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Re-manufacturing single use medical devices (information for manufacturers)

Fact sheet no. 37

October 2006

What are single use medical devices?

Single use medical devices (SUDs) are medical devices that are labelled by the original manufacturer as "single use" and are only intended to be used once.

Background to regulation

In 2001 the Australian Health Ministers Advisory Council agreed reprocessing SUDs is a manufacturing activity requiring regulation by TGA to the same level as the original manufacturer.

The legislation

The legislation that applies to the re-manufacture of SUDs is:

  • The Therapeutic Goods Act 1989 (the Act),
  • The Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), and
  • The Therapeutic Goods Regulations 1990.

Applying the legislation

Section 41BG of the Act defines a manufacturer of medical devices. Facilities or individuals who meet this definition will be regulated as a manufacturer of medical devices.

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Definition of a manufacturer

Section 41BG (2) of the Act defines a manufacturer as including:

The person who, with a view to supplying the device under the person's name, does one or more of the following using ready made products:

  1. assembles the device
  2. packages the device
  3. processes the device
  4. fully refurbishes the device
  5. labels the device
  6. assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following
    • the labelling of the device
    • the instructions for using the device
    • any advertising material relating to the device.

Refurbishment is defined under Regulation 1.5 (2) of the Medical Devices Regulations as involving among other things:

  1. stripping the device into component parts or sub-assemblies; or
  2. checking parts of the device for suitability for reuse; or
  3. replacing component parts or sub-assemblies of the device that are not suitable for reuse.

Remanufacturing SUDs for reuse may involve any number of these steps and changing its intended purpose from single use to reusable. The person undertaking these activities as a manufacturer is obligated to comply with labelling requirements including affixing the name and address of the manufacturer to information that accompanies the device. The person then must have a view to supplying the product under their name.

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Activities not covered under this legislation

The regulation of the re-manufacture of SUDs currently excludes:

  • Reprocessing opened but unused SUDs. "Opened but unused" is the term used to refer to a SUD whose packaging has been damaged /opened but the device was not used and/or did not come in contact with blood, tissue or bodily fluids.
  • Individuals who re-manufacture an SUD for their own personal use. The Therapeutic Goods Act does not regulate the activities of individuals unless they are for the purpose of supply in trade or commerce.

Obligations of a manufacturer

Manufacturers have obligations under the Act.

For further help regarding the obligations of manufacturers please refer to Guidance Document No. 20 <http://www.tga.gov.au/docs/html/devguid20.htm>.

Becoming a manufacturer - where to begin

Before making a decision to become a re-manufacturer of SUDs, it is important to:

  • identify the SUDs to be re-manufactured,
  • undertake a cost benefit analysis,
  • build a business case, and
  • acquire an understanding of the regulatory requirements and the relevant Standards that apply to a medical device or the manufacturing systems for a medical device.

Once the decision is made, it is recommended that the following steps be completed:

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Step 1 - Classifying a medical device

Medical devices are classified according to their potential risk to a human body. The level of pre- market intervention by the regulator is proportional to the level of potential risk.

The risk category for a device is determined by taking into account the manufacturer's intended purpose for the medical device and by the application of a set of classification rules.

Applying these rules will classify medical devices into one of the following classes:

  • Class I - low risk devices including low risk devices that are sterile and/or have a measuring function
  • Class IIa - low-medium risk devices,
  • Class IIb - medium-high risk devices,
  • Class III - high risk medical devices, and
  • Class AIMD - Active Implantable Medical Devices (AIMDs). These are treated in a similar way to Class III medical devices.

N.B. The classification, and hence the assessment requirements, of a re-manufactured SUD may differ from the original classification, if the re-manufacturer, in addition to changing the intended purpose from single use to reusable, also changes other aspects of its intended use, including changing the sterility status of the product.

For further help regarding classifying a medical device please refer to Guidance Document No. 25 <http://www.tga.gov.au/docs/html/devguid25.htm>.

Step 2 - Conformity assessment procedures

The re-manufacturer of SUDs other than those classified as class I will need to apply an appropriate CAP and obtain Conformity Assessment Certification from the TGA.

