicable items before returning the surgical loan kit to the manufacturer.
• The hospital records any single-use implantable medical devices used or discarded during surgery and reports this to the manufacturer via a tracking sheet when returning the surgical loan kit.
• Some hospitals keep surgical loan kits on long-term consignment. 

Since 25 November 2021, surgical loan kits have been exempted from inclusion in the ARTG if:

• they are supplied on long-term consignment or loan to a hospital in Australia
• they are for use in specific surgical procedures
• they contain medical devices that are:
  • reusable surgical instruments supplied sterile or non-sterile for sterilisation before use
  • implantable medical devices supplied sterile or non-sterile for sterilisation before use
  • single-use medical devices supplied sterile or non-sterile for sterilisation before use
• each component medical device in the surgical loan kit is included in the ARTG. 

This exemption is specified in Schedule 4, Part 2, Item 2.16 of the Therapeutic Goods (Medical Devices) Regulations 2002.

This exemption established obligations of surgical loan kit manufacturers to:

• check all component medical devices in the surgical loan kit
• retain records
• report adverse events
• allow Therapeutic Goods Administration (TGA) inspections, if requested.

1. The exemption does not permit supply of medical devices in a surgical loan kit that are outside the above requirements but does not restrict the supply of non-therapeutic goods, including excluded goods, with the surgical loan kit.
2. The exemption does not apply if the kit:

• is not supplied on long-term consignment or loan to a hospital in Australia
• contains component medical devices not included in the ARTG, such as exempt medical devices
• contains therapeutic goods other than medical devices such as medicines, other therapeutic goods, or biologicals
• contains medical devices accessed through unapproved goods pathways:
  • Authorised Prescriber
  • Special Access Scheme
  • Clinical Trial Notification

The exemption recognises that risks associated with a surgical loan kit are managed by requiring each component medical device to be included in the ARTG. 

Each component medical device must be supplied: 

• with its IFU and patient information materials, where applicable
• in a way that is consistent with the component manufacturer’s IFU
• in a way that is consistent with the intended purpose specified for that component medical device in the ARTG, and
• with its Unique Device Identifier (UDI), where applicable.

A kit that is not exempt must:

• be included in the ARTG using manufacturer’s evidence of conformity from the TGA or a comparable overseas regulator
• comply with applicable UDI requirements at kit-level as well as for any applicable component medical devices.

Case study

A surgical loan kit includes an instrument tray, scissors, tweezers, gloves, K-wires, pins, and orthopaedic plates.

To qualify for the exemption, all component medical devices in the kit must be included in the ARTG. 

If the instrument tray is supplied separately to the other items in the surgical loan kit, it needs its own ARTG inclusion in addition to ARTG inclusions for the other items. 

If the kit is included as a System or Procedure Pack (SOPP) in the ARTG, all items are covered by that single ARTG inclusion. 

Where the kit qualifies for the exemption, it is also exempt from UDI requirements at the kit-level; however, component medical devices must meet all applicable UDI requirements. Where the kit is included in the ARTG as a SOPP, it must meet applicable UDI requirements at the kit-level and any component medical devices in the SOPP must also meet all applicable UDI requirements as well.

Essential Principle 13 of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 sets out the requirements for the information that must be provided with a medical device. This information includes the label, the IFU, and (if applicable) the Patient Implant Card (PIC) and Patient Information Leaflet (PIL).

This information is important for component medical devices in surgical loan kits to ensure safety and performance, especially when considering sterilisation or reuse.

Electronic IFUs (eIFUs) for surgical loan kit components

Essential Principle 13.2 provides for the use of a printed document or other appropriate media, for the provision of IFU which are specified in Essential Principle 13.4, when it is not practicable to comply with the requirement for providing these directly on the device, or directly on the device packaging.

The TGA considers that cases meeting the 'not practicable' test could include, for example, providing the IFU to professional users, such as surgeons for implantable medical devices. It is not practicable to provide the IFU directly on the implantable device; and the IFU for an implantable device are also too lengthy and complex to be provided directly on the device packaging.

