BD—Jamshidi and Illinois Bone Marrow Biopsy/Aspiration Needles: Sterility May Be Compromised

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Problem: ​In a July 15, 2021, Urgent Medical Device Correction letter submitted by ECRI member hospitals, BD states that has received a report of an open seal on the packaging of the above needles. BD also states that an incomplete package sealing could result in an open seal, leading to nonsterile conditions (see Figures 1 and 2 in the letter for images of an open seal). BD further states use of a nonsterile needle for bone marrow biopsy/aspiration or intraosseous (IO) infusion would lead to risk of infection which could be local, regional, or systemic in nature. Long-term consequences of an infection related to bone marrow biopsy/aspiration or IO access/infusion are numerous, examples of which range from complications from osteomyelitis (i.e., abscess, bone deformity, septic arthritis, and others) to death secondary to systemic infection. However, knowledge of aseptic technique by healthcare professionals serve to mitigate...