Cardiology
Catheter-lab workflow, sterile field, implant trace.
IND-B · requirements matrix
Boston Scientific Clinical Specialties & Device Requirements
A device category is a starting point; each care setting changes sterility, training, traceability, and service expectations.
Clinical routes
Map the use environment before comparing products
Oncology
Longitudinal care, compatibility, adverse-event routes.
Orthopedics
Procedure kits, reprocessing, implant records.
Neurology
Programming, follow-up, software configuration.
Critical Care
Alarm response, cleaning, uptime, handoff.
Anesthesia
Circuit workflow, disinfection, preventive checks.
Radiology
Imaging compatibility and data exchange.
Pathology & Lab
Sample trace, QC, contamination controls.
OB-GYN
Patient contact, cleaning, accessory control.
Pediatrics
Size ranges, labeling, caregiver instruction.
Ophthalmology
Precision setup, optical path, reprocessing.
Urology
Endoscopic handling, sterile barriers, turnover.
Selection trade-offs
Clinical requirements change the acceptable evidence
No route is universally preferable. Risk-benefit analysis depends on reprocessing validation, case volume, labor, waste targets, availability, patient-contact profile, and local policy.
| Decision | Route A | Route B | Verify before selection |
|---|---|---|---|
| Single-use vs reusable | A single-use device (SUD) may simplify turnover and isolate each case from reprocessing variability. | Reusable instruments may reduce unit waste and cost when validated cycles and staff capacity are stable. | IFU, ISO 17664 instructions, reprocessing validation, cycle limits, sterility assurance level (SAL) or disinfection claim, labor, waste, and recall trace. |
| Sterile vs non-sterile supply | Terminally sterile product requires package integrity and shelf-life control. | Non-sterile product transfers cleaning or sterilization responsibility to the facility. | Ethylene oxide sterilization or other method, ISO 11135 or applicable validation, residuals, load definition, receiving inspection, and storage. |
| Disposable dental item vs durable equipment | Consumables require lot control, compatibility, and replenishment planning. | Durable equipment adds installation, maintenance, calibration, and uptime exposure. | Unique device identification (UDI), material contact, electromagnetic compatibility (EMC) if applicable, training, spares, and service owner. |
| Standardized kit vs configurable set | Standard kits reduce picking steps and variation. | Configurable sets may reduce unused items but increase catalog and change-control complexity. | Procedure match, substitution rules, packaging validation, device master record (DMR), SKU governance, and value-analysis approval. |
Known boundaries
- A company-level certificate does not establish clearance or conformity for every SKU.
- SAL 10−6 is relevant to validated terminal sterilization claims; it does not replace aseptic handling after package opening.
- Reusable safety depends on device-specific cleaning, inspection, cycle limits, and facility execution.
- Dental equipment compatibility must be checked against the actual accessories, utilities, software, and local installation code.
Start with the specialty, workflow, and market
Then identify the exact product record and evidence set.
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