When it is not practicable to provide the IFU directly on the device or device packaging, the IFU may be provided in a printed document or other appropriate media, in accordance with Essential Principle 13.2.

The TGA considers that ‘other appropriate media’ for providing the IFU as specified in Essential Principle 13.4 to professional users (not the general public) could include online through a website, or by other electronic means.

For more information on IFUs, see Supplying electronic instructions for use (eIFU) for medical devices.

Reusable surgical instruments

Surgical loan kits often contain reusable surgical instruments such as retractors, clamps, forceps, and scissors. These instruments are designed for safe reuse after proper processing. 

Regulation 1.3 Reusable surgical instrument
Reusable surgical instrument means a medical device that is intended by the manufacturer:
   a. to be used surgically, without being connected to an active medical device, for cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or any other similar procedure; and
   b. to be reused after the appropriate procedures (such as cleaning, disinfection and sterilisation) specified by the manufacturer in the instructions for use have been carried out.
 

IFU for reusable surgical instruments

The IFU for reusable surgical instruments must include: 

• instructions for appropriate processes to allow reuse of the device, including:
  • cleaning
  • disinfection
  • sterilisation
  • packaging
  • transport
  • storage, and
  • re-sterilisation, if relevant.
• Information on when the device should no longer be reused, such as:
  • an indication of the number of times the device may be safely reused, or
  • how to detect signs of material degradation. 

The component manufacturer must validate all processing steps to ensure the process is effective and devices are safe for intended use or reuse. 

Any processing of reusable surgical instruments should be done according to processing instructions in the IFU.

Where practical, hospitals may record reuse and processing information on a companion tracking sheet and share it with the surgical loan kit manufacturer when the kit is returned. The surgical loan kit manufacturer may use this information to assess device quality and decide when to decommission devices according to the component manufacturer’s IFU. 

Single-use medical devices

Single-use medical devices are those intended for a single patient during a single procedure. 

The component medical device label and IFU must clearly indicate the device is single-use per Essential Principle 13.3, Item 7 and Essential Principle 13.4, Item 8. 

The component manufacturer may supply single-use devices sterile or non-sterile. 

The component medical device label and IFU must clearly indicate if a device is sterile with the word ‘STERILE’ and information about the method that was used to sterilise the device per Essential Principle 13.3, Item 10 and Essential Principle 13.4, Items 11 and 12.

IFU for single-use medical devices

If supplied non-sterile and requiring sterilisation, the IFU must include cleaning and sterilisation instructions that maintain safety and performance per Essential Principle 13.4, Item 13. The component manufacturer may also add information or warnings about re-sterilisation. 

For single-use devices supplied sterile, the IFU must include:

• an indication that the device is sterile
• information about the method that was used to sterilise the device
• information about what to do if sterile packaging is damaged, and
• if appropriate, instructions for resterilisation of the device.  

If sterile packaging is opened but the device is unused, users must follow the component manufacturer’s instructions and confirm if processing and reuse are permitted. 

Implantable medical devices

Implantable medical devices include: 

• joint replacements
• implants for spine or trauma surgery
• ancillary devices such as anchors, screws, sutures, buttons, wedges, K-wires, and plates.

Implantable medical devices are single-use devices. If an implant such as an orthopaedic plate is trialled during surgery or held near the surgical site to estimate the size of the implant required, and contacts blood, tissue, or bodily fluids, it is considered ‘used’ and must be discarded. 

Implantable medical devices that do not contact blood, tissue, or bodily fluids and are not implanted in a patient are referred to as ‘opened but unused’ implants. 

‘Opened but unused’ implantable medical devices - those not contaminated and not implanted - may be processed again only if the component manufacturer allows processing of the device. They must be decontaminated and sterilised before reuse. 

Implantable medical devices may have limits on the number of permitted processing cycles. 

