# Bitua > Bitua provides real-time traceability of clinical inventory for hospitals, clinics and medical-device suppliers in Latin America: RFID smart cabinets, IoT hardware and an AI-assisted platform that cut stockouts, losses and expired stock, with full control of every critical supply. Bitua is based in Santiago, Chile and operates across Latin America (Chile, Colombia, Costa Rica, Brazil and more). Products include RFID smart cabinets (Smart Cabinet, Smart Cabinet Flex, Smart Mini), consignment tracking (Smart Trace), instrument counting (Smart Count), textile/laundry tracking (Smart Laundry) and a real-time web platform. Contact: hola@bitua.io · +56 9 5738 3340 · https://app.bitua.io. The website is available in Spanish (default), English and Portuguese; markdown versions of every page are linked below. --- # Bitua · Real-time clinical inventory control > Real-time traceability of clinical inventory: fewer stockouts, fewer losses and control of every critical supply. RFID, IoT and AI for hospitals. Total control of clinical inventory, in real time. Real-time traceability that eliminates stockouts, cuts losses and controls every critical supply and medication. RFID, IoT and AI technology for hospitals and healthcare suppliers. [Contact](https://bitua.io/en/contacto.html) [See the platform](https://bitua.io/en/plataforma.html) +200 solutions installed +50 hospitals +10 countries bitua.io en vivo Healthcare leaders trust Bitua *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* ## Missing traceability doesn’t just cause losses. It creates clinical risk. Poorly managed clinical inventory costs time, capital and patient safety. 5 a 10% of consignment inventory expires unused 40% of operating time is lost to manual counts 15% monthly stockouts in critical supplies ## All built by Bitua: from device to cloud Hardware, firmware, software and artificial intelligence to solve healthcare’s critical problems. ### Hardware and devices UHF RFID electronics, IoT and clinical-grade sensors. ### Embedded firmware Embedded software that runs every device in real time. ### Cloud platform Scalable infrastructure with live data and multi-hospital operation. ### AI and data science Consumption and expiry prediction, plus operational analytics. ### Integrations HL7 · HIS · ERP · WMS, via an open API, connecting hospitals and suppliers. ### Security and compliance High standards of cybersecurity and data protection. ## Integrated technology solutions for every clinical need In-house hardware and software, connected to a single Bitua platform. Smart Cabinet **RFID cabinet** · Medical devices and implants Smart Cabinet Flex **Modular RFID cabinet** · High-volume supplies Smart Mini **Compact cabinet** · Controlled medications Smart Count **Handheld RFID reader** · Fast counts and inventories Smart Trace **Mobile app** · Supplier inventory Tracking Cabinet **Dispensing cabinet** · High-rotation supplies Smart Laundry **RFID cabinet** · Surgical textiles [See all solutions](https://bitua.io/en/productos.html) ## Bitua technology operating in hospitals and clinics *(image: Bitua en terreno)* ## Talk to a clinical inventory specialist Tell the Bitua team about your operation and get expert guidance. [hola@bitua.io](mailto:hola@bitua.io) [+56 9 5738 3340](tel:+56957383340) [/company/bitua](https://www.linkedin.com/company/bitua) --- # An operational-intelligence platform, end to end > Bitua.io turns every movement into visibility, prediction and action: stock, expirations, alerts and ERP/HIS integration in real time. Hardware, IoT, software and AI in a single platform: from supply intake to actionable data, in real time. bitua.io en vivo ## Supply control, from intake to audit ### Automatic identification Every supply is identified and logged automatically by RFID, code or biometrics as it enters or leaves. ### Full traceability Who, what, when and where: an end-to-end clinical history for every item. ### Consignments Track consignment stock by supplier and reconcile it automatically. ### Replenishment alerts Get notified when an item drops below its minimum, before a stockout occurs. ### Controlled access Authorized-user access with a record of every supply withdrawal. ### Compliance and standards GS1-accredited software, aligned with hospital control and audit processes. ## A robust, flexible integration engine HL7 and GS1 standards, native connectors to corporate ERP and an open REST API: every institution connects with what it already has, without rebuilding its architecture. ### Clinical standards HL7 messaging to exchange information with the hospital’s clinical systems. ### Corporate ERP Integration with SAP and Oracle for purchasing, costs and consignment reconciliation. ### Clinical HIS Connection with hospital information systems to work on the same records. ### Open API A REST API for custom integrations with any other system in the institution. - HL7 - GS1 - SAP - Oracle - Clinical HIS - ERP - WMS - REST API ## The intelligence layer that connects everything Every read becomes a decision, in real time and with AI prediction. AI consumption forecasting Expiry anticipation Deviation detection Operational analytics by location ## From captured data to the clinical decision The platform turns every movement into visibility, prediction and action, in real time. 01 ### Capture Bitua devices send every inventory movement to the platform, with no manual work. 02 ### Centralization All inventory across locations in a single panel: live stock, lot and expiry. 03 ### Intelligence AI projects consumption, anticipates expirations and flags deviations automatically. 04 ### Action Replenishment alerts, consignment reconciliation and ERP/HIS integration. ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Connected solutions on a single platform > Smart Cabinet, Flex, Mini, Count, Trace, Laundry and Tracking Cabinet: RFID cabinets, handheld reader and software, a solution for every area of the hospital. Scalable solutions for every clinical need. 01 *(image: Smart Cabinet)* ### Smart Cabinet A smart UHF RFID cabinet for critical, high-value clinical inventory. Every withdrawal, return and replenishment is logged in real time, with authorized per-user access. - **Type**: UHF RFID cabinet - **Traceability**: Item · lot · exp. - **Data**: Real time Benefits - Consignment controlled per supplier, billing-ready - No more manual counts: inventory updates itself - Expiry and replenishment alerts before the stockout Use cases - Cath lab - Orthopedics - Ophthalmology - Surgery [Contact](https://bitua.io/en/contacto.html) [Download brochure](https://bitua.io/assets/fichas/smart-cabinet.pdf) 02 *(image: Smart Cabinet Flex)* ### Smart Cabinet Flex A modular cabinet for the highest-volume areas: one or two bodies per central control tower, with a 10.1" touchscreen and an interior configurable with hospital-grade baskets and trays. - **Type**: Modular RFID cabinet - **Traceability**: Item · lot · exp. - **Data**: Real time Benefits - High supply volumes under a single control tower - Modular configuration: one or two bodies, expandable on site - Automatic RFID inventory when the door closes Use cases - Clinical supply - Operating room - Cath lab [Contact](https://bitua.io/en/contacto.html) [Download brochure](https://bitua.io/assets/fichas/smart-cabinet-flex.pdf) 03 *(image: Smart Mini)* ### Smart Mini Smart Cabinet technology in a compact format for controlled, oncology and anesthesia medications, with traceability by lot, serial and expiry. - **Type**: Compact cabinet - **Traceability**: Lot · serial · exp. - **Data**: Real time Benefits - High security: restricted access and every dose logged - Permanent audit trail by user, dose and patient - Full traceability by lot, serial and expiry Use cases - Controlled meds - Anesthesia - Small stores [Contact](https://bitua.io/en/contacto.html) [Download brochure](https://bitua.io/assets/fichas/smart-mini.pdf) 04 *(image: Smart Count)* ### Smart Count A handheld UHF RFID reader that turns the manual inventory process into an automatic read, syncing consumption, intake, batch and expiry in real time with the Bitua cloud. - **Type**: Handheld RFID reader - **Traceability**: Item · lot · exp. - **Data**: Real time Benefits - Turns hours of manual counting into minutes - Consumed vs. added live, with adjustable RFID power - AI expiry prediction Use cases - Inventories - Consignment - Trunk stock - Warehouses [Contact](https://bitua.io/en/contacto.html) [Download brochure](https://bitua.io/assets/fichas/smart-count.pdf) 05 *(image: Smart Trace)* ### Smart Trace Bitua’s platform to manage surgical kits and cases with full visibility: inventory, reservations and proof-backed deliveries, visible to the whole team. - **Type**: Software · mobile app - **Traceability**: Case · surgical kit - **Data**: Real time Benefits - Real-time kit and case inventory, from mobile - Photo-backed deliveries with proof of record - Coordinated reservations and auditable history Use cases - Surgical kits - Consignment - Distributors [Contact](https://bitua.io/en/contacto.html) [Download brochure](https://bitua.io/assets/fichas/smart-trace.pdf) 06 *(image: Tracking Cabinet)* ### Tracking Cabinet A controlled dispensing cabinet for high-rotation supplies and medications. It records who withdraws, when and for which clinical destination, with native HIS, ERP and Bitua platform integration. - **Type**: Dispensing cabinet - **Traceability**: User · shift - **Data**: Real time Benefits - Access by fingerprint, code, NFC or 2D scanner, with up to 10,000 fingerprints enrolled - Temperature/humidity logging with replenishment and expiry alerts - Consumption and turnover reports: thermal printer + web dashboard Use cases - Surgery - Inpatient wards - Emergency - Operating rooms [Contact](https://bitua.io/en/contacto.html) [Download brochure](https://bitua.io/assets/fichas/tracking-cabinet.pdf) 07 *(image: Smart Laundry)* ### Smart Laundry RFID traceability of hospital textiles and linens across their full wash-and-use cycle. - **Type**: Textile RFID cabinet - **Traceability**: Garment · wash cycle - **Data**: Real time Benefits - Per-garment tracking - Loss and shrinkage control - Auditable wash cycles Use cases - Surgical linens - Wash cycles - Linen room [Contact](https://bitua.io/en/contacto.html) [Download brochure](https://bitua.io/assets/fichas/smart-laundry.pdf) Every Bitua system integrates with your HIS, ERP and WMS through an open API. ## Everything converges on one platform Every cabinet, reader and app feeds Bitua.io: a single panel for stock, rotation, expirations and alerts, integrated with your ERP and HIS. Smart Cabinet Smart Cabinet Flex Smart Mini Smart Count Smart Trace Tracking Cabinet Smart Laundry ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Clinical inventory and traceability, explained > Guides on hospital RFID, medical device traceability, consignment, trunk stock, clinical dispensing and medication control. Technical guides for supply chain, pharmacy and operating room teams, and for medical device suppliers. ### Chile Technical Standard 247: what it requires The scope, the four obligations, the minimum data set, the list of implantable devices with mandatory records and who inspects compliance. 