An old activity seen in a new light – supervision in 2010 of organizations that are authorized to deal with corneas etc. for human use in Norway: implementation and experience
Summary of Report of the Norwegian Board of Health Supervision 2/2011
In 2010, the Norwegian Board of Health Supervision carried out supervision of organizations that deal with corneas etc. for human use.
In Norway, keratoplasty (corneal transplantation) is carried out by Oslo University Hospital Trust, Bergen Hospital Trust and St. Olavs Hospital Trust. 258 keratoplasty operations were carried out in 2009, nearly all of them with corneas imported from the USA.
The conclusions of the supervision carried out by the Norwegian Board of Health Supervision were:
- Based on our experience of supervision, we have no reason for concern about the way in which the organizations deal with imported corneas. However, all the organizations lacked written procedures and routines for documentation, to the extent that is specified in the regulations. Thus, they operate with a greater level of risk (fewer safety barriers) than that which is specified in the regulations. The Norwegian Board of Health Supervision will follow up these health trusts to ensure that they fulfil their responsibility for correcting these deficiencies.
- Keratoplasty in Norway is almost always carried out with corneas imported from the USA. From the perspective of supervision, this makes insight into the arrangement difficult.
- Conditions should be adapted so that Norwegian patients can be offered corneas that have been donated in Norway in the future.