01
Infusion & syringe therapy
Compare CADD ambulatory protocols and Medfusion syringe accuracy bands against pharmacy drug-library governance and alarm fatigue limits.
Open product tabs →
RESPIRATORY · INFUSION · VASCULAR ACCESS
Engineered support for high-acuity airways and infusion lines.
Smiths Medical helps procurement, biomedical and clinical leads compare Portex airway, CADD and Medfusion infusion, Level 1 fluid warming and Jelco vascular access references against the current IFU, UDI and market status.
PROCUREMENT COMPARE
Two deployment models, one documentation standard.
Use this side-by-side view when value-analysis committees must separate ICU capital infusion platforms from high-volume vascular access and airway consumables.
| Decision field | ICU / OR life-support platform | Consumables & infection-control flow |
|---|---|---|
| Primary SKUs | CADD Solis ambulatory pumps, Medfusion 3500/4000 syringe pumps, Level 1 H-1200 fluid warmers, Portex tracheostomy systems | Jelco ProtectIV Plus catheters, ViaValve safety IV, CLEO 90 infusion sets, Thermovent T2 HME, Acapella therapy devices |
| Evidence pack | 510(k) substantial equivalence summary, IEC 60601 electrical safety / electromagnetic compatibility (EMC) file, cybersecurity SBOM notes, service MTTR and loaner policy | unique device identification (UDI) DI/PI, sterile barrier symbols, sterility assurance level (SAL) where labeled, biocompatibility testing contact class, lot/expiry receiving checklist |
| Integration | HL7 / EMR drug library update plan, pump drug-error-reduction software change control, FSE coverage map | GPO contract tier, par-level and CSSD reprocessing boundary, sharps and single-use labeling review |
| Buyer roles | ICU director, pharmacy informatics, biomedical engineering, value analysis | Materials management, infection prevention, nursing education, ASC purchasing |
| Typical cycle | 6–18 months capital evaluation with clinical trial and TCO model | Quarterly formulary refresh with reference-level substitution rules |
PRODUCT PATHWAYS
Start with the clinical workflow, not a catalog wall.
02
Airway & respiratory support
Route Portex tracheostomy, Acapella oscillatory PEP and Thermovent humidification references to the IFU revision used in your OR or ICU kit.
Check Spec Library →
03
Vascular access consumables
Confirm Jelco ProtectIV radiopaque markers, gauge, length and safety mechanism against nursing insertion policy before substitution.
COMPLIANCE DETAIL
Recognize the framework. Verify the device file.
These rows describe review categories used in Smiths Medical tenders. They are not blanket claims that every SKU shares the same pathway.
FDA
FDA 510(k) cleared pathways
Where applicable, capital and consumable devices ship with a clear 510(k) substantial equivalence predicate narrative. Do not describe 510(k) devices as “FDA approved.” Premarket approval (PMA) language is reserved for separately designated products.
MDR
CE marked under MDR 2017/745
European placements require the current EU MDR technical documentation set, UDI-DI and authorized representative details for the specific configuration.
QMS
ISO 13485:2016 quality system
Design history file (DHF), device master record (DMR) and CAPA records support hospital supplier qualification under quality system regulation (QSR) expectations. Request the certificate issue date and scope that match your audit checklist.
60601
IEC 60601 electrical safety
Powered infusion and fluid-warming platforms include electrical safety and EMC evidence packages for biomedical acceptance testing.
UDI
UDI / GUDID traceability
Device identifier and production identifiers support receiving, implant/consumable logging and field-action readiness across the installed base.
NEXT STEP
Ready to scope a demo or document pack?
Share the care setting, target SKUs and whether you need IFU revision, cybersecurity SBOM, drug-library migration notes or vascular-access formulary support.
- Reference + market + decision question in one request
- No patient-identifiable information in the form
- Clinical specialist or FSE routing based on your region