Dive Brief:
- An ongoing shortage of breast biopsy needles is expected to continue through March 2027, the Food and Drug Administration said in a Tuesday letter to healthcare providers.
- In January, Hologic removed all lots of 9 gauge needles for its Brevera Breast Biopsy system because of a risk of metal and plastic particles being dislodged during the procedure. Hologic told customers to quarantine and return the affected devices.
- The supply disruption is expected to affect patient care, the FDA said, and may require changes to clinical management of patients scheduled for a breast biopsy.
Dive Insight:
The FDA first added breast biopsy needles to its medical device shortage list in March. In the latest update, the agency extended the expected duration for the shortage and provided recommendations for healthcare providers.
The agency said providers should develop needle conservation strategies, such as diversifying needle gauges and lengths, expanding supplier networks and limiting device waste. Providers should monitor inventory, forecast how many devices are needed based on scheduled biopsy volumes and focus on minimizing delay for cancer diagnosis or treatment, the FDA added.
The American College of Radiology warned in May that “limited alternatives have not fully met clinical demand, which has broadly strained the supply chain.”
Hologic said on its website that it is expanding manufacturing shifts and expediting orders to increase the supply of biopsy needles. The company has also updated its Brevera system so it can be used as a standalone imaging unit.