9 min read ### Medical device traceability regulation by country A comparison of traceability and UDI frameworks across eight jurisdictions, with calendars, databases and the difference between binding the manufacturer and binding the hospital. 10 min read ### RFID in hospitals: clinical traceability guide What RFID is, how it differs from barcodes, which frequency each clinical application uses and how a traceability project is structured. 8 min read ### Medical device traceability: UDI and GS1 How the UDI code is built, what GTIN and GS1 application identifiers are, how traceability differs from inventory and what regulation requires. 9 min read ### Consignment and trunk stock in medical devices Consignment, trunk stock and loaner sets explained: who owns what, where visibility is lost and how to recover it without slowing the OR. 9 min read ### Clinical dispensing: models and automated cabinets The four hospital dispensing models, what an automated cabinet solves, what each access method implies and how to choose by service. 8 min read ### Hospital medication control: a practical guide The four medication groups where risk concentrates, the specific problem of the crash cart, cold chain, expiry and what to record at every event. 8 min read ### Stockouts and expiry in clinical inventory How stockouts and expiry arise, why adjusting safety stock does not fix them, which metrics to track and which mechanisms cut both costs. 8 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- # The intelligent infrastructure for clinical inventory. > Bitua is a Chilean HealthTech designing and building end-to-end clinical traceability technology. Meet the team, the numbers and the partners. Bitua is a leading developer of innovative technology solutions for healthcare: hardware, software and AI that optimize clinical inventory, improve traceability and speed up logistics across hospitals, clinics and health institutions. [Contact](https://bitua.io/en/contacto.html) [See the platform](https://bitua.io/en/plataforma.html) R&D · Bitua +50 hospitals & clinics +10 countries +200 solutions installed 2021 founded in Santiago From spreadsheets and blind counts to every supply as real-time data. Fewer losses, zero stockouts and safer patient care. That’s the difference Bitua delivers. ## The people behind Bitua *(image: Daniel Ortúzar)* Daniel Ortúzar CEO *(image: Germán García Nieto)* Germán García Nieto CRO *(image: Francisco Irarrázaval)* Francisco Irarrázaval CFO *(image: Dennis Allende)* Dennis Allende R&D *(image: Agustín Bereciartúa)* Agustín Bereciartúa Tech Lead *(image: Natalia Florás)* Natalia Florás Customer Success Lead *(image: Tomás Venegas)* Tomás Venegas Supply Chain *(image: Javier Araneda)* Javier Araneda Producción *(image: Pamela Mancilla)* Pamela Mancilla Customer Success *(image: Ignacio Macfarlane)* Ignacio Macfarlane Customer Success *(image: Giorgio Caro)* Giorgio Caro Dev *(image: Tomás Molina)* Tomás Molina Soporte Hardware *(image: Marco Torres)* Marco Torres DevOps Leader *(image: Martín Serey)* Martín Serey Hardware Designer *(image: Lucas Pedrero)* Lucas Pedrero Full Stack *(image: Alejandro Crisóstomo)* Alejandro Crisóstomo Full Stack ## Partners taking Bitua solutions to the world A network of local allies supporting hospitals and suppliers with on-the-ground expertise, wherever they are. Farmapack MD LINK Vitalmex Manah Smart Solutions Promed Maxima Medical Axis Care Seminsa Medpro Denovo Solutions ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Healthcare leaders that trust Bitua > Brands, clinics and health institutions running on Bitua across Chile, Argentina, Brazil, Mexico, Costa Rica, Panama and more. Institutions, clinics and suppliers running on Bitua technology Brands & partners *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* Clinics, hospitals & institutions *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* ## Bitua technology operating in hospitals and clinics *(image: Bitua en terreno)* > We went from hours-long manual inventories to counting in minutes. RFID traceability gave us real control over consignments. Head of Procurement Private clinic · Santiago > Stockouts in the OR have practically disappeared. The clinical team trusts the supply will be there. Biomedical Engineering High-complexity hospital > Supplier reconciliation stopped being a monthly nightmare. Today it is automatic and auditable. Operations Management Regional health network Trusted by the clinical network across Chile · Argentina · Brazil · Mexico · Costa Rica · Panama · Ecuador · Dominican Rep. · Puerto Rico · Middle East +200 solutions installed +50 hospitals & clinics +10 countries +1M supplies traced ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Talk to a clinical inventory specialist > Talk to the Bitua team and see the solution working with your real clinical workflow. hola@bitua.io · +56 9 5738 3340 · Santiago, Chile. Tell the Bitua team about your operation and get expert guidance. [hola@bitua.io](mailto:hola@bitua.io) [+56 9 5738 3340](tel:+56957383340) [/company/bitua](https://www.linkedin.com/company/bitua) --- # Real-time control of clinical supplies > RFID cabinets that track supplies, implants and medications in real time, integrated with your ERP and HIS. Book a no-cost operational assessment. RFID cabinets that record every withdrawal of supplies, implants and medications without manual counts, and feed that usage straight into your ERP and HIS. Book an operational assessment No cost, no commitment. We reply within one business day. Healthcare leaders trust Bitua *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* ## What not seeing your inventory costs Four situations that recur in the OR, the pharmacy and the storeroom, and how automatic traceability resolves them. ### Stockouts mid-surgery The critical supply is not where it should be and the OR stops. The cabinet keeps verified stock and warns before it runs out. ### Losses to expiration High-value product expiring in the storeroom unnoticed. The platform prioritises usage by expiry date and alerts in advance. ### Counts that consume whole shifts Hours of clinical staff spent counting boxes. An RFID read completes the full inventory in minutes. ### Consignment without an audit trail Supplier replenishment and invoicing nobody can audit. Every movement is logged with user, date and time. ## The right equipment for each area From the OR to the pharmacy and the storeroom, on one platform. Smart Cabinet **RFID cabinet** · Medical devices and implants Smart Cabinet Flex **Modular RFID cabinet** · High-volume supplies Smart Mini **Compact cabinet** · Controlled medications Smart Count **Handheld RFID reader** · Fast counts and inventories +200 solutions installed +50 hospitals & clinics +10 countries +1M supplies traced ## Let us review your operation with data Tell us which area you want to control — OR, pharmacy or storeroom — and we will schedule a 30-minute session to review your current workflow and estimate the return. [hola@bitua.io](mailto:hola@bitua.io) [+56 9 5738 3340](tel:+56957383340) [/company/bitua](https://www.linkedin.com/company/bitua) --- # Your consigned inventory, visible in every hospital > See your consigned inventory in every hospital in real time, with usage confirmed by lot and serial. Book a Smart Trace demo. Traceability of implants, kits and surgical cases from mobile: what is in each account, what was used and what needs replenishing, with no spreadsheets and no blind visits. Book a demo 30 minutes, with your real operation on the table. Healthcare leaders trust Bitua *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* *(image: Abbott)* *(image: Medtronic)* *(image: Boston Scientific)* *(image: Zimmer Biomet)* *(image: Arthrex)* *(image: Terumo)* *(image: Solventum)* *(image: Johnson & Johnson)* *(image: Clínica Alemana)* *(image: Clínica Dávila)* *(image: Clínica Santa María)* *(image: Clínica Biobío)* *(image: Clínica Bíblica)* *(image: CCSS Costa Rica)* *(image: Fundación Santa Fe de Bogotá)* *(image: Hospital Sírio-Libanês)* ## What operating blind in the account costs Four situations familiar to any commercial team working with consigned inventory. ### Blind inventory at the hospital Not knowing what is left in each account forces overstocking. Smart Trace shows real stock per hospital, kept current. ### Usage invoiced late The implant was used, but the record arrives weeks later. Every use is confirmed at the moment, with lot and serial. ### Cases and kits out of circulation Instruments idle at a hospital that is not using them. Per-case traceability shows where each set is and since when. ### Counts that take a whole visit Reconciling a consignment with pen and paper consumes the rep's day. Smart Count reads the full cabinet in minutes. ## What distributors use Software to manage the account and hardware to verify it. Smart Trace **Mobile