Result card

  • TEC7: What material investments are needed to use IVIG?
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What material investments are needed to use IVIG?

Authors: Jesús González-Enríquez, Nadine Berndt, Houria Mouas

Internal reviewers: Romana Tandara Haček, Mirjana Huic, Anna-Theresa Renner

Refer to domain search and domain methodology section.

The material investment needed for the use of IVIG is mainly {NZ Clinical Immunology Group, 2013; ACT Health, 2013; Octapharma 2007; Octapharma 2014; Baxter 2011}{ 32,33,34,35,36}:

- For the proper storage of IVIG products according to the product SPC (storage and handling part) which may require for some - including all IVIG supplied as liquids, refrigerated storage between 2°C and 8°C, whereas others, could be stored at room temperature. In some instance, when refrigeration is required, eg. in the case of the product is diluted, the preparation should be used as soon as practicable, in order to reduce microbiological hazard,but if storage is necessary, it should be stored at 2°C to 8°C for not more than eg. 24 hours(depends on stability studies).  Accredited blood refrigerators are needed and a close temperature monitoring shall be performed in order to guarantee a correct temperature range for this storage. IVIG that requires refrigeration and that are stored at a temperature below 2°C should not be used because of the likelihood of the product damage. Solutions must be kept away from freezing.

 - For the use of IVIG, an infusion pump (see TEC9) may be needed and standardized emergency equipment should be readily available during the infusion.

- For traceability of IVIG use: establishment and maintenance by the hospital or the institution of a system, ideally a computer program in order to ensure both patient and product traceability. The system shall allow linking each patient to the product received and vice versa.

- For potential (recurrence of) shortage of IVIG: discussion of a risk management plan to identify, characterize, prevent and minimize the risks of shortage. This plan may include, in some premises / hospitals back-up investments.

(Please also refer to TEC12, B0012).

González-Enríquez J et al. Result Card TEC7 In: González-Enríquez J et al. Description and technical characteristics of technology In: Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 2 December 2022]. Available from: