Table 2

The main participants in the Dent-O-Sept outbreak and some of their roles, responsibilities and actions.

Participant
Role and responsibilities

The producer
"Snøgg AS"
• Produced the Dent-O-Sept swab

• Did not adhere to the laws and regulations for production of medical devices

• Lacked a quality assurance system for the production

• Did not implement advise after external evaluation

• Stopped the swab production as soon as the connection with the outbreak was established

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

The hospitals
• Treated patients and procured medical devices

• Many lacked quality assured systems for procurement, storage and use of medical devices

• Many lacked systems for training of health care workers

• Many had inadequate reporting systems for faulty medical devices

The health care workers
• Treated and cared for patients

• Many reused the "single use" swabs contrary to the text on the wrap

• Many did not report faulty medical devices

The patients
• Received medical treatment and care

• Many were seriously ill and susceptible for contracting infections with the P. aeruginosa bacterium

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

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

• Ignored the deadline to appeal the police's decision not to press charges.

Iversen et al. Emerging Themes in Epidemiology 2008 5:22   doi:10.1186/1742-7622-5-22