app** · Supplier inventory Smart Count **Handheld RFID reader** · Fast counts and inventories Smart Cabinet **RFID cabinet** · Medical devices and implants +200 solutions installed +50 hospitals & clinics +10 countries +1M supplies traced ## Let us look at your consignment operation Tell us how many hospitals hold your consigned inventory and we will show you what that operation looks like in Bitua. [hola@bitua.io](mailto:hola@bitua.io) [+56 9 5738 3340](tel:+56957383340) [/company/bitua](https://www.linkedin.com/company/bitua) --- # Chile Technical Standard 247: what it requires from institutional health providers > What Chile's Technical Standard 247 requires: traceability records from reception through use or implantation, minimum data set and who inspects. General Technical Standard No. 247 requires institutional health providers to record medical device traceability from the moment they receive a device until it is used or implanted in a patient. This guide summarises what it asks for, who it binds, which data must be recorded and who inspects compliance. Updated August 2026 · 9 min read ## What Technical Standard 247 is Its full name is General Technical Standard No. 247 on patient safety and quality of care regarding traceability of medical devices in institutional health providers. It was issued by the Patient Safety and Quality of Care Department of the Undersecretariat of Healthcare Networks at the Chilean Ministry of Health, and approved by Exempt Decree No. 33 of 2025. Its general objective is to implement a medical device traceability record system from reception through use or implantation in the patient, so as to reduce the risk of an adverse or sentinel event. That is where the meaningful difference lies. Technical Standard 226 already required traceability records for medical devices up to the moment of reception. Standard 247 takes that finish line and turns it into a starting line: it requires following the device inside the facility, whether stored, in use or implanted in a patient. Standard 247 does not replace 226, it complements it. The data required by 226 remains mandatory, and 247 adds the record inside the facility on top of it. ## Who it binds The scope is broad and does not distinguish by facility size or ownership. Institutional health providers and inpatient care facilities Outpatient care facilities Public and private sector alike Armed Forces and Public Order and Security institutions ## The four obligations The standard sets four concrete requirements for the institutional provider. Maintain a record system, manual or electronic, holding the minimum data set. It may be a centralised institutional application or be split across clinical services, provided the records can be linked and consulted in full Formally designate, through an institutional document issued by the Technical Directorate, a professional responsible for the implementation and a substitute, with protected hours for that function Record traceability from reception and entry of the device until it remains in the facility, whether stored, in use or implanted in a patient Run at least one traceability simulation per year on a randomly chosen device, reviewing processes, response times and implementation effectiveness, and producing a written report The annual simulation is the practical test of everything else. A record that exists but cannot reconstruct one unit's history within a reasonable time is exposed precisely there. ## The minimum data set On top of the data already required by Technical Standard 226, Standard 247 requires the following information about the device and the clinical area. Device status, for example in the warehouse, in use, implanted, quarantined, on loan, returned to the supplier, destroyed, withdrawn or explanted Health registration number, where applicable and required Method of acquisition, for example public tender, direct award, donation or CENABAST Date of conforming reception of the device Inventory number, where applicable Name of the clinical area or service that will use the device, and reception date in that area For implantable devices the record must extend to patient data from the clinical chart: national ID, implantation and explantation dates where applicable, the name of the professional performing the procedure and the name of the surgical service or procedure. For all other devices, reaching the location is enough. ## Which devices it covers In a first stage the standard applies to prioritised medical devices: the medical equipment covered by the technical standard on preventive maintenance of critical medical equipment, the devices considered in the Accreditation System for Institutional Health Providers, and the implantable devices listed in its annex. | Category | Implantable devices with mandatory records | | Orthopaedic | Hip implants, knee prostheses, upper and lower limb prostheses, orthopaedic rod implants, vertebral replacement and growth stimulator | | Cardiology | Implantable pacemaker and defibrillator, cardiac resynchronisers, vena cava filter, vascular prosthesis, coronary stent, mitral or tricuspid ring, mechanical valve, biological aortic or mitral valve and ventricular assist implant | | Reconstructive | Bladder support mesh and breast implants | | Ophthalmology | Intraocular lens, corneal implant and ophthalmic stent | | Dental | Dental implants | | Neurology | Hydrocephalus valve, neurostimulation systems for incontinence and for gait, vagus nerve stimulation, implantable pulse generator for analgesia and intracranial pressure measurement system | | Infusion | Implantable ports | | Gastric | Gastroesophageal prosthesis, intragastric balloon, gastroplasty band and gastric pacemaker | | Hearing | Cochlear implant | | Gynaecology | Implantable contraceptives, including intrauterine devices | ## What the record must look like, and who inspects it The standard allows paper, but attaches conditions that make it hard to sustain in practice. Information must be current, accessible and available for inspection by the competent authority. It cannot be altered with amendments or leave blank spaces between entries. And when a correction is needed, evidence of it must remain along with the signature of whoever authorised the change. That set of requirements describes a record with change history and an identified owner for every movement, which is exactly what an electronic system delivers by design and a notebook does not. Compliance is subject to inspection by the Providers Intendancy of the Superintendency of Health. ## How compliance works in practice The distance between complying and not complying rarely lies in the team's willingness. It lies in whether the record happens on its own or depends on someone writing it down afterwards. Identify by unit, with lot, serial and expiry, because without a unique identifier there is no way to reconstruct one item's history Capture the event at the point of use, so withdrawal and implantation are recorded without adding a task for the clinical team Link the record to the clinical chart, which is what the standard requires for implantables Keep a change history, with author and date on every correction Be able to answer the annual simulation in minutes, walking the full path of a randomly chosen unit [How radio frequency traceability works](https://bitua.io/en/resources/rfid-in-hospitals.html) ## Frequently asked questions ### Does Technical Standard 247 replace 226? No. It complements it. Standard 226 covers traceability up to the moment of reception by the institutional provider, and its data remains mandatory. Standard 247 adds the record inside the facility, from that reception through use or implantation in the patient. ### Is a paper record acceptable? The standard allows manual records, but requires no amendments and no blank spaces, that corrections leave evidence and the signature of whoever authorised them, and that the information stays accessible for inspection. Sustaining that on paper across a year and several services is possible but costly. ### Who inspects compliance? The Providers Intendancy of the Superintendency of Health. ### What is the annual traceability simulation? It is a mandatory exercise, at least once a year: the designated owner picks a device at random and reconstructs its full traceability, reviewing processes, response times and implementation effectiveness. The result is captured in a written report. ### Does it also apply to outpatient care? Yes. The scope covers inpatient and outpatient care facilities, in both the public and private sector, as well as Armed Forces and Public Order and Security institutions. ### What must be recorded for non implantable devices? The record must reach the device location, meaning warehouse, clinical area or unit. Patient data is only required for the implantable devices included in the standard. ## Keep reading ### Medical device traceability: UDI and GS1 How the UDI code is built, what GTIN and GS1 application identifiers are, how traceability differs from inventory and what regulation requires. 9 min read ### RFID in hospitals: clinical traceability guide What RFID is, how it differs from barcodes, which frequency each clinical application uses and how a traceability project is structured. 