Laboratorieutrustning för primärvården bör utprövas av oberoende organ. Skandinaviska SKUP ett bra alternativ

Lakartidningen

Volumn 105, Issue 46, 2008, Pages 3334-3339

  Sandberg, Sverre ^a,b   Nordin, Gunnar ^c   Mårtensson, Arne ^d   Grinsted, Per ^e   Jensen, Esther ^e   Jacobsen, Camilla Eide ^c   Monsen, Grete ^a  

^a UNIVERSITY OF BERGEN   (Norway)

^b HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^c VD ^*

^d EQUALIS   (Sweden)

^e ODENSE UNIVERSITY HOSPITAL   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; DIAGNOSIS, MEASUREMENT AND ANALYSIS; EQUIPMENT; HOSPITAL INFORMATION SYSTEM; HUMAN; INSTRUMENTATION; LABORATORY; METHODOLOGY; PRIMARY HEALTH CARE; QUALITY CONTROL; STANDARD; SWEDEN;

EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; HUMANS; LABORATORIES; LABORATORY TECHNIQUES AND PROCEDURES; POINT-OF-CARE SYSTEMS; PRIMARY HEALTH CARE; QUALITY CONTROL; SWEDEN;

EID: 56749154425     PISSN: 00237205     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. Sandberg S, Hellsing K, Jørgensen P, Mårtensson A, Monsen G. Skandinavisk utprøving av laboratorieutstyr for primæ rhelsetjenesten. Etablering av SKUP og igangsetting av de første evalueringene. Klinisk kemi i Norden. 1999;11:56-60.
2. Christensen NG, Monsen G, Sandberg S. Utprøving av analyseinstrumenter. En veiledning spesielt beregnet for utprøving av instrumenter for primærhelsetjenesten. Bergen: Alma Mater; 1997.
3. Kristensen GB, Nerhus K, Thue G, Sandberg S. Standardized evaluation of instruments for self-monitoring of blood glucose by patients and a technologist. Clin Chem. 2004;50:1068-71.
4. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. OJ L 331, 1998:1-37. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0079:EN:NOT
5. Kravspesifikasjoner til blodsukkerteststrimler som Arbeids- og velferdsetaten (NAV) gir refusjon for. http://www.uib.no/isf/noklus/diabetes/ kravspes.pdf
6. In vitro-diagnostik - Användning av externa kvalitetsbedö mningsprogram för utvärdering av hur in vitro-diagnostiska undersökningar fungerar. http://www.sis.se/DesktopDefault.aspx?tabName= @DocType_1&Doc_ID=36759
7. Guidelines on a Medical Devices Vigilance System. EU MEDDEV 2.12-1 rev 4: 2001. http://ec.europa.eu/enterprise/medical_devices/meddev/2_12_1-rev_5-2007- fin2.pdf
8. National Health Service (NHS) Purchasing and Supply Agency. http://www.pasa.nhs.uk
9. Mahoney J, Ellison J. Assessing the quality of glucose monitor studies: A critical evaluation of published reports. Clin Chem. 2007;53:1122-8.