By K. Richard Douglas
Buckminster Fuller, the American architect and designer, once noted; “You never change things by fighting the existing reality. To change something, build a new model that makes the existing model obsolete.”
This may be why certain individuals gain prominence for thinking outside the box. There is often a way of doing something that has historical precedent or time-tested substantiation. In medicine, there is evidence-based medicine that provides clinicians with guidance based on the efficacy of a procedure or therapeutic in the past.
Biomeds have their own evidence-based maintenance that many utilize. The procedures used fall under compliance requirements set forth by regulators. Yet, testing alternatives, when the circumstances demand it, can provide solutions that are workable.
The COVID-19 pandemic challenged biomeds on many levels. It increased the patient load for most hospitals substantially, it restricted access to patients and required a more general use of PPEs and an increased need for respirators and ECMO machines.
At one hospital, one of these pandemic-related challenges was the combination of the numbers of patients being treated with the inability of biomed to access beds for scheduled PMs. How would they inspect, maintain and repair the beds if they had no access? Was there a viable alternative?
“Faced with an increased patient census, after COVID restrictions were lifted, we found ourselves unable to access the VersaCare beds and had to postpone our original equipment manufacturer (OEM) preventive maintenance (PM) schedule,” says Mark Cooksey, DME quality engineer at Norton Healthcare in Louisville, Kentucky.
An internal audit resulted in a non-conformance in this area. Faced with having the routine method of inspecting the beds impeded, a quick assessment was in order to devise an alternative approach that would assure that the beds were being maintained and the procedures adapted met scrutiny.
The situation led to some important questions. Did the OEM schedule actually prevent failures? Could beds be put on a repair-as-needed (RAN) schedule without incurring the risk of increasing repair downtime?
“To validate this observation, I conducted a statistical analysis using the Chi-Square test. (A Chi-Square test is a statistical procedure used to determine if there is a significant difference between the observed and expected frequencies of the outcomes. In this case, we looked at the number of bed repairs following the OEM versus the RAN PM schedule.) The results revealed no statistically significant difference in the rate of repairs between the OEM PM schedule and the repair-as-needed (RAN) approach,” Cooksey says.
What happened in confronting this challenge, and the information learned, was put into a 2023 MD Expo presentation by Cooksey, which he delivered at the event in Orlando, Florida.
The challenge of non-conformance, and the search for a solution, leaned on Cooksey’s lengthy Lean Six Sigma training and experience.
Lean Six Sigma is a process improvement methodology that seeks to improve performance by systematically removing operational waste and reducing process variation. It is a combination of Lean Management and Six Sigma.
One of the principles of Lean Six Sigma is to focus on the problem and that is what Cooksey did.
“Not every nonconformance necessitates the full application of a Lean Six Sigma project. We often select tools from our Lean Six Sigma toolkit based on the complexity of the problem at hand. The issues identified with the bed PM nonconformance, tied to a surge in patient census following the easing of COVID restrictions, made it a suitable candidate for a more comprehensive application of the Lean Six Sigma tools,” Cooksey says.
He says that recognizing the surge in patient census as a key factor impeding the department’s preventive maintenance schedule, they decided to leverage their experience with Lean Six Sigma to develop a comprehensive response.
“We assessed the risks using Lean Six Sigma tools, ensuring patient safety and equipment reliability while adapting to the restricted access to preventative maintenance,” Cooksey adds.
Non-Conformance as a Catalyst
The biomed team members at Norton Healthcare hold themselves to high standards. When their audit discovered a problem, meaning non-conformance, that was not an acceptable status. Cooksey suggests changing perspective on this scenario and seeing a non-conformance as an opportunity for improvement.
“Non-conformances can emerge in a multitude of ways: a defective part or vendor service, a customer complaint, an audit finding, or a deviation from standard work instructions. If a non-conformance requires additional investigation, a formal CAPA (Corrective and Preventive Action) is generated. Our department views any non-conformance as an opportunity for improvement, aligning with our commitment to ISO 13485,” Cooksey explains.
He says that in this case, there was also a cost/benefit analysis of the PM.
“Upon identifying a non-conformance, our immediate step is to evaluate the associated risk. This evaluation helps us understand the severity and potential impact of the non-conformance. We then conduct a root cause analysis to understand the underlying issues. This analysis is crucial in identifying the factors contributing to the non-conformance,” Cooksey says.
At this point, corrective and preventive actions can be formulated and applied.
“Guided by the root cause analysis, we devise immediate corrective actions to address the current non-conformance. Additionally, we establish long-term preventive measures to avoid recurrence of similar non-conformances in the future. In essence, our department’s initial response to any non-conformance is a systematic approach that not only addresses the immediate issue but also aims to prevent future occurrences. This approach underscores our commitment to continuous improvement and quality assurance,” Cooksey says.
ISO 13485 as a Guide
In addition to applying Lean Six Sigma principles to the evaluation of the problem, and search for a solution, the team applied ISO 13485 QMS procedures as a guiding standard.
“Relatively few in-house medical device service organizations have achieved ISO 13485 certification, yet it provides a universal structure for maintaining high standards of quality and compliance,” Cooksey says.
He says that the ISO 13485-based QMS helped his team identify the best solution for the VersaCare bed non-conformance. It guided the team in establishing standardized procedures for maintenance and repair, ensuring the safety and performance of the beds. The ISO 13485 QMS provided a framework for identifying and addressing potential issues, minimizing downtime and enhancing patient care. ISO 13485 QMS ensures robust processes for risk assessment, root cause analysis, and implementing corrective and preventive actions.
“In situations like the one mentioned, adhering to ISO 13485 enables us to effectively address non-conformances and maintain the safety and performance of our medical devices, even under challenging circumstances such as a spike in patient census,” Cooksey says.