8 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Medical device traceability regulation, country by country > UDI and medical device traceability in the US, Europe, Brazil, Chile, Colombia, Argentina and Mexico: what each framework requires and who it binds. Medical device traceability frameworks converge on the same standard and differ on something decisive: who carries the obligation. This guide compares the United States, the European Union, Brazil, Chile, Colombia, Argentina, Mexico and Saudi Arabia. Updated August 2026 · 10 min read ## Why every framework looks alike Behind almost every regulation in force sits the same model: UDI, Unique Device Identification, the framework that standardises how a medical device is identified and which the international forum of medical device regulators promotes. The practical consequence is that the differences between countries are not about data format. A GTIN is a GTIN in Santiago, in São Paulo and in Riyadh. The differences sit in three places: which risk class comes first, on what date, and above all who is required to act. [How the UDI code is built and what GS1 contributes](https://bitua.io/en/resources/medical-device-traceability.html) ## Comparison by jurisdiction | Jurisdiction | Framework | What it requires | | United States | FDA UDI rule, GUDID database | Obliges whoever applies the label, generally the manufacturer, to assign the UDI and submit product information to the public database. The health facility is not required to record the UDI unless it acts as a labeler itself. | | European Union | Regulation 2017/745, Article 27, EUDAMED database | Obliges health institutions to record and store, preferably by electronic means, the UDI of the class III implantable devices they receive and supply. In force since 26 May 2021. | | Brazil | RDC 591/2021, amended by RDC 884/2024, SIUD database | Calendar by risk class: class IV from 10 July 2025, class III from 10 January 2026, class II from 10 January 2027 and class I from 10 January 2028. | | Chile | Technical Standards 226 and 247 | Standard 226 requires institutional providers to record traceability up to the moment of reception. Standard 247 extends that record inside the facility, through use or implantation in the patient, and is subject to inspection by the Superintendency of Health. | | Colombia | Resolution 1405 of 2022, Article 15 | Incorporation of the UDI-DI to secure commercialisation. For class IIa devices registered before February 2024, the deadline is 9 February 2026. | | Argentina | ANMAT Disposition 2303/2014 | Identification under the GS1 standard and chain wide traceability for a defined group of medical products, within the National Traceability System for Medical Products. | | Saudi Arabia | SFDA UDI requirements, Saudi-DI database | The manufacturer or authorised representative assigns the UDI through an accredited issuing agency, GS1, HIBCC or ICCBBA, and submits the UDI-DI before placing the device on the market. | | Mexico | NOM-137-SSA1-2025 | A labelling standard that admits QR codes, RFID and other electronic media to complement the information, without adopting the UDI framework. | Calendars are updated frequently and the governing reference is always each authority's official publication. ## The difference that matters most: who is required to act Read together, the frameworks split into two families, and that split explains why the same project moves fast in one country and stalls in another. In the first family the obligation begins and ends with industry. The United States and Saudi Arabia require the manufacturer to assign the identifier and submit the data to a public database. The hospital receives a well identified product, but no rule asks it to record anything. There, internal traceability is a management decision rather than a compliance one. In the second family the obligation reaches the facility. The European Union requires health institutions to keep the UDI of the class III implantables they receive and supply. Chile goes further and requires the record through use or implantation in the patient. There, internal traceability stops being optional. Obligation on the manufacturer: United States, Saudi Arabia, Brazil and Colombia at their current stage Obligation reaching the health facility: European Union and Chile Labelling framework without UDI adoption: Mexico Chain traceability over a contained group of products: Argentina ## United States and European Union: the two reference frameworks The UDI rule from the United States Food and Drug Administration was the first large scale implementation and set the vocabulary the rest later adopted. It binds whoever is responsible for the label, in most cases the manufacturer, though it can also be a repackager, a reprocessor or a convenience kit assembler. All that information is submitted to the public identifier database. The European Union Medical Device Regulation introduced the change that affects a hospital most. Its Article 27 requires health institutions to record and store, preferably by electronic means, the UDI of the class III implantable devices they receive and supply. It has applied since 26 May 2021 and relies on the European medical device database. That European clause is the direct precedent for what later appeared in Chile: the recognition that traceability breaks precisely where the distribution chain ends and the hospital begins. ## Latin America: four different speeds Brazil has the most defined calendar in the region. The resolution that established UDI was amended in 2024 to extend the deadlines, and the requirement now enters by risk class, from class IV down to class I, with the national identification database as the repository. Chile is the only country in the region that reached the point of use. Technical Standard 226 covered traceability up to reception and Technical Standard 247 extended it inside the facility, through use or implantation, with inspection by the Superintendency of Health. Colombia is advancing through the health registration route: incorporating the UDI-DI is a condition for maintaining commercialisation, with deadlines differentiated by risk class. Argentina solved it earlier than the rest, but with a different scope. Its national traceability system, built on the GS1 standard, covers a contained group of medical products across the chain. Mexico is the outlier. Its labelling standard expressly admits QR codes, RFID and other electronic media to complement package information, but does not adopt the UDI framework. [Technical Standard 247: the Chilean case in detail](https://bitua.io/en/resources/chile-technical-standard-247.html) ## What it means for anyone supplying several countries For a manufacturer or distributor with regional operations, following each calendar separately is the most expensive way to comply. The alternative is to treat the most demanding requirement as the internal standard and apply it everywhere. The cost of capturing the complete data set is practically the same as capturing quantity alone. Recording lot, serial and expiry from the source avoids redoing the process every time an authority moves a date or adds a risk class. Adopt an accredited issuing agency and use the same identifier across every market Tag at source, because tagging at destination multiplies the work by each country Capture lot, serial and expiry from the first movement, even where the local market does not yet require it Deliver traceability data on the shipping document, which is what several standards require providers to demand Prepare the hospital's internal traceability where regulation already reaches it, because that is the stage coming next across the region ## Frequently asked questions ### Which country demands the most on medical device traceability? It depends who you look at. For the manufacturer, the most demanding frameworks on data submission are those of the United States and the European Union. For the health facility, the most demanding is Chile, because Technical Standard 247 requires records through use or implantation in the patient. ### Is the UDI the same in every country? The structure is. The identifier is made of a fixed part identifying the model and a variable part with lot, serial and expiry, issued by an accredited agency such as GS1, HIBCC or ICCBBA. What changes is the database it is declared in and the enforcement calendar. ### Does Mexico require UDI? No. Its current labelling standard admits QR codes, RFID and other electronic media to complement package information, but does not incorporate the UDI framework. ### Is a hospital in the region required to record the UDI? Today it depends on the country. In the European Union yes, for class III implantables. In Chile the institutional provider must keep the record inside the facility. Across the rest of the region the obligation falls mainly on industry, and the hospital's internal record is a management decision. ### Is it worth waiting until local regulation requires it? Calendars tend to move forward rather than backward, and the pattern repeats: first the product must arrive identified, then the facility must record it, and finally that record must link to the patient. Capturing the complete data set from the start avoids redoing the process at every stage. ## Keep reading ### Chile Technical Standard 247: what it requires The scope, the four obligations, the minimum data set, the list of implantable devices with mandatory records and who inspects compliance. 9 min read ### Medical device traceability: UDI and GS1 How the UDI code is built, what GTIN and GS1 application identifiers are, how traceability differs from inventory and what regulation requires. 