The Solution

Original equipment manufacturers (OEM) and the service technicians who work for them know what it takes for safe and effective servicing. Through extensive training, continuing education, and oversight from the FDA, OEM servicers know what is required to properly maintain equipment while protecting patients. Important steps can be taken by policymakers to ensure that all servicers are meeting the same quality and safety standards.

Third-Party Servicers Should be Required to:

Register

All servicers of medical devices should be required to register with the FDA.

Adopt Quality Management Systems

All servicers of medical devices should be required to adopt and maintain a quality management system that ensures devices are returned to safe and effective condition.

Report Adverse Events

All servicers should be required to report adverse events to the FDA when they encounter death, serious injury, or device malfunction.