By James Jernigan
How would you define a medical equipment software update? How about a software upgrade? Have you found that answering these questions is not so simple? You are not alone. It is very difficult to define software updates versus upgrades because the answer varies based on the industry source, the type of device, and the subjective description of the changes involved with each. However, it is incredibly important that we understand these terms, because the difference between an update and upgrade could mean many thousands of dollars spent—or saved—for your organization.
A software update often includes changes to software that address safety-related issues or correct the performance or capability of features that already exist on the platform. When a service agreement is in place, the original equipment manufacturer (OEM) often provides non-safety-related software updates. However, be aware its response and inclusion can vary depending on the level of coverage your clinical/biomedical engineering department has purchased.
A software upgrade provides new capabilities to the platform and is usually sought via a capital purchase. Many times, manufacturers use “free” or reduced-price software upgrades as an enticement to purchase an equipment service agreement. It is important to note that software upgrades vary greatly by manufacturer and device. For example, software upgrade options for imaging systems will likely be very different from those for a patient monitoring system. Imaging system software changes can change the dose or treatment of patients, while the monitoring system changes often improve the user interface and efficiency of monitoring.
In many cases software updates are free to the customer even without a service contract, especially if they are patient safety-related. One example includes a fairly recent software update of the software on external defibrillators. The device’s software self-test to ensure proper function did not always detect defects in some electronic components, which could lead to failure. The company issued a software update for the device’s self-test, which improved the device’s ability to detect electrical component defects.
For software upgrades, there is almost always an associated cost. It is important to examine each available software upgrade and decide whether it will truly benefit your organization. You may find some software upgrades offer great value. Many software upgrades increase patient safety, improve patient throughput, and enhance the capabilities of the equipment. For others, however, the true benefit may be questionable and a detailed return-on-investment analysis is needed. If you forgo a recommended software upgrade, you may be taking some risks—potentially losing ground to competition, sacrificing cutting-edge quality (especially with imaging equipment), or jeopardizing interoperability. And while in some cases these risks may be worth taking, it is different for every health care facility and it depends on its strategy, mission, and goals.
Software upgrades are typically optional, but note that some are required. For example, concern over radiation exposure from imaging devices continues to escalate, generating alerts and industry action. Specifically, many OEMs’ CT scanner software upgrades will need to be rolled out, causing any scan that exceeds the maximum routine dose to alert or warn the operator, or even prevent the scan from proceeding. This is a change to the operation and function of the CT software in that the dose information was previously available on the systems, but the systems would not automatically take action based on those readings.
A software update often includes changes to software that address safety-related issues or correct features that already exist on the platform.
Another note to be aware of is that while software updates and upgrades are typically separate, this is not always the case. There is a great deal of ambiguity and “legalese” differentiating software updates and upgrades, and even hardware updates and upgrades. It is not always clear, so it is imperative that you understand what would be included in a service contract, as well as the warranty, before making a purchase.
These are complex issues, ones that can become confusing and overwhelming even for industry professionals with decades of experience. As you navigate the sometimes-murky waters of medical equipment software, keep the following in mind:
* Negotiate up front. Before an equipment purchase, be very clear with vendors about what updates and upgrades are included. If possible, negotiate that all updates and software keys and codes be included over the life of your equipment.
* Only buy what you need. It often does not make financial sense to purchase software upgrades in advance, and therefore you should not include them as part of a service contract. When you purchase upgrade options in service contracts, you are purchasing software that does not yet exist, and may never exist (sometimes called “vaporware”). It is often best to wait for the upgrade to be created, and then evaluate its specific worth to your organization. Specialty devices are sometimes the exception to this rule, those that have well-documented past schedules of frequent valuable upgrades, which would result in a greater cost to purchase each upgrade individually, as opposed to the contract coverage option.
Prior to upgrading, consider the age of your current equipment, the cost of the upgrade, your upgrade history, as well as the contract options.
* Research before purchase. Software upgrades can be large purchases, often many thousands of dollars each. Prior to upgrading, be sure it is right for your organization and situation. Consider the age of your current equipment, the cost of the upgrade, your upgrade history, as well as the contract options. If a contract option is to be considered, it is important to get the upgrade schedule in writing from the manufacturer before the purchase.
* Work closely with your IT/IS department. Anti-virus program issues are one of the biggest challenges clinical/biomedical engineering departments face today on computer-based medical devices. Running an after-market anti-virus program on a medical device could potentially alter the function of the device, and this needs to be researched with the OEM before installation. This is one of the areas in which clinical engineering and IT departments must work together. Many times one department does not fully understand the intentions or impact of the other, so open communication is necessary. A close partnership with IT will help you remain proactive in managing critical equipment, stay in compliance, and improve Environment of Care standards in your specific clinical environment.
* Keep detailed records, including downtime records. Track information in your computerized maintenance management system (CMMS) to analyze the service history, and leverage it for future purchases and upgrade discounts. Be sure to track system downtime, as well as the time in-house technicians invested in troubleshooting equipment issues; you may be able to use this data in future negotiations. One Indiana-based health care organization successfully negotiated a reimbursement from the OEM based on downtime, and another Arizona-based health care organization successfully negotiated a significant extension of the warranty with the OEM; both due to keeping detailed records on downtime and service history in their CMMS.
It is highly recommended that you back up your current system before a software update or upgrade is installed.
* Follow back-up procedures. It is highly recommended that you back up your current system before a software update or upgrade is installed. That way, if the system fails you can reinstall from the backup, which includes configuration information (as well as prior updates and upgrades) that would be missing from an original installation disc rebuild, minimizing downtime. Many computer backup options exist, and this is another key area in which to partner with your IT/IS department for additional savings. However, it is imperative that the original software installation disks, as well as the disks needed to install prior software updates and upgrades, are all retained on-site. Replacement disks will often cost as much as the original purchase.
* Remain compliant. Though OEMs should let your facility know about alerts, hazards, and recalls that may necessitate a software update, it is a good practice to be proactive in seeking out this information to help ensure patient safety. The MedSun Medical Product Safety Network on the FDA website is a great resource to use.
* Partner with an independent consultant. When making equipment purchases that may include future updates and/or upgrades, make sure you have the right people at the decision-making table. Inviting an independent consultant to be part of your capital equipment project ensures that no one particular party moves too quickly without a proper review of the purchase, and that everyone’s interests and needs are taken into account for the final decision.
In the future, perhaps industry stakeholders will work together to decide on and promote consistent definitions for medical equipment software updates and upgrades. In the meantime, remember that success with updates and upgrades is almost always contingent upon how well the organization negotiated up front, and how well the clinical/biomedical engineering department is integrated into the entire medical equipment life cycle. 24×7 Service Solutions March 2013
James Jernigan is the director of national field service, training, and technology for TriMedx, a clinical engineering and technology asset management consulting firm headquartered in Indianapolis.
Updates and Upgrades: The Bottom Line
Software updates can address safety-related issues and are often free, while software upgrades usually come at a price. A checklist can ensure you ask the necessary questions and cover the important points before proceeding:
• Before purchasing, negotiate that all updates be included for the life of the equipment.
• Do not purchase software upgrades in advance.
• Research the upgrade before purchasing, and be sure it is 100% right for your organization.
• Work closely with your IS/IT department to ensure you remain compliant when implementing upgrades or updates. The MedSun Medical Product Safety Network on the FDA website can provide information on alerts, hazards, and recalls. ()
• Track downtime and time spent troubleshooting—information that can empower you in future negotiations.
• Partner with an independent consultant that can make sure everyone’s interests are equally represented at the decision-making table.