9 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- # RFID in hospitals: how clinical supply traceability works > A practical guide to hospital RFID: how it differs from barcodes, HF and UHF frequencies, where it applies in the OR and pharmacy, and how to implement it. Radio frequency identification makes it possible to know which supply entered the hospital, where it is and who used it, without scanning item by item. This guide explains how the technology works, where it applies inside a hospital and what an implementation requires. Updated August 2026 · 8 min read ## What RFID is and how it differs from a barcode An RFID tag is a label containing a chip and an antenna. When a reader emits a radio signal, the tag responds with a unique identifier. It needs no battery, no physical contact and no line of sight to the reader. The real difference from a barcode is not speed but the unit of information. A barcode identifies a product: it says the package is a stent of a given reference. An RFID tag identifies one specific unit: it says this is that stent, with that lot and that expiry date, distinct from the other twelve identical ones sitting in the same tray. Reading without line of sight, even with the box closed Hundreds of units read per second in a single pass A distinct identifier per unit, not per commercial reference Automatic record of entry, movement and consumption That distinction is what makes lot and expiry traceability possible. Without a unique identifier per unit there is no traceability, only counting. ## HF and UHF: which frequency each clinical application uses Two RFID families coexist in a hospital and each solves a different problem. HF, the 13.56 MHz band that NFC belongs to, works within a few centimetres. It is the technology behind access control, staff credentials and item by item identification in pharmacy, where bringing the package to the reader is a natural part of the process. UHF, the 860 to 960 MHz band, reaches several metres and reads many units at once. It is what sustains inventory: cabinets that know their own contents, portals that register what leaves the warehouse and handheld readers that cover an entire shelf in seconds. Metal and liquids degrade UHF reading. Supplies that arrive in metallised blisters or in solution require tags designed for that condition, and this is settled during testing, not during go live. ## Where it applies inside the hospital Radio frequency traceability pays off where three conditions meet: high value supplies, meaningful expiry dates and consumption that is hard to record at the moment it happens. Operating room and cath lab: stents, catheters, balloons, implants and anything opened mid procedure Orthopaedics and ophthalmology: broad families with many sizes and references per case Pharmacy and crash carts: unit level control of critical and high cost medication Central warehouse and service sub stores: reception, dispatch and replenishment Clinical textiles: surgical and inpatient linen, where loss is silent and sustained ## What an RFID implementation requires A traceability project has five components. When one fails, it is almost always because it was assumed to be already solved. Tagging: ideally at source, applied by the manufacturer or distributor. Where that does not exist, the hospital tags on reception, and that task needs an owner and allocated time Read points: cabinets at the point of use, portals at access points and handheld readers for counts and audits Software: the layer that turns raw reads into inventory, consumption, expiry and replenishment Integration: recorded consumption must reach the ERP, the clinical system and the patient record with no intermediate typing Data governance: who tags, who replenishes, who audits and how often ## What changes in the operation The first effect is that inventory stops being a monthly snapshot and becomes a permanent state. The question shifts from how much there was at closing to how much there is now and at which point of the hospital. The second is that consumption is recorded when and where it happens, linked to the procedure and the patient. That feeds billing, replenishment and regulatory traceability from a single event, instead of three manual records that later fail to reconcile. The third is expiry. A system that knows the lot and date of every unit can prioritise consumption of whatever expires soonest and warn in advance, not afterwards. ## Common mistakes in an RFID project Tagging the whole hospital from day one instead of starting with the supply family where lack of control costs most Failing to define who tags what arrives untagged, which leaves the inventory incomplete from birth Installing read points without integrating consumption into the clinical system, which forces the manual record to continue in parallel Measuring the project by tags read rather than by stockouts avoided, waste recovered and counting hours freed ## Frequently asked questions ### Does RFID replace barcodes? No. They coexist. Barcodes remain the reception and billing standard across much of the chain, and RFID is added where the unit must be identified and read without handling. A serious traceability system must operate with both. ### Can RFID be used with medication? Yes. Unit level control of critical, high cost and crash cart medication is one of the most direct applications, because it shows what was consumed, on which patient and what is close to expiring without opening the cart. ### Does it interfere with medical equipment? Commercial readers operate in industrial, scientific and medical bands regulated in each country, and at low power. In critical areas the installation is validated with the hospital clinical engineering team before go live. ### What happens with supplies that arrive untagged? They are tagged on reception. It is a contained task when limited to the families in scope, and it is the point where the supplier should be brought in so tagging migrates to source. ### How long does it take to implement traceability in one service? The timeline depends on scope and integration availability, not on hardware installation. A contained service, with defined families and clean master data, goes live far sooner than a project attempting to cover the entire hospital at once. ## Keep reading ### Medical device traceability: UDI and GS1 How the UDI code is built, what GTIN and GS1 application identifiers are, how traceability differs from inventory and what regulation requires. 9 min read ### Consignment and trunk stock in medical devices Consignment, trunk stock and loaner sets explained: who owns what, where visibility is lost and how to recover it without slowing the OR. 9 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Medical device traceability: UDI, GS1 and what regulation requires > What medical device traceability is, how the UDI code is built, what GS1 standards contribute and which data regulators require in each country. Tracing a medical device means being able to reconstruct its full path: who manufactured it, under which lot, whose hands it passed through, which patient received it and what happened next. This guide covers the standards that make it possible and the data that must be captured. Updated August 2026 · 9 min read ## What tracing a medical device actually means Tracing a device is not knowing how many units sit in the warehouse. It is being able to answer three questions about one specific unit: where it came from, where it has been and who it was used on. That capability becomes critical in the worst case. When a manufacturer recalls a lot, a hospital with traceability identifies within minutes which units of that lot remain in stock and which patients received the ones already implanted. A hospital without traceability goes through folders. Identification: every unit carries a code that sets it apart from the rest Path: every movement is recorded with date, place and owner Use: consumption is linked to the procedure and the patient Reconstruction: the history can be recovered later, not only viewed live ## UDI: how the identifier is built UDI, Unique Device Identification, is the international framework that standardises how a medical device is identified. A UDI code has two parts, and that split explains almost everything. The device identifier, DI, is the fixed part: it identifies the manufacturer and the model. It is the same across every unit of that reference. The production identifier, PI, is the variable part: lot, serial number, expiry date and manufacturing date, depending on the device type. It is what tells one unit from another. Without a PI there is no lot or expiry traceability. A system that reads only the DI knows which product it holds, not which unit. UDI is expressed in two simultaneous formats: one machine readable, the barcode or the RFID tag, and one human readable, printed on the package. Both must match. ## GS1 in practice: GTIN, application identifiers and DataMatrix GS1 is one of the accredited issuing agencies for UDI codes and the most widespread standard across the clinical supply chain. The GTIN is the number identifying the trade item and, in most cases, plays the DI role within the UDI. Application identifiers are the bracketed prefixes that structure the remaining data. They are the reason a reader can interpret a long string with no ambiguity. (01) GTIN: which product it is (17) expiry date (10) lot number (21) serial number On small devices the usual standard is GS1 DataMatrix, a two dimensional code that fits within a few millimetres. In UHF RFID, the SGTIN scheme encodes the GTIN together with the serial number inside the tag, so the unit is identified without reading the package. ## Traceability is not the same as inventory This confusion is the most frequent cause of projects that stall halfway. An inventory system answers how much there is. A traceability system answers which one it is and where it has been. The difference is granularity. Inventory works on references and quantities: twelve units of a given catheter. Traceability works on individual units: this unit, from this lot, expiring on this date, used in this procedure. A hospital ERP usually handles inventory well and is not designed for the unit. That is why traceability is implemented as a layer that captures the event at the point of use and then hands the ERP the consolidated consumption it expects to receive. ## What regulation requires The UDI framework has been adopted in stages across the main markets, on separate calendars and generally by device risk class. The pattern repeats across jurisdictions: first the product must arrive identified and documented, then the facility must keep a record of that data, and finally that record must be linkable to the patient. The distinction that matters most to a hospital is who carries the obligation. In most frameworks the requirement starts with the manufacturer and reaches the facility through the data it must receive and keep. The European Union and Chile go one step further and bind the provider directly. For an operation supplying more than one country, the practical conclusion is to capture the complete data set from the start. Recording lot and expiry costs the same as