site rite vison with sapiens

MunoRN, RN · Jul 6, 2011

We've been using the site-rite for a while now and we've been using Sapiens for a few weeks although in conjunction with an Xray for placement confirmation, mainly to let everybody get used to it without having to completely relying on it for tip placement and positioning confirmation. We move to Sapiens-only confirmation next week. Some of the PICC nurses were concerned about Sapiens because they aren't really that familiar with EKG's, but they've since gone through the training and seem to feel OK with it.

There are still plenty of patients who will still need an Xray due to their p-wave morphology, but for the rest of the patients, avoiding an Xray is a big plus.

iluvivt, BSN, RN · Jul 7, 2011

I would like to know what others are doing as well? We are awaiting our new Vision and Sapiens tablet. I have seen the Vision and I loved it..the picture was so clear and and I really liked the clinician preference settings. I also appreciated that we can accurately measure the selected vein so we can document and take a screen shot of it as well. However, it has come to my attention that there is some controversy about the legal need for a CXR post placement. I am aware that the FDA has approved the products for use clinically but they DO Not set the standards of care. INS is still stating a CXR is needed post placement. I figure we will deal with all of this when we get it. MANY IV experts are saying should anything go wrong and you do not have that CXR..you the RN will be held accountable to the standard of care. I also think we will not order the printer and just use a flash drive so we do not increase the weight of the items we truck around with us..we already look like a traveling circus.

MunoRN, RN · Jul 8, 2011

I would like to know what others are doing as well? We are awaiting our new Vision and Sapiens tablet. I have seen the Vision and I loved it..the picture was so clear and and I really liked the clinician preference settings. I also appreciated that we can accurately measure the selected vein so we can document and take a screen shot of it as well. However, it has come to my attention that there is some controversy about the legal need for a CXR post placement. I am aware that the FDA has approved the products for use clinically but they DO Not set the standards of care. INS is still stating a CXR is needed post placement. I figure we will deal with all of this when we get it. MANY IV experts are saying should anything go wrong and you do not have that CXR..you the RN will be held accountable to the standard of care. I also think we will not order the printer and just use a flash drive so we do not increase the weight of the items we truck around with us..we already look like a traveling circus.

The INS does not set legal requirements. INS is free to express concerns about a product or encourage the use of a product, but INS approval is not required for use. In terms of safety and efficacy of the product, FDA approval is the standard. Clinical information on Sapiens has been available for almost a year so if INS has something to say about it now would be the time to do it.

Standards of Care are determined by the results of evidence and well substantiated practice recommendations, these come from a variety of sources with the INS being just one of them. In terms of liability, you are not personally held responsible as acting outside of reasonable practice by using a product you have been properly trained to use in the manner which it was approved and consistent with your facility policies.

I think you may be over-exaggerating the omnipotence of the INS. We recently re-did all of our IV related P&P and Standards of Care, and while we didn't necessarily go out of our way to avoid INS recommendations, I can't think of any aspect that relied on the INS. We used recommendations and standards from the CDC, HICPAC, Cochrane, Joanna Briggs, Mosby's Skills/Consult, and others.

Golf Nurse · Jul 22, 2011

I agree with MunoRN. However, I do hear that in court of law, INS standards are what to follow.

INS standard actually says

"Tip location of a CVAD shall be determined radiographically or by other approved technologies prior to initiation of infusion therapy."

iluvivt, BSN, RN · Jul 23, 2011

I will post what I read from Lynn Hadaway a very respected IV expert once I find the comment. Thanks for sharing b/c I do want to know what others are doing. I have been writing our policies for some 20 yrs plus now and have always used multiple resources. I do know that in a court of law the question will always be "was the standard of care followed" and the FDA does not decide this.

iluvivt, BSN, RN · Jul 25, 2011

here is what i read from lynn hadaway..this is her direct quote

there are several technologies that will assist with locating the catheter tip following initial insertion. but any one who is trying to say that a product or technology is "approved" to do something that will alter a standard of care is sadly misinformed. first of all, the fda does not approve devices. devices are cleared for market. this concept is thoroughly explained in the ins textbook in my chapter on iv equipment. the national standards are not established by one device, product or technology. standards of practice are established by professionals, not the manufacturer, based on solid scientific evidence. i do believe that these technologies such as ecg guidance will allow us to remove the need for a chest xray from the standard of care at some point in the future, but we are not there yet. so a chest xray is what you would be held accountable for doing in a court of law. we did not remove the need for a chest xray after the insertion of all cvcs in the 2011 ins standards of practice. the legal standard of care is established in a given legal case with numerous documents, published research etc. it is based on testimony of experts relying on those documents. i believe that any manufacturer of one of these technologies claiming that no chest xray is needed is posing a serious hazard legally. is ecg guidance better than a chest xray? for many, but not all, patients it probably is. but this has not been totally established yet. nor do we have published evidence about how to evaluate each patient to determine who is not a candidate for ecg guidance. so do not rush to eliminate those chest xrays just yet. lynn

--

lynn hadaway, m.ed., rn, bc, crni

lynn hadaway associates, inc.

126 main street, po box 10

milner, ga 30257

iluvivt, BSN, RN · Jul 25, 2011

Thoughts anyone out there?

linda1208rn · Jul 25, 2011

Hi iluviti, i saw on another post that you responded to regarding pH of diluent/drug and use of midline, picc or piv, i think it was about iron iv infusion and you mentioned that you had article /policy regarding pH and what types of line for treatment. may i ask for a copy of the info please? i'm sorry if this is confusing, but in my experience this subject is seldom brought up and i appreciate little known or addressed facts with care of iv's. thank you. [email protected]