CAPs are described in Schedule 3 of the medical devices regulations and are the means by which a manufacturer demonstrates that a medical device conforms to the EP of safety and performance. The classification of a medical device will determine which CAPs are appropriate. Although there are six different CAPs it is unlikely that all will be appropriate for re-manufacturers of SUDs. The most appropriate CAPs for remanufacturing SUDs are:

2.1 Full Quality Assurance Procedure

Part 1 of Schedule 3 of the Regulation is appropriate for re-manufactured Class AIMD and Class III, IIb or IIa SUDs.

This CAP is suitable for manufacturers who produce new models and/or improve, modify or correct their devices on a regular basis. A manufacturer may apply this procedure by implementing a full quality management system that takes into account the regulatory requirements for the design, production, packaging, labelling and final inspection processes, and implements a post-production phase monitoring system.

This procedure requires a manufacturer to implement a QMS and to have the QMS audited by the TGA. The object of a QMS is to provide the manufacturer with the means to consistently manufacture a medical device that is of minimal risk, performs as intended and meets customer and regulatory requirements. This includes systems for measuring the performance of the QMS itself and correcting the QMS if required. ISO 13485:2003 Medical Devices- Quality management systems- Requirements for regulatory purposes is the standard used by the TGA for auditing medical device manufacturers.

Details of this Standard and information regarding purchasing can be found on the SAI website <http://www.standards.com.au>.

2.2 Design Examination

Class III or AIMD devices assessed via the Part 1 Full Quality Assurance Procedures also require design examination of the remanufactured product. This involves an extensive assessment of the technical documentation by the TGA.

2.3 Production Quality Assurance Procedure

Part 4 of Schedule 3 of the Regulations is most appropriate for re-manufactured Class IIa SUDs and Class I SUDs that are supplied sterile or have a measuring function where they have self assessed compliance with the EP by following the procedure described below under Section 2.3.

The Production Quality Assurance procedure also requires a QMS to be implemented and audited as described in section 2.1 above. The procedure would not require a manufacturer to implement Clause 7.3 - Design and Development of ISO 13485: 2003

2.4 Declaration of Conformity - not requiring assessment by the TGA

Part 6 of Schedule 3 of the Regulations is applicable to Class IIa medical devices and Class I medical devices that are supplied sterile or have a measuring function.

This procedure is a self declaration by the manufacturer in relation to compliance with the EP and does not require pre-market assessment by the TGA. The manufacturer ensures that the device(s) comply with the EP and prepares documentation that allows the conformity to be assessed. This procedure must be combined with another procedure that imposes requirements on the production process.

For further help regarding the above or other conformity assessment procedures please refer to Guidance Document No. 3 <http://www.tga.gov.au/docs/html/devguid3.htm>.

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Step 3 - Essential principles (EP)

The EP are described in Schedule 1 of the medical devices regulations and set out the requirements relating to the safety and performance characteristics of a medical device.

The EP may define results to be achieved, performance levels, and hazards to be addressed, or issues to be considered, but do not necessarily specify how the principles can be satisfied or complied with.

It is the manufacturer's responsibility to demonstrate compliance with the EP for their medical devices. Applying the appropriate medical device standard is one way of demonstrating compliance; however the use of standards is not compulsory.

For further help regarding the EP please refer to Guidance Document No.22 <http://www.tga.gov.au/docs/html/devguid22.htm>, and the Medical Devices EP checklist <http://www.tga.gov.au/devices/epcheck.htm>.

Step 4 - Technical documentation

Application of a QMS will produce technical documentation that must be organised, and be able to be presented, in a form that may be independently assessed. The documentation must clearly show how compliance with each of the relevant EP has been demonstrated.

The manufacturer must treat each remanufactured device model as a product in its own right, with technical documentation addressing every EP and every aspect of the device design and production.

