OUTSOURCING STERILIZATION SERVICES: A SUCCESSFUL COLLABORATION BETWEEN TWO FRENCH PUBLIC HOSPITALS
European Statement
Production and Compounding
Author(s)
T. SANKAR, O. LASNE, E. REMY, G. BRETOT
CENTRE HOSPITALIER INTERCOMMUNAL ELBEUF-LOUVIERS-VAL DE REUIL, PHARMACIE – STERILIZATION, SAINT-AUBIN-LÈS-ELBEUF, FRANCE.
Why was it done?
Without outsourcing, HA’s sterilization department would have closed, jeopardizing surgical interventions and patient care. Therefore, the collaboration with HB was chosen as a cost-effective solution because private providers were expensive. The aim of the initiative was to guarantee continuous sterilization services, maintain patient safety, and ensure uninterrupted surgical activity despite the renovation.
What was done?
The sterilization department of Hospital A (HA) must make renovations to comply with standards. During six weeks of renovation work in 2024, a temporary outsourcing initiative was implemented to guarantee the continuity of surgical and care activities. During this time, the sterilization was subcontracted to Hospital B (HB), located 50 km away and operating with similar activity profile.
How was it done?
A formal agreement defined the activity volume, distribution of resources, responsibilities, and invoice procedures. Anticipated challenges included logistics, equipment shortages, management of urgent requests, and maintaining instrument-level traceability. These were addressed through regular communication with hospital management, technical services, and end-users. A site visit and staff meetings prepared the teams. IT department enabled secure remote access to maintain full traceability. In practice, washing in washer-disinfectors and preparation of surgical sets were performed at HA, followed by three daily shuttle transports to HB, where sterilization was carried out by three HA agents working on-site.
What has been achieved?
The initiative ensured:
• Complete maintenance of instrument traceability.
• Processing of 207,310 instruments, either individually or as part of surgical sets, over six weeks.
• An average turnaround time of 24 hours.
• No surgery cancellations, no instrument loss/breakage, and no major logistics incidents, only minor same-day delays of some surgeries.
• A total cost of €71,977 for transport and subcontracting
• High satisfaction: 17/18 service beneficiaries and 12/13 staff judged the experience positively.
What next?
This initiative demonstrates that inter-hospital cooperation, even across different hospital groups, is feasible and safe to manage temporary shutdowns. The initiative maintained high standards of quality while optimizing costs. Its success relied on strong preparation, effective communication, and staff commitment. This model can be transferred to other healthcare settings facing similar situations, offering a sustainable alternative to private outsourcing.
GREEN BREATH PROJECT: A COMPREHENSIVE APPROACH TO REDUCING THE ENVIRONMENTAL IMPACT OF INHALER USE IN SPAIN
European Statement
Clinical Pharmacy Services
Author(s)
Noe Garin Escriva, Borja Zarate Tamames, Unax Lertxundi Etxebarria, Jose Javier Martínez Simon, Rocio Tamayo Bermejo, Eguzkiñe Ibarra Garcia, Olaia Serna Romero, Anna Pelegri Pedret, Yolanda Torremorell Alos
Why was it done?
The GREEN BREATH Project aimed to reduce the environmental impact of inhaler use in Spain. It consisted of three components: (1) a sustainable inhaler prescription framework with a database on the environmental impact of inhalers, scenario projections to estimate benefits of alternative inhaler use and a decision-support algorithm for greener prescribing in Spain; (2) a nationwide patient education project across 40 hospitals focusing on proper inhaler disposal, assessing pharmacists interventions; and (3) a hospital pilot project for optimizing the disposal of used inhalers, reducing hydrofluorocarbon emissions.
What was done?
Inhalers contribute to global CO2 emissions, with over 15 million pMDIs used annually in Spain, generating 400,000 tonnes of CO2 equivalent. Prescription practices often ignore sustainability, and improper disposal exacerbates this problem. The project aimed to integrate environmental criteria into prescribing practices and raise awareness to improve disposal methods, without compromising patient care.
