Regulatory constraints for sterilization at health care facilities

Recently, following incidents, the activity of sterilization departements in hospital, is confronted with reglementary obligations. The ministry of health has specified obligations, since 1997, distribing a document (n(o) 672 from 20(st) of October 1997). The law of sanitary security (law n(o) 98-535 from 1(st) of July 1998) has made obligatory a quality system. At last, the law n(o) 99-649 from 27(st) of July 1999. defines the conditions of subcontracting of sterilization, between hospitals. In the same time, an order n(o) 96-345 Gum 24(st) of April 1996. has made obligatory the hospitals accreditation and the quality system is a measure of this accreditation. The European and International Standards concern the sterilization medical devices and the sterilizer use. At last, in the near future, the Good Practices of Medical Devices Preparation will be legal opposable.