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Why Regulation Updates Don't Need to be a Headache

Posted by Mike Roggmann on Oct 23, 2014 11:27:00 AM

In Data Management, Departmental Communication, Safety, Compliance



As much as I loved being a Biomedical Engineer and Safety Officer in a former life, I could still spend the next day ranting about the daily headaches biomeds face. But for whatever reason, regulation update annoyances stick out to me like a sore thumb. With so many regulatory agencies infiltrating our brains with a never-ending stream of confusing jargon, it can seem impossible to stay on top of every update. This led me to ask myself, how can Biomedical Engineers keep up with all of the changing regulations without causing themselves constant headaches?

Lost in translation

I don't know about you, but there have been times where I would have rather jumped into a pool of snakes than sit down to decipher the newest regulatory release document. After sifting through the gibberish, I usually found myself wondering if this would be easier with a law degree. Despite this, it is critical to understand what it really means. What does this change mean for my team? How can we ensure that we are complying with the regulation? How does it affect my day-to-day activities? Are these changes sustainable and good long-term decisions for our hospital?

Always stay

It is true that regulatory agencies have gotten better at providing comprehensive documentation, but I have found that confusion inevitably arises with each new update. For example, about two years ago, Centers for Medicare & Medicaid Services (CMS) issued a regulatory compliance change regarding Preventative Maintenance scheduling. CMS stated that everyone would have to utilize the equipment’s exact Manufacturer requirements rather than the Hospital’s experience. The buzz about this change spread like wildfire across the biomed community and everyone, of course, had an opinion. This is going to increase the cost of healthcare in the long term! This is definitely not sustainable! Why should we follow these requirements when the Manufacturers don’t?

Pushing back

Figuring out how to comply with the new rules can be quite confusing, and it is important for your department to seek clear direction from CMS or any other agency issuing updated requirements. Learning what the regulatory update requires and which medical products are impacted by the new requirement are among the first steps to take. In the previously referenced example, CMS ultimately instituted a standard stating that if no history was available for the equipment, then biomeds should follow the Manufacturer requirements. But, if device history was available, you would be able to designate the historic processes as the Alternative Equipment Maintenance. This means that for well-documented processes and histories, no change was necessarily required. This is a perfect example of why it is so important to take the time to understand each update.

Effective Implementation

I actually ended up agreeing with this amended process (amazing, huh?) and think it forced our department to evaluate our Preventative Maintenance scheduling standards. The coolest thing about this change was that larger health systems could still pull equipment history from their vast database if they wanted to. One of the key changes that this requirement had on the day-to-day life of our biomeds was ensuring that Alternative Equipment Maintenance schedules made it into the system. This case was a testimony to how important it is to stay on top of these types of changes, understand them in detail, and ensure that you push back when appropriate in order to implement the most efficient process.The last thing you want is to be audited and unprepared. While it is important to educate yourself on the changes, make sure that your department is also taking action to be fully accountable if an audit were to take place.


Regulation updates no longer need to be headaches!



Are you a Mainspring client? Here’s a quick tip on flagging your Alternative Equipment maintenance within Asset Enterprise.


Quick Tips on AEM Flagging