How was it done?
We contacted pharmaceutical companies to develop the carbon footprint database. The prescribing algorithm was designed by a multidisciplinary team. We used data from the Ministry of Health to calculate national projections. We also conducted a study across 40 hospitals focusing on asthma patients, using a questionnaire with a 3-month follow-up. Finally, we piloted an in-hospital inhaler waste management program in a single hospital.
What has been achieved?
The project demonstrated significant impact. We provided the first environmental database on inhalers in Spain. We estimate that shifting 10% of pMDI prescriptions could reduce CO2 emissions by 40,000 tonnes annually. Preliminary results show that over 50% of patients were unaware of inhaler disposal’s environmental impact, and that pharmacists interventions doubled proper inhaler waste disposal. Additionally, the hospital pilot project prevented up to 341 tonnes of CO2 emissions annually by optimizing inhaler waste management.
What next?
Educational resources have recently expanded to four languages used in Spain (Spanish, Catalan, Basque, Galician). We continue disseminating and collaborating with institutions to implement these and other activities. Additionally, sustainable prescribing should be integrated into electronic medical records to drive broader healthcare sustainability and reduce inhaler-related emissions. The project offers a replicable model for other healthcare systems.
IMPROVING INTRAVENOUS CHEMOTHERAPY ADMINISTRATION SAFETY VIA SMART INFUSION TECHNOLOGY: ONE-YEAR IMPLEMENTATION AT HYGEIA HOSPITAL
European Statement
Patient Safety and Quality Assurance
Author(s)
IOANNIDIS KONSTANTINOS
SCARLATINIS IOANNIS
KORRE OURANIA
BOTSIOU MARIA
NIKOLAOU KATERINA – ANGELIKI
Why was it done?
The integration of clinical pharmacists in oncology settings plays a critical role in ensuring the safe and effective administration of chemotherapeutic agents. At Hygeia Hospital, over the past five years, clinical pharmacists have identified and prevented 1,272 chemotherapy-related medication errors, corresponding to 2.4 errors per 100 chemotherapy days. Despite this substantial contribution, challenges persist in the administration process by nursing staff, particularly regarding infusion parameters. Common errors include incorrect infusion rates and the omission or improper use of required filters and light-sensitive infusion sets, and their prevention remains a persistent challenge.
What was done?
To mitigate these risks, Hygeia Hospital has implemented parameterized electronic infusion pumps as an additional safety mechanism.
How was it done?
These pumps are pre-programmed by clinical pharmacists with non-modifiable infusion time limits for each chemotherapeutic agent, preventing unauthorized alterations by nursing personnel. Furthermore, the pumps provide mandatory prompts regarding the use of filters or/and light sensitive infusion sets, as specified in the Summary of Product Characteristics (SPC) of each drug.
What has been achieved?
Since their introduction one year ago, these infusion pumps have facilitated the identification and correction of previously undetectable administration errors, with an observed rate of 0.15 errors per 100 chemotherapy days. The majority of these involved incorrect selection of infusion duration by nursing staff. These findings underscore the value of pump parameterization in uncovering latent errors and reinforcing adherence to safe administration practices.
What next?
Future steps include expanding the use of parametrized infusion pumps beyond oncology to other high-risk areas, such as intensive care units, where precise and safe administration is equally critical. By reducing reliance on manual intervention and standardizing administration protocols, this approach enhances the overall safety and efficacy of drug delivery across multiple clinical settings.
RATEC PLATFORM: A REGIONAL DIGITAL SYSTEM FOR THE REQUEST PURCHASE AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES AND AND IN VITRO DIAGNOSTICS
European Statement
Introductory Statements and Governance
Author(s)
E. Santarossa, F.F. Faccioli, L. Dal Cin, M.C. Libralato, M. Saia, A. Cavazzana
Governo Clinico, Azienda Zero, Padova, Italy
elisabetta.santarossa@gmail.com
Why was it done?
