메뉴 건너뛰기




Volumn 16, Issue 11, 2011, Pages 1439-1449

Quality of medical devices and in vitro diagnostics in resource-limited settings

Author keywords

Invitro diagnostics; Medical devices; Poor countries; Quality problems; Regulatory surveillance

Indexed keywords

DECISION MAKING; DEVELOPING WORLD; FIELD SURVEY; HEALTH MONITORING; HEALTH POLICY; LABORATORY METHOD; LITERATURE REVIEW; QUALITATIVE ANALYSIS; REGULATORY APPROACH; RESOURCE USE;

EID: 80053645201     PISSN: 13602276     EISSN: 13653156     Source Type: Journal    
DOI: 10.1111/j.1365-3156.2011.02852.x     Document Type: Article
Times cited : (29)

References (76)
  • 1
    • 0025835937 scopus 로고
    • A report on radiology at Muhimbili Medical Center, Dar es Salaam, Tanzania
    • Baker ME & Porter FR (1991) A report on radiology at Muhimbili Medical Center, Dar es Salaam, Tanzania. American Journal of Roentgenology 157, 195.
    • (1991) American Journal of Roentgenology , vol.157 , pp. 195
    • Baker, M.E.1    Porter, F.R.2
  • 2
    • 35548983467 scopus 로고    scopus 로고
    • Evaluation of diagnostic tests for infectious diseases: general principles
    • Banoo S, Bell D, Bossuyt P et al. (2006) Evaluation of diagnostic tests for infectious diseases: general principles. Nature Reviews Microbiology 4 (Suppl. 9), S21-S31.
    • (2006) Nature Reviews Microbiology , vol.4 , Issue.SUPPL. 9
    • Banoo, S.1    Bell, D.2    Bossuyt, P.3
  • 3
    • 12344305561 scopus 로고    scopus 로고
    • Improving the accuracy of malaria-related laboratory tests in Ghana
    • Bates I, Bekoe V & Asamoa-Adu A (2004) Improving the accuracy of malaria-related laboratory tests in Ghana. Malaria Journal 3, 38.
    • (2004) Malaria Journal , vol.3 , pp. 38
    • Bates, I.1    Bekoe, V.2    Asamoa-Adu, A.3
  • 4
    • 80053630477 scopus 로고    scopus 로고
    • BBC news Two accused over 'fake' HIV tests. (last accessed date 12 April 2011).
    • BBC news (2006) Two accused over 'fake' HIV tests. (last accessed date 12 April 2011).
    • (2006)
  • 5
    • 33749448415 scopus 로고    scopus 로고
    • Evaluation of rapid diagnostic tests: malaria
    • Bell D & Peeling RW (2006) Evaluation of rapid diagnostic tests: malaria. Nature Reviews Microbiology 4 (Suppl. 9), S34-S38.
    • (2006) Nature Reviews Microbiology , vol.4 , Issue.SUPPL. 9
    • Bell, D.1    Peeling, R.W.2
  • 7
    • 80053629672 scopus 로고    scopus 로고
    • Bloomberg China Counterfeit Diabetes Tests Tracked by J&J (Update1). (last accessed date 12 April 2011).
    • Bloomberg (2007) China Counterfeit Diabetes Tests Tracked by J&J (Update1). (last accessed date 12 April 2011).
    • (2007)
  • 8
    • 4544379633 scopus 로고    scopus 로고
    • A comparative study of the effectiveness of diagnostic tests for visceral leishmaniasis
    • Boelaert M, Rijal S, Regmi S et al. (2004) A comparative study of the effectiveness of diagnostic tests for visceral leishmaniasis. American Journal of Tropical Medicine and Hygiene 70, 72-77.
