RESUMEN
Quality control and standardized preservation methods are essential in the field of transplantation. The International Organization for Standardization (ISO) has established a common set of manufacturing, trade and communications standards that are applicable worldwide and that provide the basis of a quality plan for Tissuebreak Banks.The Sectorial Tissue Banking (STB) of the Regional Blood Transfusion Center (RBTC) of Córdoba (Spain) is a non-profit-making tissue bank, established in 1992 to provide tissues for surgical procedures to the hospitals in a regional area. In 1998, the STB as a part of the RBTC embarked upon the path of becoming ISO-certified: after two years of the implementation of the project, STB attained ISO 9002 certification, thus becoming one of the first tissue banks in Europe to achieve this qualification. In this paper we describe the process of becoming ISO-certified, to demonstrate the positive impact that it has had on our entire organization.The assistance of an outside consultant who provided the necessary information for implementing an ISO quality management system was required. The initial improvement was: a well-defined quality manual to address all elements of the ISO 9002 standard, an improved document control system, detailed standard operating procedures (SOPs) and improved employees training processes. A quality committee team and developed quality indicators were created. The internal quality auditing program was established by the selection of employees from a cross-section of the organization, who were trained in internal auditing processes. A formal corrective action system was developed and implemented to facilitate process improvement. The consultant conducted a pre-certification audit, and one month later the certification audit was performed.In conclusion, the implementation of an ISO quality program in the STB has helped our center to establish a control process in the manufacturing of products and services to meet the expectations of our customers, by providing components and services that comply with the national regulatory standards and requirements.
RESUMEN
Spain has one of the highest incidences of bacterial resistance to antimicrobials, possibly linked to drug consumption patterns. Using Ministry of Health and Consumer Affairs records, data were obtained on non-hospital sales of antibiotics for the period 1987-1997, and equivalents calculated in weight of active drug ingredient and defined daily doses per 1000 population per day (DDD/1000/day). The number of packages sold declined from 75 million in 1987 to 55 million in 1997. None the less, there was a gradual yet steady rise in consumption in tonnage terms (249 to 275 tonnes). Furthermore, in terms of DDD/1000/day, consumption rose sharply until 1995 and then held steady at 21 DDD/1000/day, a level comparable to the mean for other developed countries. Penicillins were the group to register the highest consumption in Spain, followed-in the latter years of the study-by macrolides, cephalosporins and quinolones. The marked rise in these latter three groups was noteworthy. Despite the decrease in the number of packages sold, antibiotic consumption in Spain has risen. This consumption pattern is different from that of other European countries and might serve to explain differences in the generation of resistance.
Asunto(s)
Antibacterianos , Bases de Datos Factuales , Utilización de Medicamentos , Humanos , EspañaRESUMEN
OBJECTIVE: An analysis of the impact of the commercialisation of intranasal administration on calcitonin consumption. DESIGN: Descriptive study. SETTING: Non-hospital ambit within the national health system. PATIENTS AND OTHER PARTICIPANTS: A protected population group within the national health system, with occupationally active people and pensioners being differentiated. INTERVENTIONS: Commercialisation of a new way of administering calcitonins in March 1992. MEASUREMENTS AND MAIN RESULTS: The consumption of calcitonins dispensed in prescriptions by the national health system was differentiated according to methods of administration; calculations being made for the number of containers, cost and daily dosage defined (DDD) by population groups (overall and pensioners) and for the distribution of consumption for Autonomous Communities in DDD per 1,000 inhabitants and per day. In 1992 123% more containers and 47.29% more DDD of calcitonins were used than in 1991. In February 1993, DDD consumption of calcitonins intranasally was twice the parenteral consumption. Pensioners consumed 77.63% of the DDD of parenteral calcitonins, compared with the active population; and 71.78% compared with intranasally taken calcitonins. CONCLUSIONS: The market introduction of intranasal methods has led to a notable increase in calcitonin consumption. Intranasal methods make up an ever-growing percentage of consumption and reached double the parenteral consumption in February 1993. By population groups, it was observed that pensioners used parenteral more than intranasal methods.