Overwhelmed Recall and Safety-Alert Management Programs
November 24, 2014 | Evaluations & Guidance
Many kinds of problems can occur with medical devices, ranging from lower-priority issues to potentially life-threatening ones. These problems can result in the issuance of recalls or safety notices from the manufacturer or safety alerts from organizations like FDA or ECRI Institute; these are intended to inform facilities about identified problems before additional incidents occur. However, alerts alone cannot protect patients from harm; healthcare facilities...