recording quantity alone, and it avoids redoing the process every time a local requirement changes. [Traceability regulation country by country, with deadlines and databases](https://bitua.io/en/resources/medical-device-traceability-by-country.html) ## How to implement it without slowing clinical work The friction point is always the same: recording competes with care. If tracing requires someone to type a lot number while the procedure moves on, the record is postponed and later completed from memory. That is why the design rule is that the event must capture itself, at the moment it happens. The cabinet that registers the withdrawal, the portal that registers the exit and the reader that registers the count all generate data without adding a task for the clinical team. Start with the families where lot and expiry carry real consequences: implants, high cost devices, consignment Require the supplier to deliver traceability data on the delivery note or invoice, not in a separate email Clean up master data before installing anything: one badly loaded reference carries the error through the entire history Define what happens when something arrives unidentified, because it will Integrate consumption into the clinical system and the ERP, so the record serves billing and replenishment, not only compliance ## Frequently asked questions ### What is the difference between UDI and GTIN? The GTIN identifies the trade item. The UDI identifies the unit and includes the GTIN as its fixed part, plus the production data that varies from one unit to another, such as lot, serial number and expiry. ### Is the barcode already printed on the package enough? It depends on what it holds. If the code carries only the GTIN, it identifies the product but not the unit. If it is a GS1 DataMatrix with lot, expiry and serial, it contains what is needed to trace. Many packages carry both, and that is the most common source of reception errors. ### Which data must be kept, and for how long? The common minimum is device identification, lot or serial, expiry, origin, reception date, location and use destination. The retention period is set by each local regulation and is usually longer for implantable devices. ### Is the supplier or the provider responsible? Both, over different stretches. The supplier is responsible for delivering the device identified and with documentation stating its traceability data. The provider is responsible for keeping the record inside the facility and for linking use to the patient. ### Can traceability be achieved without RFID? Yes. Traceability is a data requirement, not a technology requirement, and it can be met by scanning GS1 DataMatrix codes. The difference is effort: item by item scanning depends on someone doing it at every movement, while radio frequency reading captures the event with no intervention. ## Keep reading ### RFID in hospitals: clinical traceability guide What RFID is, how it differs from barcodes, which frequency each clinical application uses and how a traceability project is structured. 8 min read ### Consignment and trunk stock in medical devices Consignment, trunk stock and loaner sets explained: who owns what, where visibility is lost and how to recover it without slowing the OR. 9 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Consignment and trunk stock: controlling inventory you do not own > How consignment inventory works, what trunk stock is, why control breaks down and how to fix it without slowing the OR or overloading the supplier. In the operating room, much of the high value supply does not belong to the hospital until the moment it is used. That model solves the capital problem but shifts the control problem. This guide explains how it works, why control breaks down and what it takes to fix it. Updated August 2026 · 9 min read ## What consignment inventory is Under consignment, the supplier places stock physically inside the hospital but retains ownership. The hospital has not bought it: it has it available. The sale happens only at the moment the item is used on a patient, and the supplier invoices against that consumption. The model exists because operating room supplies are expensive, come in many variants and cannot be predicted precisely. An angioplasty may require any stent diameter and any length. Buying the full assortment in advance would tie up capital no hospital wants to tie up. The result is inventory that sits in the hospital, is used by the clinical team, is replenished by the supplier and appears in neither party's books with sufficient precision. ## Trunk stock and loaners: the other forms of inventory you do not own Trunk stock is the stock a supplier representative carries and brings to the procedure. The name comes from its usual location: the boot of the car. It is not in the warehouse, it is not in the system and it shows up in the OR on the day of surgery. A loaner is the instrument set delivered for one specific case and returned afterwards. It is common in orthopaedics, where a single surgery may require several trays of sizes that go back to the supplier almost complete. Consignment: supplier stock, stored in the hospital, permanently available Trunk stock: supplier stock, carried by the representative, present only during the case Loaner: instruments or sets delivered for one procedure and returned afterwards Direct purchase: hospital stock, bought in advance The first three share the same blind spot: the hospital uses a product that is not in its inventory, and the supplier cannot see what happens to a product that is still theirs. ## Why control breaks down The loss of control does not come from bad faith, it comes from the moment of recording. The item is opened in the middle of a procedure, when the team's priority is the patient. The record is made later, on paper, from memory or on a spreadsheet someone fills in at the end of the shift. From there, every party builds its own version of the truth. The hospital records what it believes it used. The representative counts what they find on their visit. The supplier system reflects what was invoiced. The three figures rarely match. Consumption is recorded late and incompletely Counting depends on the representative's visit, which happens every few weeks Nobody watches expiry dates, because the stock belongs to nobody until it is used Discrepancies surface at reconciliation, once they can no longer be reconstructed Replenishment is triggered by perception rather than by real consumption ## What it costs each party For the hospital, the cost is operational and clinical before it is financial. An item believed to be available and missing forces a change of technique or a cancellation. Consumption recorded badly is billed badly or not at all. And the space consignment stock occupies is operating room space. For the supplier, the cost is direct. Every consigned unit is capital immobilised where it cannot be seen. Every expired unit is a full loss, not a discount. And every hour a representative spends counting boxes is an hour not spent selling. ## How to bring it under control The principle is simple and hard to implement: consumption must be recorded at the point of use, at the moment of use, without adding a task for the clinical team. Once recording is automatic, everything else falls into place. Replenishment stops being estimated and starts being triggered by consumption. Reconciliation stops being archaeology and becomes a query. And expiry is anticipated, because the system knows which lot is there and when it lapses. Identify by unit, not by reference: lot, serial and expiry for every piece Capture the withdrawal at the point of use, with the cabinet or the reader, not with a form Give shared visibility: the supplier should see their own stock without having to come and count it Trigger replenishment from real consumption rather than from the visit schedule Close the loop with the ERP: the same event that depletes stock generates the billing evidence ## Metrics worth tracking A well run consignment programme is recognisable by a handful of numbers. If they are not being measured, control is most likely still declarative. Inventory accuracy: the gap between what the system says and what a count finds Days of consignment inventory by service and by supplier Expired units and their value, separated from damage write offs Time between consumption and invoicing Turnover by reference, to surface stock that is never used ## Frequently asked questions ### Who owns consignment inventory? The supplier, until the moment of consumption. The hospital holds and uses it, but ownership transfers only when the item is applied to a patient, which is also the moment the payment obligation arises. ### Who absorbs the loss when a product expires? In most contracts the supplier, because the product was still theirs. That makes expiry control a direct supplier interest and not only a hospital one, and it is the easiest argument for shared visibility. ### What is the difference between consignment and trunk stock? Location and permanence. Consignment is stored in the hospital on a stable basis. Trunk stock travels with the representative and is only present during the procedure, which makes it harder to record and easier to lose. ### How is consignment consumption invoiced? Against use. The supplier issues the invoice from the hospital consumption report, so the quality of that invoice depends entirely on the quality of the record. Badly captured consumption becomes a commercial dispute weeks later. ### Can it be controlled without the supplier entering the operating room? Yes, and that is precisely the goal. Once withdrawals are recorded automatically, the supplier reaches the state of their stock remotely and the visit is reserved for what genuinely needs presence, instead of being spent on counting. ## Keep reading ### Medical device traceability: UDI and GS1 How the UDI code is built, what GTIN and GS1 application identifiers are, how traceability differs from inventory and what regulation requires. 