| 2. |
- Björling, Gunilla, Docent, et al.
(författare)
-
Risk Evaluation of Therapy Medical Devices and Implants for Increased Patient Safety : REMISS Horizon 2020 Research and Innovation Action
- 2017
-
Konferensbidrag (refereegranskat)abstract
- Current knowledge in the area of medical devices remains insufficiently complete, and many of the established test methods and international standards (ISO (International Organization for Standardization) standards) open up to individual interpretation on how the test should be performed and the results reported. Treating long-term diseases such as cancer imposes a stringent sequence of various treatments on patients. For instance, cancer may be treated with radiation and chemotherapy; the latter in many treatment protocols requiring the implantation of an intravascular catheter during a prolonged period of time. To maximize the effect of such measures, as well as issues related to the patient Health Related Quality of Life (HRQoL), integrated and validated methodologies are needed as decisional basis for appropriate risk management and patient safety with regard to clinical use of intravascular catheters.The ambition of the REMISS project is to: Establish integrated and validated methodologies for risk management of the clinical use of intravascular catheters with respect to the clinical service lifetime, improved patient treatment, safety and HRQoL. This is assumed to reduce patient suffering due to complications associated with material deployment and degradation associated side effects for e.g. cancer patients receiving treatment with chemotherapeutical drugs using an intravascular catheter.The main vision is to improve the standards for eliminating side effects (complications) caused by deployment from and degradation of intravascular catheters, as well as loss of performance due to material-drug-biological system interactions, compared to the current state-of-the-art. Realising the project goals the rate of catheter-associated complications can be lowered by 40-50%, which in turn will improve patient treatment, safety and HRQoL, as well as health care related costs.Package integrally developed methodologies, predictive models, databases, and other project findings, as a potential product with a holistic coverage. It is believed that commercialisation of (selected) results will be the best option in order to create sustainable availability of this service based on continued research on intravascular catheters according to integrated and validated methodologies.REMISS answer the call NMBP-12-2017 Development of a Reliable Methodology for Better Risk Management of Engineered Biomaterials Advanced Therapy Medicinal Products and/or Medical Devices Marcy, P. Central venous access: techniques and indications in oncology. European Society of Radiology, 2008; 18; 2333-44 Maki DG, et al The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc 2006: 81 (9): 1159-71. Frostell, C., Björling, G., Strömberg, E., Karlsson, S., and Aune, R. E., Tracheal Implants Revisited, The Lancet (2017), 389(10075) pp.1191
|
|
