Automation is a growing trend in the healthcare industry. Due to this fact, the need to use connected medical devices also is evolving. But the problem is in the connectivity and accessibility of the data from those devices. In this article, we'll explain what standards and challenges has medical device interoperability and how they enhance patient care.
- What does interoperability mean in healthcare?
- Why is interoperability important in healthcare?
- What are the challenges of medical device interoperability?
- Medical device interoperability standards
There are a lot of ways to make the medical device industry more innovative and patient-centric. There are currently a host of wearable devices including self-controlled and remote diagnostic applications, doctor appointment portals, remote consultation opportunities, and others for outpatients. However, when it comes to in-hospital care for serious patients, the interoperability of the medical devices is a more critical concern.
In this article, we are going to explain the importance of this concept and the way it can improve the level of care for your patients.
What does interoperability mean in healthcare?
Interoperability in healthcare is the process that enables medical devices and other systems to interact with each other in real-time. For example, a patient may have special equipment such as a Holter device for continuous measurement of blood pressure and heart rate. If there are interoperability opportunities, the device may track and send vital information right to the patient’s electronic health record (EHR), and to the applications used by attending physicians so they will be notified immediately if the patient's vital signs become critical.
Medical diagnostic device interoperability excludes the need for manual data sharing which reduces the risk of errors. However, according to a report by West Health, 90% of medical institutions use six or more devices that could potentially be integrated with EHRs, but only 30% of the facilities make use of this opportunity and therefore miss out on crucial benefits to the hospital’s operations and patient care.
Interoperability vs. connectivity of medical devices
There is a difference between medical alert devices’ interoperability and connectivity. There is no interoperability without connectivity, which is a simple feature that allows medical devices to be connected to communicate with each other.
Medical device interoperability affords smart interactions, and instant data sharing, processing, and analysis.
Why is interoperability important in healthcare?
The largest medical device companies have long appreciated the importance of medical device interoperability. In practice, this opportunity offers the following benefits:
- Better data management. When it comes to data management, there is no better solution than a system that puts data on virtual shelves automatically. Depending on how your devices and systems are programmed, you can more effectively manage your data as required by your hospital.
- Error reduction. When the data is automatically transferred from a wearable or implanted devices into a patient's electronic medical record (EMR), you eliminate the risk of human data entry errors, and the doctors get the opportunity to work with real-time information on the patient's health so they can make fully-informed decisions.
- Saves time. When medical devices and systems are interconnected and interoperable, doctors can save time that was spent on data transfer and analysis, and focus on caring for patients. A lot of time and effort can also be saved with the help of remote monitoring features wherein the medical device, the EHR system, and the doctor’s application are connected and able to interoperate and send and receive instant alerts on a patient's health conditions.
What are the challenges of medical device interoperability?
According to experts, the issue of medical monitoring devices and their interoperability with other systems and solutions is a challenge in itself. However, there are some major points to pay attention to if you want to make your medical devices and systems compatible with each other.
- The safety challenge. The issue of safety comes first whenever there are data sharing and transfer possibilities so there are some standards for medical devices the Food and Drug Administration (FDA) has approved.
- The outsourcing challenge. There are a lot of technically specific and costly issues to be addressed to make the best medical alert devices compatible, integrable, connectable, and interoperable with each other. That’s why top medical device companies are looking for outsourcing opportunities that match the cost with the quality of medical device product development.
- Control and management challenges. If some medical devices can interconnect with others, is there a hidden threat here? For example, if we are talking about implantable medical devices based on the Internet of Things (IoT) technology, can it be controlled from the system it shares data with? Such control is possible, and that poses a threat to patients in the event of unauthorized access to the shared system.
Medical device interoperability standards
When it comes to medical device interoperability, the core standard which applies to the field is the ANSI/AAMI/ UL 2800-1: 2019—Standard for Safety for Medical Device Interoperability. This is the document that highlights the most essential issues to take into account when it comes to medical data transfer and sharing between devices and systems. Its core rules concern the issue of cybersecurity. It also establishes must-follow practices for medical device manufacturers to leverage security risks and come up with easily integrable solutions.
Here are some additional medical device regulations that should be followed:
- The Standard for Medical Devices – Application of Risk Management to Medical Devices ISO 14971
- Standard for Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, IEC 60601-1
- The Application of Risk Management for IT Networks Incorporating Medical Devices, IEC 80001
It’s clear that making the devices used in your hospital interoperable is a difficult technical task that requires your development vendor to have a lot of experience with the creation of medical solutions, and obliges the company selected to be completely involved in your operational process. That’s why you should be careful when looking for medical development companies near you as there is nothing more important than the life and health of patients. We at Cprime Studios take medical development seriously, and we would be happy to assist you with your medical device interoperability issues.