    • (2004) American Journal of Tropical Medicine and Hygiene , vol.70 , pp. 72-77
    • Boelaert, M.1    Rijal, S.2    Regmi, S.3
  • 10
    • 33750287177 scopus 로고    scopus 로고
    • External quality assurance for the laboratory diagnosis of Buruli ulcer disease in Ghana
    • Bretzel G, Siegmund V, Nitschke J et al. (2006) External quality assurance for the laboratory diagnosis of Buruli ulcer disease in Ghana. Tropical Medicine & International Health 11, 1688-1693.
    • (2006) Tropical Medicine & International Health , vol.11 , pp. 1688-1693
    • Bretzel, G.1    Siegmund, V.2    Nitschke, J.3
  • 12
    • 80053630093 scopus 로고    scopus 로고
    • Chennai online NACO Pulled up for Substandard HIV Kits in Country. (last accessed date 12 April 2011).
    • Chennai online (2008) NACO Pulled up for Substandard HIV Kits in Country. (last accessed date 12 April 2011).
    • (2008)
  • 15
    • 16844363878 scopus 로고    scopus 로고
    • Field evaluation of latex agglutination test for detecting urinary antigens in visceral leishmaniasis in Sudan
    • El-Safi SH, Abdel-Haleem A, Hammad A et al. (2003) Field evaluation of latex agglutination test for detecting urinary antigens in visceral leishmaniasis in Sudan. Eastern Mediterranean Health Journal 9, 844-855.
    • (2003) Eastern Mediterranean Health Journal , vol.9 , pp. 844-855
    • El-Safi, S.H.1    Abdel-Haleem, A.2    Hammad, A.3
  • 16
    • 80053627935 scopus 로고    scopus 로고
    • Emergo Worldwide Medical Device Regulations. (last accessed date 12 April 2011).
    • Emergo (2011a) Worldwide Medical Device Regulations. (last accessed date 12 April 2011).
    • (2011)
  • 17
    • 80053624451 scopus 로고    scopus 로고
    • Emergo Medical Device Regulatory Requirements for Egypt. (last accessed date 12 April 2011).
    • Emergo (2011b) Medical Device Regulatory Requirements for Egypt. (last accessed date 12 April 2011).
    • (2011)
  • 18
    • 80053641019 scopus 로고    scopus 로고
    • European Commission Medical Devices Current Legislation. (last accessed date 12 April 2011).
    • European Commission (2011a) Medical Devices Current Legislation. (last accessed date 12 April 2011).
    • (2011)
  • 19
    • 80053647554 scopus 로고    scopus 로고
    • European Commission Revision of the Medical Device Directives. (last accessed date 27 June 2011).
    • European Commission (2011b) Revision of the Medical Device Directives. (last accessed date 27 June 2011).
    • (2011)
  • 20
    • 80053622574 scopus 로고    scopus 로고
    • FDA Overview of IVD Regulation. (last accessed date 12 April 2011).
    • FDA (2011) Overview of IVD Regulation. (last accessed date 12 April 2011).
    • (2011)
  • 21
    • 80053631076 scopus 로고    scopus 로고
    • FDA. Significant Dates in U.S. Food and Drug Law History. (last accessed date 12 April 2011).
    • FDA. Significant Dates in U.S. Food and Drug Law History. (last accessed date 12 April 2011).
  • 22
    • 80053638333 scopus 로고    scopus 로고
    • GHTF Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices. (last accessed date 27 June 2011).
    • GHTF (2008a) Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices. (last accessed date 27 June 2011).
    • (2008)
  • 23
    • 80053625111 scopus 로고    scopus 로고
    • GHTF Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. (last accessed date 27 June 2011).
    • GHTF (2008b) Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. (last accessed date 27 June 2011).
    • (2008)
  • 25
    • 78649924175 scopus 로고    scopus 로고
    • External quality assessment on the use of malaria rapid diagnostic tests in a non-endemic setting
    • Gillet P, Mukadi P, Vernelen K et al. (2010) External quality assessment on the use of malaria rapid diagnostic tests in a non-endemic setting. Malaria Journal 9, 359.
