6 | HAEMODIALYSIS PATIENTS IN EUROPE | 2021
I would love to try it in the hospital and in our outpatients Martin Kuhlman practice . Moreover , procedures may vary by region as institutions must adhere to local , national and international guidelines and regulations . Despite potential variables in the procedural details , there was a significant uniformity to the general process outlined by the attendees . The decision units may go by different names and the specific forms or timelines may vary , but the general process remains the same and is as follows :
• Seek support from those who directly attend to dialysis patients ( e . g ., nurses , matrons ) to trial the new technology .
• Coordinate with the product evaluation / procurement team with a proposal to test in a small number of patients ( e . g ., 20 – 30 patients ) to see if the product is easy to use and effective as compared to available data .
• Evaluate and discuss : Does the technology do what it is meant to do ? Do you get the same result as the available data ? Do you observe something that has not been reported ? Are patients receptive ?
• Present the proposal to the purchasing department for financial considerations .
• Decision typically made by departmental head or hospital manager and in line with region / country processes .
Defining a new standard of care It was the consensus of the Faculty that ClearGuard HD antimicrobial barrier caps appear to be a game-changer product in the prevention of haemodialysis catheter infection , with a strong US evidence base . Unsurprisingly , it is unknown in Europe . Raising awareness of the product ’ s availability , and of its life-saving and cost-saving benefits could aid in implementation of this device in Europe .
A barrier will be the absence of European hospital data . Attendees discussed the necessity of a randomised clinical trial . Although considered a gold standard in clinical research , RCTs can hold a lot of biases and can be difficult to effectively monitor outcomes . Some argued that powerful observational studies should suffice .
Like what Connie Jo Hemeyer did in her institution , four Faculty ( Marlies Ostermann , UK ; Martin Kuhlman , Germany ; Maxence Ficheux , France ; Maria José Soler Romeo , Spain ) have volunteered to conduct quality improvement studies in their hospitals as soon as the product can be made available to them . This could at least start building the European evidence base in the absence of a large-scale clinical trial .
Additionally , attendees discussed the importance of gaining recommendation and buy-in from various associations . European
associations such as EDTA , EDTNA or countryspecific associations such as the Association of Nephrology Nurses UK or British Renal Council could help push the field for trials or even grant the financial backing for trials .
Guidelines can also play an important role . NICE has selected ClearGuard HD for Medical Technologies Guidance ( MTG ) development in 2021 .
Germany is introducing a Quality Standard for ambulatory dialysis , which currently lacks a line for catheter infections . Reporting of catheter infections could perhaps be introduced here and in other similar national Quality Standards . The European Renal Association – European Dialysis and Transplant Association ( ERA-EDTA ) may prove an appropriate platform for proposing such action .
In the US , ClearGuard HD is rapidly becoming the standard of care for best practice for infection control in CVC patients . With the European launch in early 2021 , there is an opportunity to define a new standard of care for haemodialysis .
Key messages
• With continued use of central venous catheters comes the potential for infection .
• Quantifying and comparing the cost of infection prevention vs . infection management is not completely straightforward as infection can have several indirect costs and consequences .
• Guidelines can vary by country , but most institutions seem to incorporate multiple guidelines into their practices .
• The ClearGuard HD antimicrobial barrier cap is the first and only device clinically proven to reduce the rate of bloodstream infection in haemodialysis catheters .
• ClearGuard HD is rapidly becoming the standard of care in the US .
• Adoption in the US and early feedback from European key opinion leaders highlight the potential for ClearGuard HD antimicrobial caps to become a global standard of care .
• ClearGuard HD appears to be a game-changer product in the prevention of haemodialysis catheter infection .
• Four Faculty from four different countries have volunteered to conduct quality improvement studies in their hospitals to begin developing a European evidence base for ClearGuard HD .
The advisory board “ Infection prevention of haemodialysis catheters ” was convened virtually via Microsoft Teams on 7 December 2020 with the support of ICU Medical and was attended by doctors and nurses from four European countries and the US .