Best practices for managing medical device launches

As technology advances seem to develop at the speed of light, healthcare delivery facilities continue to upgrade their technology to improve the quality of patient care and the delivery of critical services. However, the process of introducing new medical devices is not as simple as the installation of the device.

Successful implementation of the device will make the difference between seamless conversion and poorly performed devices, thus interfering with the delivery of patient care.

The importance of a purposeful and accurate plan

Successful medical device deployment begins with stakeholder participation. Stakeholders include clinicians, IT departments, facility representatives and hospital administrative representatives. These stakeholders have a wide variety of work and perspectives and understand the ins and outs of their personal needs. This approach ensures that the entire organization is involved in the deployment and is tailored to the needs of the people who use the equipment every day.

Details are required when creating a deployment schedule. It is best to work backwards from clinical requirements including training windows, exam periods and integration tests. The best project managers know that healthcare environments are full of unknowns, so they build the buffer era to every stage. Instead, the best suppliers are real partners, not just suppliers.

The Procurement/Procurement Department must define the objectives and reporting levels in the Service Level Agreement and establish clear communication channels. Ideal suppliers are experienced and can provide guidance during implementation.

The ins and outs of compliance

Healthcare equipment deployment comes with unavoidable risks that must be prevented. Here are a few steps hospitals can take to ensure they are compliant:

• Perform a thorough failure mode and effect analysis of each device to determine how it fails and affects patient care and provide a backup plan in case of failure.
• Plan for each risk, describing the controls achieved when an event occurs. The most preventable risk factor is communication failure.
• Create clear paths to upgrade and make sure that clear command lines make decisions quickly. Daily status meetings may find smaller issues before they become bigger issues. For example, we installed an anesthesia machine in the operating room in one of my high priority projects. Technical personnel are required to work outside of regular working hours. To ensure smooth and efficient communication before and during installation, I created a group of text messages with key members directly involved in the deployment project. As a project manager, I regularly update all stakeholders via daily emails and weekly meetings. This approach allows everyone to stay connected and informed based on their level of engagement throughout the process and their need for awareness. During deployment, patient safety is always an issue. They can only be used in actual patient care after mimicking the use of new devices in a clinical setting.
• If all legal and regulatory requirements are not met, the use of medical equipment cannot be implemented. This is where Procurement and Information Security (IT INFOSEC) plays a critical role in ensuring access to all necessary documents to confirm that the product complies with relevant standards and regulations (including FDA guidelines) if applicable. This process also includes reviewing the embedded software and verifying manufacturer compliance. This document is important for regulatory review and support budget basis and future upgrade plans. In my current position, our project team ensures that the equipment meets all legal and compliance requirements before posting a purchase order. From there, if any software updates are required, we evaluate whether they are performed by the vendor or processed internally and determine deployment methods, especially when processing sensitive patient data to comply with HIPAA regulations.
• Verification is the process of checking whether the device can work as intended in your specific environment. It is also necessary to check how the equipment may operate under normal conditions and abnormal conditions that may occur during use. For example, high-priority devices (such as ventilators, patient monitors, etc.) need to back up the battery in the event of a power outage. Once the device is in real time, the technical and clinical team should sign it to show that the device is good in terms of performance and user expectations.

Labor training and adoption

The effectiveness of even the best medical technology depends on its proper use. Therefore, it is important to meet people they are and provide training at different methods and technical maturity levels at various stages.

Several ways to do this are to provide practical training courses, tutorials, and micro-learning segments. Superusers selected from staff provide additional training and support to other members of the department to ensure continuity of knowledge within the department. These people will use to translate the device and its technical language used into everyday language that clinicians will understand and use.

A competency test should measure the effectiveness of this training. These should be based on the actual use of the product and factors not only in technical use, but also on how it is integrated into the current workflow. In my workplace, deployment is not possible unless 80% of the employees who will use the equipment successfully complete the training. The trainer also retains records of attendees who participated in the training to perform training compliance.

It is important to have support materials such as quick reference guides and troubleshooting guides to ensure that users can maintain the necessary level of competency even after completing the training.

The deployment process will generate data that can be used for future deployments. This data should include timelines, costs, delivery processes and user satisfaction during the implementation and implementation phases. They allow quantitative analysis of the device rollout and help evaluate where there is room for improvement. The 30-day, 60-day and 90-day review after implementation is critical to addressing new challenges and assessing changes in clinical performance. Comments must be based on input from end users who spend the most time on the device, so information that may be relevant to the project management team can be provided. Needless to say, the use analysis of the deployed device will help further improve the device. These analyses reveal whether unused features may require more training, or whether there are unexpected usage patterns that may indicate poor workflow or unmet needs.

Medical institutions cannot stop their patient care during equipment replacement. Strategies that can be implemented to avoid interference and ensure that each clinical department can continue its operations during deployment, including temporary dual systems, step-by-step implementation of departments, implementation phases, or integration of new systems during peak periods. Data backup is also a critical process that helps minimize risks encountered during the transition process. Instead, the downtime procedure, as well as the simulation options for digital systems and any emergency action plan should be detailed.

Medical device deployment is a process of combining new technologies with existing organizational structures without disrupting patient care. Effective rollout strategies include planning, stakeholder management and performance monitoring to ensure that healthcare organizations can integrate new equipment without compromising service quality.

Photo: Chanut Iamnoy, Getty Images

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