The Therapeutic Goods Administration (TGA) is aware of concerns in regard to implantable medical devices, including: 

• ‘Opened but unused’ implantable medical devices in surgical loan kits such as devices in screw caddies or implant banks may undergo decontamination and sterilisation many times across facilities with no tracking before implantation into a patient.
• Hospitals have observed material degradation such as corrosion and surface damage of implantable medical devices caused by repeated processing. 

Manufacturers often intend implantable medical devices for single use because: 

• materials used in manufacture of the device may not be designed for repeated processing
• design and construction of the device may not facilitate adequate cleaning and sterilisation, or
• the device may not perform as intended by the manufacturer if it is repeatedly processed. 

Risks of repeated processing of single-use implantable medical devices include: 

• potential cross-infection or contamination associated with using inadequately cleaned and sterilised devices
• failure of the device to perform as intended
• material degradation
• biocompatibility risks
• endotoxic reactions caused by residues from processing. 

Some surgical loan kit manufacturers have adopted measures to prevent use of implantable medical devices no longer fit for purpose to minimise these risks by: 

• using electronic systems to record device processing and use
• using individual sterile packaging of implantable medical devices. 

We regulate medical devices based on the manufacturer’s intended purpose. The TGA and overseas regulators generally do not assess whether a device can be subjected to further processing if it is made for single use.
 

Case study

A surgical loan kit is supplied to a hospital for an orthopaedic procedure. It contains single-use devices, including: 

• screws

• hooks

• plates

• washers

• nuts, and

• associated trauma implants.

The surgical loan kit manufacturer provides instructions for processing and sterilising these implants before use.

The sterile set on implants is opened in the operating suite. Some single-use devices remain unused and have not contacted blood, tissue, or bodily fluids. These become ‘opened but unused’ devices. 

The hospital records which implants were used and the processing details for all other devices included in the surgical loan kit.

These unused implants may only undergo further processing if the component manufacturer explicitly permits it. 

If any single-use device was used or contacted blood, tissue, or bodily fluids – whether when being trialled by being held near the surgical site or from a surgeon’s gloves – it cannot be processed for reuse and must be discarded appropriately. 

Hospitals should maintain records of discarded implants and report this information to the surgical loan kit manufacturer when returning the kit. 

IFU for implantable medical devices

For implantable devices in a surgical loan kit, if the IFU is electronic, the kit should include clear instructions for professional users on how to access the IFU. These instructions should clearly explain how to locate the correct version on the manufacturer’s website. 

The surgical loan kit manufacturer must: 

• Demonstrate that each component medical device complies with the Essential Principles by ensuring each component medical device in the surgical loan kit:
  • is included in the ARTG
  • has an IFU and any required patient information materials available to users
  • has any labelling necessary for safe use, and
  • is compatible with other components, with particular attention to contraindications, warnings, storage, and transportation information in the IFU and labels of devices
• Retain records of supply of surgical loan kits to Australian hospitals per Schedule 3, Part 1, Clause 7.6 of the Regulations:
  • for 5 years if the surgical loan kit does not include an implantable medical device
  • for 15 years if the kit includes an implantable medical device
• Be prepared to provide the above records to the TGA within 20 working days if requested.
  • Note: these records include but are not limited to distribution records to hospitals, so that for example in the event of an adverse event, details of the manufacturer and where each batch or lot of devices were supplied may need to be traced.
• Allow authorised persons to enter and inspect the premises where the surgical loan kit is manufactured.
  • Note: The TGA does not routinely inspect surgical loan kit manufacturing facilities but may do so, for example, to assist in the investigation of a serious adverse event.
• Report any adverse events or incidents within the timeframes specified below using the TGA’s online incident reporting tool.

Under the exemption, surgical loan kit manufacturers do not need to obtain certification for the surgical loan kit itself. The exemption does not apply to the component medical devices, as each device must be included in the ARTG and supplied with its IFU, labels, and any required patient information materials. 

