WHY REDSENSEall about redsense blood loss detection

redsense risk01

Poster

Although hemodialysis has become a routine treatment, adverse side effects, and occasionally life threatening clinical complications, still happen. The EDTNA & ANNAhas produced 12 practice recommendations to help reduce the risk and detect blood loss as early as possible. 10

 

 

 

 

 

RISK ASSESMENT TOOL

Each patient should be assessed for the risk of VND. Minimizing the risk of VND requires a combination of skills, vigilance and technology. The assessment tool allows staff to identify the highest risk patients for whom devices intended to detect blood loss to the environment can be used to ensure that an alarm is raised if VND occurs.26

redsense risk02

 

 

 

 

 

 

 

 

 

 

Patients at risk of VND quotation

Reference

Venous needle dislodgement is a potentially life-threatening complication of dialysis that can happen to anyone in any dialysis setting throughout the world.

Hurst41,
Axley, B et al43

Patients with a well functioning AV fistula e.g. p> 25mmHg, amounts to 50% of all AV fistulas.

Polaschegg H-D1
Polaschegg H-D18

Low-Poor lighting in the room

Hurst J11,37
Mactier et al 15

Patients experiencing restlessness towards the end of the dialysis Restlessness throughout

Hurst J11,12, 37
Mactier et al 15
Liback-Pedersen L13
Polaschegg H-D2
VA Patient Safety Advisory16
VA Patient Safety Advisory17

Patients with frequent blood pressure drops or muscle cramps

Mc Cabe M8a
Axley, B et al43

Patients covering the access during dialysis this include ex. Patients who are cold, sleeping typically patients in beds

Hurst J11,12,37
Lindley E 10
Polaschegg H-D1,2
Sandroni S4
Liback-Pedersen E13
Almen7
VA Patient Safety Advisory16
VA Patient Safety Advisory17
Axley, B et al43

Patients with extensive hair growth around the access points which makes fixation of the needles more difficult. Patients with skin conditions, ex. Allergies to patches, eczemas, extensive sweating

Van Waeleghem, J-P et al9
McCabe M8,8a
VA Patient Safety Advisory16

If venous pressure before treatment is below 25mmHg, the patient should be regarded as "high risk" for VND RPA. Keeping Kidney Patients Safe45
Patients on nocturnal and or home dialysis Axley, B et al43

Patients with history of VND

McCabe M8a

Patients who are mentally, cognitive, neurological impaired Ex. Dementia, patients not understanding the implications of a VND, reduced sensitivity

Patients who are uncooperative

Patients who are agitated

McCabe8a
Mactier et al 15
Van Waeleghem, J-P et al9
Liback-Pedersen E13
Polaschegg H-D 2
VA Patient Safety Advisory16
VA Patient Safety Advisory17
Axley, B et al43

Patients with fistulas located other then cephalica or brachea, e.g. locations which are not visible easily submitted to friction

Van Waeleghem, J-P et al9
Mactier et al 15

Patient with known small blood leakage oozing around venous needle

Van Waeleghem, J-P et al9
McCabe M8a

Patients with diabetes and frequent hypoglycemic episodes during HD therapy

McCabe M8a

All patients dialyzing without or with limited supervision e.g.

Sleeping
Nocturnal
Self care / Low care
Home
Isolation rooms in clinics,
ICU

Van Waeleghem, J-P et al9
McCabe M 8a
Almen7
Sandroni S. EDTNA disc. Forum.10
Lindley E10
Hurst J11,12,37
VA Patient Safety Advisory16
VA Patient Safety Advisory17
Axley, B et al43

Minimizing the risk of VND requires a combination of human skills, vigilance and technology

Van Waeleghem JP et al26

Patient and staff awareness is important

Hurst37
Axley, B et al43

 

Hemodialysis machines failing to detect VND

VP alarm failed to detect VND until significant blood loss

VA Patient Safety Advisory16
VA Patient Safety Advisory17

Pressure drop caused by a cannula slipping such event is usually too small to be detectable by the venous pressure monitor Sandroni S3
Almen7
Polaschegg H-D1?
Van Waeleghem JP et al26
VP measure is an unreliable method for detecting needle dislodgement Polaschegg H-D18
Pennsylvania Safety Advisory35
Venous needle dislodgement during hemodialysis without triggering the venous pressure alarm was reported in an online medical device safety report from 1998 Axley, B et al43
Study to examine the success rate of VND detection in different types of dialysis access, using the venous pressure monitoring system. Only 29% of fistula VNDs were detected related to discrepancies in pressure. Ribitisch, W et al44

 

Incidence and severity of incidents of VND

1/126 718 treatments, a catastrophic hemorrhage with 33% mortality = 136 deaths / year (=2/week)

1/62 500 serious bleeding (include cath & needles = 2/day)

5% has a needle come out (=200/day)

6.1% VND incidents (review of all type of incidents 562 over 1 year)

0,1% VND incidence rate

1/500 000 death

3% of treatments bleeding leading to corrective action (0.9% complete VND)

Post VND higher mortality risk due to infections

VND incidents are underreported

VND remains the most common cause of preventable death in dialysis and is a serious risk for the home patient.

