The U.S. Food and Drug Administration (FDA) recently announced that, beginning this month, it will ban the use of powdered gloves in surgery, powdered patient examination gloves, and absorbable powder used on surgical gloves.
The ban, which will take effect Jan. 18, comes after an investigation in which it was determined the products present an “unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling.”
The federal regulatory agency acknowledged that medical gloves play an important protective role for patients and healthcare personnel. The latter rely on the gloves to prevent the transmission of infectious diseases and contaminants during surgical procedures and less-invasive contact with patients.
However, the FDA noted that the use of various types of powder to lubricate medical gloves (so they can be put on and removed more easily) poses numerous risks to patients and healthcare workers, including severe airway inflammation; hypersensitivity reactions; allergic reactions (including asthma); allergic rhinitis; conjunctivitis; dyspnea (shortness of breath); granuloma (inflammation in tissue, particularly lung tissue); and adhesion formation when exposed to internal tissue.
In explaining its decision, the FDA cited a thorough review of all available information. The agency said it carefully evaluated the risk/benefit profile of powdered gloves relative to risks and benefits of the state-of-the-art substitutes, such as non-powdered alternatives.
Investigators determined the risk of potential illness or injury associated with powder-lubricated gloves — including healthcare worker and patient sensitivity to natural rubber latex (NRL); surgical complications associated with post-operative peritoneal adhesions; delayed wound healing; and a variety of other adverse health events not limited to surgery, such as inflammatory responses to glove powder — is “unreasonable and substantial,” and outweighs any public health benefit that would come from their continued marketing.
Moreover, the FDA said its ban on surgical-glove lubrication likely will have minimal impact economically or on the gloves’ availability to the healthcare industry. The transition to alternatives should not result in any substantial negative impact on public health, is not expected to impose significant costs on society, and should reduce the incidence of adverse events associated with powdered glove use, the agency determined.
The FDA estimates that the maximum annual net benefit of the ban will range from $26.8 million to $31.8 million.
The change will apply to all powdered surgical gloves and powdered patient examination gloves without reference to the material from which the gloves are made. The only exception to the ban will be powdered radiographic protection gloves, because the FDA is not aware of any non-powdered radiographic protection gloves on the market and lacks the evidence to determine if the criteria for a ban would apply to that particular device.
Powder lubricants for use in, or on, other medical devices, such as condoms, will not be affected because the FDA has not found evidence that powder intended for use in those products presents the same public health risks as in powdered medical gloves.
The FDA said it has considered potential environmental effects of the ban, including impacts related to landfills and the incineration of solid waste at municipal solid waste facilities nationwide. In the end, the agency concluded the ban is unlikely to significantly impact municipal solid waste and landfill facilities, or the human environment in affected communities. Consequently, an environmental impact statement will not be required.
Before determining the ban is justified, the FDA took public comments on the proposed move. During the comment period, which closed June 20, 2016, the agency received about 100 submissions from a cross-section of stakeholders, including patients and consumers, medical professionals, device manufacturers and professional and trade associations. According to the FDA, a majority of the commenters supported the objectives of a ban in whole or in part.
Details and discussion of the comments can be found in this document, while a full discussion of the ban’s economic impact, including a list of changes made in the final regulatory impact analysis, is available under docket number FDA-2015-N-5017 for this rule at this link.