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Official Journal of the Italian Association for Cutaneous Ulcers
Indexed/Abstracted in: EMBASE, Scopus, Emerging Sources Citation Index
Online ISSN 1827-1774
Salvatico E., Rosa M. C.
1 Direttore Unità Operativa Farmacia Ospedaliera Azienda Ussl 10 Veneto, Università di Udine, Udine, Italia
2 Corso di Laurea in Infermieristica, Università di Udine, Asl 12 Veneziana, Udine, Italia
Aim. The Veneto centralized purchasing model designed to curb health care costs entails the announcement of a regional tender in which participating hospitals confer proxy on the contracting hospital. The Veneto regional tender (announcement resolution No. 275 of 15/06/06) for the procurement of advanced orthopedic supplies concluded with the award of contracts for medical devices (MD) in December 2008: a challenging experience for the Technical Commission which had to evaluate 232 products from 27 suppliers. Given the diverse types of MD and the structure of the tender, which required the submission of documents whose reliability could not be directly verified, the Commission decided to carry out in vivo tests on patients to determine the real efficacy of the devices.
Methods. The tender comprised various sections. The Commission examined the submitted attachments (Attachments D, G, F) which provided parameters for evaluating the MD. The sampling rate was calculated on the basis of the number of experimenters per lot, the MD technology, the forms/product for in vivo testing. A total of 52 evaluation forms were devised, with about 8 items per form derived from international guidelines. For each item a score from 1 to 4 was assigned. The experimental data were expressed as the mean and compared with the technical specifications furnished by the supplier. Based on the terms of the tender, the MD were evaluated according to technical criteria (maximum score 30), using the parameters from Attachment G given by the supplier; technical evaluation form (maximum score 20); functional characteristics (maximum score 20), as resulted from in vivo tests on patients; packaging characteristics and completeness of labelling information (maximum score 20); technical capability of the supplier (maximum score 20). The total score was 100 points. The functional characteristics were taken from the results of the in vivo tests; the mean values were then scaled according to the tender conditions which required a quality/price ratio of 60:40.
Results. The MD were tested on 1233 patients (mean, 23.7 patients/lot). Based on the area of competence, there was an average of 3 experimenters per lot. Some 80% of the lots won the tender; based on the knock-down price, the contract value was about 12 million euros for a 3-year- period, with a savings of 4.5 million euros over the same period. The number of lots awarded was in line with the standards of previous regional tenders. On the whole, the mean score for the MD was 73.46/100 before scaling.
Conclusion. Devising a form that objectifies as far as possible experimentation on the patient allows for testing of MD effectiveness in real care settings, within an area not yet subject to rigorous randomized clinical trials. That the forms were an efficacious assessment tool, despite the lack of a gold standard as reference in the market for each lot, was confirmed by the absence of interrater variability. Although the Technical Commission which drew up the tender tried to objectify the evaluation as far as possible, the tender placed greater importance on the technical criteria, thus minimizing the experimental data. This indicates that when the next tender is drawn up, greater involvement is needed of an expert panel comprising members from scientific societies who could formulate items/parameters with major clinical relevance. The knock-down prices led to a further limitation in awarding the tender, as this resulted in contracts for lower quality MD. The work methodology the Commission applied provides a resource for drawing up future tenders more in line with the needs of health care operators. In this perspective, the Region of Veneto has recently set up a Technical Commission for the evaluation of new devices and commissions for health technology assessment.