Top 5 Takeaways
- Outbreak Identification: Seven patients developed tuberculosis after spinal surgery, linked to a contaminated bone graft product (product A).
- Nationwide Recall: The manufacturer issued a voluntary nationwide recall of product A after the outbreak was identified.
- High Attack Rates: 83% of patients showed laboratory or imaging evidence of tuberculosis, with significant symptoms and complications.
- Health Care Personnel Exposure: 152 health care personnel and seven patients were identified as exposed to recipients of product A.
- CDC Recommendations: Immediate assessment and four-drug treatment for all patients nationwide who had undergone surgery with the affected product lot.
Original Article Author and Citation
Corresponding Author
Noah G. Schwartz, nschwartz@cdc.gov
Suggested Citation
Summary
In May 2021, a Delaware hospital reported seven cases of tuberculosis linked to a contaminated bone graft product used in spinal surgeries. The CDC, in collaboration with the FDA, initiated a field investigation and issued a nationwide recall of the product. The investigation revealed high attack rates and multiple opportunities for M. tuberculosis exposure among patients and health care personnel.
Methods
Investigators collected clinical, laboratory, and imaging data from medical records and interviewed patients. They assessed potential exposures related to the storage, handling, and use of product A, as well as reprocessing of surgical instruments and patient care. The investigation adhered to federal law and CDC policy.
Discussion
The investigation identified 23 patients who underwent surgery with the recalled product lot, with 83% showing evidence of tuberculosis. Health care personnel and patients were potentially exposed to M. tuberculosis during and after surgeries. The CDC recommended immediate assessment and treatment for all affected patients and evaluation of health care contacts.
Conclusion
The rapid detection of this outbreak led to a multistate investigation, product recall, and initiation of tuberculosis treatment for affected patients. Ongoing efforts are needed to identify and evaluate exposed contacts and prevent future exposures from contaminated medical products.
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