    • (2010) Malaria Journal , vol.9 , pp. 359
    • Gillet, P.1    Mukadi, P.2    Vernelen, K.3
  • 26
    • 79751532893 scopus 로고    scopus 로고
    • Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts
    • Gillet P, Maltha J, Hermans V, Ravinetto R, Bruggeman C & Jacobs J (2011) Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts. Malaria Journal 10, 39.
    • (2011) Malaria Journal , vol.10 , pp. 39
    • Gillet, P.1    Maltha, J.2    Hermans, V.3    Ravinetto, R.4    Bruggeman, C.5    Jacobs, J.6
  • 28
    • 80053640574 scopus 로고    scopus 로고
    • Government Accountability Project World Bank Funding Use of Defective HIV-Testing Kits. (last accessed date 12 April 2011).
    • Government Accountability Project (2007) World Bank Funding Use of Defective HIV-Testing Kits. (last accessed date 12 April 2011).
    • (2007)
  • 30
    • 33751195287 scopus 로고    scopus 로고
    • Evaluation of rapid diagnostic tests: chlamydia and gonorrhoea
    • WHO, Diag TSTD.
    • Herring A, Ballard R, Mabey D, Peeling RW, WHO, Diag TSTD (2006b) Evaluation of rapid diagnostic tests: chlamydia and gonorrhoea. Nature Reviews Microbiology 4 (Suppl. 12), S41-S48.
    • (2006) Nature Reviews Microbiology , vol.4 , Issue.SUPPL. 12
    • Herring, A.1    Ballard, R.2    Mabey, D.3    Peeling, R.W.4
  • 31
    • 80053637970 scopus 로고    scopus 로고
    • Indian Express In the house. (last accessed date 12 April 2011).
    • Indian Express (2009) In the house. (last accessed date 12 April 2011).
    • (2009)
  • 33
    • 80053639220 scopus 로고    scopus 로고
    • Lifescan Counterfeit OneTouch Test Strip Alert. (last accessed date 12 April 2011).
    • Lifescan (2009) Counterfeit OneTouch Test Strip Alert. (last accessed date 12 April 2011).
    • (2009)
  • 34
    • 0034978397 scopus 로고    scopus 로고
    • Direct measurement of microkeratome gap width by electron microscopy
    • Liu KY & Lam DS (2001) Direct measurement of microkeratome gap width by electron microscopy. Journal of Cataract & Refractive Surgery 27, 924-927.
    • (2001) Journal of Cataract & Refractive Surgery , vol.27 , pp. 924-927
    • Liu, K.Y.1    Lam, D.S.2
  • 35
    • 80053638709 scopus 로고    scopus 로고
    • Ludhiana Tribune Dengue Outbreak 'Benefits' Docs, Labs. (last accessed date 12 April 2011).
    • Ludhiana Tribune (2008) Dengue Outbreak 'Benefits' Docs, Labs. (last accessed date 12 April 2011).
    • (2008)
  • 37
    • 23044473647 scopus 로고    scopus 로고
    • Implementation of a quality systems approach for laboratory practice in resource-constrained countries
    • Martin R, Hearn TL, Ridderhof JC & Demby A (2005) Implementation of a quality systems approach for laboratory practice in resource-constrained countries. Aids 19(Suppl 2), S59-S65.
    • (2005) Aids , vol.19 , Issue.SUPPL. 2
    • Martin, R.1    Hearn, T.L.2    Ridderhof, J.C.3    Demby, A.4
  • 38
    • 54549121436 scopus 로고    scopus 로고
    • Performance indicators for quality in surgical and laboratory services at Muhimbili National Hospital (MNH) in Tanzania
    • Mbembati NA, Mwangu M, Muhondwa EP & Leshabari MM (2008) Performance indicators for quality in surgical and laboratory services at Muhimbili National Hospital (MNH) in Tanzania. East African Journal of Public Health 5, 13-16.
