By Nancy Chobin, RN, AAS, ACSP, CSPM
Q: Our sterile processing department (SPD) is sent explanted implants (screws, plates) to clean and sterilize so the patient can take them home. I have questioned this practice but do not have documentation to challenge this decision.
A: The Food and Drug Administration (FDA) defines an implantable device as “a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. The FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also "implants." [21 CFR812.3(d)]. Orthopedic trauma related screws and plates fall into this category. Technically (and legally in many states) the patient has the right to the explanted implants because they paid for them; however there are Occupational Safety and Health Administration (OSHA) and manufacturer’s instructions for use issues that need to be considered.
The first thing to do is to obtain and review the implant manufacturer’s written instructions for use. Follow their recommendations. Usually, implant manufacturers specify that “used implants should not be reprocessed." This means that if the implant came in direct contact with the patient, it should not be processed; it should be removed from the set. Some manufacturers specifically state that if the implant was in contact with blood, it should not be processed. Since the recommendations can vary, you need to begin with your specific implant manufacturer’s written instructions for use (IFU). Make sure you have the most current IFU. It is recommended to obtain this from the home office of the company, as webpages do not always have the most current information.
Second, if it is confirmed that the manufacturer does not recommend reprocessing, then you have no information how to make the implant safe to give to the patient. Cleaning and/or sterilization instructions have not been provided because these items were not intended to be reprocessed.
Since the implant cannot be safely decontaminated, it must be considered contaminated and labeled as such. OSHA states, “Specimens of blood or other potentially infectious materials shall be placed in a container that prevents leakage during collection, handling, processing, storage, transport, or shipping. The container for storage, transport, or shipping shall be labeled or color-coded according to paragraph and closed prior to being stored, transported, or shipped. Labels required by this section shall include the following legend. These labels shall be fluorescent orange or orange-red or predominantly so, with lettering or symbols in a contrasting color.” This would include the explanted implant.
The practice of giving explanted implants back to the patient should be discussed by a multi-disciplinary team consisting of (at least) infection prevention, risk management, SPD and the operating room. A policy and procedure should be developed and approved by the infection prevention committee. SPD and OR personnel should be in-serviced in the provisions in the policy and compliance monitored. SPD should not be processing any device without written instructions from the device manufacturer. Any non-compliance would put the facility at risk. While we would like to accommodate the patient’s request, we must always comply with the standards and manufacturer’s instructions.
Nancy Chobin, RN, AAS, ACSP, CSPM, is a sterile processing consultant and educator.
Reference: Occupational exposure to blood-borne pathogens (29 CFR Part 1910.1030)1. §1910.1030 Bloodborne pathogens, 1991, 2001.