414 episodes of fatal VND episodes are likely an underestimate

Without doubt VND is the most unexpected and potentially life-threatening complication in dialysis.

Sandroni S4
VA Patient Safety Advisory16
RPA Renal Physicians assosiation19
Pennsylvania Safety Advisory35
Almen7
Derik White, Gambro20
T. Court: Physicist engineer (PhD)
Gambro R&D
21
Derik White, Gambro20
Robin Fields, Probuplica25
Peter Laird39
Martin Lascano40?
Hurst41



C
ost related to VND

VND Costly complication

Minor VND $522-$1,183/blood transfusion and additional dose of erythropoiesis- stimulating agents (ESAs)  

Severe VND - 4 days hospitalization/blood/ESAs/Plasma expanders….    $114, 000 to $150,000 and up

Liability costs

Hurst22
Hurst41

Cost of blood transfusion $522-$1,183/transfusion

Shander23

 

Minimization of undetected VND

Minimization of undetected VND episodes can be aided by blood loss detection devices use.

Martin Lascano40

 

Blood Transfusion complications

Cost of blood transfusion 522-1183$/transfusion

Shander23

Blood transfusion related to 16% higher long term mortality

Surgenor24

 

Incident Reporting

Only Hospital-operated facilities must report events under the Act 13 of the Medical Care Availability and Reduction of error Act of 2002 (freestanding dialysis clinics are excluded)

Pennsylvania Safety Advisory35

 

Electrical Safety 

Further a direct electronic sensor such as a moisture or enuresis detector is not suitable since research have shown that a DC 5 V power supply could cause a micro shock by ionization in the skin.

Akihiro T et al36

 

Literature list

Review includes the following publications:

