Breast implant Sizers are commonly used to assist the surgeon in selecting the appropriate permanent implants for either cosmetic augmentation or reconstruction mammaplasty following mastectomy. The implant size is a crucial factor in determining which implants to use and must accurately reflect the permanent implant device that will be inserted. In an ambulatory surgery setting, gel or silicone breast implant Sizers can be reused for multiple patients after the initial use when reprocessed in accordance with the manufacturer’s instructions for use. Conversely, saline breast Sizers are intended for single-use only.
How many times can a gel or silicone breast Sizer be re-sterilized? Manufacturers have specific instructions regarding the re-sterilization of their products, and these may vary from manufacturer to manufacturer. The manufacturer’s instructions for use must be followed. Generally, re-sterilizable gel or silicone Sizers are intended for ten (10) additional uses after initial use and only after adequate cleaning, disinfecting, and re-sterilization by validated techniques. DO NOT reuse re-sterilizable Sizers more than ten (10) times after initial use or per the manufacturer’s instructions. DO NOT use disinfectant on the re-sterilizable Sizer. The facility must ensure that a record of the reprocessing details of each gel or silicone Sizer is documented to enable product identification, device traceability, and the number of sterilizations the Sizer has undergone to ensure that the manufacturer’s instructions are not exceeded.
QUAD A standard 7-A-2 applies to this practice –The facility policy manual should include infection control policies and procedures that are consistent with current CDC guidelines.
Recently, surveyors have encountered multiple facilities that were unable to produce or demonstrate a documented process for tracking the number of sterilizations a breast Sizer has undergone, and evidence that single-use breast Sizers were being re-sterilized and used on multiple patients. This unsafe practice poses a significant risk to the health and safety of the patients and is not consistent with the manufacturer’s instructions for use. One of the reasons this is a risky practice is that biological contaminants may be difficult to remove from the Sizer surface. If the Sizers are processed past the manufacturer’s designated number of sterilizations, the breast Sizer material breaks down, and the risk of contamination increases. The manufacturer will no longer guarantee the integrity of the product once the designated number of re-sterilizations has been reached.
We appreciate your commitment to patient safety. Please ensure your facility practice follows the standards. If you have any questions, feel free to reach out to your accreditation specialist.
Since 1980, QUAD A (a non-profit, physician-founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of healthcare they provide – believing that patient safety should always come first.