The technical documentation for re-manufactured SUDs is likely to include:

  • clinical evidence
  • specification of the device design,
  • biocompatibility of the remanufactured device,
  • material integrity (this may be critical where the re-manufacturing affects or alters the chemical structure of the material used in the device),
  • validated cleaning, rinsing, viral inactivation and performance testing protocols,
  • validated sterilisation process (if required),
  • device performance including validation of the number of times the device can be re-manufactured and reused, and
  • documentation of the system for tracking:
    • the number of times the device is re-manufactured, and
    • the re-manufactured device to the batch and serial number of the original device.

A properly developed risk analysis is crucial in determining the likely sources of harm and the basic risks that would arise from these sources. Unacceptable risks must be mitigated, primarily by inherent design and then through protection mechanisms if there are limitations to what can be achieved in the design. Any residual risk must be communicated to the user.

Step 5 Clinical evidence

Regardless of the CAPs followed manufacturers must apply Part 8 of Schedule 3 of the Regulations - Clinical Evaluation Procedure to produce clinical evidence that would validate that a re-manufactured SUD would be fit for its intended purpose.

The benefits of a product must outweigh any residual risks and this must be validated through a critical analysis of clinical data. This critical analysis is known as clinical evidence.

The TGA recognises that a flexible, case-by-case approach should be adopted so that clinical evidence requirements are commensurate with the intended purpose of the device. Applicants are encouraged to discuss individual device requirements with the TGA.

As a general rule, the clinical data requirements will vary according to the nature and clinical application of the technology used in, or by, the device but should reflect the performance of the device under normal conditions of use, and allow evaluation of any undesirable side-effects. If some aspects of performance are likely to be similar to existing devices (as in the case of re-manufactured SUDs) some aspects of clinical data may be drawn from a literature review or history of use of a product. Where there is an extension of the intended purpose (also in the case of re-manufactured SUDs) consideration may need to be given to the conduct of a clinical investigation to generate clinical data.

For further help with clinical evidence please refer to Guidance Document No. 4 <http://www.tga.gov.au/docs/html/devguid4.htm>.

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Step 6 - Applying for certification

When an application has been made for a conformity assessment certificate a decision by the TGA to issue the certificate will depend on whether:

  • the application of procedures in section 41EB has been correctly followed,
  • a quality management system has been correctly applied,
  • there is evidence of compliance with the EP,
  • the applicant is considered to be a 'fit and proper person' to hold such a certificate,
  • the people who participate, or who are likely to participate in the management of the applicant's affairs are 'fit and proper persons'.

For further help with applying for a Conformity Assessment Certification please refer to the document "Application for a conformity assessment certificate and/or a CE certificate of conformity" <http://www.tga.gov.au/docs/html/devguid26.htm>, and Guidance Document No. 20 <http://www.tga.gov.au/docs/html/devguid20.htm>.

The manufacturer is also required to prepare and sign a 'Declaration of Conformity' (DOC) that will attest that the appropriate CAP has been applied and that in doing so they hold evidence of compliance with the relevant EP.

Step 7 - Including the device on the ARTG

All medical devices, including re-manufactured SUDs must be included on the ARTG by the Australian Sponsor before they can be legally supplied.

The Australian sponsor is the person responsible for the supply of the product to the Australian market.

If the SUD is re-manufactured in Australia, the re-manufacturer may also be the sponsor for the device, however if the SUD is re-manufactured overseas, the re-manufacturer must nominate an Australian resident or an Australian company to "sponsor" the device to the Australian market.

To enable the sponsor to apply for a medical device to be included on ARTG, the manufacturer will need to supply the sponsor with:

  • the conformity assessment certificate(s) for the chosen CAP, and
  • the Australian declaration of conformity (DOC)

Step 8 - Post market requirements

Manufacturers of medical devices must implement and maintain a post-market monitoring system to seek out and assess information about the performance of their devices. Any reportable adverse incidents must be tested against reporting thresholds defined in the regulations and conveyed to the TGA.

For further help regarding post market responsibilities please refer to Guidance Document No 3 <http://www.tga.gov.au/docs/html/devguid3.htm> and Guidance Document 12 <http://www.tga.gov.au/docs/html/devguid12.htm>.

Disclaimer

This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.

Further information

The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by:

Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email:
Website: http://www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606

© Commonwealth of Australia 2006

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