Documentation and Record Keeping Flashcards

Which document provides manufacturer-validated instructions for cleaning, disinfecting, and sterilizing a specific medical device?

Answer: The instrument's Instructions for Use (IFU)

The manufacturer's Instructions for Use (IFU) contain validated reprocessing parameters and must be followed to ensure effective decontamination and sterilization of that specific device.

What information should be documented when a loaner instrument set is received in the SPD?

Answer: Receipt date, vendor name, count, condition of instruments, and IFU availability

Documenting receipt date, vendor, count, instrument condition, and IFU availability ensures loaner sets are properly tracked, inspected, and reprocessed according to validated instructions before use.

In SPD, what does a 'chemical indicator' (CI) record in the sterilization documentation confirm?

Answer: That the package was exposed to sterilization conditions during the cycle

Chemical indicators change color or form when exposed to sterilization parameters (e.g., heat, steam, EO gas), confirming the package experienced the sterilization process, though they do not confirm sterility.

Which record-keeping practice supports a 'sterility assurance' program in an accredited facility?

Answer: Maintaining records of every sterilization load including physical, chemical, and biological monitoring

A complete sterility assurance program requires records of physical printouts, chemical indicator results, and biological indicator outcomes for every load to demonstrate consistent compliance.

When sterilizing implantable devices, what additional documentation requirement typically applies?

Answer: Biological indicator results must be reviewed and documented before the implant is released

For implantable devices, AAMI and accreditation standards require that a biological indicator be run with the load and results reviewed before the item is released for use.

What should an SPD technician do if they discover an incomplete or missing sterilization load record?

Answer: Report the discrepancy to a supervisor and follow the facility's corrective action protocol

Incomplete records are a compliance and patient safety issue; the correct action is to report the discrepancy to a supervisor and follow the facility's established corrective action protocol.

What is the primary purpose of a sterilizer maintenance log?

Answer: To document preventive maintenance, repairs, and calibration to ensure equipment is functioning properly

A maintenance log documents scheduled preventive maintenance, repairs, and calibration events, providing evidence that the sterilizer is operating within validated performance specifications.