    • (2008) East African Journal of Public Health , vol.5 , pp. 13-16
    • Mbembati, N.A.1    Mwangu, M.2    Muhondwa, E.P.3    Leshabari, M.M.4
  • 40
    • 38749083486 scopus 로고    scopus 로고
    • The quality of sputum smear microscopy diagnosis of pulmonary tuberculosis in Dar es Salaam, Tanzania
    • Mfinanga GS, Ngadaya E, Mtandu R et al. (2007b) The quality of sputum smear microscopy diagnosis of pulmonary tuberculosis in Dar es Salaam, Tanzania. Tanzania Health Research Bulletin 9, 164-168.
    • (2007) Tanzania Health Research Bulletin , vol.9 , pp. 164-168
    • Mfinanga, G.S.1    Ngadaya, E.2    Mtandu, R.3
  • 41
    • 80053640164 scopus 로고    scopus 로고
    • MHRA MDA/2006/070-LifeScan OneTouch Ultra, LifeScan InDuo and LifeScan PocketScan Blood Glucose Meters. (last accessed date 12 April 2011).
    • MHRA (2006) MDA/2006/070-LifeScan OneTouch Ultra, LifeScan InDuo and LifeScan PocketScan Blood Glucose Meters. (last accessed date 12 April 2011).
    • (2006)
  • 42
    • 80053621643 scopus 로고    scopus 로고
    • Monobind. Counterfeit Monobind Test Kits. (last accessed date 12 April 2011).
    • Monobind (2007). Counterfeit Monobind Test Kits. (last accessed date 12 April 2011).
    • (2007)
  • 43
    • 0035949121 scopus 로고    scopus 로고
    • Estimated risk of HIV transmission by blood transfusion in Kenya
    • Moore A, Herrera G, Nyamongo J et al. (2001) Estimated risk of HIV transmission by blood transfusion in Kenya. Lancet 358, 657-660.
    • (2001) Lancet , vol.358 , pp. 657-660
    • Moore, A.1    Herrera, G.2    Nyamongo, J.3
  • 44
    • 80053628125 scopus 로고    scopus 로고
    • FDA Seeks to Modify Regulation of Medical Devices: Challenges for Resource-Poor Settings? Rapid Response at BMJ.com. (last accessed date 12 April 2011).
    • Mori M, Ravinetto R & Jacobs J (2010) FDA Seeks to Modify Regulation of Medical Devices: Challenges for Resource-Poor Settings? Rapid Response at BMJ.com. (last accessed date 12 April 2011).
    • (2010)
    • Mori, M.1    Ravinetto, R.2    Jacobs, J.3
  • 47
    • 66549098398 scopus 로고    scopus 로고
    • WHO comparative evaluation of serologic assays for Chagas disease
    • Otani MM, Vinelli E, Kirchhoff LV et al. (2009) WHO comparative evaluation of serologic assays for Chagas disease. Transfusion 49, 1076-1082.
    • (2009) Transfusion , vol.49 , pp. 1076-1082
    • Otani, M.M.1    Vinelli, E.2    Kirchhoff, L.V.3
  • 48
    • 80053644534 scopus 로고    scopus 로고
    • Outlook India NACO Pulled up for Substandard HIV Kits in Country. (last accessed date 12 April 2011).
    • Outlook India (2008) NACO Pulled up for Substandard HIV Kits in Country. (last accessed date 12 April 2011).
    • (2008)
  • 49
    • 13644256971 scopus 로고    scopus 로고
    • Medical equipment in government health facilities: missed opportunities
    • Pardeshi GS (2005) Medical equipment in government health facilities: missed opportunities. Indian Journal of Medical Sciences 59, 13-19.
    • (2005) Indian Journal of Medical Sciences , vol.59 , pp. 13-19
    • Pardeshi, G.S.1
  • 51
    • 84860426256 scopus 로고    scopus 로고
    • People for better treatment Medical Negligence" of Another Kind: Use of Defective HIV Kits. (last accessed date 12 April 2011).
