Depot Repair Service Reports at PartsSource is a recent innovation we have incorporated to support clinical engineering and HTM priorities and needs. One of the challenges customers often talk about with us consistently points to finding the time and resources needed to be in compliance with CMS’ preventative maintenance schedules or Alternative Equipment Maintenance requirements.
We heard you.
Our Depot Repair customers now have access to a new report to help with compliance and transparency: Depot Repair Service Reports—an email notification and online feature available through us to help track and quickly locate service reports to meet your compliance requirements. In addition, we have added AEM Workshops and webinar content to support clinical engineering departments in hospitals with this challenging issue.
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
3. Engagement of people
4. Process approach
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?
Using data to drive decisions in healthcare is critical to process improvement and patient care. A report from the Health Sector Supply Chain Research Consortium published in Healthcare Purchasing News sited improving data transparency across the supply chain as an important area of focus for 83 percent of healthcare providers and 88 percent of suppliers.
An escalated focus on transparency, and data-driven insights for better decision-making remain at the forefront of healthcare supply chain and clinical engineering leaders. In our upcoming communications and events, we will continue to address the topics most important to you, including those reported in a GHX survey of 50 top healthcare supply chain leaders:
These challenges provide opportunities. Using data to drive decisions to evaluate and benchmark the current state and implement improvement plans in each area realize measurable results that impact patient quality and care.
Specific to purchased services, Big Data was the cover story of TechNation focused on how hospitals can and should apply data to clinical engineering and HTM departments to make science-driven decisions to standardize price, product, and process.
“Knowledge is power for HTM professionals."
Learn more about how customers can use our data to drive decisions and how to apply a formulary approach to sourcing and purchasing in healthcare technology management.
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