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- Borowiec, Jan W.
(författare)
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Clinical research challenges in the era of cardiovascular medical devices
- 2016
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Ingår i: Polish Journal of Cardio-Thoracic Surgery. - : Termedia Sp. z.o.o.. - 1731-5530 .- 1897-4252. ; 13:3, s. 236-241
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Tidskriftsartikel (refereegranskat)abstract
- New therapeutic alternatives, such as innovative medical devices, are frequently the only treatment options left for patients when other efficient medical modalities are lacking or insufficient. Development of novel devices, which are safe and effective, requires understanding of complex premarket and postmarket provisions, including characteristics of clinical trials. Speeding up patient access to new technologies may imply the need to make choices in terms of extent and robustness of clinical evaluation without losing the patient safety perspective. In such situations, some challenges can readily arise due to existing methodological solutions and aspects of current legislation in the field. In this context, some challenges, occurring at various stages of the device lifecycle, will be presented in order to observe the changes and hopefully to contribute to better knowledge and improvements in the area.
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| 2. |
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| 3. |
- Borowiec, Jan W.
(författare)
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Surgical site infections in cardiac surgery - "Vision Zero"
- 2010
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Ingår i: Kardiochirurgia i Torakochirurgia Polska. - 1731-5530. ; 7:4, s. 383-387
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Tidskriftsartikel (refereegranskat)abstract
- The reported incidence of postoperative surgical site infections (SSI) of surgical wounds after cardiothoracic surgery ranges between 0,5% to as high as almost 30% and postsurgical mediastinitis varies between 1% and 5%. These, together with postoperative low output syndrome and stroke are most serious complications after heart surgery. Surgical site infections increase morbidity and mortality rates, prolongs length of hospital stay and increases cost of health care. Although great progress has been made in medical sciences and technology the situation regarding SSI has not changed to better. Just opposite, some new problems associated with infections are threatening our patients. A new approach aiming at reduction of SSI is necessary. The current circumstances constituting positives and negatives of possibility to develop sustainable strategy of SSI reduction are presented in the paper.
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