Infusion Pump Authorization Matrix for Role- and Therapy-Specific Access
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Solution Overview
Problem
Current medical device protection systems, such as those for infusion pumps and blood treatment machines, lack flexibility in granting access authorizations, as they are hard-coded and restrict or prevent the adaptation and extension of code-specific manipulations, limiting user access based on predefined levels.
Innovation Solution
A database system is implemented to store multiple operator types or hierarchy levels with assigned authorization levels and specific manipulations, along with drug/therapy-specific authorizations, allowing flexible assignment of manipulations based on operator identity and therapy/drug type, using authentication and validation devices to grant identity-specific authorizations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a permanently programmed code lock is used for critical drugs and therapies, then patient safety is improved through restricted access, but the system loses flexibility in adapting and extending code-specific manipulations
Solution Approach 1:
The patent segments the authorization system into multiple hierarchy levels (e.g., level 1 for nurses, level 2 for doctors, level 3 for specialists) with progressively increasing manipulation permissions. Each level can be independently configured for specific drugs and therapies, allowing flexible adaptation while maintaining safety through structured access control.
Solution Approach 2:
The system transitions from static hard-coded authorization to dynamic, configurable authorization levels that can be adjusted through authentication. The manipulation permissions are not fixed but can be dynamically assigned based on operator identity, drug type, and therapy requirements, enabling both safety and adaptability.
2Reliability
If authorization levels are hard-coded into the device software, then access control is simplified and reliable, but the system prevents adaptation and extension of manipulations for different operators and drugs
Solution Approach 1:
The patent changes the authorization parameters from fixed hard-coded values to variable, configurable parameters stored in databases. The system uses operator-specific parameters (identity, hierarchy level) combined with drug-specific parameters to dynamically determine manipulation permissions, allowing both reliable access control and easy adaptation to different scenarios.
Solution Approach 2:
The patent introduces an intermediary authorization management system that sits between the operator and the device functions. This intermediary layer uses authentication devices and database lookups to translate operator identities into appropriate manipulation permissions, decoupling the access control logic from the device software and enabling flexible configuration.
3Device complexity
If a single code is used for all critical manipulations, then the protection system is simple to implement, but it restricts or prevents adaptation to different operator needs and drug-specific requirements
Solution Approach 1:
The patent adds dimensional complexity to the authorization system by introducing multiple hierarchy levels and drug-specific dimensions. Instead of a single flat code structure, the system uses a multi-dimensional authorization matrix where permissions are defined across operator levels, drug types, and manipulation categories, enabling fine-grained control without overwhelming complexity.
Data Source
AI summary
A protection system of or for a medical device is configured to issue identity-specific, selectable authorization releases to operators for carrying out authorization-dependent manipulations on the medical device. The system includes a data memory containing data that identifies a number of authenticatable operators to whom individual authorization levels are assigned or can be assigned, and an authentication device for this purpose. The data memory also includes the identity of a current operator and a validation device configured to confirm the identity of the authenticated operator based on the data stored in the data memory. An authorization release selection device is configured to select and grant a predetermined authorization release in the event of successful authentication, depending on the authorization level of the authenticated operator. A method can be performed for issuing identity-specific authorization releases to operators for executing authorization-dependent manipulations on a medical device.