The risks of losing the ISO 13485 Accreditation

Assuming SSD = Sterile Services Department, the hospital would be at potentially high risk, but the actual level depends on why ISO 13485 was lost.

Loss of certification does not automatically mean instruments are unsafe, but it removes an important independent assurance that the SSD’s QMS is controlled. Your hospital would likely be at medium risk if the loss was administrative, but high risk if it resulted from process-control failures. If the SSD cannot demonstrate validated sterilization, effective cleaning, controlled release, traceability, competent staff, maintained equipment, and effective CAPA, the risk becomes patient-safety critical, not merely a quality-system issue.