Medical Device Regulation – Australian TGA
Meeting the Essential Principles – Principles about Design and Construction
Principle 12 – Medical Devices with an Energy Source
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Australian and international standards related to electromedical safety, electromagnetic compatibility, medical device software and active implantable medical devices are also relevant to Essential Principle 12.Standards that may provide further guidance, but are not mandatory standards that must be used include:
– IEC 60601: a family of standards relating to the safety and performance of medical electrical equipment
– IEC 62304: Medical device software—Software life cycle processes
– AS ISO 9918: Capnometers for use with humans—Requirements
– AS ISO 9703: Anesthesia and respiratory care alarm signals
– ISO 5356: Anesthetic and respiratory equipment
Medical devices incorporating electronic programmable systems
A medical device that incorporates an electronic programmable system must be designed and produced in a way that ensures that:
- the performance, reliability, and repeatability of the system are appropriate for the intended purpose of the device; and any consequent risks associated with a single fault condition in the system are minimized.
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. …
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12.1 Medical devices incorporating electronic programmable systems
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Safety dependent on internal power supply
– This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will depend on an internal power supply for the device.
The device must be fitted with a means of determining the state of the power supply.
12.2 Medical Devices with an Energy Source – Safety dependent on internal power supply
This Essential Principle only applies if the safety of the patient will depend on the internal power supply for the device. If that is the case, there should be some sort of indication (if it is possible) on the device showing the state of the internal power supply. Moreover, there should be visual and/or audible alarms, if the state of the internal power supply goes below a certain range.
The work undertaken by the manufacturer could involve, but is not restricted to:
– addressing the safety issue as a part of the risk analysis and indicating what control measures are in place to reduce the risk
– documenting how the visual indication showing state of the internal power supply and alarms are designed and tested as a part of the technical documentation
– providing information about the visual indication of the internal power supply and alarms as a part of the Instructions for Use
Safety dependent on external power supply
– This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will depend on an external power supply for the device.
The device must be fitted with an alarm system that indicates whether a power failure has occurred.
12.3 Medical Devices with an Energy Source – Safety dependent external power supply
This Essential Principle only applies if the safety of the patient will depend on the external power supply for the device. For example, if there is an external power supply to a ventilator or anaesthetic machine and a power failure occurs, there should be visual and audible alarms.
External power supplies include:
– electrical
– battery powered
– gas powered
– pneumatic
– liquid or solid fuels
The work undertaken by the manufacturer could involve, but is not restricted to:
– addressing the safety issue as a part of the risk analysis and indicating what control measures are in place to reduce the risk to the patient
– documenting how the visual and audible alarms are designed and tested as a part of the technical documentation
– providing information about the visual and audible alarms as a part of the Instructions for Use
Medical devices intended to monitor clinical parameters
A medical device that is intended by the manufacturer to be used to monitor one or more clinical parameters of a patient must be fitted with an appropriate alarm system to warn the user if a situation has developed that could lead to the death of the patient or a severe deterioration in the state of the patient’s health
2.4 Medical Devices with an Energy Source – Medical devices intended to monitor clinical parameters
Medical devices that monitor variations in cardiac performance, respiration and activity of the nervous system are relevant examples for this Essential Principle.
The work undertaken by the manufacturer could involve, but is not restricted to:
– as part of the risk analysis, indicating what control measures are in place to reduce the risk to the patient if the variations of any physiological parameters monitored are of a kind that could result in immediate danger to the patient
– documenting how the alarm system is designed and tested as a part of the technical documentation
– providing information about the alarm system as a part of the Instructions for Use
– IEC 60601-1-8[1] can provide further guidance, but is not a mandatory standard that must be used.
Minimization of risk of electromagnetic fields
A medical device must be designed and produced in a way that ensures that the risk of an electromagnetic field being created that could impair the operation of other devices or equipment being used in the vicinity of the medical device is minimized.
12.5 Medical Devices with an Energy Source – Minimization of risk of electromagnetic fields
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Protection against electrical risks
A medical device must be designed and produced in a way that ensures that, as far as possible, when the device is installed correctly, and the device is being used for an intended purpose under normal conditions of use and in the event of a single fault condition, patients, users, and any other persons, are protected against the risk of accidental electric shock.
12.6 Medical Devices with an Energy Source – Protection against electrical risks
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Protection against mechanical risks
A medical device must be designed and produced in a way that ensures that a patient, the user, and any other person, is protected against any mechanical risks associated with the use of the device.
12.7 Medical Devices with an Energy Source – Protection against mechanical risks
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Protection against risks associated with vibration
– A medical device must be designed and produced in a way that ensures that any risks associated with vibrations generated by the device are minimised.
If vibrations are not part of the intended performance of the device, particular attention must be given to relevant technical progress, and the available means, for limiting vibrations, particularly at source.
12.8 Medical Devices with an Energy Source – Protection against risks associated with vibration
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Protection against risks associated with noise:
- A medical device must be designed and produced in a way that ensures that any risks associated with noise emitted by the device are minimised.
12.9 Medical Devices with an Energy Source – Protection against risks associated with noise
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis of the significance of any foreseeable noise emitted by the device, either intentional or unintentional
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Protection against risks associated with terminals and connectors
A medical device that is intended by the manufacturer to be connected to an electric, gas, hydraulic, pneumatic or other energy supply must be designed and produced in a way that ensures that any risks to the user associated with the handling of a terminal or connector on the device, in relation to the energy supply, are minimized.
12.10 Medical Devices with an Energy Source – Protection against risks associated with terminals and connectors
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Protection against risks associated with heat
A medical device must be designed and produced in a way that ensures that, during normal use, any accessible part of the device (other than any part intended by the manufacturer to supply heat or reach a given temperature), and any area surrounding an accessible part of the device, does not reach a potentially dangerous temperature.
12.11 Medical Devices with an Energy Source – Protection against risks associated with heat
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Protection against risks associated with administration of energy or substances:
- This clause applies in relation to a medical device that is intended by the manufacturer to be used to administer energy or a substance to a patient.
- The device must be designed and produced in a way that ensures that:
- the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and
- as far as possible, the accidental release of dangerous levels of energy or of the substance is prevented.
- The device must be fitted with a means of indicating or, if appropriate, preventing inadequacies in the rate and amount of energy, or of the substance, administered that might cause danger to the patient, the user or any other person.
- The functions of each control and indicator on the device must be clearly specified on the device.
12.12 Medical Devices with an Energy Source – Protection against risks associated with administration of energy or substances
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– ensuring that operational information displayed by the device is clearly understandable
– evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Active implantable medical devices
An active implantable medical device must display a code that can be used to identify:
- the type of device; and
- the manufacturer of the device; and
- the year of manufacture of the device.
12.13 Medical Devices with an Energy Source – Active implantable medical devices
The format of the code is determined by the manufacturer.
One way to display this code is to inscribe the device using radio-opaque materials that can be viewed on an x-ray of the patient. For example, to enable medical staff to re-program a patient’s implantable pacemaker in an emergency situation, an x-ray of the patient can be taken to read the radio-opaque code shown on the pacemaker, and this code can be used to determine the make and model of a suitable programming device.
The work undertaken by the manufacturer could involve, but is not restricted to:
– documenting how a unique code is assigned to the device
– documenting how the code is affixed to the device during manufacture
– documenting how the code can be read without the need for surgery (possibly as part of the Instructions for Use)
– producing technical drawings showing the artwork for the code on the device
[1]IEC 60601-1-8 is a standard relating to medical electrical equipment and general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
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 >>>