Evidence map›Paper›PMID 42540737›Full record

ReviewMedical devices (Auckland, N.Z.)2026

Mechanical versus Electronic Infusion Systems in Subcutaneous Immunoglobulin Therapy: A Structured Literature Review of Infusion-Site Reactions and Device Performance.

Anna Majapuro-Hirvonen, Brent Rutland, Jasmin Bosshard

Abstract readReview
In one paragraph

Review in Medical devices (Auckland, N.Z.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Anna Majapuro-HirvonenGlobal Clinical and Medical Affairs, KORU Medical Systems, Mahwah, NJ, USA.ORCID 0009-0006-7226-4664
Brent RutlandGlobal Clinical and Medical Affairs, KORU Medical Systems, Mahwah, NJ, USA.ORCID 0009-0004-6965-2346
Jasmin BosshardGlobal Clinical and Medical Affairs, KORU Medical Systems, Mahwah, NJ, USA.ORCID 0009-0005-9942-8270

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Objective was to compare spring-driven mechanical and electronic infusion systems used for subcutaneous immunoglobulin (SCIg) therapy in patients with primary or secondary immunodeficiency (PID, SID) and chronic inflammatory demyelinating polyneuropathy (CIDP), with a focus on local infusion-site reactions and reliable dose delivery. Methods: A structured literature review was conducted (PubMed, Cochrane Library, Google Scholar; January 26, 2026). Eligible studies reported safety outcomes. As direct measures of dose delivery were not consistently reported, infusion system performance was evaluated using pharmacodynamic response, with immunoglobulin G (IgG) levels at the end of the study period considered an indicator of successful dose delivery. Data were extracted and descriptively aggregated across studies. Risk of bias was appraised using validated tools appropriate to study design. Results: Fourteen studies met the inclusion criteria (4 mechanical, 10 electronic). Mechanical infusion systems were associated with lower reported proportions of local infusion-site reactions, including swelling (23.1% vs 61.4%), redness (28.6% vs 44.0%), and soreness (22.9% vs 50.0%) compared with electronic infusion systems. Variability across studies was substantial, likely reflecting differences in patient populations, immunoglobulin formulations, infusion protocols, publication era, and outcome reporting methods. Across studies, both mechanical and electronic infusion systems achieved IgG levels consistent with therapeutic targets, supporting effective SCIg delivery. Conclusion: Mechanical infusion systems were associated with consistently lower reported rates of local infusion-site reactions compared with electronic infusion systems in this descriptive synthesis, while both system types effectively achieved IgG levels consistent with adequate dose delivery. Although variability across studies warrants cautious interpretation, the overall pattern suggests a favorable tolerability profile for mechanical systems. Device selection should remain individualized, and further comparative research is warranted.

Indexed as

drug delivery systemsinfusion pumpsinfusion site reactionmedical devicessubcutaneous immunoglobulin

Identifiers

PMID42540737
PMCPMC13426497

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.