Category Archives: Technology

Giving Life-Saving Equipment a Second Chance

Tucked inside DXE Medical’s warehouse, Biomedical Manager Dave Strang troubleshoots a Physio-Control LIFEPAK 15 Defibrillator while typing out an email response to a customer. For Strang, answering questions about life-saving equipment is just one of many tasks he juggles behind the double doors of this white-walled workshop, DXE Medical Inc. in Brentwood, Tennessee.

Whether he’s assisting customers over the phone or via email, training technicians, ordering parts or troubleshooting equipment, Strang has become a jack-of-all-trades in the three years he’s worked at DXE Medical.

“I wear a lot of different hats,” Strang explains after hitting the “send” button and swiveling his chair around to talk more about his role at DXE Medical.

Were you a tinkerer as a kid?

I was always kind of a tinkerer as a kid. And then, in my early 20s, when I first moved to Steamboat Springs, Colorado I was a bicycle mechanic. I like to work with my hands, but I like to think at the same time.

What type of units does DXE Medical, Inc. repair?

DXE repairs all types of medical devices. We specialize in the EMS field — specifically, monitor/defibrillators, infusion pumps, respirators and vital signs monitors.

Can a unit be too old for you to fix? Why?

No, as long as we can find parts or a repair solution, we will repair devices of any age. Of course, we will advise the customer.

Why wouldn’t you want to send it back to the manufacturer?

We are our own repair depot here. There are certain things that the manufacturer won’t sell us — like software in our devices. There are a few manufacturers that we do end up sending stuff off to, but we like to be able to manage everything that we can here first. And only in those situations — where it’s outside of our scope because we don’t have the test equipment, calibration equipment, software or it’s something that requires specific training that we don’t have — that’s when we’ll try to source those things out. But everything else we try to handle as much as we can here in-house.

Who does DXE serve with its repair services? 

DXE serves all EMS/Fire companies, health care clinics as well as general public access.  We also provide additional support to other service providers.

Is a recertified unit just as reliable as a new unit? Why? 

Yes, I believe recertified units are just as reliable as new units.  Many of the components in these units have life cycles in the hundreds of thousands, when the actual use can sometimes be in the hundreds, leaving years of life left in them.  Also, after the recertification process any worn or damage parts are replaced with new items as well. They are also rigorously tested for performance and function.

When is a piece of equipment beyond repair?

With the AEDs, if they have a malfunction sometimes to replace the part to fix it, is going to cost more than replacing the AED itself — that’s when we’ll say, ‘hey, you need to end up replacing your unit.’ Because, at the same time, we need to make sure we strive to save the customer as much money as they possibly can, because a lot of the devices we see come from small or rural [places] or even volunteer fire or EMS departments. So, they don’t have big budgets to spend on repairs and that type of stuff. So we try to make sure we do everything as cost effective for them as we can.

What is your favorite part about working in the biomed? 

It’s a combination of things.  I have always been technically oriented so I enjoy that part of it.  There is quite a bit of problem solving when troubleshooting repair issues, I like that challenge too, but also knowing that the work we do can have an end result of helping save lives.

Use Facebook to Comment on this Post

DXE Medical PMA Series – Part 1

fda

FDA’s new stringent evaluation standards are set to improve dependability of AEDs. The goal of this series is to educate customers on the issue.

To learn more about what is being covered in this series, click here.

Q: What is the Pre-Market Approval ruling made by the FDA?

A: The FDA made a final ruling (Section 515(b)(1)(A) of the FD&C Act (21 U.S.C. 360e(b)) in February of 2015 that stated that current and future devices with an AED (Automated External Defibrillator) function would have to go through the more robust Pre-Market Approval (PMA) process to carry the FDA’s approval. The PMA process is the same as what drugs must go through to get approval for use in the U.S. Previously, the FDA allowed these devices to go through a less rigorous process called the 510k. This new process is both time-consuming and expensive, and has caused the manufacturers of existing devices to evaluate whether or not to pursue the PMA for older products that they do not expect to make any longer. Any new products or products currently manufactured MUST go through the PMA process in order to be sold into the U.S. market.

Source: Find more about PMAs from the FDA here.

 Q: Why did the FDA make this ruling?

A: The FDA has been concerned with failure rates of AEDs, and wanted more oversight into the approval process. The purpose is always to protect the U.S. population from unnecessary risk, and make sure that only quality products are being used on people in need.

From the FDA:

“Automated external defibrillators save lives,” said William Maisel, M.D., M.P.H, deputy director for science, chief scientist and acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”

Q: What does “PMA” mean and what do the manufacturers have to do to get this approval?

A: PMA stands for “Pre-Market Approval.” Manufacturers of devices or products must submit an adequate amount of information, field studies, patient data, etc. to get this approval. This is why devices are usually launched in countries other than the U.S. first. The product is “tested” in these other countries and the manufacturer uses the data gathered to support making it available in the U.S.

Source: Find more about PMAs from the FDA here.

Models previously sold by DXE Medical that were affected by this new regulation are:

  • Physio-Control Lifepak 500 AED
  • Physio-Control Lifepak 10, 11
  • Philips HeartStart FR2 AED
  • Philips XL
  • Zoll PD1400
  • Zoll M Series monitor/defibrillator
  • Zoll E Series monitor/defibrillator

*For a complete list of affected devices, please contact us.

Trade-In & Trade-Up Program
If you do have an affected device, DXE offers a Trade-In & Trade-Up Program. Right now, if you are ready to trade in your M Series, you can use this trade-in value for a new or recertified Lifepak 12 or Philips HeartStart MRx defibrillator from DXE Medical.

DXE Medical will be sending out a series containing more information regarding the FDA’s recent change in regulations for PMAs on devices with AED functionality. There are many questions that will be answered, but if you have a question you would like us to answer, please submit your questions. If you do have any questions, please call 866-349-4363 or email customerservice@dxemed.com.

DXE Medical, Inc. was founded in 1999. It provides new and refurbished defibrillators, AEDs, EKGs, as well as other medical equipment and has grown to serve customers in all 50 states and 40 countries worldwide. For more information, please visit: http://www.cardiopartners.com/.

To stay up-to-date and sign up for all future releases, please sign up at the bottom of this page.

Use Facebook to Comment on this Post