The US Food and Drug Administration (FDA) recently issued a Consumer Update for the general public on how to use hand sanitizers safely and effectively. Hand sanitizers are regulated as over-the-counter drugs by the FDA. Besides use by the general…
Most of the regulatory guidance we provide to our customers includes a reference to “always follow manufacturers’ instructions for the safe and efficacious use” of a particular dental product or patient care device. A recent article posted on American Dental…
On October 28, the US Food and Drug Administration (FDA) issued a recall notice that Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 because it…
In December 2017, the U.S. Food and Drug Administration (FDA) issued a final rule banning 24 ingredients found in over-the-counter (OTC) antispetics used for hand hygiene in the healthcare industry. The final rule becomes effective on December 20, 2018. According…
In October, 2016, the ADA adopted a new ADA Statement on the Use of Opioids in the Treatment of Dental Pain, which provides recommendations for dentists on prescribing opioids to patients. In addition to specific practice recommendations, the statement urges…
Effective January 18, 2017, powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove will be banned from use in the United States. According to the Food and Drug Administration (FDA), these devices “present an…
Cold sterilants are chemical solutions used for the purpose of destroying all forms of microbial life including bacterial spores and are used to process heat-sensitive critical and semi-critical dental instruments for reuse. The Food and Drug Administration (FDA) is responsible…
The Centers for Disease Control and Prevention (CDC) categorizes patient-care dental items (instruments, devices, equipment) into three categories: Critical items cut bone and/or penetrate soft tissue and carry the highest risk of disease transmission. Semi-critical items touch mucous membranes or…
