The FDA has warned healthcare providers that a shortage of stereotactic breast biopsy needles could affect patient care through the end of the first quarter of 2027 and urged facilities to adopt conservation strategies.
The supply disruption stems from recent supplier issues and follows a Jan. 2 action by Hologic to remove all lots of its Brevera Breast Biopsy System disposable 9-gauge needles, according to a June 16 agency letter. Hologic said there was a risk that metal and plastic particles could be dislodged from the device during use, potentially leading to complications including infection, hematoma or contamination of biopsy specimens.
The FDA added stereotactic breast biopsy needles to its Medical Device Shortages List March 13. The shortage has drawn concern from the American College of Radiology, which warned in May that supply constraints were disrupting patient access to diagnostic care nationwide and could delay diagnoses of suspicious breast lesions.
The FDA recommended that providers expand supplier networks, diversify needle gauges and lengths, use prior-generation devices when clinically appropriate and reduce unnecessary device waste. The agency also encouraged health systems to centralize inventory tracking and forecast utilization trends based on scheduled biopsy volumes.
Providers should communicate delays to patients, consider alternative biopsy locations when supplies are available and prioritize minimizing delays in cancer diagnosis and treatment, the letter said. The FDA also said it is working with manufacturers and providers to monitor the situation and evaluate potential solutions to mitigate patient impact.
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