Medical device Adverse Event Information Notification Concerns the risk of powdered medical gloves
2021-12-25 16:33
Medical gloves are indispensable medical equipment products in clinical medical work, the main role is to protect patients and medical staff in medical operations, control infection, its wide use, large dosage. Medical gloves are limited by material and production process, in order to prevent the failure of gloves due to adhesion, powder (talc powder, starch or modified starch) is usually added in the production process as a isolating agent. Due to the addition of powder, there are certain risks for patients and users in the use of powdered medical gloves.
The State Drug Administration has carried out an assessment of the use and risk of powdered medical gloves in our country. After evaluation, the benefits of adding powder to medical gloves are to prevent gloves from sticking and to make them easy to wear. The risk is that it may cause wound infection of patients and lead to allergic reaction of medical staff, formation of granuloma, adhesion of organs and other complications. 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 the operator.
At present, powdered medical gloves are still the mainstream products of the market in our country. After seeking the opinions of relevant departments, in order to reduce the risk of harm to patients and ensure the safety of medical gloves used by the public, it is recommended that medical institutions choose to use appropriate medical gloves according to their own conditions and specific operational needs, under the premise of meeting relevant regulations, and use powdered medical gloves with caution in invasive operations such as clinical surgery. Medical institutions with conditions can phase out powdered medical gloves; Units that do not have the conditions for elimination can gradually reduce the use of powdered medical gloves.
Powdered medical gloves manufacturers should further improve the warning information in product manuals and labels to remind medical institutions and users of reasonable choice and safe use. At the same time, strengthen the monitoring of adverse events, carry out continuous research on the safety of products after the market, evaluate the risks and benefits of products, and effectively take effective measures to ensure the safety of equipment.
The drug regulatory department should strengthen the supervision of such product registration, production, adverse event monitoring and other links, and urge enterprises to implement the main responsibility for product quality and safety.
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