6 Factors To Consider When Performing Software Updates For Medical Equipment
Just as your smartphone and computer rely on regular updates to function properly and benefit from added features, today's medical equipment requires software updates for enhanced performance and usability. Modern medical devices also rely on software patches to fix issues found in older versions of medical devices.
No matter what type of software update your medical devices need, extreme care should be taken throughout the entire process. There are numerous factors that could mean the difference between a successful software update and one that causes significant delays and excessive costs.
1. Patient Safety
Patient safety is always paramount when dealing with any type of medical equipment. No software update should ever compromise the safety features of your medical equipment or interfere with your ability to keep patients safe while using said equipment. When pushing software updates, be aware of any safety alerts or recalls for medical equipment in need of an update.
Staying in compliance with the latest FDA regulations is also paramount when dealing with software updates for medical equipment. Software updates pose a special challenge, as the current regulatory approval process for bringing new drugs and medical devices to market can stymie faster-paced software development and result in updates that are perpetually out-of-date. Fortunately, efforts are being made to speed up the process without negatively impacting regulatory and patient safety concerns.
Minor software changes, including the addition of anti-virus or encryption software to medical equipment, could potentially take the device out of compliance. Regression testing is essential for ensuring that such changes do not cause compliance issues when implemented.
Compatibility is yet another factor that should be considered when performing software updates. A software update should not interfere with a medical device's ability to interact and interface with other equipment. Any potential incompatibility issues should be studied and rectified prior to pushing the software update.
Medical facilities are often a mix of networked and standalone devices. It's easy for unconnected devices to miss out on updates pushed to networked equipment, resulting in an inconsistent end-user experience. Coordination is the key when delivering software updates, even if it means dispatching field engineers for manual updates of standalone equipment.
During remote upgrades, it's up to the medical staff to ensure the updates are applied correctly to the right devices. All equipment slated for remote updating should be put into service mode before any patches are pushed to the targeted devices.
In today's interconnected world, the need for effective cybersecurity takes center stage. Hackers often target systems that are inadequately patched or kept deliberately out-of-date, since these systems lack the robust defenses offered through regular patches and software updates. Keeping up with the latest patches can help prevent unauthorized access to medical equipment and patient data.
Whether software upgrades take place on-site or remotely, engineers or other personnel must have the proper authorization and authentication to access and patch the targeted medical equipment. Accountability is also crucial from a security and regulatory standpoint. All software upgrades should have an established audit record detailing the persons involved in the software update and their credentials, among other crucial information.
As any computer or smartphone owner can attest to, even the most straightforward software update can behave in unpredictable ways. Unexpected errors in the software patch, operating system or low-level equipment hardware can lead to inoperative devices. External problems such as power outages and network interruptions can also cause catastrophic failures during an update.
Backups are essential for ensuring your medical equipment can be reverted back to a normal operating state in case a software update or upgrade goes wrong. System backups should always be done before pushing any patch or upgrade through. All backups should also contain configuration data for the devices you're updating since original installation discs lack the configuration data needed to restore custom settings and details.
Reach out to a place like Ultimate Biomedical Solutions for your medical equipment repairs, whether their software or the machinery itself needs adjusting.