Medical Device Adverse Events: Focus on One-time Use Package Risk

Medical network January 17 hearing the one-time use of production packages mainly by the production list, equipment list, and other basic configuration, as well as surgical gowns, headgear, hoods, masks, gloves, umbilical cord, umbilical cord and other optional configuration for obstetrics Clinical use.

January 1, 2016 to May 1, 2017, Country drug Adverse reactions Monitoring Center received a total package suspicious medical instruments 264 reports of adverse events, according to the incident performance is divided into two categories of patient injury and device failure: ① patient injury mainly as follows: user or patient contact with the product swelling and pain, infant umbilical infection, infant umbilical cord junction bleeding, severe May lead to shock; ② equipment failure mainly as follows: pad single, surgical clothing and other leakage occurred in the package there is foreign body or visible bacterial contamination, umbilical cord rubber band rupture.

An analysis of the above adverse events that may or may cause serious injury indicates that painful swelling at the user's or patient's site of exposure is similar to damage to the skin with ethylene oxide (sterile residue); Related to bacterial levels; infant umbilical cord bleeding and components of the umbilical cord ligation of the cord rupture, may be related to ligation, does not rule out product quality Problems; padding, surgical gown leakage does not rule out product quality factors may also be related to the improper use of personnel.

Based on the above product risks, production enterprise Should take to strengthen product quality control, strict sterilization management, and strengthen user training and risk control measures.Medical institutions should strengthen the incoming inspection; medical staff should be used before the necessary inspection of the product, the timely replacement of damaged products, Familiar with the performance of adverse events, strengthen clinical inspections, timely detection and control of possible adverse events of the product, and timely feedback to the dealer or manufacturer of adverse events, and to the area where the medical device monitoring or adverse event monitoring department report.