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2SPD-042 Medical device’s active vigilance of the pharmacist in the digitalisation of intraocular lenses logistic path
  1. M Elena1,
  2. R Dutto1,
  3. M Mondini1,
  4. M Viglione1,
  5. M Cavallo1,
  6. E Bastonero1,
  7. C Fruttero2
  1. 1Hospital Pharmacy, Ao Santa Croce E Carle, Cuneo, Italy
  2. 2Director of Hospital Pharmacy, Ao Santa Croce E Carle, Cuneo, Italy


Background and importance Intraocular lenses (IOLs) are prosthetic medical devices (PMDs) used for the treatment of cataracts. The pharmacist is often the professional person able to guarantee the success of the PMD management path during all phases: acquisition, stock management and correct use. Active vigilance of the PMDs, digitalisation and collaboration with the different professionals (ophthalmologist, operating room nurse, administrative assistant) can improve the logistic path.

Aim and objectives The purpose of the project conducted by the pharmacist was to improve the digitalisation of the path for PMDs to increase traceability and safety through active medical device vigilance.

Material and methods Since the second half of 2019, evaluation of the efficiency of the PMD supply chain has been underway. Management has been entrusted to pharmacy, which deals with their coding and uploading to the management programme using barcodes with storage of serial numbers (SNs) and expiration dates. This new PMD management downloads to patients and to user cost centres the specification of the IOLs (dioptre and SN) with a concomitant computerised reorder to restore the deposit account (DA). If it is necessary to return the IOL to the company for any reason, it must be downloaded from the warehouse, passing through the pharmacy.

Results In 2019, 3094 IOLs of 18 different models were implanted. In 95% of patients (2918 implants), we used only two models. Between October and November 2019, 98.5% of the IOLs in the hospital on the DA were encoded and uploaded to the management programme (eight models with 332 different codes). This allowed an acceleration of DA recovery, more traceability of the implants and easier report data.

Between January and November 2019, 2879 IOLs were implanted with no incident report received. Between December 2019 and February 2020, 772 IOLs were implanted; of these, six defective IOLs were returned to the pharmacist who provided a report of the incident to the Ministry of Health. The problems concerned defects of the pre-loaded IOL injectors.

Conclusion and relevance The IOL project managed by the hospital pharmacy, in addition to a logistic improvement, has allowed further investigation into the causes of their return and has encouraged the ophthalmologist to point out non-compliances. The project slowed down during the COVID emergency but will be extended to other types of PMDs.

Conflict of interest No conflict of interest

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