[Issues on package inserts of percutaneous tracheostomy kits].
BACKGROUND
Percutaneous tracheostomy using a dedicated kit, which has been a common surgical procedure in intensive care settings, must be carefully performed with sufficient knowledge regarding both the technique and the kit. The aim of this study was to investigate the accuracy and adequacy of information contained in package inserts of kits, as the primary official documents for providing information on safe and sure performance of the procedure.


METHODS
We investigated the contents of package inserts for three percutaneous tracheostomy kits available in Japan, and ascertained whether the distributors of the kits showed the contents on the Internet.


RESULTS
Package inserts did not necessarily provide accurate and sufficient information in terms of generic names, warnings, contraindications, indication for use, instructions for use and/or handling, cautions or clinical records. Not all distributors followed the ordinance from the Pharmaceuticals and Medical Devices Agency to show this information to the public.


CONCLUSIONS
The importance of package inserts in safety measures related to medical devices has been growing since the enforcement of the revised Pharmaceutical Affairs Law in 2005. The significance of package inserts must be emphasized, and distributors of kits need to be encouraged to improve inserts.
Mori
Masakazu
M
Department of Anesthesiology, Faculty of Medicine, Oita University, Oita 879-5593.
Noguchi
Takayuki
T
D004869:Equipment Safety; D006077:Government Agencies; D006801:Humans; D007564:Japan; D011356:Product Labeling / Q000331:legislation & jurisprudence / Q000592:standards; D014139:Tracheostomy / Q000379:methods*