We recommend surgical loan kit manufacturers undertake the following voluntary practices to help ensure the safety and performance of the devices in the surgical loan kit. These practices are not regulatory requirements: 

• Implement a quality management system (QMS) that includes:
  • procedures and records for inspection of component medical devices in surgical loan kits supplied to and returned by hospitals
  • procedures and records to track the processing of reusable devices in surgical loan kits
  • appropriate storage and transportation procedures of surgical loan kits between the manufacturer and the hospital, including container and tray designs that support safe transport in line with the component manufacturer’s instructions
  • procedures for managing changes to the QMS
  • procedures for identification and traceability of devices in the surgical loan kit
  • management of corrective actions, including procedures for handling non-conforming devices, monitoring, adverse event reporting, and recalls
  • control of documents and records including record retention.
• Retain evidence that each component medical device in the surgical loan kit is included in the ARTG
• Establish arrangements with hospitals (such as contracts or policies) that consider:
  • Procedures or evidence required by the hospital that demonstrate disinfection or sterilisation of the component medical devices in the surgical loan kit, such as a decontamination certificate or universal cleaning and sterilisation guarantee – also known as a ‘green form’ – that a previous hospital may have provided when they returned the surgical loan kit.
  • Procedures for tracking device usage and processing of component medical devices in the surgical loan kit, such as a tracking sheet supplied with the kit for the hospital to record usage and processing details that the surgical loan kit manufacturer reviews upon return of the kit.
  • Procedures ensuring surgical loan kits are numbered and labelled appropriately to support transportation and handling requirements. 

The Unique Device Identification (UDI) regulatory framework was introduced in March 2025, introducing new requirements for medical devices supplied in Australia. For Guidance on UDI see our Unique Device Identification (UDI) hub.

Surgical loan kits are exempt from UDI requirements at the kit-level; however, component medical devices in the surgical loan kit must meet UDI requirements if they are:

• Class Is (supplied sterile)
• Class IIa
• Class IIb
• Class III

The tray, tub, case, or caddy used for transport is considered a logistics unit which is not required to meet UDI requirements.

Component manufacturers must assign a UDI including the UDI-Device Identifier (UDI-DI) and UDI-Production Identifier (UDI-PI) to each model of device. 

The component manufacturer must provide the UDI for each device to the surgical loan kit manufacturer, ready to be easily accessible at the point of care. The surgical loan kit manufacturer must provide the UDI for each component medical device in the kit to the hospital when they supply the surgical loan kit. 

Component manufacturers and surgical loan kit manufacturers may adopt flexible approaches consistent with international regulators to provide the UDIs to the surgical loan kit manufacturer and hospital. These methods include:

• stickers
• tags
• inventory sheets
• data carrier strips. 

With some exceptions for small non-sterile devices, these methods must ensure that the full UDI for every component device in the surgical loan kit is provided to the surgical loan kit manufacturer for provision to the hospital, ready to be easily accessible at the point of care. 

Component sponsors must ensure that a UDI record for each model of device is submitted to the Australian UDI Database (AusUDID). 

Ruby the component manufacturer

Ruby manufactures component medical devices. She must meet UDI requirements for all medical devices that are Class Is, Class IIa, Class IIb, or Class III.

Emily the surgical loan kit manufacturer

Emily assembles surgical loan kits. Each surgical loan kit includes reusable surgical instruments, implantable medical devices and single-use devices. Emily ensures each component medical device is included in the ARTG and meets UDI requirements, where applicable.

Emily’s surgical loan kit contains 4 Class I medical devices and 10 Class III medical devices.

Emily must ensure each of the 10 Class III medical devices meet UDI requirements. However, UDI requirements do not apply to Class I medical devices.

Emily does not need a UDI for the surgical loan kit itself.

John the component medical device sponsor

John is the sponsor of Ruby’s component medical devices. He must ensure that any medical devices that are Class Is, Class IIa, Class IIb, or Class III meet UDI requirements.