In Italy, regions frequently fail to comply with the spending cap for medical devices (MDs) and in vitro diagnostics (IVDs). Guided by the principles of Regulation (EU) 2021/2282, the RATEC platform employs HTA to facilitate timely access to innovation, promote efficient resource allocation through uniform HTA criteria, and foster collaboration among healthcare organizations (HCOs) to avoid duplicative assessments.
What was done?
The RATEC platform digitizes the regional process for the request and health technology assessment (HTA) of new MDs and IVDs. It was developed within the framework of the NET 2018-12368077 ministerial program, funded by the Ministry of Health and the Veneto Region.
How was it done?
The process starts with the healthcare professional completing a specific form (Non-Urgent MDs/IVDs, Urgent MDs/IVDs, Biomedical Equipment,). After validation by the head of the department, the request is evaluated by the Multidisciplinary Hospital Unit for MDs/IVDs assessment (called UVA-DM). RATEC provides to UVA-DM an HTA methodology with a clearly defined PICO (Population, Intervention, Comparator, Outcome) and includes a Multi-Criteria Decision Analysis (MCDA). The model graphically displays the evaluation outcome (Y: Value, X: Risk) and suggests a decision orientation: innovative technologies for central reporting, technologies to be approved or technologies to be rejected. Technologies defined as innovative are forwarded to the central phase for HTA reports, which will be available to all regional HCOs.
What has been achieved?
By October 2025, 1054 MDs/IVDs purchase requests had been submitted to RATEC, with 695 evaluated by UVA-DM and 13 reaching the central phase for the HTA report. The approved requests are estimated to have an economic impact of € 4,181,740, excluding biomedical equipment. From 2025 onwards, all regional public HCOs must use RATEC for evaluation of MDs/IVDs.
What next?
The RATEC platform is not only a tool for regional governance but a scalable digital infrastructure that fosters transparency, equity, and value-based decision-making in healthcare. Its continuous enhancement aims to expand the model beyond regional borders, positioning RATEC as a best practice for integrating HTA into procurement processes and ensuring rapid, sustainable access to innovation.
IMPROVING INTRAVENOUS CHEMOTHERAPY ADMINISTRATION SAFETY VIA SMART INFUSION TECHNOLOGY: ONE-YEAR IMPLEMENTATION AT HYGEIA HOSPITAL
European Statement
Patient Safety and Quality Assurance
Author(s)
IOANNIDIS KONSTANTINOS
SCARLATINIS IOANNIS
KORRE OURANIA
BOTSIOU MARIA
NIKOLAOU KATERINA-ANGELIKI
Why was it done?
The integration of clinical pharmacists in oncology settings plays a critical role in ensuring the safe and effective administration of chemotherapeutic agents. At Hygeia Hospital, over the past five years, clinical pharmacists have identified and prevented 1,272 chemotherapy-related medication errors, corresponding to 2.4 errors per 100 chemotherapy days. Despite this substantial contribution, challenges persist in the administration process by nursing staff, particularly regarding infusion parameters. Common errors include incorrect infusion rates and the omission or improper use of required filters and light-sensitive infusion sets, and their prevention remains a persistent challenge.
What was done?
To mitigate these risks, Hygeia Hospital has implemented parameterized electronic infusion pumps as an additional safety mechanism.
How was it done?
These pumps are pre-programmed by clinical pharmacists with non-modifiable infusion time limits for each chemotherapeutic agent, preventing unauthorized alterations by nursing personnel. Furthermore, the pumps provide mandatory prompts regarding the use of filters or/and light sensitive infusion sets, as specified in the Summary of Product Characteristics (SPC) of each drug.
What has been achieved?
