Review of the regulations for the use of stainless steels for orthopedic implants in Argentina

Abstract

Motivated by the relatively high rate of failure of orthopedic implants in Argentina, the authors review the current normative regulating the use of stainless steels in the fabrication of these metallic parts in the country, and compare it with the regulations currently in use in other countries. The analysis shows that several standards in effect in the country do not comply with broadly recognized international standards. This situation is aggravated by a recent revision of the normative that failed to improve the quality standards to reach levels similar to those applied in developed countries or even in MERCOSUR associates. The national organization in charge of implant certification in Argentina, complying with the law, accepts the applicability of IRAM standards to certify stainless steels implants. In the opinion of the authors, the current practice used to certify implants does not guarantee the structural stability and biocompatibility of the devices, increasing the risk of failure in service, and escalating the cost of the public health care system.