The Mayo Clinic Center for Sleep Medicine estimated that the recall impacted more than 16 million domestic and international patients.
This message was delivered via email and physical letter to approximately 9,000 impacted patients who receive sleep medicine and respiratory care at Mayo Clinic. Within this population, Mayo Clinic notified the legal guardians of 60 pediatric patients using the recalled BiPAP and CPAP devices.
Mayo Clinic staff forwarded peers’ requests for advice on their recall responses and permission to this letter as a template for patient-facing communications. These requests became frequent enough that the subject matter experts and I authored a Journal of Clinical Sleep Medicine article, titled “Rapid response to medical device recalls: an organized patient-centered team effort.”
Quantitative data suggested patients’ needs were met with a downward trend of calls to care teams. In early July 2021, Mayo Clinic’s Rochester campus received approximately 200 contacts per day. By the week of July 19, these call volumes went down to 100 contacts per day. Since then, the number of calls continued to decrease. Qualitatively, numerous patients provided positive feedback and expressed their gratitude for Mayo Clinic’s assistance with navigating the sticky web of correcting faulty medical devices.