Since their introduction one year ago, these infusion pumps have facilitated the identification and correction of previously undetectable administration errors, with an observed rate of 0.15 errors per 100 chemotherapy days. The majority of these involved incorrect selection of infusion duration by nursing staff. These findings underscore the value of pump parameterization in uncovering latent errors and reinforcing adherence to safe administration practices.
What next?
Future steps include expanding the use of parametrized infusion pumps beyond oncology to other high-risk areas, such as intensive care units, where precise and safe administration is equally critical. By reducing reliance on manual intervention and standardizing administration protocols, this approach enhances the overall safety and efficacy of drug delivery across multiple clinical settings.
MANAGEMENT AND TRACEABILITY OF IMPLANTABLE MEDICAL DEVICES: THE BREAST IMPLANT CONSIGNMENT STOCK
European Statement
Selection, Procurement and Distribution
Author(s)
M Rivano, N Tatti, V Mureddu, G Bertolino, M Atzeni, R Deidda, A Cadeddu
Why was it done?
Breast implants are invasive medical devices classified as Class III — the highest risk category. The European Medical Device Regulation (EU MDR 2017/745), fully applicable since 26 May 2021, requires implantable devices to be tracked using a Unique Device Identification (UDI) code, serial number, batch number, and expiration date.
In addition, a National Breast Implant Registry was established in Italy in 2023 (DM 207/2022), which must be completed after each implantation. The Registry’s objectives are to ensure clinical follow-up for individuals who have undergone implantation, enabled timely patient traceability when needed, and support epidemiological surveillance. This initiative aimed to ensure compliance with both European and national requirements while improving device availability and minimizing waste.
What was done?
The hospital pharmacy implemented a new management system for breast implants used in plastic surgery, based on a consignment stock model and computerized traceability of each device.
How was it done?
To comply with regulatory requirements and optimize surgeons’ workflow, the hospital pharmacy in collaboration with plastic surgery department, set up a consignment stock for breast implants. Devices are recorded upon arrival at the pharmacy and stored within the surgical department. A predefined selection of implants of various sizes is made available in the operating room, allowing surgeons to choose the most suitable option for each procedure.
After implantation, the surgeon completes the implant form and registers the device in the National Registry, while the pharmacy issues the corresponding billing order.
What has been achieved?
The consignment stock ensures the availability of different sizes according to patient needs and provides cost savings, as devices are billed only after implantation, thereby reducing product expiry.
Computerized registration guarantees accurate tracking of serial numbers and UDIs in compliance with MDR regulations and the National Breast Implant Registry.
In 2024, a total of 106 breast implants were made and registered, with a stock expiry rate of 0%. Currently, 47 devices, including sizers and implants, are available in the consignment stock.
What next?
This management model has already been extended to other class III devices, such as aortic endoprostheses used in vascular surgery, and is increasingly being applied in interventional cardiology. Future implementation is planned for cochlear implants and pacemakers.
UDI-BASED END-TO-END TRACEABILITY: A SMART APPROACH TO MEDICAL DEVICE MANAGEMENT
European Statement
Patient Safety and Quality Assurance
Author(s)
Andrea Piovanelli, Ivan Schimmenti, Enrico Almici, Paola Crosasso, Fabio Genestrone, Elena Toniato
Why was it done?
Medical devices’ traceability is a critical issue in hospital settings due to the high cost of devices and the need to associate item-patient-procedure. Standardized identification systems become fundamental to manage clinical risk, while addressing inefficiencies in inventory management, and minimizing waste from poorly monitored expiration dates. RFID-based solutions have been tested to implement identification and traceability with the promise of automating procedures and facilitating personnel activities, nonetheless their complexity and cost have limited their adoption so far. EU Regulation 2017/745 (MDR) introduced the requirement of native UDI (Unique Device Identifier) codes present on each medical device. As such, it is now possible to implement simple and cost-effective solutions for identification and traceability that do not require specific hardware or tedious relabeling procedures compared to RFID, and exploit 2D data carriers natively present on MDs.
