American College of Radiology urges FDA to address breast biopsy needle shortages

The American College of Radiology is warning of ongoing breast biopsy needle shortages it says are having a detrimental impact on care.

ACR voiced its “urgent concerns” in both a news update to members Thursday and a letter to the U.S. Food and Drug Administration. This after the agency recently added stereotactic breast biopsy needles to its medical device shortage list in mid-April, estimating supply scarcities could last through the rest of 2026.

The college said it has received recent reports of “significant backorders from key manufacturers,” and it wants the federal government to respond.

“According to widespread reports from the breast imaging community, these shortages are creating immediate and substantial challenges for breast imaging practices nationwide, negatively impacting patient access to diagnostic care and, ultimately, critical therapeutic intervention,” ACR CEO Dana H. Smetherman, MD, MBA, MPH, wrote to the agency on May 11. 

ACR noted that the shortage began earlier this year after a “major” manufacturer stopped shipments to “correct an issue.” Since then, “limited alternatives have not fully met clinical demand,” Smetherman added, which has “broadly strained the supply chain.” The college did not name the vendor in its messages. However, in late December, Hologic sent customers a field safety notice for all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needles. The manufacturer noted that the needles, used to retrieve breast tissue samples for histopathology, pose potential danger due to the risk of pieces dislodging during procedures. 

In the FDA letter, ACR emphasized that image-guided biopsies are a “cornerstone of timely breast cancer diagnosis.” Continued limitations in access to these devices will directly impact care. Ramifications could include delays in the diagnosis of suspicious breast lesions, increasing patient uncertainty regarding outcomes, and the emergence of more invasive and costly cancer cases. Continued shortages also are likely to create inefficiencies in “already strained imaging workflows,” Smetherman added.

“The current backlog is not an isolated operational inconvenience, but rather, it represents a broader patient safety and public health concern, particularly in high-volume centers and safety-net institutions where alternatives may be limited or unavailable,” she wrote. “Therefore, the ACR respectfully requests FDA consideration of the following actions, where feasible, to support supply chain resilience and the continuity of patient care.”

Possible remedies could include expedited FDA review of alternative biopsy devices, increased communication and coordination with specialty societies, and streamlined pathways to allow for temporary importation of needles. ACR also is asking the agency to engage with manufacturers, encouraging them to prioritize bolstering biopsy supplies, alongside coordinating with Health and Human Services around contingency planning. Concerns about the shortage arose at the college’s recent annual meeting in Washington, with ACR activating its Quick Response Team to devise an answer, according to the May 14 news update.