  1. Polaschegg, H-D. Neglected Safety Aspects in Hemodialysis Machines and their Related Problems. Hemodialysis Horizons , AMMI, 2006 Page 66.
  2. Polaschegg, H-D. EDTNA/ERCA Conference, Prague, September 2008, Seminar, Venous needle dislodgement: A safety issue. Possible methods for detection and prevention of major blood loss” Page 40.
  3. RPA Penal Physicians Association, Health and Safety Survey to improve patient safety in end stage renal disease (2007)
  4. Sandroni, S, Shockerman, T, Hayes-Light, K, Catastrophic Hemorrhage from Venous Needle Dislodgement during Hemodialysis, Journal of the American Society of Nephrology, volume 9, November 2008, Abstract issue.
  5. Blagg CR. Home haemodialysis: ’home, home sweet, sweet homes!”.Nephrolog 2005:10(3):Page 206–14
  6. Esther Saner et al. Outcome of home haemodialysis patients: a case-cohort study. Nephrol Dial Transplant (2005) 20: Page 604–610
  7. Ahlmén J, Gydell KH, Hadimeri H, Hernandez I, Rogland B, Strömbom U (2008) A new safety device for hemodialysis Hemodialysis International 12 (2), Page 264–267.
  8. McCabe M, et al, 38th EDTNA/ERCA International Conference Abstract. (Risk Assessment Tool Dundee)
  9. Van Waeleghem JP, Chamne M, Lindley, M, Pancirova, J, Venous needle dislodgement How to minimize the risks, Journal of renal Care 2008, Page 163-167.
  10. Lindley E, EDTNA/ERCA Journal discussion club summary 2005. www.edtnaerca.org/pages/education/journalclub/summary2005_2.php
  11. Hurst, J, Keep an Eye On Your Needle, Kidney Times #312
  12. Hurst, J, Venous Needle Dislogement, Virgo publishing http://www.renalbusiness.com/09/09/2009
  13. Liback Pedersen, E. Allvorlig Blodtab under heamodialyse, Dialäsen 5, 2008
  14. Cafazzo, J-A. et al, Barriers to the Adoption on Nocturnal Hemodialysis, American Society of Nephrology 2009, ISSN:1555-9041/404-0784
  15. Mactier, R, Worth D, Artery Issue Issue 41, March 2007
  16. Patients Safety Advisory; Veteran Health Administration Warning System; Published by VA Central Office; October 21, 2008 http://www.patientsafety.gov/alerts.html#2010
  17. Patient Safety Alert, Health Administration Warning System; Published by VA Central Office; July 6, 2010 http://www.patientsafety.gov/alerts.html#2010
  18. P Polaschegg H.-D. (2010). Venous needle dislodgement: the pitfalls of venous pressure measurement and possible alternatives, a review. Journal of Renal Care 36(1), 41-48.olachegg, H-D. Neglected Safety Aspects in
  19. RPA Penal Physicians Association, Health and Safety Survey to improve patient safety in end stage renal disease (2007)
  20. Derik White, Gambro; Oral presentation EDTNA Congress Florence 2007
  21. T. Court: Physicist engineer (PhD) Gambro R&D – France, Dr M. Chawki Néphrologist Ermont- Cormeilles en Parisis (95) France 2008
    1. (Oral presentation)
  22. Hurst J, A Costly Complication: Venous Needle Dislodgement. http://www.renalbusiness.com/
  23. Shander, A., Hofmann, A., Ozawa, S., Theusinger, O., Gombotz, H., Spahn, D. "Activity-based Costs of Blood Transfusions in Surgical Patients at Four Hospitals." Transfusion. April 2010, Volume 50, Issue 4, Pages 753-765
  24. Surgenor SD, et all ; Northern New England Cardiovascular Disease Study Group. The association of perioperative red blood cell transfusions and decreased long-term survival after cardiac surgery. http://www.ncbi.nlm.nih.gov/pubmed/19448195
  25. Robin Fields, When Needles Dislodge, Dialysis Can turn Deadly. ProPublica, Nov 10, 2010. www.propublica.org/article/when-needles-dislodge-dialysis-can-turn-deadly
  26. Van Waeleghem JP, Chamne M, Lindley EJ, Olausson S, Pancirova J, Sundsttröm M, Tattersall JE. Abstract: The tragedy of Venous Needle Dislodgement. ANNA 2011
  27. Tricia West, R.N., BSN, MBA/HCM, PHN, LNC, Knowledge is power, www. http://www.pjwa.com/resources/knowledge_is_power.pdf
  28. News coverage NBC, http://dailynightly.msnbc.msn.com/_news/2010/12/30/5739313-diagnosing-dialysis-an-investigative-report
  29. Robin Fields, In Dialysis, Life-Saving Care at Great Risk and Cost. ProPublica, Nov 9, 2010. http://www.propublica.org/article/in-dialysis-life-saving-care-at-great-risk-and-cost/single
  30. Robin Fields, New Study Shows Higher mortality Risk at Fro-Profit Dialysis Chains, Dec 9, 2010. http://www.propublica.org/article/new-study-shows-higher-mortality-risk-at-in-for-profit-dialysis-chains/single
  31. Robin Fields, http://www.propublica.org/article/dialysis-data-once-confidential-shines-light-on-clinic-disparities
  32. Robin Fields, http://www.propublica.org/article/feds-to-follow-propublica-release-dialysis-clinic-data
  33. Robin Fields, http://www.propublica.org/article/sen-grassley-demands-information-on-dialysis-clinic-conditions
  34. Olsson P. Sundström M. Annotated Pro Publica Articles (25, 29-33)
  35. Pennsylvania Patient Safety Authority. Vol 7, No. 3 September 2010. http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Sep7(3)/Pages/87.aspx
  36. Takeuchi A, Ishida K, Morohoshi Y, Shinbo T, Hirose M, Ikeda N, Study of light transmission through gauze pad effected by blood or liquids to detect needle dislodgement. J Clin Monit Comput 2010; 24:35–39
  37. Hurst Jane, RN, CLNC Venous Needle Dislodgement Precautions. aakpRENALLIFE July volume 8. http://www.aakp.org/userfiles/File/AAKP_Renalife-July%202011%20-%20Final.pdf
  38. J Cowperthwaite, A Rivers, M Sundström, J Hegbrant Abstract & oral presentation. ADC March 2011
  39. Peter Laird, MD. Taking Hemodialysis Home Safely. Renal Business today October2011
  40. Dr. Martin E. Lascano, Michael Bradley Andersen RN, Cleveland Clinics; Venous Needle Dislodgement Prevention in Hospital Based Hemodialysis. Abstract ASN November 2011
  41. Hurst Jane, RN, CLNC , Venous Needle Dislodgement - A Universal Concern. European Nephrology, volume 5, issue 2, winter 2011. http://www.touchbriefings.com/ebooks/A1uupa/euneph52/
  42. Michael Morales, CHT, CCHT-A, CCNT, CBNT, Grace Padilla-Kastenberg, MPH, Venous Needle Dislodgement In Dialysis Clinic Settings. A special report. Feb 2013.
  43. Axley, B, Speranza-Reid J, Williams H. (2012) Venous needle dislodgement in patients on hemodialysis. Hephrology Nursing Journal, 39(6), 435-445. http://www.annanurse.org/download/reference/journal/vndArticle.pd
  44. Ribitish W, Schilcher G, Hafner-Giessauf H, Krisper P, Horina J, Rosenkranz A, Schneditz D. Prevalence of Detectable Venous Pressure Drops Expected with Venous Needle Dislodgement. Seminars in Dialysis. Sept-Oct 2014; 27 (507-11).
  45. RPA Renal Physicians Association, Keeping Kidney Patients Safe. Venous Needle Dislodgement. http://www.kidneypatientsafety.org/didyouknow_needledislodgement.aspx
  46. Faratro, R., Jeffries, J., Nesrallah, G. E. and MacRae, J. M. (2015), The care and keeping of vascular access for home hemodialysis patients. Hemodial Int, 19: S80-S92.