Q: The FDA has released its report “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).” What are your thoughts?
A: Thank you MD Publishing (TechNation and ICE magazines) and AAMI for keeping the HTM community informed and “on point” as this issue made its way through the process. Thank you to my peers who participated in forums, local and national meetings and submitted comments to the FDA. I salute all of you.
However, please pay attention to the actions that the FDA will continue to pursue. It is incumbent upon us as professionals to continue to grow our programs with a constant pursuit of patient safety and delivering an exceptional experience for that patient that depends on us to be excellent everyday. To that point, do not let down your guard or take your foot off of the accelerator! If you are not familiar with quality systems and/or the ISO 13485:2016 standard, learn it! Put that standard into practice for everything you and your teammates do for healthcare technology management. Are you paying attention to the devices in your inventory that are connected to a network? What about devices that contain PHI? Are your USB ports on your medical devices locked out either with software or physical controls? Do you know what the MAC addresses and IP addresses are for the devices in your inventory? What about the operating systems for these devices? Is all of this information documented in your CMMS product and easily accessible for your HTM technical staff as well as your Information Services co-workers?
Our patients are depending on us. The FDA is depending on us. Your employer is depending on you. Be excellent! Drive your program toward excellence! Leadership is not about the title you have, it is about doing the right thing and being an example for the responsibilities you have in your career. Read! Attend conferences (local and national) or webinars (many of them are no cost to attend)! Communicate with your peers. Join professional organizations! There are so many resources available to you and most have little or no cost associated with them. Heck, make the investment into your career. Make the investment into yourself! Forgo that cup of coffee everyday and use that money to join a professional organization.
A: Well said! Or, increase the continuing education and training of your team members.
A: They got it right this time!
A: DAVID 1, GOLIATH 0 – early in the first quarter.
Q: I have a problem with my Thermo Fisher Scientific Shandon Excelsior ES valve clogging. Could you help? The valve section of the device is filled with paraffin or similar crystals. The device is clogging. I cleaned it, but then it was the same problem again. I need your suggestions to solve this problem. The motor section is filled with a paraffin-like substance. We clean it up, but then it fills again. What is the solution to this problem in your opinion?
A: The motor is underneath the chamber. If I understand what you said, the processor is working, but you are getting a repeated build up of residue on the motor, coming from the chamber. I would expect that it is due to the agitate seal, and possibly the static seal. If you are going to replace these, you would want to replace the port seal at the same time. Do not replace the rotor outer seal, unless necessary. If you don’t have a service manual, you definitely need one.
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