He says that seeking ISO 13485 certification can provide numerous benefits to a company that services medical equipment, enhancing its reputation, operational efficiency, and customer satisfaction. It’s a strategic decision that Norton Healthcare chose for the following reasons:
- Quality Assurance: ISO 13485 is an internationally recognized standard that ensures a high level of quality in the design, manufacture, and servicing and is specific to medical devices. By adhering to this standard, the company demonstrates its commitment to providing high-quality services.
- Regulatory Compliance: Many regulatory bodies around the world recognize ISO 13485 certification as a mark of compliance with certain regulatory and legal requirements related to medical devices. This promotes consistency across Norton’s different locations.
- Risk Management: ISO 13485 emphasizes risk management throughout the product life cycle, which is crucial in the medical device industry because of potential impacts on patient safety.
- Customer Confidence: Whether your organization is an in-house servicer like Norton Healthcare or a third-party external servicer of medical equipment, certification can enhance customer confidence in the company’s services, as it serves as an assurance that the company follows internationally recognized best practices in its operations.
- Continuous Improvement: The ISO 13485 standard promotes the implementation of a quality management system (QMS) that focuses on continuous improvement, helping the company to continually refine its processes and services.
- Competitive Advantage: Health care organizations operate in a competitive market. Being ISO 13485 certified can provide a significant advantage, as it demonstrates the company’s commitment to quality and customer satisfaction.
Standing Up to Scrutiny
Will the solution stand up to the scrutiny of an audit? That is the last component of the changes instituted to assure continued safety, functionality, cost-savings, resource-utilization and robustness.
The adopted solution must meet muster, reflected in both internal audits and the scrutiny of an accreditation organization’s audit. The use of a tested quality system by the team means that solutions are carefully crafted and more refined.
“Auditors seek evidence of adherence to procedures and continuous improvement, which is documented through our Corrective and Preventive Actions (CAPA) processes. This ensures that all audits can verify our commitment to maintaining high standards and improving patient care,” Cooksey says.
He says that by integrating ISO 13485 into the department’s processes, they facilitate the evaluation of improvements by auditors, whether they are internal or external DNV auditors.
Cooksey notes that before changing the bed PM to a Repair as Needed (RAN) candidate, they conducted a comprehensive risk assessment, considering factors such as potential patient safety, device reliability and maintenance requirements. They evaluated key PM components and subsystems of the bed, such as: bed frame, hydraulics, mattress, control panel, side rails, casters, brakes, power supply unit and motor assembly.
“The VersaCare bed was selected for this approach due to its high usage rate, limited maintenance access, and the availability of dedicated repair resources. These characteristics made it a prime candidate for a RAN approach, allowing us to optimize our resources and ensure timely maintenance,” Cooksey says.
He says that they found that the OEM PM procedure basically consisted of operating the bed, which is done on a regular basis by end-users.
“The bed has built-in diagnostics and safe stop (fail-safe functionality) to mitigate risks. The observation of the OEM PM procedure, and the low risk, further reinforced our decision to designate the bed PM as a RAN candidate. By leveraging the bed’s built-in features and the regular operation by end users, we can ensure that potential issues are identified and addressed promptly,” Cooksey says.
He added that the CE team frequently brainstorm to identify other devices that might benefit from a similar approach, focusing on those that are often in use and thus hinder the ability to carry out scheduled preventive maintenance (PMs).
“Under our ISO 13485 methodology, we work closely with our customers to address potential issues. This involves regular communication, feedback sessions and collaborative problem-solving to ensure we meet their needs and maintain the highest standards of patient safety,” Cooksey says.
He says that this approach helps mitigate potential patient injuries, inconvenience to clinicians, or other possible electrical or contamination problems that could arise if a problem is discovered when the patient is in a bed.
“Our goal is to prevent these issues from occurring in the first place, and we continually review and refine our processes to achieve this. We are committed to continuous improvement and welcome feedback from all stakeholders to help us enhance our PM process,” Cooksey says.
Are there other examples of equipment that might be a good candidate for this approach beyond the VersaCare bed?
“The first step in applying this approach to other equipment is identifying devices with high usage and limited access. Similar to the VersaCare bed, you should evaluate the OEM PM process to understand the preventative measures involved. OEM PMs are designed to prevent failures and potential hazards by ensuring that the equipment is functioning correctly and safely. In theory, regular maintenance can help identify and resolve issues before they become serious problems, enhancing patient safety and device longevity,” Cooksey says.
He says that data analysis is used to answer this simple question: “Does the OEM PM schedule reduce failures and improve longevity?”
“Next, conduct a risk analysis to assess the severity of not performing PMs per the OEM schedule. After brainstorming potential hazards associated with the proposed change,” Cooksey says. “The risk analysis must take the following factors into account:
- Risk Severity: The potential impact of the hazard if it were to occur.
- Likelihood of Occurrence: The probability of the hazard occurring.
- Detectability: The ability to detect the hazard “He adds that medical devices with hazards of low severity, relatively rare occurrence, and that have self-diagnostic capabilities or safe stop functionality are ideal candidates for a RAN PM schedule.”
In the end, evaluating a PM cost/benefit analysis from a risk perspective and a calculation of FTE savings are just two of the considerations in moving from an OEM PM schedule to a repair-as-needed approach.
The old adage that states that “when life gives you lemons; make lemonade” has a real application in the biomed department when the right quality system and problem-solving model can be applied to form a solution.
All of these considerations can help an HTM department apply logic from the experience of the CE department at Norton Healthcare.
Click here to access the MD Expo presentation on this topic.