    • People for better treatment (2009) Medical Negligence" of Another Kind: Use of Defective HIV Kits. (last accessed date 12 April 2011).
    • (2009)
  • 54
    • 80053627154 scopus 로고    scopus 로고
    • FDA seeks to modify regulation of medical devices
    • Roehr B (2010) FDA seeks to modify regulation of medical devices. British Medical Journal 341, c4415. doi:.
    • (2010) British Medical Journal , vol.341
    • Roehr, B.1
  • 55
    • 34248559868 scopus 로고    scopus 로고
    • Additional counterfeit tests strips found
    • Ruder K (2007) Additional counterfeit tests strips found. Diabetes Forecast 60, 29.
    • (2007) Diabetes Forecast , vol.60 , pp. 29
    • Ruder, K.1
  • 56
    • 80053652206 scopus 로고    scopus 로고
    • South Asian Post Fake Diabetic Kit Alert. (last accessed date 12 April 2011).
    • South Asian Post (2007) Fake Diabetic Kit Alert. (last accessed date 12 April 2011).
    • (2007)
  • 59
    • 33745449263 scopus 로고    scopus 로고
    • Comparison of two amoxicillin/clavulanic acid-resistant profiles employing two types of assay disks: a pilot study in 50 isolates from a tertiary care hospital in India
    • Subhash CA, Agarwal N & Agarwal S (2006) Comparison of two amoxicillin/clavulanic acid-resistant profiles employing two types of assay disks: a pilot study in 50 isolates from a tertiary care hospital in India. Current Therapeutic Research 67, 151-156.
    • (2006) Current Therapeutic Research , vol.67 , pp. 151-156
    • Subhash, C.A.1    Agarwal, N.2    Agarwal, S.3
  • 60
    • 80053641758 scopus 로고    scopus 로고
    • The Economic Times NACO Pulled up for Substandard HIV Kits in Country. (last accessed date 12 April 2011).
    • The Economic Times (2008) NACO Pulled up for Substandard HIV Kits in Country. (last accessed date 12 April 2011).
    • (2008)
  • 61
    • 80053633726 scopus 로고    scopus 로고
    • The Times of India No Tests to See if a Pathology Lab is Accurate. (last accessed date 12 April 2011).
    • The Times of India (2002) No Tests to See if a Pathology Lab is Accurate. (last accessed date 12 April 2011).
    • (2002)
  • 62
    • 80053622374 scopus 로고    scopus 로고
    • The Times of India Diagnostic Kits Cleared by Testing Agency Despite Ban. (last accessed date 12 April 2011).
    • The Times of India (2009a) Diagnostic Kits Cleared by Testing Agency Despite Ban. (last accessed date 12 April 2011).
    • (2009)
  • 63
    • 80053641949 scopus 로고    scopus 로고
    • The Times of India Row Over Supply of Preventive Kit. (last accessed date 12 April 2011).
    • The Times of India (2009b) Row Over Supply of Preventive Kit. (last accessed date 12 April 2011).
    • (2009)
  • 64
    • 80053651262 scopus 로고    scopus 로고
    • U.S. FDA. Recalls, Market Withdrawals, amp; Safety Alerts. (last accessed date 12 April 2011).
    • U.S. FDA. Recalls, Market Withdrawals, & Safety Alerts. (last accessed date 12 April 2011).
  • 65
    • 40749147258 scopus 로고    scopus 로고
    • Sputum smear microscopy: evaluation of impact of training, microscope distribution, and use of external quality assessment guidelines for resource-poor settings
    • Van Rie A, Fitzgerald D, Kabuya G et al. (2008) Sputum smear microscopy: evaluation of impact of training, microscope distribution, and use of external quality assessment guidelines for resource-poor settings. Journal of Clinical Microbiology 46, 897-901.
