August 9, 2015
Hardly a week goes by when your smartphone or personal PC doesn’t ping you with another update required to keep it functional and secure.
Likewise, medical devices that enable patient care need regular patches, updates and upgrades to keep patients safe and the data they carry accurate and secure.
The difference, of course, is that medical devices present four added obstacles:
- They’re FDA-regulated machines whose software updates can throw them out of compliance and harm patients if applied incorrectly.
- Their updates and upgrades often sit behind a few manufacturer-controlled hoops – often at a high price.
- Updates & upgrades may not be cost-effective or in the best interest of your facility and patients.
- Mismanaged changes can sink a lot of dollars in your facility.
Read on for eight best practices (and potentially big savings) for medical equipment updates and upgrades.
1. Research before purchasing.
Upgrades can be high-dollar purchases, often costing thousands of dollars each. Prior to upgrading, make sure it’s right for your organization and situation. Consider the age of your equipment, the cost of the upgrade, your upgrade history and contract options. If a contract option is to be considered, it’s important to get the upgrade schedule in writing from the manufacturer before the purchase.
2. Negotiate upfront.
Before an equipment purchase, be crystal clear with vendors about what updates and upgrades are included. If possible, negotiate for all updates, software keys and codes to be included over the life of your equipment.
3. Buy only what you need.
Ever heard of “vaporware”? That term refers to hypothetical, future software updates that may never be created. It often doesn’t make financial sense to purchase inexistent software upgrades in advance, so don’t include them in your service contract.
Instead, wait for the upgrade to be created, then evaluate its worth to your organization. An exception to this rule may be specialty devices: those with well-documented histories of frequent upgrades, which would cost you more to purchase individually, as opposed to the contract coverage option.
4. Work closely with your IT/IS department.
Anti-virus issues are one of the biggest challenges clinical engineering departments face today on software-driven medical devices. Running an after-market anti-virus program on a medical device could potentially alter the function of the device and throw it out of FDA compliance. That scenario would not only put patients at risk, but potentially corrupt the device’s output and the data stored in it.
To avoid those issues, partner with IT/IS to research software changes with the manufacturer before installation. (A good rule of thumb is that the software change must be regression-tested and okayed by the manufacturer first, so don’t go applying just any anti-virus or encryption software to any medical device.)
This is one of the areas clinical engineering and IT/IS must work together. A close partnership between the two competencies will help you remain proactive in managing critical equipment, stay in compliance, and improve Environment of Care standards in your specific clinical environment.
5. Remain safe & compliant.
Beyond the FDA compliance considerations mentioned above, it’s wise to be proactive in seeking out equipment alerts, hazards and recalls that may require an update. While OEMs should keep you informed of these items, it’s in your best interest to seek out information regularly. The ECRI Institute and MedSun Medical Product Safety Network on the FDA website are two good resources.
6. Keep detailed records (including downtime).
Track and analyze your equipment’s service history in your CMMS, and leverage it for future purchase and upgrade discounts. Be sure to also track equipment downtime and the time your in-house technicians spend troubleshooting issues. Use that intel in future negotiations.
7. Follow back-up procedures.
Save yourself time and grief by backing up your current system before installing an update or upgrade. That way, if failure strikes, you can re-install from the backup, including configuration details and prior changes that would be missing from an original installation disc re-build.
Many backup options exist, and this is another key area in which to partner with IT/IS for additional savings. Note that it’s imperative to retain all original software, update and upgrade installation disks on-site. Replacement disks often cost as much as the originals.
8. Partner with an unbiased, independent service provider.
When purchasing equipment, updates or upgrades, make sure your decision is based on data – not hunches, personal preferences or a compelling sales pitch by the manufacturer. Inviting a vendor-neutral service provider to the decision-making table can ensure all purchases are high-ROI ones that truly reflect the needs of your organization and waste no money or resources.