抽象的

Platinum Contamination of Laparoscopic Instruments During Pressurized Intra Peritoneal Aerosol Chemotherapy (PIPAC)

Cedric Demtroder, Gerhard Tophoven, Jurgen Zieren, Clemens Tempfer and Marc A Reymond

Background: Beside room and hardware surfaces in the operating room, instruments used during Hyperthermia Intra-Peritoneal Aerosol Chemotherapy (HIPEC) or Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) represent another potential source of contamination. Current regulations in Germany prohibit re-sterilization of medical devices used for distributing radioisotopes or cytotoxic drugs. Methods: We examined the PIPAC process in order to identify which instruments can be potentially contaminated with chemotherapy and to determine the effective level of contamination of these instruments with platinum before and after sterilization. Analysis was blinded and performed by an external certification laboratory. Results: During PIPAC, only the laparoscopic camera is exposed to chemotherapy and is not a single-use instrument. All other laparoscopic instruments, trocars, tubes, etc. are removed before chemotherapy application or are single-use instruments. Eleven cameras were examined for the presence of platinum traces. Three samples were wiped before sterilisation, eight samples afterwards. All samples showed no traces of platinum after sterilization. One out of 3 cameras wiped before sterilization exhibited a detectable amount of platinum, corresponding to 0.001 percent of the drug applied during PIPAC, or 1:10-6 of a usual systemic chemotherapy dose. Conclusion: After PIPAC, minimal traces of platinum were present on the laparoscopic camera. After sterilization, no more traces of platinum were detected. We conclude that laparoscopic cameras can be safely reused after PIPAC