The Food and Drug Administration (FDA) has finalized a rule banning the use of powdered gloves in medical and surgical practice. It is very rare for FDA to issue a medical device ban. The ban was proposed in March 2016 and in the words of Jeffrey Shuren, Director of FDA's Center for Devices and Radiological Health, it was about “protecting patients and health care professionals from a danger they might not even be aware of.” The United Kingdom and Germany had banned cornstarch powder on medical gloves long back.[1]
The cornstarch powder promotes wound infection, peritoneal adhesions and granulomatous peritonitis, and latex allergy.[2] As early as 1994, it was shown that use of powdered gloves increased adhesions formed in the abdominal cavity in animal models.[3] At the same time, glove powder was shown to lead to increased adhesion and growth of tumor cells.[4] In fact, starch particles can migrate from vagina to abdominal cavity and lead to postoperative adhesions in animal models.[5]
The glove cornstarch has documented detrimental effects on wound closure techniques and potentiates wound infection. Powdered gloves have been shown to have higher natural rubber latex proteins compared to nonpowdered gloves.[6] These powders can cause life-threatening allergic reaction in sensitized patients and pose a risk to both patients and healthcare workers who use them.[2,3,6] Long-term results and success of clinical procedures in dentistry have been shown to be adversely affected by their use as well.[7]
It's high time the Indian medical fraternity takes its stand on the use of powdered gloves with countries such as the United Kingdom, Germany, and now, the United States rallying against their use. With good powder-free alternatives available, justification for the use of powdered gloves cannot be made. Use of such alternatives will go a long way in ensuring both patients’ and surgeons’ health and provision of quality health care.
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References
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