Packaging & Sterilization

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Delilah Neal
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1 Packaging & Sterilization Packaging & Sterilization 1 Dr. Norman Clinical Consultant

2 General Sterilization Packaging System in Hospitals Sterilization Packaging System Disposable Reusable Crepe paper Woven textile Non-woven wrap Containers and cassettes* 2 Peel pouch * including trays, mats, holders, or any other component that is used for sterilization of medical devices.

3 Common Reusable Sterilization Packaging System Woven textile Non-validated metal drum 3 Cassette Validated rigid container

4 Packaing All medical devices requiring sterilization should be packaged after they have been cleaned, dried and inspected. 4 Check before use

5 Check Before Use 5

6 Inappropriate packaging technique 6

7 Packing Technique Good Samples 7

8 Packing Technique Good Samples 8

9 Packing Technique Good Samples 9

10 Packing Technique Good Samples Chemical indicator Tape Secure Pack 10

11 Packing Technique Samples Label 11

12 Non-validated Metal Container - Issues Issues with non-validated metal container Poor microbial barrier there is no filter system in place Condensate after sterilization Not suitable for keeping surgical items in bulk for multiple use e.g. cotton, gauze etc. 12

13 Common Disposable Sterilization Packaging Materials Non-woven wrap Crepe paper 13 Peel Pouch Package Packaging pouch

Package Closure Accessories used to secure packages should be

constriction of the package Maintain package integrity Tape

secure package, nor should safety pins, paper clips, rubber

14 Package Closure Accessories used to secure packages should be chosen to allow the steam sterilization process to occur Avoid constriction of the package Maintain package integrity Tape (other than sterilization indicator tape) should not be used to secure package, nor should safety pins, paper clips, rubber bands or tape should not be used to hold instrument together in a group 14

15 Sequential Double Wrap Envelop Fold 15

16 Sequential Double Wrap Square Fold 16

17 Maxium weight limit pounds for containerized instrument sets 7 pounds for a wrapped basin set

18 Packaging Secure No pin, paper clips, staples, ropes or other sharp objectives 18

19 Package closures Tip Protectors, should be steam-permeable, fit loosely 19

20 Package Labels 20

21 Correct Loading for Paper-Plastic Pouches Reprinted from ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 with permission of Association for the Advancement of Medical Instrumentation, Inc AAMI 21 ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, Section 8.5.2

22 Correct Loading Do not over loading 22

23 Cleaning, Disinfection and Sterilization Process Flow Sterile item Storage / Distribution / Documentation Cleaning & Decontamination Solied Items Quality Control Sterilization process Cleaning items Inspection / Assembly 23 Sterilizer loading Packaging (materials, technique)

24 24 APSIC COE

25 Vacuum Sterilization Exhaust Dry Temperature Pressure 25

26 Process: Vacuum assisted sterilizers Pressure Phase 1: Conditioning Phase 2: Sterilization Phase 3: Drying and pressure equilibration Time 26

27 Steam sterilization process Steam injection Start of sterilization phase Steam sterilization condition Pressure Time 27 Suction

28 Air (gas mix) removal Pressure Time 28

29 Steam injection Pressure Time 29

30 Steam penetration and condensation Condensation front Gases sucked out, textile stays wet Good penetration 30 Time

31 Saturated steam? A or B? B B A A 31

32 Hot Topic 32

33 However New Technology: Complex and expensive medical Device 33

34 Heat/moisture sensitive Instruments 34

Ethylene Oxide 35 Efficacious Highly penetrating low temperature sterilant Materials compatibility Medical devices Packaging materials Cost-effective

35 Ethylene Oxide 35 Efficacious Highly penetrating low temperature sterilant Materials compatibility Medical devices Packaging materials Cost-effective Operational and maintaince cost saving Environmentally Responsible Catalytic convert EO to water vapor and carbon dioxide Long history of safety use C 2 H 4 O

36 Sterilant Comparative Toxicity Sterilant OSHA NIOSH PEL (8 hr. TWA) IDLH EO 1ppm 800ppm H ppm 75ppm Form-aldehyde 0.75ppm 30ppm OSHA Occupational Safety and Health Administration PEL TWA Permissible Exposure Limit Time Weighted Average NIOSH National Institute for Occupational Safety and Health IDLH Immediate Danger to Life and Health (the lower the value the greater the concern for health and life) 36 Source: Hilliker, D.J., Employee Safety and Sterilant Gasses, Infection Control Today, March 1998

37 Safety In Fact, If sterilizing agents were no toxic, they would not be able to kill microorganisms! While each presents different type of safety risks, each is safe if used properly 37

38 /lectures/wfhss_conf _lecture_sp_s702_en.pdf

39 Low Temperature Sterilization Each low temperature sterilization method has its advantages and disadvantages. Therefore, selection of suitable sterilization methods should be based on scientific knowledge and recommendations from professional organization, regulatory agencies and international guidelines. 39

6 Handling, collection, and transport of contaminated items General rationale Separation of waste and reusable items at point of

6 Handling, collection, and transport of contaminated items General rationale Separation of waste and reusable items at point of Contents Glossary of equivalent standards... ix Committee representation... xi Acknowledgments...xiii Background on Amendment 1...xiii Foreword... xiv Introduction: Need for the recommended practice...1