FDA says shortage of stereotactic breast biopsy needles expected to last through March 2027, offers guidance to providers

The U.S. Food and Drug Administration (FDA) has announced that a nationwide shortage of stereotactic breast biopsy needles due to a manufacturing disruption is expected to last through March 2027.

In the meantime, it states that the supply disruption “is expected to impact patient care and may require adjustments to the clinical management of patients indicated to undergo a breast biopsy.” It also recommends providers “consider strategies to conserve the use of stereotactic breast biopsy needles,” and that “providers should use their clinical judgment when developing and implementing conservation strategies.”

The disruption emerged on Jan. 2, when manufacturer Hologic issued a customer letter stating that all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed due to a risk of metal and plastic particles being dislodged from the device during use. “If particulate matter originating from the device is left behind in a patient post-biopsy, potential adverse effects such as foreign body reaction, hematoma/hemorrhage, and infection may arise,” states the FDA. “If particulate matter enters a biopsy specimen, an additional biopsy procedure may be required due to contamination of the specimen.”

On Mar. 13, the FDA updated its Medical Device Shortages List to include stereotactic breast biopsy needles (product code KNW). The FDA states that it is “working with manufacturers and providers to monitor the current situation to help ensure stereotactic breast biopsy needles remain available for patients when medically necessary; evaluating potential solutions for mitigating patient impact; and informing the public as new information becomes available.”

The FDA states that providers should consider the following in “developing strategies to preserve the supply for patients at highest risk”:

• Expand supplier networks with vendor diversification.
• Diversify and utilize all needle gauges and lengths to avoid dependence on limited “standard” inventory.
• Utilize prior-generation devices where clinically appropriate.
• Limit unnecessary opening and wasting of devices.
• Centralize inventory tracking across breast imaging sites.
• Monitor inventory with a daily/weekly inventory dashboard available to all radiologists performing biopsy procedures.
• Forecast utilization trends based on scheduled biopsy volumes and distribute biopsy needles appropriately across health systems and facilities.
• Communicate delays to patients transparently.
• Offer alternative locations where biopsy needles are available, if alternative biopsy devices are not suitable.
• Maintain focus on minimizing delay for cancer diagnosis and treatment.

Access the FDA’s full letter to healthcare providers on the issue here.