Globus Medical Clinical Applications

Compliance: IEC 60601-1 / 60601-1-2 EMC · FDA 510(k) clearances by K-number · ISO 13485:2016 · HIPAA / BAA pathways · UDI inventory controls.

Typical SKUs: multi-slice CT (64–320-row planning class), 1.5T / 3.0T MRI, DR rooms, ultrasound carts, fluoroscopy / C-arm.

Archive trade-off — Vendor-Neutral Archive (VNA) vs integrated PACS: VNA favors DICOMweb (WADO-RS / STOW-RS / QIDO-RS) portability and multi-vendor consolidation; integrated single-vendor PACS favors deeper worklist, hanging-protocol, and AI tooling with one support contract. Globus Medical modalities ship both VNA-ready export and legacy C-STORE failover—committees must pick the archive strategy before go-live.

Boundary: Enterprise routing and 24/7 FSE coverage assume contracted service tiers; outcomes depend on protocol governance and medical-physics review, not modality purchase alone.

Compliance: CMS Conditions for Coverage · OSHA · AAMI ST79 adjacent sterile workflows · IEC 60601 for powered imaging.

Typical SKUs: compact C-arm / fluoroscopy, cart ultrasound, digital radiography for pre/post imaging.

Trade-off — single-use drapes/covers vs reusable sterile packs: Single-use favors predictable sterility and faster turnover when SPD capacity is thin; reusables favor lower cost per case and less packaging waste when ISO 17664 / AAMI ST91-aligned validation and cycle limits are enforced. Imaging hardware choice does not settle that OR policy debate.

Boundary: Compact rooms may constrain detector travel, tube heat units, and cooling—confirm site drawings before quoting.

Compliance: DICOM Conformance Statements · ACR accreditation pathways · CTDIvol / DLP / SSDE dose dashboards · ALARA committee evidence.

Typical SKUs: multi-slice CT, 1.5T / 3.0T MRI, mammography (where cleared), ultrasound, DR.

Selection notes: Throughput RFPs should request hanging-protocol ownership, DMWL / MPPS validation scripts, and phantom constancy schedules—not brochure “speed” claims. Tesla class and CT detector-row class must match scheduled exam mix (neuro / MSK / body / trauma).

Boundary: ACR accreditation readiness depends on local physics staffing and protocol version control; Globus Medical supplies documentation packs, not accreditation itself.

Compliance: HIPAA · local radiation-safety rules · state registration where required.

Typical SKUs: musculoskeletal ultrasound (2–18 MHz broadband class), digital X-ray / portable DR, point-of-care ultrasound.

Trade-off: Cloud archive simplifies multi-site clinics with limited biomed staff; on-prem mini-PACS keeps PHI inside clinic firewalls but raises backup and patch burden. Specify HL7 FHIR Observation / ORU handoff expectations up front.

Boundary: Limited on-site FSE coverage may extend MTTR beyond Tier-1 hospital SLAs—state geography in the service quote.

Compliance: IRB-aware research imaging · IEC 62304 for research SaMD overlays · FDA Predetermined Change Control Plan discussions for ML reconstruction where applicable · ISO 14971 risk files.

Typical SKUs: research MRI/CT packages, advanced reconstruction workstations, Enhanced MR / Structured Report export, dual-archive research and clinical pathways.

Trade-off — robotic / advanced OR navigation imaging vs conventional fluoroscopy: Advanced suites may shorten selected reconstructions but raise capital, training, and room-time cost; conventional pathways remain appropriate when RCT-comparable outcomes and access economics do not justify the premium. Globus Medical documents both modality and interoperability options without claiming outcome superiority.

Boundary: Research sequences and investigational overlays may be market-restricted; confirm labeling and clinical vs research indications before pilot kickoff.

Compliance: HIPAA · facility transfer protocols · OSHA bloodborne where portable imaging crosses units.

Typical SKUs: portable ultrasound and DR for bedside triage before hospital transfer.

Selection notes: Prioritize battery runtime (documented minutes under load), rugged cart mass, simple DICOM send to receiving ED PACS, and UDI / asset tags for shared-fleet tracking.

Boundary: Portable imaging supports triage; it does not replace hospital-grade CT/MRI when protocol requires higher diagnostic confidence.