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  • 1 Magyar Betegbiztonsági Társaság Budapest Kerékgyártó u. 36–38. 1147
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A világon az egészségügyi technológiai ipar évente több ezer új eszközt hoz forgalomba. Ugyanakkor nagy szakadék van az egészségügyi műszerek elfogadásának folyamatában és a forgalomba hozatal utáni ellenőrzésben. Bár a gyógyszerek ezrei csak akkor használhatók a klinikumban, ha randomizált, kontrollált vizsgálaton esnek át, világviszonylatban viszonylag kevés eszköznél, új eljárásnál történik hasonló vizsgálat. A sebészet veszélyes üzem, az új technológiáknak komoly betegbiztonsági kockázatuk lehet. Orv. Hetil., 2011, 152, 2091–2095.

  • Aggarwal, R., Mytton, O. T., Greaves, F.: Technology as applied to patient safety: an overview. Qual. Saf. Health Care, 2010, 19 (Suppl. 2), i3–i8.

    Greaves F. , 'Technology as applied to patient safety: an overview ' (2010 ) 19 Qual. Saf. Health Care : i3 -i8.

    • Search Google Scholar
  • Hetherington, C., Flin, R., Mearns, K.: Safety in shipping: the human element. J. Safety Res., 2006, 37, 401–411.

    Mearns K. , 'Safety in shipping: the human element ' (2006 ) 37 J. Safety Res. : 401 -411.

  • Pronovost, P. J., Goeschel, C. A., Olsen, K. L. és mtsai: Reducing health care hazards: lessons from the commercial aviation safety team. Health Aff., 2009, 28, 479–489.

    Olsen K. L. , 'Reducing health care hazards: lessons from the commercial aviation safety team ' (2009 ) 28 Health Aff. : 479 -489.

    • Search Google Scholar
  • Feldman, M. D., Petersen, A. J., Karliner, L. S. és mtsai: Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J. Gen. Intern. Med., 2008, 23 (Suppl. 1), 57–63.

    Karliner L. S. , 'Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment ' (2008 ) 23 J. Gen. Intern. Med. : 57 -63.

    • Search Google Scholar
  • Maisel, W. H.: Medical device regulation: an introduction for the practicing physician. Ann. Intern. Med., 2004, 140, 296–302.

    Maisel W. H. , 'Medical device regulation: an introduction for the practicing physician ' (2004 ) 140 Ann. Intern. Med. : 296 -302.

    • Search Google Scholar
  • Feigal, D. W., Gardner, S. N., McClellan, M.: Ensuring safe and effective medical devices. N. Engl. J. Med., 2003, 348, 191–192.

    McClellan M. , 'Ensuring safe and effective medical devices ' (2003 ) 348 N. Engl. J. Med. : 191 -192.

    • Search Google Scholar
  • Kessler, L., Richter, K.: Technology assessment of medical devices at the Center for Devices and Radiological Health. Am. J. Manag. Care, 1998, 4, 129–135.

    Richter K. , 'Technology assessment of medical devices at the Center for Devices and Radiological Health ' (1998 ) 4 Am. J. Manag. Care : 129 -135.

    • Search Google Scholar
  • U.S. Food and Drug Administration. Listing of CDRH substantially equivalent (SE) 510(k) summaries or 510(k) statements, for final decisions rendered; April 16, 2007. http://www.fda.gov/cdrh/510khome.html

  • U.S. Food and Drug Administration. 510(k) Premarket notification database entry K023943: CT Colonography, GE Medical Systems, Inc.; April 5, 2007. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10186

  • Banerjee, S., Van Dam, J.: CT colonography for colon cancer screening. Gastrointest. Endosc., 2006, 63, 121–133.

    Dam J. , 'CT colonography for colon cancer screening ' (2006 ) 63 Gastrointest. Endosc. : 121 -133.

    • Search Google Scholar
  • U.S. Food and Drug Administration. FDA announces recommendations to reauthorize medical device user fee program. FDA News. http://fda.gov/bbs/topics/NEWS/2007/NEW01609.html

  • U.S. Food and Drug Administration. The medical device user fee and modernization act of 2002-FAQs; August 1, 2003. http://www.fda.gov/cdrh/mdufma/faqs.html#1

  • Avorn, J.: Paying for drug approvals – who’s using whom? N. Engl. J. Med., 2007, 356, 1697–1700.

    Avorn J. , 'Paying for drug approvals – who’s using whom? ' (2007 ) 356 N. Engl. J. Med. : 1697 -1700.

    • Search Google Scholar
  • Kessler, L., Ramsey, S. D., Tunis, S. és mtsai: Clinical use of medical devices in the “Bermuda Triangle”. Health Aff., 2004, 23, 200–207.

    Tunis S. , 'Clinical use of medical devices in the “Bermuda Triangle” ' (2004 ) 23 Health Aff. : 200 -207.

    • Search Google Scholar
  • Drummond, M., Sorenson, C.: Nasty or nice? A perspective on the use of health technology assessment in the United Kingdom. Value Health, 2009, 12 (Suppl. 2), S8–S13.

