True or False

[Guest]

I have a ?--We are in the process of taking out competencies for SPD/OR and there is is true/false ? that reads: Flash sterilization of implantables is recommended. According to these OR policies, if they are ran on a 10 minute flash cycle then it is ok to repeatedly flash implants. My training of implants and talking with several reps of different companies is that they do not recommend flash sterilization of any implantables. That is the purpose of companies providing implants ahead of time except in the cases of immediate use after delivery. I answered the above question as "false" because according to standards "if " there is time, then run it on a full cycle. "If" there is not enough time, then by all means run it on a 10 minute flash cycle. Can someone let me know if my answer is wrong? This question can be both true and false depending on the situation.
THX!

[dongordon]

Flash Sterilization of implants is absolutely not recommended!

Don

[Guest]

Thank you Mr. Gordon for your answer. Now could you possibly let me know if there is some sort of documentation to substantiate the false answer so I may show it to my supervisor and to the O.R. educator? I really appreciate the help!

[Chuck Hughes]

The AAMI recommendation of NOT flashing implants was adopted by ANSI as our American Standard in 1996. The following is directly from the document:

ANSI/AAMI ST37:1996 Flash Sterilization

Section 7.3.1

Flash sterilization of implantable devices is not recommended; however, if it is unavoidable, full traceability to the patient shall be maintained.

Rationale: Certain quality control measures (e.g., the use of biological indicators [BIs]) do not yield final results until after the sterilizer load has been used. In addition, sterilization quality control relies heavily on historical data, especially where quality control measures yield conflicting evidence. Record-keeping is needed both for epidemiological tracking and for ongoing assessment of the reliability of the sterilization process. Accountability to the patient and surgeon for sterility of an implantable item requires documentation of biological monitoring results that can be directly traced to the patient.

Chuck Hughes
General Manager/Educator
SPSmedical Supply Corp.
1-800-722-1529