The State Drug Administration issued a notification of medical device adverse events, reminding medical institutions to pay attention to the risks of using powdered medical gloves, and recommending that medical institutions use caution and even eliminate powdered medical gloves. This is the first medical device adverse event information circular issued by the State Food and Drug Administration this year.
The notice shows that medical gloves are indispensable medical device products in clinical medical work, and they are widely used and used in large amounts. Restricted by the material and production process, in order to prevent the glove from failing due to adhesion, medical gloves usually add powder (talc, starch or modified starch) as a separator during the production process. Due to the addition of powder, powdered medical gloves pose a certain risk to patients and users during use.
The notice showed that the State Food and Drug Administration conducted an assessment of the use and risk of powdered medical gloves in China. After evaluation, the benefits of adding powder to medical gloves are to prevent glove from sticking and easy to wear; the risk is that it may cause complications such as wound infection, granuloma, and adhesion of organs, and may cause allergies to medical personnel. In the production process of powdered medical gloves, due to the need to add powder to the gloves, it will also lead to environmental pollution and injury to operators.
The notice also emphasized that manufacturers of powdered medical gloves should further improve the warning information in the product instructions and labels to remind medical institutions and users to make reasonable choices and safe use; at the same time, strengthen the monitoring of adverse events and conduct continuous research on the safety of products after listing , Evaluate the risks and benefits of products, and effectively take effective measures to ensure the safety of public equipment. The drug regulatory department should also strengthen the supervision of such product registration, production, and monitoring of adverse events, and urge enterprises to implement the main responsibility of product quality and safety.
At present, China's powdered medical gloves are the mainstream products in the market. In order to reduce the risk of injury to patients and ensure the safety of clinical use of medical gloves, the notification recommends that medical institutions choose to use appropriate medical gloves based on their own circumstances and specific operational requirements, in accordance with the relevant regulations, in clinical operations and other invasive operations Use powdered medical gloves with caution. Medical institutions with conditions can gradually phase out powdered medical gloves; units that do not yet have the conditions for phase-out can gradually reduce the use of powdered medical gloves.