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The main participants in the Dent-O-Sept outbreak and some of their roles, responsibilities and actions. |
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| Participant |
Role and responsibilities |
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| The producer "Snøgg AS" |
• Produced the Dent-O-Sept swab |
| • Did not adhere to the laws and regulations for production of medical devices |
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| • Lacked a quality assurance system for the production |
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| • Did not implement advise after external evaluation |
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| • Stopped the swab production as soon as the connection with the outbreak was established |
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| The water supplier "Kristiansand municipality" |
• Supplied drinking water to the producer |
| • The P. aeruginosa bacterium may have been introduced into the production plant with the water |
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| The hospitals |
• Treated patients and procured medical devices |
| • Many lacked quality assured systems for procurement, storage and use of medical devices |
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| • Many lacked systems for training of health care workers |
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| • Many had inadequate reporting systems for faulty medical devices |
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| The health care workers |
• Treated and cared for patients |
| • Many reused the "single use" swabs contrary to the text on the wrap |
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| • Many did not report faulty medical devices |
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| The patients |
• Received medical treatment and care |
| • Many were seriously ill and susceptible for contracting infections with the P. aeruginosa bacterium |
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| The surveyor and investigator "Norwegian Institute of Public Health" |
• Responsible for surveillance of infectious diseases and for outbreak investigations |
| • There is no national surveillance system for P. aeruginosa infections |
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| National administrative body "The Norwegian Directorate for Health and Social Affairs" |
• Responsible for national administration within certain areas of the health care system |
| • Responsible for the audit of the producer |
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| • Ignored the deadline to appeal the police's decision not to press charges. |
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Iversen et al. Emerging Themes in Epidemiology 2008 5:22 doi:10.1186/1742-7622-5-22 |
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