SPD Documentation and Record Keeping 2

Question 1

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

Accepted Answer

The instrument's Instructions for Use (IFU)

Answer

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.

Question 2

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

Accepted Answer

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

Answer

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.

Question 3

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

Accepted Answer

That the package was exposed to sterilization conditions during the cycle

Answer

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.

Question 4

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

Accepted Answer

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

Answer

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

Question 5

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

Accepted Answer

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

Answer

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.

SPD - Sterile Processing Department Technician Certification Practice Test

SPD - Sterile Processing Department Technician Certification Practice Test

SPD Documentation and Record Keeping 2