Medical equipment production situation is not optimistic, perfect the trace system is imperative

Medical equipment industry in China in recent years the rapid development, but in the related management system there still exist a lot of loopholes. Recently a medical instrument news caused everybody's attention: the Beijing tongzhou district a denture manufacturer production environment polluted and save safe hidden trouble, metal scrap is recycling, mechanic common with leather shoes oil blot out false tooth steel bracket, to reach brightening effect. But this batch of quality extremely poor to the detriment of his health dentures unexpectedly is sold to large normal hospital, behind this audit system without let chilling, relevant traceability system and the establishment of perfect is imperative.

Medical equipment and drug, although all belong to the food and drug supervision and administration departments at various levels supervision areas, but in recent years in the regulatory effect is "ice hot flame" : on the one hand, with the "qi effectively" event, and a number of major JiaYaoAn exposure and investigated, and drug supervision system increasingly strict, the problem of fake drugs preliminary be contained; On the other hand, fake medical equipment problems but intensified: not only false medical instrument filled with fake, and even heart surgery use heart bracket, connection broken bone use of steel plate and implanted into the body of medical apparatus and instruments also appeared a lot of JiaLie products, to make the same score in patients with many new painful at the same time, also makes the doctor-patient relationship further deterioration.

Objectively speaking, in order to control medical devices field fake inundant disarray, and in recent years at all levels of food and drug supervision and administration departments have also made a lot of efforts: for example, set production enterprise must be of the medical device manufacturing enterprise license "and" medical instrument registration certificate two card complete can begin production. According to the problems existing in the dentures products, the state food and drug administration in 2003 also specially introduced the fixed system denture registered interim provisions "; At the same time, food and drug supervision and administration departments at all levels for some illegal production enterprises is also carried out in a big way exposure and investigate. But unfortunately, in the huge profits, tempted by these measures was clearly not to achieve an ideal effect.

A confusing is, in medical equipment supervision, the traceability system was food and drug supervision and administration department abandon need not: for the problems found in the supervision, they only punishment or illegal manufacturers and not tracing problem where medical devices, or punished only such as hospital medical institutions and not the source of the equipment shall be investigated for problems, so that to fake medical devices lack of law enforcement action like problem drug regulation action that deterrent force.