    Sorenson C. , 'Nasty or nice? A perspective on the use of health technology assessment in the United Kingdom ' (2009 ) 12 Value Health : S8 -S13.

    • Search Google Scholar
  • Mason, A., Smith, P. C.: Health basket project benefit report: England. Dublin: European Health Management Association, 2005. ( http://www.ehma.org/index.php?q=node/81 )

    Smith P. C. , '', in Health basket project benefit report: England , (2005 ) -.

  • Cairns, J.: Providing guidance to the NHS: the Scottish Medicines Consortium and the National Institute for Clinical Excellence compared. Health Policy, 2006, 76, 134–143.

    Cairns J. , 'Providing guidance to the NHS: the Scottish Medicines Consortium and the National Institute for Clinical Excellence compared ' (2006 ) 76 Health Policy : 134 -143.

    • Search Google Scholar
  • Rawlins, M. D., Culyer, A. J.: National Institute of Clinical Excellence and its value judgments. Br. Med. J., 2004, 329, 224–227.

    Culyer A. J. , 'National Institute of Clinical Excellence and its value judgments ' (2004 ) 329 Br. Med. J. : 224 -227.

    • Search Google Scholar
  • Culyer, A. J., McCabe, C., Briggs, A. és mtsai: Searching for a threshold, not setting one: the role of the National Institute for Health and Clinical Excellence. J. Health Serv. Res. Policy, 2007, 12, 56–58.

    Briggs A. , 'Searching for a threshold, not setting one: the role of the National Institute for Health and Clinical Excellence ' (2007 ) 12 J. Health Serv. Res. Policy : 56 -58.

    • Search Google Scholar
  • Goreczky P., Szabó G., Baranyai Zs.: Inkontinenciatermékek hatásosságának mérése: Próbatanulmány. IME, 2009, 8, 50–53.

    Baranyai Zs. , 'Inkontinenciatermékek hatásosságának mérése: Próbatanulmány ' (2009 ) 8 IME : 50 -53.

    • Search Google Scholar
  • Goreczky P.: Gyógyászati segédeszközök értékelése az ESKI-ben. IME, 2008, 7 (Egészség-gazdaságtani különszám, 2008. október), 18–20.

    Goreczky P. , 'Gyógyászati segédeszközök értékelése az ESKI-ben ' (2008 ) 7 IME : 18 -20.

    • Search Google Scholar
  • Silverman, W. A., Altman, D. G.: Patient’s preferences and randomised trials. Lancet, 1996, 347, 171–174.

    Altman D. G. , 'Patient’s preferences and randomised trials ' (1996 ) 347 Lancet : 171 -174.

    • Search Google Scholar
  • Ah See, K. W., Molony, N. C., Maran, D.: Trends in randomized controlled trials in ENT: a 30-year review. J. Laryngol. Otol., 1997, 111, 611–613.

    Maran D. , 'Trends in randomized controlled trials in ENT: a 30-year review ' (1997 ) 111 J. Laryngol. Otol. : 611 -613.

    • Search Google Scholar
  • Bonchek, L. I.: Sounding board: are randomized trials appropriate for evaluating new operations? N. Engl. J. Med., 1979, 301, 44–45.

    Bonchek L. I. , 'Sounding board: are randomized trials appropriate for evaluating new operations? ' (1979 ) 301 N. Engl. J. Med. : 44 -45.

    • Search Google Scholar
  • Fung, E. K., Lore, J. M.: Randomized controlled trials for evaluating surgical questions. Arch. Otolaryngol. Head. Neck. Surg., 2002, 128, 631–634.

    Lore J. M. , 'Randomized controlled trials for evaluating surgical questions ' (2002 ) 128 Arch. Otolaryngol. Head. Neck. Surg. : 631 -634.

    • Search Google Scholar
  • Makary, M. A., Sexton, J. B., Freischlag, J. A. és mtsai: Patient safety in surgery. Ann. Surg., 2006, 243, 628–632.

    Freischlag J. A. , 'Patient safety in surgery ' (2006 ) 243 Ann. Surg. : 628 -632.

  • Khuri, S.: Safety, quality, and the National Surgical Quality Improvement Program. Am. Surg., 2006, 72, 994–998.

    Khuri S. , 'Safety, quality, and the National Surgical Quality Improvement Program ' (2006 ) 72 Am. Surg. : 994 -998.

    • Search Google Scholar
  • Kulin L., Baranyai Zs.: A betegbiztonság növelését célzó erőfeszítések és kezdeményezések a világ országaiban. IME, 2011, 10, 35–38.

    Baranyai Zs. , 'A betegbiztonság növelését célzó erőfeszítések és kezdeményezések a világ országaiban ' (2011 ) 10 IME : 35 -38.

    • Search Google Scholar
  • WHO – Safe Surgery Saves Lives. http://www.who.int/patientsafety/safesurgery/en/

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