Recently, the servicing of medical devices was evaluated for quality by the FDA. The Agency ruled that they will not impose more regulations on third-party service providers of medical devices. Here’s what the FDA will focus on instead, and a quick explanation of why:
1. Promote the adoption of Quality Management Principles.
Why? Because having a Quality Management System (QMS) in place helps to check the quality of a device being serviced, and the safety and recall information for a device that’s been serviced. The 7 Quality Management Principles are:
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management
2. Clarify the differences between servicing and re-manufacturing.
Why? These are two distinct conditions of a device and have varying quality requirements. Re-manufacturing a device changes its fundamental design; refurbishing or reconditioning a device brings it back to its original fit and form.
3. Strengthen cybersecurity practices associated with servicing medical devices.
Why? Because clearing out patient information and data protects patients.
4. Foster evidence development to assess the quality, safety and effectiveness of medical device servicing.
Why? So we can identify and track medical devices that have been serviced, are due for preventative maintenance, and ensuring patient data is protected to stay HIPAA compliant.
While the FDA’s areas of focus are important, these are things that PartsSource already does to support our customers. We use an automated Quality Management System to drive our pursuit of quality products from quality partners. But we continue to look for ways to improve because we believe great quality enables sustainable growth for an organization and we have seen our overall quality continuously improve because of a concerted effort on quality. What does your organization do to help ensure quality?
