https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-em...
Lynn,
What is your take on this recent umbrella EUA revocation from the FDA on using IV extension tubing to extend the pumps outside of patient rooms? Still working through this at my facility with everybody and their brother.
Andrew Walker BSN, RN, VA-BC, CRNI, PCCN
Very happy to see this revocation of the EUA!! Use of excessive extension tubing must only be used in a true crisis situation when the focus shifts from doing what is best for the individual patient over to doing what is best for the most patients. When a hospital is overrun with covid patients and PPE was in critically short supply, this was a reasonable action. But it should only be for a short term when the crisis has past. There are far too many issues of safety associated with this practice to continue its use outside of a true crisis situation.
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
The ability to use extended length IV tubing to place pumps outside the room didn't come from the EUA. One, the FDA doesn't regulate practice, and two, there are already extended length IV tubing products that are FDA approved to be used for this purpose (mainly for MRI and airborne isolation rooms). We stock 30 foot IV tubing for this purpose (even prior to Covid).
What the EUA was referencing was temporary approval for marketing of products not already approved to be used as IV tubing or to extend IV tubing length.
This of course shouldn't be routine practice in the general patient population, but it's still a necessary part of caring for COVID patients, I'm not sure where the idea comes from that the "crisis has past".
In our confirmed COVID positive unit the staff wear PAPRs at all times, and it's not possible to hear a beeping IV pump when the pump is in the room. For non-positive patients who are in isolation due exposure or other reason it's not feasable to use PAPRs and there is still not a sufficient N95/100 supply chain, staff end up having to wear respiratory protection that fails to meet the OSHA minimum requirement as it is, and that's with having the pump outside the room when necessary which avoid unecessary PPE usage when dealing with upstream occlusion alarms (our most common alarm) and rate changes/bag changes.
Thanks for the great feedback! Do you have any policy/practice/procedure language you can share on utilizing extended IV tubing for places like MRI or COVID pos. etc.
"What the EUA was referencing was temporary approval for marketing of products not already approved to be used as IV tubing or to extend IV tubing length."
That is how I took the FDA statement as well.
Our education department included the practice considerations related to this in their competency education for Covid related care. The main and really only significant difference between having the pump outside vs inside the room is that we add a second IV pole in between the patient and the pump to keep the tubing off the floor. We don't use this practice for independently ambulatory patients since in theory at least they know to call when the IV pump alarms.
No new policies were created related to this as it is already covered in existing policies related to IV infusion management and assessment.
I disagree that the only difference is the added IV pole to keep the tubing off the floor. Due to the much longer tubing, the entire time for delivery of IV medications is much greater, requiring a larger quantity of fluid to ensure that it reaches the blood stream in a timely manner, plus the other factors identified by the pump manufacturers and any changes to their accuracy ratings, etc. This is only indicated when crisis standards are in effect.
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
The need to consider the various factors that contribute to the flow dynamics of infusions, and how that affects the pharmacokinetics of those infusions, doesn't change based on how far the pumps are from the patient, this includes the intraluminal volume of tubing which is not a new consideration.
Our supply chain of appropriate respiratory protection for healthcare workers caring for confirmed and suspected COVID-19 patients is still insufficient to allow for doing away with PPE conservation measures. If we were to stop utilizing these measures, which includes positioning the pumps outside the room to address things like upstream occlussion alarms (our most common alarm), then that would exacerbate PPE shortages and HCW high risk exposures to COVID.
I'm certainly not opposed to bringing your concerns to my administrators, but I would need to explain how the risks of having pumps outside the room are clearly greater than having HCWs provide direct care to COVID patients with insufficeint respiratory protection.
What you are saying is that crisis standards prevail at your facility rather than the normal standard of care. Crisis standards are when things are so bad you have to only think about the good of the majority of patients. Normal standards of practice would be where the safety of each patient is the center of care.
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Preventing nocosomial infections is part of the normal standard of care, it's not something that only exists within crisis standards of care.
Failing to engage in infection prevention measures where the risk of a nocoosomial outbreak is potentially catastrophic in order to avoid a risk-mitigatoin practice that has a signficantly lower risk of harm clearly falls short of the 'normal' standards of care. Reducing the risk of nocosomial infection transmission is how we avoid having to resort to crisis standards.
I'm still not clear on the risk-beneift analysis that would suggest that extended-length IV tubing is clearly a bigger risk to patients than not utilizing the established infection-prevention measures to mitigate the spread of a pandemic within a hospital patient population.