Leadership by experts of the Association for the Advancement of Medical Instrumentation (AAMI) Infusion Device Committee, and representations supported by the follow-on EMPIR project Metrology for drug delivery (18HLT08, MeDDII), led to state-of-the-art flow metrology being adopted in the widely-used AAMI TIR 101 standard, that the relevant IEC technical committee decided to use as the basis for flow metrology requirements in a planned revision of IEC 60601-2-24.
More details on the impact of our research on the upgrading of international standards are given in the official site of EURAMET in the following link:
For critical infusion applications to vulnerable patients, well-controlled medication care is needed. If infusion pumps deliver drugs inaccurately, this can have large adverse effects on the effective administration of the medication. During the first JRP, the necessary metrological infrastructure has been put into place.
The availability of intravenous (directly into a vein) administration devices that can guarantee accurate drug dosage is of paramount importance to fulfil this need. Therefore, all available knowledge on the actual infusion system used for patient care should be incorporated in relevant written standards on the calibration of infusion devices to ensure suitable calibrations are being performed by those relying on these standards.
With the inclusion of the latest know-how on low-flow calibration, manufacturers will be able to perform more reliable and accurate tests on their infusion devices. This will help in enhancing the dosing accuracy, especially for low flow rates; and, in turn, will increase the quality of the patient treatment.
The current standards lack relevant corrections required for low flow (< 2 ml/h) applications, as well as a rigorous uncertainty analysis. Based on the developed, validated and accredited calibration facilitates in the initial MeDD-project, a good methodology is now available for low flow rate calibrations.
Best metrology practices
The best metrology practices relating to calibration of infusion devices will be incorporated into standards ISO 7886-2 and IEC 60601-2-24. This will ensure proper low-flow rate calibrations for infusion devices.
The following will be suggested to be included or updated in the standards:
- Inclusion of an uncertainty calculation to approve or disapprove certain items with respect to certain thresholds, e.g. the maximum compliance for a syringe.
- Inclusion of the need to calibrate certain instruments in order to achieve traceability and a sufficiently low measurement uncertainty.
- An amendment of correction terms for low flow rate calibrations, for example buoyancy on the dispensing needle; and discussion on the relevance of all correction factors.
- Inclusion of how correction terms can be estimated, for example the evaporation rate.