Explore the critical importance of servicing in the lifecycle of medical devices. Learn how effective servicing enhances device performance, complies with regulations, and mitigates risks, ultimately ensuring patient safety and quality care.
Technology has and still is changing the face of medical devices, with servicing being at the very center of these complex creatures’ lifecycle.
Serving of medical devices includesmaintaining repair and modifications of medical devices so that the services are always in accordance with the technical requirements agreed upon.
For many institutions, this is a critical component of keeping our devices under some sort of control to ensure patient safety and the reliable performance from these devices. Manufacturers also are responsible for developing and documenting service instructions and procedures that comply with the provisions established by the regulation.
Importance of Servicing in Quality Management
Maintaining Device Performance: In the same way that medical in-servicing aims to keep everything functioning properly for the life of a device, effective servicing preserves the intended performance of medical devices across its lifecycle. With a host of complex parts and intricate engineering that goes into their making, over time these devices tend to wear out or slowdown in performance or many other factors leading to problems with use may develop in due course of time. Scheduled servicing also functions as a preventative maintenance inspection that allows manufacturers to pinpoint a problem before it grows out of control. This is an approach that increases the life of the device, better’s patient outcomes and lowers the chance of adverse events.
Adhering to Regulations: The healthcare industry is governed by strict regulations meant to uphold the safety and functionality of medical devices. Meeting the QSR requirements for servicing, beyond a strict approach to compliance, is an indication of how far a manufacturer goes to ensure high quality standards. Compliance creates trust between regulatory bodies, healthcare providers, and patients. It serves as a measure of commitment to the set standards and an assurance of quality.
It is a Risk Mitigation: Servicing is a form of risk management. Through analyzing and applying the appropriate statistical methodology to service reports, as required by QSR, manufacturers can uncover emerging trends or persistent issues. It ensures that any risks are caught and addressed before they become a problem. By addressing these issues as soon as they are recognized, manufacturers can avoid anything going wrong with the device which will reduce the possibility of causing harm to a patient.
Post-Market Surveillance: This process typically requires monitoring how well medical devices are performing within the economy. The systematic collection and analysis of data allows manufacturers to understand how devices are performing, detect signs of equipment failure early, and take corrective measures in a timely fashion when required. Continuous monitoring is also valuable, as it helps manufacturers to react quickly to new safety concerns which ultimately contributes to ensuring the performance and safety of devices.
Servicing incorporated into Complaint Handling & Reporting
Service reports are treated as complaints under the QSR. The event must be reported to the Food and Drug Administration (FDA) and therefore automatically classifies as a complaint if it is identified by a service report. This requires that manufacturers also manage service reports accordingly at the same standard as complaints.
This is all about deep down, looking on root cause and taking corrective & preventive actions. Integrating servicing with complaint handling and reporting processes, manufacturers establish comprehensive post-market surveillance that delivers improved patient safety and regulatory compliance.
Key Data in Service Reports
The quality of your service reports is only as good as the data inside. They must include:
Machine Serviced Name
Unique Device Identifier (UDI) or Universal Product Code (UPC)
Additional Device Identification and Serial Numbers
The Date of Service
Information of People in charge to Service
Description of the Service Rendered
Data for Testing and Inspection of the Serviceable Device
Servicing is much more than just a play; it is an essential aspect of servicing providers’ obligation to provide proper patient care and the quality of their equipment. It is a covenant to get those devices to what they need to do, and keeps them doing it effectively over the life cycle of that device. It is also a pledge of transparency, trust and compliance with all the requirements of the law.
Conclusion: The Covenant of Servicing in Healthcare
Adopting servicing as part of a quality management system solidifies the reliability and assurance in medical devices.) Both parties will trust each other and this increases the reliability and safety of the healthcare infrastructure.
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