The FDA’s safety push is a matter of public record, but the agency has moved decisively on this area on several occasions in the month of April. Some of the moves were entirely expected, but one arose with little warning, making clear that while the agency has a definite safety agenda, that agenda can be modified at a moment’s notice.
The FDA advised industry in January it would be more active in the area of device safety via the medical device safety action plan, but the agency’s guidance agenda for the current fiscal year also lists a number of items that can be attributed to the push for safety. In mid-April, the FDA said it would pull the marketing authorizations for all surgical meshes for pelvic organ prolapse, a move that followed the agency’s 2016 up-classification of these devices/indications from class II to class III. The FDA notice indicated that the two sponsors that had decided to submit PMA filings had failed to demonstrate a reasonable assurance that those devices presented an acceptable benefit-risk profile, although devices that have been the subjects of Section 522 postmarket surveillance studies will have to complete those studies.
More recently, the agency posted a draft guidance for the use of nitinol used in medical devices, which was driven at least in part by contraceptive devices, although devices for the circulatory system are also caught up in this issue. Former FDA commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health, said in a statement that nitinol is not the only material of immediate concern at the agency as graphene, too, is on the agency’s safety agenda.
The impact of any moves on nitinol will be keenly felt in the cardiovascular space, thanks to widespread use in items such as aortic valve replacement devices. The draft guidance for nitinol in implanted devices is product agnostic, but the FDA makes reference to standards that have emerged for material characterization as a resource for ensuring device performance. One of the considerations is the material’s susceptibility to corrosion, but while the draft does not suggest any impending regulatory action, device makers may have to include more detail in their regulatory filings going forward.
The draft states that product labels may have to include warnings about allergic reactions to nitinol, although it is not clear whether a test for such sensitivities is routinely offered to patients. Among the entries in the literature on this point is an article in the March 6, 2017, issue of the Journal of Vascular Surgery Cases and Innovative Techniques, which describes a patient who experienced “a full-body, desquamating macular-papular pruritic rash” after implant of a stent in the popliteal artery for acute limb ischemia. The patient’s condition improved after the device was removed, although he continued to experience less severe episodes out to two years, which were blamed on exposure to other products that contain nickel, including occupational exposure and bottled alcoholic beverage containers.
Surgical staples, staplers also on the list
Surgical staplers and staples also fell under the FDA’s watchful eye, as demonstrated by several related announcements. In one instance, the agency proposed to reclassify some staplers from class I to class II, and an accompanying announcement lists a May 30 advisory committee to take up this question, but the issue is significant enough to warrant a statement from CDRH chief Jeff Shuren. Shuren said the agency has received in excess of 41,000 medical device reports for surgical staplers and staples for internal use, which includes more than 32,000 malfunctions and 366 patient deaths between January 2011 and the end of March 2018.
The agency also issued a draft guidance for labeling for staplers and internal-use staples, the scope of which captures four products codes. The draft would require that labels reflect a number of advisories, such as not to use a staple on large blood vessels, including the aorta. The agency is taking comment through June 23, but it seems plausible this draft will undergo more than the usual amount of revision before reaching final form, given that the advisory hearing will take place prior to the end of the comment period.