By Nancy Chobin, RN, CSPM, CFER
Q: We have an offsite facility that will be sending a wrapped scope to be sterilized maybe once a week. It is only one item. Does this fall under the AAMI guidelines for transportation of soiled items? What is the best way to transport this? It will be in a courier van.
A: If the scope has already been cleaned and packaged, it is not considered contaminated and therefore would not have to be identified with a biohazard label. However, there are other issues to be considered.
How was the scope pre-cleaned, leak tested, inspected and packaged? Technically, when you sterilize a scope that has been cleaned and packaged by another department/area, you are still responsible for the process.
Did you ever visit the facility to see if they are complying with the scope manufacturer’s instructions for use (IFUs)? Otherwise, you would be attempting to sterilize a scope that was not cleaned properly which would lead to a sterilization failure.
Have you been provided with a copy of the scope manufacturer’s IFUs to reference which methods were validated by the scope manufacturer for processing? How do you know that the method of sterilization was tested and validated by the scope manufacturer? What if the scope manufacturer only recommended high-level disinfection? Since you are processing the scope, you are responsible to verify all this information.
Did you ever open up the package (prior to sterilization) to see how the scope was prepared? If there was a chemical indicator inside the package? Was the chemical indicator the correct one for the process?
In addition to the quality and risk assessment items noted above, the recommended transport of the scope is as follows: Place the wrapped scope inside a clear plastic bag, and seal it; then place in a clean, impervious tote bin.
I recommend having holes drilled into the tote bin’s lid and base (bear the handles) so that break-away locks (e.g. locks used for code carts) are inserted at each end. The locks serve as a tamper-evident seals.
When returning the scope (after sterilization) a similar process should be used to ensure no one tampered with the packaging.
AAMI ST-79 states that, “Vehicles used for transporting contaminated items between healthcare facilities should provide for the complete separation of contaminated items from clean and sterile items. Transport vehicles and handling practices should allow for ease of loading and unloading.” The vehicle should not be left unattended, completely enclosed and have temperature and humidity controls (this is especially true in the summer).
I recommend that you develop a written processing agreement (policy and procedure) between the facilities requesting and providing the services. This agreement should be approved, reviewed and signed by the respective sterile processing department managers. Each manager should retain a copy of the signed form and maintain with department records. Each facility’s legal counsel should review the “contract” to ensure both facilities are legally covered.
A list of items and their quantities (e.g., four cystoscopy sets) being sent to the facility must accompany the items. A three-part form is recommended; the original copy is retained in the sending facility, and the other two copies travel with the items to the receiving facility. Manufacturers’ instructions for processing all devices sent must accompany the devices or they will not be processed. At the receiving facility, the forms are presented to the supervisor/manager who should verify that all manufacturers’ instructions have been received.
Regarding the rest of the process:
- Sterilize all devices per manufacturer’s instructions.
- Items requiring a biological monitor should be identified.
- After sterilization, confirm all items accounted for on the Inventory sheet.
- Place all items in clear plastic bag, seal. Then place in cleaned, disinfected tote bins. Place tamper-evident locks on bins.
- Return one copy of the inventory sheet confirming all items sent are being returned.
- Specify that the facility must report any positive BI test results immediately, send a copy of the sterilization log form showing the information how the device was sterilized.
While this seems like a lot of work for one scope a week, it is equally important to remember you are assuming responsibility for sterilizing this device therefore you need specific documentation to protect you, your facility, and most importantly, the patient.
Nancy Chobin, RN, CSPM, CFER, is a sterile processing educator and consultant.
Reference: Association for the Advancement of Medical Instrumentation, ST-79, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, 2013