[Qualification of low temperature vaporized hydrogen peroxide sterilization: Towards greater harmonization of practices?] / Qualification de stérilisateurs à basse température au peroxyde d'hydrogène : vers une meilleure harmonisation des pratiques ?

OBJECTIVES: Comparing performance qualification procedures for low temperature vaporized hydrogen peroxide sterilization. Assessing conformity with draft standard ISO/DIS 22441. METHODS: Qualification reports from several providers have been compared according to specific criteria: choices of cycles, loads, sterile barrier systems, probes, biological and chemical indicators; checking of packaging integrity and exposure to sterilizing agent. RESULTS: Six out of 8 reports based on 4 distinct sterilizers have been performed by third-party providers. Routine and process challenge devices are respectively used in 6 and 3 of these reports. Sizes and masses are never mentioned whereas load configuration is always specified. All reports use at least one biological indicator and 50% of them use one chemical indicator at a minimum. Most frequent wrapping materials are Ultra® and Tyvek® bags (respectively 50% and 37.5% of reports). Each qualification monitors per process pression and temperature, and 37.5% of them also quantify hydrogen peroxide concentration. Packaging integrity and environmental exposure are checked in respectively 50% and 12.5% of all reports. All reports have received providers approval. CONCLUSION: Qualification procedure is based on steam sterilization NF EN 14937 standard, which seems unsuitable for low temperature process. The lack of autonomy, the heterogeneity of loads and measurement choices reveal a low harmonization of practices. New standard should dispel the doubts about this heterogeneity.

The role of oncoplastic surgery in breast cancer.

The authors discuss the objectives of oncoplastic surgery in breast cancer management. Indications and advantages are summarised. Some surgical techniques are described. The authors report their own experience with oncoplastic surgery (26 patients who had immediate breast reconstruction after tumorectomy, and 126 patients who had lumpectomy alone. Oncoplastic surgery was characterised by a wider excision, with negative margins in all cases. In isolated breast conservative tumorectomy, 20% of the margins were positive, requiring re-excision or radical mastectomy. Oncoplastic surgery is preferred especially in younger patients with smaller breasts, since it is less cosmetically mutulating and allows complete tumor resection with save margins.