RADIATION IS COOL! Martell Winters. Director of Science

Transcription

1 RADIATION IS COOL! Martell Winters Director of Science

2 VDmax ALLOWABLE BIOBURDEN STERILIZATION DOSE MINIMUM MAXIMUM kgy 0.1 CFU 1.5 CFU 17.5 kgy 0.1 CFU 9.0 CFU 20.0 kgy 0.1 CFU 45 CFU 22.5 kgy 0.1 CFU 220 CFU 25.0 kgy 0.1 CFU 1,000 CFU 27.5 kgy 1 CFU 5,000 CFU 30.0 kgy 1 CFU 23,000 CFU 32.5 kgy 1 CFU 100,000 CFU 35.0 kgy 1 CFU 440,000 CFU AAMI/ISO 13004:2013

3 METHOD 1

4 AAMI TIR 76 VDmax with any SAL and any sterilization dose

5 SHOW AND TELL In essence: 10-sample Method 1 Allows for optimization of radiation doses

6 COBALT SUPPLY SHORTAGE? There is not a cobalt shortage Nordion has contracts until the 2050s And continues to work on more Other cobalt suppliers have not provided Nordion picking up the slack

7 OPTIMIZE STERILIZATION DOSES Be wise stewards of sterilization processes Is 25 kgy really necessary? Check with contract irradiators for available processing categories Consider optimizing to 20 kgy if possible

8 RECOVERY EFFICIENCY Updated : No mention of 50% as target Why? 50% was arbitrary 49% is just as good as 50% (actually same number) What is the target? Are the replicates consistent with each other? What does the product need?

9 RECOVERY EFFICIENCY What are appropriate values? Radiation: higher values would be better EO, steam: lower values appropriate If done at all What is consistent? Typical range for microbiology is ± 20% More to come

10 RECOVERY EFFICIENCY REPETITIVE RECOVERY EXTRACTION CFU COUNTS % RECOVERY: 48.2% 45.5% 49.1% 37.8% 58.6% AVERAGE % RECOVERY: 47.8% What really matters? What is consistent in microbiology?

11 RECOVERY EFFICIENCY REPETITIVE RECOVERY EXTRACTION CFU COUNTS WHAT DO WE DO WITH THIS?

12 RECOVERY EFFICIENCY GUIDANCE ISO :2018

13 TESTING PACKAGING :2018 A When sampling for the determination of bioburden, a product should be contained in its usual packaging. Typically, it is sufficient to perform a bioburden determination on a product after its removal from its packaging system and to omit the packaging system from the determination. Depending upon the sterile label claim, internal packaging components, such as a tray or product insert, may need to be tested based upon factors such as what is intended to be sterile, when the package is an integral part of the product, or for specific evaluation.

14 TESTING PACKAGING :DRAFT A.6.2 Generally, it is sufficient to perform a test of sterility on a product after its removal from its packaging system and to omit the packaging system from the test. If packaging is to be tested, it should be noted that many packaging materials float on top of the media. This does not allow for contact with the media and most of the packaging material to be tested. When this is the case, attempts should be made to obtain better contact between the media and the packaging material.

15 FAILURES (TOO MANY POSITIVES) They re all different! Don t make assumptions or guesses I am happy to discuss specific situations, if needed, afterward

16 FAILURES The Lone Ranger and Tonto went camping in the desert. After they set up their tent, both men fell sound asleep. Some hours later, Tonto wakes the Lone Ranger and says, Kemo Sabe, look towards sky, what you see? The Lone Ranger replies, "I see millions of stars. "What that tell you?" asked Tonto.

17 FAILURES The Lone Ranger ponders for a minute then says, "Astronomically speaking, it tells me there are millions of galaxies and potentially billions of planets. Astrologically, it tells me that Saturn is in Leo. Time wise, it appears to be approximately a quarter past three in the morning. Theologically, God is all-powerful and we are small and insignificant. Meteorologically, it seems we will have a beautiful day tomorrow. What's it tell you, Tonto?"

18 FAILURES "You dumber than buffalo poop. Someone stole the tent!"

19 SDR (POPULATION C) Table 3 AAMI/ISO :2006 D-value % Whitby and Gelda, Population C Foundation to Method 1 and VDmax Why aren t BIs used for radiation?

20 RADIATION RESISTANT BUGS Cryptococcus yeast Alternaria mold Cladosporium mold from Chernobyl Pink Bug conspiracy Methylobacter Gram (-) rod (pink) Deinococcus Gram (+) cocci (pink) Roseomonas Gram (-) rod (pink) Why are they more resistant than spores? Life finds a way

21 WHAT CAUSES FAILURES? MOST COMMON Increased bioburden counts Increased bioburden resistance Re-establish a higher sterilization dose Re-establish a higher sterilization dose Investigate and fix the bioburden problem Investigate and fix the bioburden problem

22 WHAT CAUSES FAILURES? MOST COMMON Underestimation of bioburden Poor shipping etiquette Perform more extensive recovery efficiency testing Not a true failure Provide multiple barriers in dosing and shipping

23 WHAT CAUSES FAILURES? MOST COMMON Contamination during testing Not a true failure Prepare samples prior to verification dose

24 WHAT CAUSES FAILURES? LESS COMMON Failed packaging Incorrect dosing Does a failed dose audit mean the Not a true failure Not a true failure product is non-sterile? Improve packaging or shipping configuration Re-dose products and test

25 STERILITY ASSURANCE LEVEL What is the typical SAL? What does it mean? Is it necessary? Not based on science No connection between 10-6 and potential impact to patients (risk assessment approach not used) AAMI ST 67

26 SAL AAMI ST67 provided alternatives to 10-6 since 2003 Currently finishing a new revision New version makes use of alternative SALs easier Allowing for terminal sterilization using other SALs rather than defaulting to aseptic processing

27 ISO TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of a terminally-sterilized, single use health care product unable to withstand processing to achieve maximally a sterility assurance level of 10-6 Compatibility of product with a sterilization process Strategies to achieve 10-6 Considerations if 10-6 cannot be achieved Great concepts and guidance!

28 SAL ISO published 01 Dec 2017 Great scientific discussions about additive nature of log reductions of different sterilization methods Gives equal preference to alternate SAL compared to aseptic processing Risk-based approach

29 SAL Papers on SAL and impact to patient Medical device SALs and surgical site infections: A mathematical model Srun et al, BI&T May/June 2012 Generally no potential impact to patient until 10-4 Using statistics as a risk analysis tool for selecting an alternate SAL Nissen et al, AAMI Industrial Sterilization 2013

30 AAMI CISS EXAM Certified Industrial Sterilization Specialist First exam offered was Nov 2017 Core exam (75 multiple choice questions) Specialties (50 multiple choice questions) Radiation EO Moist heat Broad and deep knowledge is a must Specialist is in title for a reason

31 THANK YOU