John must also ensure that a UDI record for each model of device is submitted to the AusUDID. 

UDI requirements for small non-sterile devices

We recognise the challenges in providing and retaining the UDI-PI with small non-sterile devices in surgical loan kits. These challenges include: 

• Loss of UDI Carrier during sterilisation
  • Before surgery, small non-sterile devices are often sterilised and removed from their packaging or labelling, which could contain the UDI. Once separated from the UDI Carrier, the device may be difficult to identify later in the hospital or after the surgical loan kit is returned.
• Replenishment issues
  • When small non-sterile devices are replenished in a surgical loan kit, they may come from different production batches. This makes it difficult to maintain accurate production information and track individual components.
• Direct marking impracticalities
  • While direct marking is not required for implantable medical devices, industry advised that even if required, direct marking would be technically infeasible for small non-sterile devices due to their size. 

To address these challenges, small non-sterile devices have reduced UDI requirements: 

• Surgical loan kit manufacturers must provide the UDI-DI for small non-sterile devices that are supplied in a surgical loan kit
• Surgical loan kit manufacturers do not need to provide the UDI-PI for small non-sterile devices that are supplied in a surgical loan kit. 

All devices must still be allocated a UDI-DI, and the UDI-DI must be easily accessible at the point of care.

Component manufacturers may voluntarily directly mark small non-sterile devices where technically feasible, enabling UDI-PI availability at point of care.

Ruby the component manufacturer

Ruby is a component manufacturer of small non-sterile devices to be included in a surgical loan kit.

Ruby’s devices are required to meet UDI requirements. She allocates a full UDI (UDI-DI and UDI-PI) to her devices and provides the full UDI to the surgical loan kit manufacturer when the devices are supplied.

Emily the surgical loan kit manufacturer

Emily assembles surgical loan kits using Ruby’s component medical devices. As these are small non-sterile devices, these have reduced UDI requirements. Emily provides the UDI-DI to the hospital and ensures it is easily accessible at the point of care; however, she does not need to provide the UDI-PI to the hospital.

Small non-sterile devices supplied in and outside of surgical loan kits

When a small non-sterile device is supplied both in a surgical loan kit and outside of a kit, it must carry both the UDI-DI and the UDI-PI when supplied outside of the surgical loan kit. The UDI Carrier for a device supplied outside of a surgical loan kit should follow standard UDI labelling requirements. This does not change how the UDI is provided for devices in a surgical loan kit, where alternate methods are acceptable. 

Ruby the component manufacturer

Ruby supplies small non-sterile devices both in a surgical loan kit and outside of a surgical loan kit.

For the devices supplied in a surgical loan kit, Ruby provides the full UDI to Emily the surgical loan kit manufacturer. When Emily assembles the surgical loan kit, she provides the hospital with the UDI-DI for the small non-sterile devices but not the UDI-PI.

For the devices supplied outside of a surgical loan kit, Ruby applies a UDI Carrier that includes both the UDI-DI and the UDI-PI per standard UDI labelling requirements.

Implications for market actions

Where the UDI-PI is not provided for small non-sterile devices in a surgical loan kit: 

• any market action, device incident report, or adverse event notification cannot be limited to a subset of production
• actions must include all production of the device with the relevant UDI-DI, and
• surgical loan kit manufacturers must extend regulatory actions to all surgical loan kits containing devices with that UDI-DI. 

Arabella the surgical loan kit manufacturer

Arabella recalls a screw that is supplied in multiple surgical loan kits. Because the UDI-PI was not provided to hospitals, Arabella must recall all screws with that UDI-DI. She cannot recall individual batches.

The table below provides a summary of UDI requirements for surgical loan kits and components. 

Component manufacturers, component sponsors, surgical loan kit manufacturers, and hospitals all play a role in maintaining the safety and quality of surgical loan kits. The table below outlines the key roles and responsibilities of each party.