FDA Bans Powdered Medical Gloves – Now What?
In a final ruling, the United States Food and Drug Administration (FDA) has banned the use and sale of powdered surgical and patient examination gloves in the United States effective today, January 18, 2017.
This blog looks at why the ban was proposed and the effects this could have on people working in professions that use powdered disposable gloves.
What Does the Ban Cover?
In March 2016, the FDA proposed the ban on most powdered medical gloves, prohibiting the marketing and sale of powered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgeon gloves.
The risks of illness and injury associated with glove powder outweighed its benefits to the user, which is primarily the ease of donning and doffing gloves.
The other thing that was taken into consideration was the effects to public health.
Since there are numerous available alternatives for non-powdered disposable gloves on the market, there was not a risk to public health due to a shortage of medical gloves.
The ban applies to gloves that “are already in commercial distribution and for these devices that are already sold to the ultimate user, such as small medical practices and hospitals,” according to the FDA’s website.
Powdered Glove Ban Proposal Background:
This is not the first time that a ban has been suggested on disposable powdered gloves.
In 1997, the FDA attempted passing a similar ban but due to fear of market shortages on medical grade gloves, the ban was not set in place. But, due to an increase in alternative options for disposable gloves, this wasn’t considered an issue when the proposed ban resurfaced.
Recent studies indicate that the powder – which coats the inside of the gloves to make them easier to take on and off – poses an unnecessary risk to medical workers.
Risks associated with the powder apply to both the medical professional wearing the glove and the patient being examined.
The FDA recognizes that while many people won’t react to powder, the risks for others is too great.
Potential Patient Side Effects:
From the patient’s perspective, powdered gloves can present health risks that range from irritating to life-threatening.
Including allergic reaction, wound infection and adhesion, a condition where bands of scar tissue bond organs with tissue and impair organ function.
Risks to Medical Professionals:
But powdered latex gloves have remained in use and they pose a risk to health care workers.
The aerosolized powder inside some latex carries natural latex proteins airborne which can cause “severe airway inflammation,” says the FDA ban.
The ban covers all medical-grade hand protection from the side of the worker and the patient.
Powdered Disposable Glove Alternatives:
Doctors, nurses, veterinarians and other healthcare professionals have embraced non-latex alternatives like nitrile which is quickly becoming the go-to disposable glove material.
Ready to learn about alternative disposable glove options?