A Model Center for a fully automated in-house calibration lab by the biomedical engineering dept.

Abstract

This article explores the remarkable journey of the Biomedical Engineering department at Christian Medical College, Vellore, as it transitioned from manual calibration to full automation, becoming a model center for in-house calibration. The institution’s pursuit of excellence led to its accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL), showcasing its commitment to patient safety, cost-effectiveness, and efficiency. The article highlights the challenges and benefits of this transition, emphasizing the profound impact of full automation on the healthcare sector. With plans for further expansion and proficiency testing in the pipeline, this institution is poised to set new standards in the industry.

Introduction

In the ever-evolving landscape of healthcare, ensuring patient safety, reducing downtime, extending the lifetime of equipment, increasing efficiency, and cutting maintenance costs are paramount. An often-underestimated component of this equation is the calibration of medical equipment.

The journey from manual calibration to full automation has been one of transformation for many healthcare facilities, and one such institution that has undergone this metamorphosis is highlighted here.

The Backstory

In 2010, a notable medical institution embarked on a mission to recalibrate its approach to equipment calibration. Outsourcing the task proved to be an expensive endeavour, with high charges for the minimum quantity of equipment. The calibration performance also fell short of expectations. In 2011, the institution’s Biomedical Engineering (BME) department decided to take matters into its own hands, planning for an in-house calibration facility equipped with six analyzers.

The Manual Calibration Phase

2012 saw the initiation of manual calibration. Although a significant step toward control, this approach was still far from the efficiency and accuracy the institution sought. The subsequent years from 2013 to 2016 marked the semi-automation phase with the implementation of the “ANSUR” software.

A Leap Towards Full Automation

It wasn’t until 2017 that the institution saw remarkable progress. Accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) for medical device calibration, the institution deployed six advanced analyzers covering nine categories of equipment and 24 parameters. Additionally, the institution’s association with the development process of OneQA with Fluke paved the way for full automation.

The Revolution Unveiled

In 2022, the institution witnessed a paradigm shift in its calibration process. The evolution from pre-automation to post-automation was nothing short of a revolution.

The evolution from pre-automation to post-automation was nothing short of a revolution. Here are the key highlights and the challenges faced:

Pre-Automation

Step-by-step procedures with multiple connections and reconnections.

• Manual capture and verification.
• There is no restricted access.
• Manual approval and calculation.
• Written reports with manual uploads to the server.
• Dedicated data storage server.
• Template design limitations as per NABL or ISO standards.
• The occurrence of possible manipulation of reports.
• Limited capacity – 2,000 pieces of equipment per year.
• Time-consuming with an average of 30 minutes per piece of equipment.

Post-Automation

• Fully automated procedures with one-time setup and auto-advance sequences.
• Auto capture and evaluation.
• Complete password protection.
• Automated verification algorithm.
• Auto-generated reports are integrated with Computerized Maintenance Management Software (CMMS).
• Cloud-based storage.
• Template customization meets NABL or ISO standards.
• Nil manipulation – one report per piece of equipment.
• Increased capacity – 6,000 pieces of equipment per year.
• Significantly reduced time with an average of 7 minutes per piece of equipment.

Cost Effectiveness

The transition from manual to automation brings about cost-effectiveness. The initial investment in automation software results in an impressive return on investment from the first year itself.

The manpower required for calibration is significantly reduced. A single software is used for all master analyzers, with a single license catering to 100+ users. Accessibility is facilitated through the cloud, eliminating dependence on specific PCs. Moreover, software upgrades are provided free of charge until the license’s validity expires. This cost-effective approach is particularly suitable for medium and large-scale healthcare facilities.

The Impact and the Way Forward

The impact of full automation in medical equipment calibration is undeniable. It streamlines processes, reduces costs, and enhances patient safety. As part of its roadmap, the institution plans to achieve full automation with calculations and aims to become the first hospital calibration facility in Asia to achieve full automation of the process. Additionally, the institution has been awarded accreditation by NABL for mechanical and thermal parameters. In 2023, the institution sets its sights on implementing full automation in lab equipment calibration and becoming a Proficiency Testing Provider for Medical Devices in 2024.

Conclusion

The journey from manual calibration to full automation of medical equipment calibration is a testament to the dedication of healthcare institutions to ensuring the safety and well-being of their patients. This transformation not only reduces costs but also paves the way for more efficient and accurate medical equipment calibration, ultimately benefiting the entire healthcare ecosystem. With these milestones achieved and plans in place, this institution is well on its way to setting new standards in the industry.