Do orthopedic implants need to be double packaged?

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There is no regulatory requirement for double packaging orthopedic implants but there are several factors and requirements of ISO 11607-1 that influence the decision. Section 6.2.2 requires that the medical device package allow the product to be presented in an aseptic manner. While this does not require a double package design, some surgeons prefer to have a “belt and suspenders” approach where the inner package prevents any unnecessary contact while sitting in the sterile field. Additionally, many circulation nurses prefer the ability to transfer the device to the sterile field without waiting for someone in the field to take it out of the package. A double package design can facilitate this – often called “dumping,” “throwing,” or “dropping,” by OR nurses. Additionally, the standard section 6.1.1 requires that the package protect the safety of the user and patient. Some medical device implants have sharp features that may make a double package design desired. Lastly, the issue may come down to surgeon preference.