Identify the exact reference
Record commercial name, catalog number, UDI-DI or GTIN, lot fields, manufacturing site, and current IFU revision.
Ostomy · continence · wound and skin care evidence
Compare patient-contact materials, intended use, wear and handling conditions, lot identity, and destination-market documentation before a consumable enters a care pathway.
Selection framework
This is a method comparison, not a claim about every Coloplast reference. Confirm the actual device label, IFU, material specification, and market authorization.
| Review field | Single-use pathway | Reusable pathway |
|---|---|---|
| Clinical boundary | One patient and the labeled duration or procedure | Defined patient use plus validated reuse and cycle limit |
| Contamination control | Sterile or clean supply state, package integrity, and disposal route | Cleaning, inspection, disinfection or sterilization, drying, and storage |
| Traceability | Catalog reference, UDI-DI, lot, expiry, and receiving record | Device identity, use count, reprocessing batch, damage inspection, and release |
| Economic lens | Recurring supply, storage, waste, and stockout exposure | Acquisition, labor, utilities, validation, maintenance, and failure replacement |
| Decision limit | Convenience does not establish clinical fit or material compatibility | Lower waste per use depends on validated processing and actual cycle life |
Reference → condition → method → recordFour controls before adoption
Record commercial name, catalog number, UDI-DI or GTIN, lot fields, manufacturing site, and current IFU revision.
Map skin, mucosal, breached-surface, or urinary contact; duration and user population determine the biological-evaluation questions.
Evaluate adhesion, moisture, movement, wear time, storage, removal, disposal, and foreseeable handling rather than a bench result in isolation.
Keep protocol, sample identity, comparator, acceptance criteria, deviations, raw observations, and the approved market-specific conclusion together.
Care environments
Workflow, training, storage, privacy, and follow-up change with the setting even when the product family is unchanged.
Evidence principle — not a customer endorsement
“A material result is useful only when the specimen, conditioning, contact pathway, test method, acceptance criterion, and limitation travel with it.”
Coloplast portfolio review principle · verify against the selected reference and destination market

Move from brochure to bounded evidence
The review desk will route the request to product documentation, performance methods, or medical-information follow-up.
Build an Evidence Request