What was done?
To implement a digital, end-to-end traceability system for medical devices using native UDI (Unique Device Identifier) codes, in compliance with EU Regulation 2017/745 (MDR). The objective is to improve patient safety, optimize inventory management, reduce operational costs, and ensure regulatory compliance without the need for relabelling and dedicated personnel.
How was it done?
The proposed solution leverages optical identification technologies and hands-free systems to automate device tracking from hospital entry to patient association. Smart cabinets manage inventory and access control, while smart baskets automatically link devices to patients. An AI-powered platform analyses data across all phases to support stock optimization, automatic reordering, structured reporting, and performance evaluation.
What has been achieved?
The system enables real-time inventory visibility, eliminates manual errors, improves device utilization. Avoiding costly, time-consuming and risky relabeling of MDs with RFID tags lowers implementation costs, minimizing environmental impact. Clinically, it enhances patient safety enabling rapid response to recalls and adverse events. Operationally, it streamlines logistics, reduces staff workload, and improves planning through AI-driven insights.
What next?
The adoption of an end-to-end UDI-based traceability system represents a significant advancement in medical device management. It delivers tangible benefits in terms of economic efficiency, clinical safety, organizational performance, and environmental sustainability. This innovative approach aligns with the digital transformation of healthcare and offers a scalable model for hospitals seeking to modernize their logistics and compliance processes
OPTIMIZING STERILE AND IMPLANTABLE MEDICAL DEVICE CIRCUITS: CONTRIBUTION OF THE INTERDIAG DMS® TOOL
European Statement
Patient Safety and Quality Assurance
Author(s)
Khalil MEDDINE, Yasmine EL YOUSSOUFI, Madiha ALAMI CHENTOUFI, Houda ATTJIOUI, Driss TANANI, Abdelhafid BENOMAR
Why was it done?
To identify performance gaps and critical points within the sterile and implantable medical device circuits, with the aim of guiding targeted improvements and ensuring safer, more reliable management of these devices.
What was done?
A multidisciplinary self-assessment of the sterile and implantable medical device circuits was carried out using the Interdiag DMS® evaluation tool.
How was it done?
The evaluation was conducted using the Interdiag Excel file, which includes dedicated modules for sterile and implantable medical devices. The analysis focused on the tool’s implementation, the objectives of the self-assessment, the resulting action plans, and feedback obtained throughout the process.
What has been achieved?
The assessment highlighted strong performance in information systems and traceability for implantable devices, but weaknesses were identified in their documentation management. For sterile medical devices, major deficiencies were observed in quality management, transport, and return/disposal processes (10–20% compliance), while pharmacy premises and demand management showed moderate performance (50–60% compliance). These findings allowed for the implementation of targeted corrective actions.
What next?
The findings will guide ongoing targeted improvements, enhance coordination among healthcare stakeholders, and foster a sustainable culture of quality and safety in medical device circuits.
TRACE AROUND THE BLOCK! VALIDATION OF AUTOMATED INTEGRATION OF IMPLANTABLE MEDICAL DEVICE TRACEABILITY DATA INTO AN ELECTRONIC PATIENT RECORD
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
L. Scherer(1), L. Lassara(1), A. Choquer(1), D. Delaitre(2), E. Maguer(2), L. Papin(3), O. Chauvel(1), G. Nicolaos(1), C. Dupont(1)
(1) Hospital Pharmacy, Hôpital Fondation A. de Rothschild, Paris, France
(2) Information Systems and Medical Technologies Department, Hôpital Fondation A. de Rothschild, Paris, France
(3) Operative unit, Hôpital Fondation A. de Rothschild, Paris, France
leontine-scherer@hotmail.fr
Why was it done?
French regulations require traceability of Implantable Medical Devices (IMDs) to be recorded on discharge documents and in the Electronic Patient Record (EPR). An audit carried out in 2023 showed that only 69.5% of patients’ EPRs mentioned the type of IMD used. We aimed to validate the data transfer automation from the Pharmaceutical Management Software (PMS) to the EPR via an interface.
