Customer Service: 1-800-331-7993
January 3, 2017
If you found yourself doing your best Faye Dunaway impression when you read the title to this months Practice Tips, give yourself a gold star. We wanted to express a sense of urgency for those of you who still use powdered gloves, because in just a matter of days, you will need to make sure your office is in compliance with the FDA's ban on them.
In December 2016, the Federal Register published that the FDA has officially banned use of all powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon’s gloves. This ban is scheduled to go into effect on January 18, 2017 and will affect devices currently in commercial distribution and already sold to the end user.
Early rumblings of this started back in March 2016 when the FDA issued a proposed rule to ban these devices, as they present “an unreasonable and substantial risk of illness or injury.” Risks associated with powdered gloves include: hypersensitivity reactions, allergic reactions, and severe airway inflammation.
The FDA found that the current state of the art of both surgeon’s and patient examination gloves includes numerous non-powdered alternatives that provide the same performance, level of dexterity, and protection with none of the risks that are associated with powdered gloves.
You can learn more about the ban at the Federal Register.
In order to assist you in your transition from powdered gloves, we are offering special pricing on BeeSure® Powder Free Gloves:
SPECIAL! If you call us today at 1-800-331-7993, you can take an extra 10% off our already economically priced BeeSure® non-powdered gloves. Offer is good from January 1, 2017 through February 28th, 2017. Mention special code "BS-1" to get discount. This offer is not available online.
April 27, 2016
Fresenius Kabi USA is voluntarily recalling 30 mL vials of Sensorcaine®-MPF (bupivacaine HCl). One lot (Lot Number 6111504; Product Code 470237) was found to have visible particulate matter that the company believes is glass.
Sensorcaine®-MPF injections are used as local or regional anesthesia/analgesia for dental, oral surgery, as well as therapeutic, diagnostic, and obstetric procedures.
The company warns that administering a solution containing glass particulates may result in "inflammation or injury," although, there have been no reports of adverse events. Professionals are encouraged to contact the company with any questions and patients should contact their physician should they experience any problems.
More information on the FDA MedWatch recall announcement can be found here.
April 1, 2016
A small number of reports have been received by the FDA regarding “adverse effects” thought to be associated with CT imaging of wearable and implantable medical devices such as neurostimulators, insulin pumps, and cardiac implanted devices.
If the CT scanner irradiates the circuitry of certain devices it can cause enough interference to affect the operation of the device. However, the likelihood of that happening is very low and the FDA believes that the benefit of CT scanning greatly outweighs the odds of such an event.
Professionals and patients are asked to complete and submit a report of any side effects. To learn more, please read the FDA’s safety alert: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm493739.htm