OBJECTIVESTo analyze medical device recall information of FDA U.S. and to address the safety issue of medical device.

METHODFor each report, the recall class, product name, product class and recall reason were recorded and classified for analysis.

RESULTS3093 reports were identified; the recalling reasons of the three classes were significantly different. It is found that the main recall reason for medical material is package problems (39%) and design defectiveness (19%), for medical tools are design defectiveness (27%) and package problems (26%), and for medical equipment are design defectiveness (45%) and system failures (39%). The number of software recalled is 109. The main recall reason for high risk equipment is design defectiveness, and the I class level of high risk equipment recalled was decline in 2006 compared to that in 2005.

CONCLUSIONMonitoring and application of medical device recall information should be strengthened, and the objective law of medical device safety issue should be summed up, in order to provide reference for supervision of medical device.

Equipment Safety ; Medical Device Recalls ; Product Surveillance, Postmarketing ; United States ; United States Food and Drug Administration

Idiosyncratic adverse drug reactions (IDR) induce severe medical complications or even death in patients. Alert structure in drugs can be metabolized as reactive metabolite (RM) in the bodies, which is one of the major factors to induce IDR. Structure modification and avoidance of alert structure in the drug candidates is an efficient method for reducing toxicity risks in drug design. This review briefly summarized the recent development of the methodologies for structure optimization strategy to reduce the toxicity risks of drug candidates. These methods include blocking metabolic site, altering metabolic pathway, reducing activity, bioisosterism, and prodrug.
Binding Sites ; Cytochrome P-450 Enzyme System ; metabolism ; Drug Design ; Drug Discovery ; methods ; Drug Recalls ; Drug-Related Side Effects and Adverse Reactions ; prevention & control ; Humans ; Structure-Activity Relationship

Drug-drug interaction (DDI) is defined as a change in effect or safety of a drug by another co-administered drug. The fact that more than half of the market withdrawal cases for the past ten years was caused by potentially fatal DDI's demonstrates its clinical importance. The mechanism of DDI can be categorized into pharmacokinetic and pharmacodynamic interactions. Most of the clinically important drug interactions are caused by inhibition or induction of oxidative metabolism by cytochrome P450 (CYP) isozymes. Recent researches are also focusing on drug transporter interactions as another significant factor underlying DDI's. It is hard to prevent unexpected or rare DDI's. However, most of the cases of DDI occur from an erroneous prescription of drugs that are already known to result in deleterious interactions. To avoid such well-established DDI's, physicians are first recommended to utilize hands-on summary tables for CYP substrates before prescribing. It should also be remembered that old age, polypharmacy and damaged hepatic or renal function are risk factors of DDI as well as adverse drug reactions. Moreover, patients treated with drugs with a narrow therapeutic index (immunosuppressants, antiarrhythmics, anticoagulants, digoxin, theophylline etc) deserve a special consideration when their prescriptions are changed. In Korea, the clinical significance of DDI has been underemphasized. The fundamental prescription to this old prescription habit is to teach medical students and physicians clinical pharmacology and therapeutics, which have long been neglected in Korea.
Anticoagulants ; Cytochrome P-450 Enzyme System ; Digoxin ; Drug Interactions ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Isoenzymes ; Korea ; Metabolism ; Pharmacology, Clinical ; Polypharmacy ; Prescriptions ; Product Recalls and Withdrawals ; Risk Factors ; Students, Medical ; Theophylline