9 min read ### Stockouts and expiry in clinical inventory How stockouts and expiry arise, why adjusting safety stock does not fix them, which metrics to track and which mechanisms cut both costs. 8 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Clinical dispensing: models, automated cabinets and access control > Hospital dispensing models, what an automated cabinet does, how fingerprint, PIN and NFC access control work, and how to choose per clinical area. Dispensing is where inventory turns into care. It is also where recording errors, avoidable waits and much of the waste concentrate. This guide compares the available models and explains when automation pays off. Updated August 2026 · 8 min read ## What clinical dispensing is and why it becomes a bottleneck Dispensing means delivering the right supply or medication, to the right person, at the moment it is needed, leaving evidence that it happened. All four conditions matter equally, and the last one is the first to be sacrificed. The bottleneck appears because the first three conditions are urgent and the fourth does not look urgent. When the clinical team needs something, they find it, take it and move on. The record is left for later, and later is when nobody remembers the lot. Almost every clinical inventory problem blamed on the warehouse is in fact a dispensing problem. The warehouse knows what it shipped, not what was consumed. ## The four dispensing models No hospital runs a single model. The right question is not which one to adopt but which one belongs to each service. Ward stock: the unit keeps its own stock and serves itself freely. Fastest, and the one that leaves the least traceability Unit dose: pharmacy prepares medication per patient and per schedule. Safest, and the heaviest load on pharmacy Automated decentralised dispensing: a cabinet at the point of use controls access and records every withdrawal. Combines availability with recording On demand dispensing: the item is requested case by case. Most controlled, least suited to emergencies The usual combination is unit dose for inpatient wards, automated cabinets in the operating room, emergency and critical care units, and ward stock only for low value, high movement items. ## What an automated dispensing cabinet does An automated cabinet is not a cupboard with a lock. It is a control point that identifies who withdraws, identifies what is withdrawn and records the event without asking for anything in return. When the cabinet also identifies by unit, through RFID or by reading the package code, the record includes lot and expiry. That detail is what separates access control from a traceability system. Restricts access to authorised staff and by profile Records what was withdrawn, who withdrew it and when Links consumption to the patient or the procedure where the workflow allows it Depletes stock in real time and triggers replenishment from consumption Flags lots approaching expiry before they lapse ## Access control: fingerprint, PIN and NFC The access method defines who ends up on the record, and therefore defines the quality of all downstream traceability. A cabinet opened with a shared PIN records withdrawals with no owner. A fingerprint identifies the person and cannot be lent. An individual PIN works well where fingerprints are not viable, for instance with gloves or in areas where the reader gets contaminated. An NFC credential is the fastest and depends on nobody lending the card. In practice a combination works best: fingerprint or PIN as the primary method, with NFC as an alternative for workflows where seconds matter. Per person recording is what gives access control its value, because it shows who withdrew each unit. What is stored and for how long is set during initial configuration, following the facility's own policy. ## What to measure to know it is working Share of withdrawals with a patient or procedure attached Average time between withdrawal and its appearance in the clinical system Stockouts at the point of use, measured as failed withdrawals rather than warehouse shortages Units expiring inside the cabinet Gap between system stock and physical count ## How to choose the model per area The practical criterion crosses two variables: how much the item costs and how much the wait costs. Where the item is expensive and the wait is tolerable, control wins: on demand dispensing or unit dose. Where the item is expensive and the wait is not tolerable, as in the operating room or the cath lab, the automated cabinet is the only model that solves both. And where the item is cheap and high movement, strict control costs more than it saves. [See Bitua dispensing solutions](https://bitua.io/en/productos.html) ## Frequently asked questions ### Is automated dispensing only for medication? No. The same principle applies to clinical supplies, high cost devices and implants. In the operating room the most frequent use case is not pharmacological but device related, where value per unit and traceability requirements are higher. ### Is RFID required to automate dispensing? Not to control access, but yes to identify by unit without adding work. A cabinet can record a withdrawal through on screen selection, but that method depends on the person correctly declaring what they took. Automatic reading removes that dependency. ### What happens during an emergency? The system cannot be an obstacle. The correct design allows immediate withdrawal and completes the record afterwards, flagging the event for reconciliation. A cabinet that blocks access during an emergency stops being used within a week. ### Does automated dispensing replace pharmacy? No. It changes its role. Pharmacy stops spending hours preparing and shipping replenishments and moves to supervising consumption, validating prescriptions and handling the exceptions the system raises. ### How does it integrate with prescribing? Through an interface with the clinical system. When the prescription is available at the dispensing point, the cabinet can validate against it and link the withdrawal to the patient automatically, which is the scenario that prevents the most errors. ## Keep reading ### Hospital medication control: a practical guide The four medication groups where risk concentrates, the specific problem of the crash cart, cold chain, expiry and what to record at every event. 8 min read ### RFID in hospitals: clinical traceability guide What RFID is, how it differs from barcodes, which frequency each clinical application uses and how a traceability project is structured. 8 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Hospital medication control: from the sealed box to the traced unit > How to control controlled, high cost and high alert medication, what crash carts require, how to protect the cold chain and what to record at every event. Controlling medication is not counting boxes at month end. It is knowing, at any moment, which units exist, where they are, when they expire and who withdrew each one. This guide covers the groups where risk concentrates and what it takes to control them. Updated August 2026 · 8 min read ## What controlling a medication actually means Pharmaceutical control has three layers, and usually only the first gets implemented. The first is quantity: how many units there are. The second is identity: which units those are, with which lot and which expiry. The third is accountability: who withdrew each one and for which patient. An inventory that stops at the first layer allows replenishment but not investigation. When a discrepancy appears, there is no way to tell whether it was a recording error, waste, undocumented consumption or something more serious. Quantity: how much sits at each storage point Identity: which lot and which expiry each unit carries Accountability: who withdrew it, when and for which patient Condition: whether cold chain or storage stayed within range ## The four groups where risk concentrates Applying the same level of control to the whole formulary is expensive and unnecessary. The sensible practice is to segment. Controlled substances: narcotics and psychotropics, subject to named records and per shift counts under most regulations High cost: oncology, biologics and specialised therapies, where one lost unit equals weeks of consumption of another family High alert: medication whose administration error causes serious harm, such as anticoagulants, insulins, concentrated electrolytes and sedatives Emergency: the contents of the crash cart, where availability outweighs every other consideration All four groups require unit level control. The rest of the formulary can be managed by quantity with no meaningful loss of safety. ## The crash cart: where manual control fails most The crash cart holds a contradiction: it must always be complete and always available, and its verification is a manual task competing with patient care. The usual procedure is checking the cart per shift or when the seal is broken, against a list. It is slow, it gets postponed and it catches the missing item late. In a sealed cart, moreover, the only way to know whether a medication has expired is to open it. Radio frequency reading reverses the problem: it verifies the full contents without opening the cart, in seconds, and shows at once what is missing and what is about to expire. ## Cold chain and expiry A medication that went out of temperature range is no longer safe even with intact packaging and a valid expiry date. That is why condition control belongs to inventory control rather than being a separate matter. With expiry, the problem is rarely missing information: the date is printed on the package. The problem is that the date is not in the system, unit by unit, so nobody can prioritise consumption of the lot closest to lapsing. When the system knows the expiry of every unit, the consumption rule stops depending on the discipline of whoever opens the fridge. [How to measure and cut the cost of expiry and stockouts](https://bitua.io/en/resources/stockouts-and-expiry.html) ## What to record at every event A useful record is one that lets the history be