Principle 8 – Medical Device Infection and Microbial Contamination

Medical Device Regulation – Australia
Meeting the Essential Principles – Medical Device Design and Construction

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Minimization of risk of Infection and Microbial Contamination

A medical device must be designed and produced in a way that ensures that the risk of infection to a patient, a user, or any other person, is eliminated or minimized. The device must be designed in a way that allows it to be easily handled; and if appropriate, minimizes contamination of the device or specimen by the patient, user or other person by the device or specimen.

8.1 Minimization of risk of Infection and Microbial Contamination

The work undertaken by the manufacturer could involve, but is not restricted to:

– a well-reasoned and documented risk analysis

– compliance with the MDSO (Standards for Medical Devices Required to be Sterile)

– sterilization validation reports, bioburden data and evidence demonstrating the control of tissue of animal origin

– preservative efficacy reports for multi-dose, preserved medical devices (for example contact lens solutions) to demonstrate effectiveness of the preservative system, and to verify the expiry date and the open (in-use) shelf life assigned to the device

– verification of the integrity of the packaging system for medical devices packaged in a manner that minimizes the risk of in-use microbial contamination, to verify the expiry date and the open (in-use) shelf life assigned to the device

– if the device is to be reprocessed, manufacturers must include instructions for the reprocessing in the Instructions for Use.

Medical Device Infection and Microbial Contamination

Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>

8.2 Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substances

– This clause applies in relation to a medical device that contains:

– Tissues, tissue derivatives, cells or substances of animal origin that have been rendered non viable; and

– tissues, tissue derivatives, cells or substances of microbial or recombinant origin.

– If the tissues, tissue derivatives, cells or substances originated from animals, the animals must have been subjected to appropriate veterinary controls and supervision, having regard to the intended use of the tissues, cells or substances.

– If the medical device contains tissues, tissue derivatives, cells or substances of animal origin, a record must be kept of the country of origin of each animal from which the tissues, tissue derivatives, cells or substances originated.

– The processing, preservation, testing and handling of tissues, tissue derivatives, cells or substances of animal, microbial or recombinant origin must be carried out in a way that ensures the highest standards of safety for a patient, the user of the device, and any other person.

In particular, the production process must implement validated methods of elimination, or inactivation, in relation to viruses and other transmissible agents.

Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substances

The work undertaken by the manufacturer could involve, but is not restricted to:

– evidence of the various controls, supervisory procedures, records and processing requirements for animal sources Conformity Assessment Standards Order No. 2 and ISO 22442[1] can provide further guidance on this, but are not mandatory standards that must be used:

– providing sufficient detail in the sourcing, handling and manufacturing process to demonstrate minimization of the risk of transmitting Transmissible Spongiform Encephalopathies (TSEs), refer to the TGA guidelines available on the TGA website in relation to minimizing the risk of transmitting TSEs

– for microbial and recombinant sources, detailing the materials used in the manufacturing process including confirmation or not of those materials that are known to be sourced from both animal and non-animal sources.

Infection & Microbial Contamination – Medical devices to be supplied in a sterile state

– This clause applies in relation to a medical device that is intended by the manufacturer to be supplied in a sterile state.

– The device must be designed, produced and packed in a way that ensures that the device is sterile when it is supplied, and will remain sterile, if stored and transported in accordance with the directions of the manufacturer, until the protective packaging is opened or damaged.

– The device must be produced and sterilized using an appropriate validated method.

– The device must be produced in appropriately controlled conditions.

8.3 Medical devices to be supplied in a sterile state

The work undertaken by the manufacturer could involve, but is not restricted to:

– compliance with the appropriate clean room standards for the manufacturing premises in which the device is manufactured

– compliance with packaging standards and/or results of package strength and integrity testing, as appropriate for the device

– protocols for validation of the sterilization cycle in accordance with the specific standards for the sterilization method used and reports of testing to demonstrate compliance with the protocols and acceptable outcomes of the validation process. Medical Device Standards Order No. 3 can provide further guidance on this, but is not a mandatory standard order that must be used.

Medical devices to be supplied in a non sterile state

– A medical device that is intended by the manufacturer to be supplied in a non-sterile state must be packed in a way that ensures that the device maintains the level of cleanliness stipulated by the manufacturer.

– If the device is intended to be sterilized before it is used, the device must be packed in a way that:

– ensures that the risk of microbial contamination is minimized; and

– is suitable, having regard to the method of sterilization that the manufacturer indicates is to be used for the device.

– The device must be produced in appropriately controlled conditions.

8.4 Medical devices to be supplied in a non-sterile state

The work undertaken by the manufacturer could involve, but is not restricted to:

– compliance with the appropriate standards for air quality of the manufacturing premises in which the device is manufactured

– compliance with packaging standards and/or results of package strength and integrity testing, as appropriate for the device, to ensure that the initial cleanliness of the device prior to sterilization is maintained

– results of studies demonstrating that the packaging can withstand the sterilization process, and/or is permeable to the sterilizing agent, and capable of maintaining sterility for a defined period after the sterilization process.

Infection & Microbial Contamination – Distinction between medical devices supplied in sterile and non-sterile state.

If a medical device is supplied in both a sterile state and a non-sterile state, the information provided with the device must clearly indicate whether the device is in a sterile state or a non sterile state.

8.5 Distinction between medical devices supplied in a sterile and non-sterile state

The work undertaken by the manufacturer could involve, but is not restricted to:

– the labelling and Instructions for Use provided with the sterile and non-sterile device must clearly indicate in which state the device is supplied

– labelling should be in compliance with Essential Principle 13.

[1]ISO 22442 is a multi-part standard for medical devices utilizing animal tissues and their derivatives. Each part covers a different aspect of the evaluation.

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>