What was done?
We developed an HL7 interface between our PMS and our EPR. It automatically uploads to the EPR, a file specifying the traceability data of IMDs entered in the PMS.
How was it done?
A “single day” audit was carried out by a single observer on three independent days (August and September 2024). Surgical program data were extracted via the medical management software (Web100T®, Dedalus): name, administrative file number (AFN), date and type of surgery, surgical specialty. Traceability data provided by the pharmacy were extracted from the PMS (PHARMA®, Computer Engineering): name, AFN, number of IMDs tracked. The presence of a traceability document in the EPR (DxCare®, Dedalus) was objectivized and the traceability delay was collected.
What has been achieved?
Over this period, 259 patients underwent surgery: (ophthalmology (74.5%, n=193), otolaryngology (9.3%, n=24), neurosurgery (9.3%, n=24), neuroradiology (5.4%, n=14), cardiology (1.5%, n=4)). At least one IMD was traced for 56.4% (n=146) of patients, with an average of 1.2±0.6 implants per patient ([1;5]; median=1). In all, traceability was achieved in the PMS for 146 patients (170 implants traced), including 139 patients within 48 hours after implantation (95.2% of patients, 150 implants). For these 146 patients, a traceability document was found in the EPR in 99.3% of cases (n=145). It was associated with the correct AFN for 143 patients. The presence of several traceability documents (2) was found for 2 patients, indicating that traceability had been carried out on 2 occasions (dispensing on different departments: common supply and specialized depot).
What next?
Opening up the interface between the PMS and the EPR automated the traceability data transfer (99.3%). The result is a complete EPR with exhaustive health traceability. These results encourage us to implement the final stage in the data transfer automation between the EPR and the shared digital medical record.
DESIGNING A 360° IMMERSIVE VIRTUAL REALITY TOOL FOR TRAINING IN INFUSION SET-UP
Pdf
European Statement
Education and Research
Author(s)
V. LE BIGOT, A. BROS, F. NATIVEL, T. ADNET, D. CABELGUENNE, F. LINDENBERG, S. GENAY, P. BESNIER, S. RODIER
Why was it done?
Creation of a training tool for infusion set-ups in a digital 360° virtual reality, utilizing a fun format based on learning from errors. It is specifically designed for novice professionals, with a focus on pharmaceuticals teams.
What was done?
Errors in infusion set-ups are common and can have serious consequences on patient care. Adhering to best practices in infusion is essential to mitigate these risks. Therefore, comprehensive training for both healthcare staff on proper techniques and procedures, is crucial to ensure safe and effective infusion management. Choosing a digital navigating environment allows a remote or a mobile use and enhances interactivity between the trainer and learners when used for in-person training.
How was it done?
A multicenter working-group of 9 pharmacists with expertise in infusion and healthcare simulation was formed, divided into three subgroups: two for content creation and one for reviewing. Firstly, the priority issues were selected, drawn on the guidelines issued by learned societies. An illustrated presentation of the most frequently encountered infusion errors was developed using an online Learning Management System platform, integrating the teaching content into a 360° virtual reality environment.
What has been achieved?
A virtual patient pathway was designed in 3 different environments: an operating room, a post-operative recovery room and a ward. Within the virtual spheres, 12 “points of interest” (POIs) were defined as a clickable elements, focusing on predefined key themes. Each POI was illustrated with photos or videos and included errors that required learners to answer up to three multiple choice questions (MCQs). In total, there were 25 MCQs. Additionally, each POI featured an explanatory debriefing slide that was presented afterwards.
What next?
This training tool will be tested under real-life conditions at a national pharmacy congress. It will be approved by a panel of experts/learned societies, then evaluated by trainers/learners, so that it can find its place in the training programs of all healthcare professionals involved with infusion set-up.