reconstructed without interviewing anyone. That standard defines the minimum data set. Reception: product, lot, expiry, quantity, origin and owner Storage: exact location and, where applicable, temperature Withdrawal: who, when, which unit and for which patient or procedure Return: unit returned, condition and destination Write off: reason, unit, lot and owner, separating expiry from damage and from loss ## How to implement it The most common mistake is starting with the entire formulary. The route that works starts with one contained group, in one service, treating the clinical team's real workflow as a design constraint rather than something to correct later. The second mistake is leaving recording as an extra task. If control requires someone to write down something they did not write down before, the system coexists with a parallel spreadsheet from week one. Pick one group and one service, not the whole hospital Clean up master data before installing any equipment Capture the event at the point of use, with access identified per person Integrate with prescribing and with the ERP, so the record serves pharmacy, costing and the patient chart Measure the result in shortages avoided and units expired, not in events recorded ## Frequently asked questions ### What are high alert medications? Those whose administration error has a high probability of causing serious patient harm, even when used correctly under normal conditions. Lists vary by institution but usually include anticoagulants, insulins, concentrated electrolytes, opioids and sedatives. ### How are narcotics and psychotropics controlled? With named records, locked custody, per shift counts and documented reconciliation. The specific requirements are set by each country's regulation. A cabinet with per person identified access and automatic recording covers the requirement without depending on a manual logbook. ### Does RFID work on small medication packages? Yes, with the right tag. The real constraint is not size but content: liquids and metallised packaging degrade UHF reading, so tag validation is part of the project rather than an afterthought. ### How does this relate to medication reconciliation? Reconciliation compares what was prescribed with what was administered. A dispensing record per unit and per patient supplies half the data reconciliation needs, and supplies it as it happens instead of reconstructing it later. ### How do you avoid double recording with pharmacy? By integrating. If the dispensing system and the pharmacy system do not share the same event, someone will key it twice and the figures will diverge. Integration is not an optional improvement, it is the condition for the record to be single. ## Keep reading ### Clinical dispensing: models and automated cabinets The four hospital dispensing models, what an automated cabinet solves, what each access method implies and how to choose by service. 8 min read ### Stockouts and expiry in clinical inventory How stockouts and expiry arise, why adjusting safety stock does not fix them, which metrics to track and which mechanisms cut both costs. 8 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- # Stockouts and expiry: measuring and cutting the cost of clinical inventory > How to measure the real cost of stockouts and expiry in clinical inventory, why they happen and which mechanisms reduce both without raising stock levels. A hospital that buys too little runs out and cancels. One that buys too much accumulates expiry and throws money away. The usual answer is to look for a middle point, but no middle point exists when the real problem is lack of visibility. This guide explains how to measure both costs and how to reduce them at the same time. Updated August 2026 · 8 min read ## The two opposing costs of clinical inventory Stockouts and expiry look like opposite problems and are usually handled separately, by different teams with different budgets. In practice they share one cause: nobody knows precisely what exists, where it is and when it lapses. When information is missing, the operation protects itself with stock. That extra stock covers the stockout and produces the expiry. Adjusting inventory levels therefore moves the problem from one side to the other without solving it. Stockouts are paid in cancelled care, changes of technique and emergency purchases. Expiry is paid in discarded product. Both are the same information cost, expressed in two currencies. ## What a stockout really is A stockout is not a zero in the central warehouse. It is the item not being where it is needed, when it is needed. A hospital can hold sufficient stock and still run out, because it sits in another service, on an unrecorded cart or in a box nobody found. Measuring stockouts at warehouse level systematically understates the problem. The useful measurement happens at the point of use: how many times somebody looked for something and it was not available. True stockout: no stock anywhere in the hospital Location stockout: stock exists, but not at the point of use Information stockout: stock exists at the point of use, but the system said otherwise Expiry stockout: stock exists, but it is not usable ## Why expiry is not a purchasing problem The instinctive reaction to expiry is to review how much was bought. That is almost always the wrong question. A product expires because nobody consumed it before an identical one with a later date. That happens when the system does not distinguish lots: if inventory says twelve units without specifying which expires first, the person takes whichever is nearest to hand. Expiry is, at bottom, a problem of unit identity. It is solved by making each piece's date visible at the moment of withdrawal, not by buying less. ## What to measure and how to calculate it Without these numbers, any improvement is an impression. With them, the discussion stops being about perceptions and starts being about causes. Point of use stockout rate: failed withdrawals over attempted withdrawals, by service and by family Inventory accuracy: absolute gap between system and physical count, over the total counted Expired value: cost of units written off for expiry, separated from damage and loss Coverage: days of consumption the current stock covers, by reference rather than on average Turnover by reference: to identify stock that never moves and is the natural candidate to expire Inventory ageing: share of stock with fewer than ninety days to expiry Measure by family and by service, never on average. A healthy average hides one service in permanent stockout and another with frozen inventory. ## What reduces both costs at once The mechanisms that work share one trait: they increase the precision of the data instead of increasing stock. Identify by unit, with lot and expiry, so the system can prioritise what to consume first Record consumption at the point of use, so replenishment answers real consumption rather than an estimate Apply nearest expiry consumption, with the date visible at the moment of withdrawal Warn in advance about lots that will expire, with enough margin to redistribute or return Redistribute between services before buying, which requires seeing the whole hospital's stock rather than each store separately Replenish from consumption rather than from the calendar, which is the difference between covering demand and covering habit ## The mistake of optimising only one of the two A programme chasing only expiry ends up cutting stock until stockouts appear in the operating room, and that cost never shows up in the waste report. A programme chasing only stockouts ends up raising stock until expiry grows, and that cost surfaces months later, when nobody links it to the decision that caused it. The only way to improve both indicators together is to reduce uncertainty. That is where unit level traceability stops being a regulatory requirement and becomes a financial decision. [How radio frequency traceability works](https://bitua.io/en/resources/rfid-in-hospitals.html) ## Frequently asked questions ### What is an acceptable level of expiry? It depends on the family. For high turnover, low cost supplies a small percentage is tolerable. For high value devices, a single expired unit can exceed a full year of management savings. That is why the indicator must be measured in value and by family, not in units over the total. ### How do you calculate the cost of a stockout? By adding what was spent for not having it: emergency purchase at a premium, lost operating room time, rescheduling and, where applicable, switching to a more expensive alternative. It almost always exceeds the cost of the missing unit by a wide margin. ### Does lowering safety stock reduce expiry? It reduces expiry and raises stockouts in the same proportion, unless data precision improves in parallel. Safety stock is the compensation for not knowing, so it can only come down once more is known. ### FEFO or FIFO? FEFO, first expired first out. FIFO orders by entry date, which does not always match the expiry date, because a lot received later may expire sooner. Applying FEFO requires knowing the expiry of every unit at the point of withdrawal. ### How often should inventory be counted? The question changes when inventory is permanent. With automatic reading, counting stops being a periodic event and becomes continuous, and the formal inventory shrinks to a control check instead of being the year's only source of truth. ## Keep reading ### Consignment and trunk stock in medical devices Consignment, trunk stock and loaner sets explained: who owns what, where visibility is lost and how to recover it without slowing the OR. 9 min read ### Clinical dispensing: models and automated cabinets The four hospital dispensing models, what an automated cabinet solves, what each access method implies and how to choose by service. 8 min read ## Clinical inventory, under total control Talk to a Bitua specialist. --- Site: https://bitua.io (Spanish original: https://bitua.io/, Portuguese: https://bitua.io/pt/). Per-page markdown linked from https://bitua.io/llms.txt.