Regulatory Update, March 2017
Wednesday, March 1, 2017
FDA Bans Powdered Gloves and Absorbable Powder for Lubricating Gloves
In the December 19, 2016, Federal Register, the FDA announced its determination that powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove 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 FDA banned these devices in this published final rule, effective January 18, 2017. All powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s gloves must be removed from the market upon the effective date.
Medical gloves play a significant role in the protection of both patients and healthcare personnel. Healthcare personnel rely on them as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients. Various types of powder have been used to lubricate gloves so that wearers could don the gloves more easily. However, the use of powder on medical gloves presents numerous risks to patients and healthcare workers, including inflammation, granulomas and respiratory allergic reactions.
A thorough review of all currently available information supports the FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove should be banned. Risks posed by powdered gloves, including healthcare worker and patient sensitization to natural rubber latex (NRL) allergens, surgical complications related to peritoneal adhesions and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder, are important, material and significant in relation to the benefit to public health from their continued marketing.
The FDA carefully evaluated the risks and benefits of powdered gloves and the risks and benefits of the state of the art, which includes viable non-powdered alternatives that do not carry any of the risks associated with glove powder, and has determined that the risk of illness or injury posed by powdered gloves is unreasonable and substantial. Further, the FDA believes that this ban would likely have minimal economic and shortage impact on the healthcare industry. Thus, a transition to alternatives in the marketplace should not result in any detriment to public health. The FDA also determined the ban should apply to devices already in commercial distribution and devices already sold to the ultimate user. This means that powdered gloves currently being used in the marketplace would be subject to this ban, considered adulterated and subject to enforcement action. Powdered radiographic protection gloves are exclude from the ban because the FDA is not aware of any such gloves currently on the market.
Regarding what to do about unused banned gloves remaining at hospitals, outpatient centers, clinics, medical and dental offices, other service delivery points (nursing homes, etc.) and in the possession of end users, these will need to be disposed of according to established procedures of the local community’s solid waste management system (landfills or incineration).
To read background documents or comments received on this rule, go to the docket at https://www.regulations.gov/ and insert docket number FDA-2015-N-5017 into the “Search” box and follow the prompts. A summary of comments received and FDA responses can be read in this Federal Register notice.
ICH Guidance on Clinical Investigation of Medicinal Products in the Pediatric Population
In the November 22, 2016, Federal Register, the FDA announced the availability of a draft guidance for industry titled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” It was prepared by the International Council for Harmonisation (ICH) as an addendum to the guidance titled “E11 Clinical Investigation of Medicinal Products in the Pediatric Population” (ICH E11). It updates ICH E11 and provides clarification and current regulatory perspective on topics in global pediatric drug development. The addendum includes sections on ethical considerations; age classification and pediatric subgroups including neonates; and pediatric formulations that supplement the content in the ICH E11 guidance. A new section on Commonality of Scientific Approach for Pediatric Drug Development Programs addresses issues to aid scientific discussions at various stages of pediatric drug development in different regions. The section on Approaches to Optimize Pediatric Drug Development provides additional information on extrapolation and introduces modelling and simulation. Identify comments with Docket No. FDA-2016-D-3848.
The Regulatory Update is excerpted from Research Practitioner, Volume 18, Number 01, January/February 2017.