Medical Device Adverse Event Information: Pay attention to the risk of powder medical gloves

January 19 US Food and Drug Administration announced that powder medical gloves used in the United States with the powder (talc, corn starch, etc.) may pose a security risk for powder surgical gloves, powder Inspection gloves and respirable powder surgical gloves three banned the implementation of the study showed that the medical powder attached to the powder may become a natural rubber carrier protein, causing respiratory allergies; powder itself may make granulomas and postoperative tissue adhesion Increased risk.

In the report of suspicious adverse events of medical gloves (including powder-free and powdery medical gloves) monitored by our country, the adverse events were mainly anaphylactic reactions, which were manifested as swelling and pruritus of the contact area, alleviating the allergic symptoms after stopping the use of gloves and water After investigation, most powder used in our country is modified corn starch powder medical gloves.

To ensure public safety of medical gloves and reduce the risk of injury to human beings, it is recommended that: (1) The medical gloves should be identified before use, familiar with the clinical risk brought by powder gloves; (2) Clinical surgery, invasive procedures, allergies Those who use powder gloves with caution may switch to powder-free gloves; ③ Relevant manufacturing enterprises should strengthen the monitoring of adverse product events, take the initiative to collect risk information after the listing, and take appropriate measures in time to warn the powder may cause in the product manual or label health Damage; ④ all over medical instruments Adverse event monitoring agencies to strengthen the monitoring of adverse events with powder medical gloves, timely detection of adverse events, urging enterprise Analyze the causes, evaluate and control product risks.