The new article highlights the aspects related to design considerations in the part of risk management. The document also provides an overview of the most important terms and concepts used.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to technical considerations for medical devices with physiologic closed-loop control (PCLC) technology.
The document provides an overview of the applicable regulatory requirements, as well as additional recommendations and clarifications to be taken into consideration in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.
Terms and Definitions
First of all, the guidance provides definitions for the key terms and concepts used in the context of medical devices utilising PCLC technology including, inter alia, the following ones:-
- Automation bias – The tendency for users to give greater belief to information from automation technology without verification.
- Complacency – A phenomenon that refers to the monitoring of technology less regularly or with less vigilance because of a lower degree of suspicion of error and a stronger belief in its accuracy.
- Fallback mode – Mode of operation (or state) into which the PCLC device transitions when the PCLC device stops operating due to the detection of a fault.
- Integrated clinical environment – An environment that combines interoperable heterogeneous medical devices and other equipment integrated to create a medical system for the care of a single patient.
- Physiologic Closed-loop Controlled Medical Device – A medical device that automatically adjusts or maintains a physiologic variable(s) (i.e., the controlled physiologic variable) through delivery or removal of energy or article (e.g., drugs, or liquid or gas regulated as a medical device) using feedback from a physiologic-measuring sensor(s).
The guidance also provides definitions of such terms as “loss of situational awareness”, “physiologic variable”, “physiologic-measuring sensor”, and “skill degradation”, as well as “entrance criteria” and “exit criteria”.
Design Considerations
The scope of the guidance also covers the aspects related to design considerations to be taken into account by the parties involved.
In particular, the authority states that medical devices, especially those with innovative technologies such as PCLC, require meticulous design and rigorous testing to ensure patient safety and efficacy.
The document further describes in detail the essential design considerations, encompassing risk management and verification processes, system components, and real-world utilization scenarios.
Regulatory Overview and Design Control Process
According to 21 CFR part 820.30, manufacturers must enact a robust process for design control activities throughout a medical device’s lifecycle.
This involves identifying potential hazards, estimating associated risks, implementing control measures, and consistently monitoring their effectiveness.
This design control process should cover risk analysis, evaluation, control, and feedback from the production and post-production stages.
As explicitly stated by the authority, when considering PCLC technology, the complete device’s risk, not just the PCLC functions, should be taken into consideration.
The device should ensure safe and effective use, considering the patient population, the setting in which it operates, and its integration into the clinical workflow.
Regulatory Overview and Design Control Process
According to 21 CFR part 820.30, manufacturers must enact a robust process for design control activities throughout a medical device’s lifecycle.
This involves identifying potential hazards, estimating associated risks, implementing control measures, and consistently monitoring their effectiveness.
This design control process should cover risk analysis, evaluation, control, and feedback from the production and post-production stages.
As explicitly stated by the authority, when considering PCLC technology, the complete device’s risk, not just the PCLC functions, should be taken into consideration.
The device should ensure safe and effective use, considering the patient population, the setting in which it operates, and its integration into the clinical workflow.
Risk Management Considerations for PCLC Devices
According to the guidance, PCLC devices are multifaceted systems influenced by sensors, user interfaces, software, patient physiology, and other factors.
These components can, in certain circumstances, lead to hazards – from software glitches to patient physiology disturbances. Such disruptions can potentially harm the patient, especially if there is an error in energy or medicine delivery.
Recognized standards, such as IEC 60601-1-10 and ANSI/AAMI/UL 2800-1, provide guidelines on these risk elements.
As explained by the FDA, the risk analysis for a PCLC device should be thorough, identifying:-
Patient-Related Hazards
The patient’s reaction to the treatment is crucial. Factors such as inter-patient and intra-patient variability, combined with potential external disturbances (like other therapies), can influence the device’s performance, consequently, proper characterization of the patient’s response is vitally important.
According to the guidance, this involves understanding the target patient group’s specific needs, the environment of use, and any potential differences between standard care and the PCLC device’s methods.
Device-Related Hazards
These hazards emerge from the PCLC device itself and its components. It is vitally important to understand potential uncertainties in system design and anticipate functional disturbances.
Examples include sensor inaccuracies, communication failures, cybersecurity threats, or changes in third-party components.
Manufacturers should stay updated on postmarket data of any legally marketed components incorporated into the PCLC device and be proactive in addressing potential concerns.
Use-Related Hazards
PCLC devices, especially those with automated decision-making capabilities, bring unique human interaction challenges.
Reduced user-device interaction might lead to diminished situational awareness, jeopardizing the user’s interventional ability.
There is also a risk of users overly trusting the device, resulting in complacency and potential errors. Manufacturers should consider the anticipated users, their training level, the expected clinical supervision, and any service or configuration adjustments that might be necessary.
The automation level of the PCLC device plays a pivotal role in determining these use-related risks. Manufacturers should prioritize a detailed use-related risk analysis, capturing potential misuse scenarios and known risks.
Real-world Testing and Validation
The authority also mentions that given the complexities of human-device interactions, some use errors might only surface when the device is deployed in real-world conditions.
Manufacturers should therefore incorporate real-use testing scenarios, examining user responses during clinical studies, especially when faults occur or fallback modes are triggered.
Conclusion
The document explains that designing a PCLC device requires a deep understanding both the technical details and the human interaction aspects.
With a comprehensive design control process, adherence to global standards, and rigorous real-world testing, manufacturers should ensure that their devices are safe, effective, and beneficial to the patient population they are used for.
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