Safety first! How a risk based, life-cycle approach to medical - - PowerPoint PPT Presentation
Safety first! How a risk based, life-cycle approach to medical device design improves patient safety Dr Kelly Tsang Assistant Director, Devices Conformity Assessment Section Medical Devices Branch, Therapeutic Goods Administration (TGA) TERMIS
Dr Kelly Tsang Assistant Director, Devices Conformity Assessment Section Medical Devices Branch, Therapeutic Goods Administration (TGA) TERMIS + ABMC7 2019 16 October 2019
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advertising via social media
interactions with doctors
device off label
feedback/ complaints including on social media
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challenges
is more fluid
inherent risk but also more promises of benefits
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(SaMD)
devices
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All medical devices must have evidence to demonstrate they meet the Essential Principles (about safety of the devices) and conformity assessment procedures (about the QMS requirements) Researchers have a unique role to play in the device development process
cover all stages of device lifetime, and spanning the development cycle. How are the material and technologies impacted through each stage? § Device lifetime
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– Defined in ISO 14971: systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk – What evidence can you provide to demonstrate risks have been mitigated and that the device performs as intended?
to the regulators the manufacturer has in place measures to address risks and ensure ongoing safety and performance of their devices
the company, the product and consumers
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(1) The solutions adopted by the manufacturer for the design and construction of a medical device must conform with safety principles, having regard to the generally acknowledged state of the art. (2) Without limiting subclause (1), in selecting appropriate solutions for the design and construction of a medical device so as to minimise any risks associated with the use of the device, the manufacturer must: (a) first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse* of the device; and (b) second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction; and (c) third, if appropriate, ensure that adequate protection measures are taken, including alarms if necessary, in relation to any risks that cannot be eliminated; and (d) fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted.
*Note: misuse includes incorrect or improper use of the device This Essential Principle is reproduced from TGA requirements, but similar statements are found in EU MDR ‘Essential Requirements’, in ISO 16142-1:2016 and IMDRF documents
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the manufacturer to design their severity and probability levels and some include additional considerations (e.g. detectability).
confusion or ambiguity
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Manufacturers are responsible for actively monitoring risks of their devices on the market, not just when things go wrong, or wait for things to go wrong
cases as inputs too)
– E.g. new product version design – Add new features e.g. alarms – Closer monitoring or alter acceptability criteria § This changes product specifications and should be re-validated – Undertake appropriate recall action
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– Hazard/ risk not identified or updated/ acknowledged – Risk matrix not appropriate – Risk not properly mitigated – Inconsistency between risk document and other documents – Tests and validations not carried out per risk management documents – Risk not informed by post-market experience – No regular review or update
Essential Principle 2 – Grounds for TGA to reject new device application or to cancel the ARTG entry of existing device
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managing risk and demonstrating safety and performance remains the same