    • (2008) Journal of Clinical Microbiology , vol.46 , pp. 897-901
    • Van Rie, A.1    Fitzgerald, D.2    Kabuya, G.3
  • 66
    • 80053633922 scopus 로고    scopus 로고
    • Visiongain (last accessed date 12 April 2011).
    • Visiongain (2008) (last accessed date 12 April 2011).
    • (2008)
  • 67
    • 33746315907 scopus 로고    scopus 로고
    • Increase in catheter insertion-site infections associated to the introduction of a substandard competitive antiseptic
    • Volkow P, Sandoval S, Campos AM et al. (2006) Increase in catheter insertion-site infections associated to the introduction of a substandard competitive antiseptic. American Journal of Infection Control 34, 335-337.
    • (2006) American Journal of Infection Control , vol.34 , pp. 335-337
    • Volkow, P.1    Sandoval, S.2    Campos, A.M.3
  • 68
    • 80053634734 scopus 로고    scopus 로고
    • WHO Diagnostics for TB: Global Demand and Market Potential. Annex: Regulation of In Vitro Diagnostics: A Global Perspective. TBDI.04.1 (last accessed date 12 April 2011).
    • WHO (2001) Diagnostics for TB: Global Demand and Market Potential. Annex: Regulation of In Vitro Diagnostics: A Global Perspective. TBDI.04.1 (last accessed date 12 April 2011).
    • (2001)
  • 69
    • 80053646417 scopus 로고    scopus 로고
    • WHO Medical Device Regulations: Global Overview and Guiding Principles. (last accessed date 12 April 2011).
    • WHO (2003) Medical Device Regulations: Global Overview and Guiding Principles. (last accessed date 12 April 2011).
    • (2003)
  • 70
    • 80053645649 scopus 로고    scopus 로고
    • WHO Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries: An Overview of Findings from 26 Assessment Reports. (last accessed date 12 April 2011).
    • WHO (2010a) Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries: An Overview of Findings from 26 Assessment Reports. (last accessed date 12 April 2011).
    • (2010)
  • 71
    • 84860493466 scopus 로고    scopus 로고
    • WHO Fact Sheet N°275, Revised in January 2010. (last accessed date 12 April 2011).
    • WHO (2010b) Fact Sheet N°275, Revised in January 2010. (last accessed date 12 April 2011).
    • (2010)
  • 72
    • 80053644727 scopus 로고    scopus 로고
    • WHO Counterfeit Medicines: Frequently Asked Questions. What are Counterfeit Medicines? (last accessed date 12 April 2011).
    • WHO (2011a) Counterfeit Medicines: Frequently Asked Questions. What are Counterfeit Medicines? (last accessed date 12 April 2011).
    • (2011)
  • 73
    • 80053620256 scopus 로고    scopus 로고
    • WHO Counterfeit Medicines: Frequently Asked Questions. What are Substandard Medicines? (last accessed date 12 April 2011).
    • WHO (2011b) Counterfeit Medicines: Frequently Asked Questions. What are Substandard Medicines? (last accessed date 12 April 2011).
    • (2011)
  • 74
    • 80053651071 scopus 로고    scopus 로고
    • WHO Expert Committee on Biological Standardization. (last accessed date 12 April 2011).
    • WHO (2011c) Expert Committee on Biological Standardization. (last accessed date 12 April 2011).
    • (2011)
  • 75
    • 80053653163 scopus 로고    scopus 로고
    • WHO WHO Prequalification of Diagnostics Programme. (last accessed date 12 April 2011).
    • WHO (2011d) WHO Prequalification of Diagnostics Programme. (last accessed date 12 April 2011).
    • (2011)
  • 76
    • 77957043025 scopus 로고    scopus 로고
    • WHO calls for better access to medical devices in poor nations
    • Zarocostas J (2010) WHO calls for better access to medical devices in poor nations. British Medical Journal 341, c5052. doi:.
    • (2010) British Medical Journal , vol.341
    • Zarocostas, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.