HealthPack Medical Device Packaging Technical Committee of IoPP. March 4, 2015 Norfolk, VA

Transcription

1 HealthPack 2015 Medical Device Packaging Technical Committee of IoPP March 4, 2015 Norfolk, VA

2 MDPTC 2015 HealthPack Meeting Mission Statement Provide a forum for packaging professionals representing the Medical Device Industry for discussion, exchange and development of information on technical issues, regulations, standards and new technologies

3 MDPTC 2015 HealthPack Meeting Vision Statement Provide the latest information on national and international regulatory requirements as they affect the packaging of medical devices. Provide a forum to voice the device industry packaging position on issues that affect them. Provide education to new members entering the medical device area of package engineering. Provide a timely list of tools and documents (guides, test methods and standards) that are helpful when performing the tasks related to the package engineering of medical devices. Exchange non- proprietary information regarding new materials, equipment and systems, which can improve the overall performance and quality of the medical device packaging industry. Act as a liaison for technical and regulatory updates between organizations of mutual interest such as AAMI, ISO, ASTM, ISTA and the U.S. FDA.

4 MDPTC 2015 HealthPack Meeting Officer Introduction Chairperson Jennifer Griffin, CPP Vice Chairperson Marco Ortiz Shields, CPP Membership/Secretary Eric Carlson, CPP Subcommittee Chair Treasurer Ombudsman Program Chairperson Webmaster Karen Greene, CPP Jennifer Griffin, CPP David W. DiVaccaro Charles Kanazeh Marco Ortiz Shields, CPP

5 MDPTC 2015 HealthPack Meeting Overview Membership Current committee membership = 255 Current membership in sub-committees = 44+ Linked-In group = 187 members

6 MDPTC 2015 HealthPack Meeting Subcommittees Temperature Controlled Packaging, Led by Jim Butschli Survey executed and published Sustainability, Led by Daphne Allen Survey executed and presented 2014 Labeling, Led by Dave Olson Developing a guidance document to identify consistent and repeatable tests and procedures to insure that terminally sterilized device package labels comply with the affixed and legible requirements of Subpart K 120(a) Sec 820 Education, Led by Charlie Robnett Developing a packaging value chain map for medical device Packaging Operations, Led by John Derek Thompson ASTM Standard Practice Development: Guide for the Development of Naked Eye Visual Inspection Criteria for the Acceptance or Rejection of Detected Debris and Particulate in Final Packaging of Terminally Sterilized Medical Devices Sterilization, Led by Mike Tokarski Sterilization database available on the on IoPP website

7 MDPTC 2015 HealthPack Meeting Committee meeting held March 3, 2015 March 3 meeting---39 participants Updates from Sustainability, Labeling and Operations subcommittees Webinars planned for 2015: Intro to Medical device packaging in Spanish by Marco Ortiz Packaging for reprocessed medical devices by Chris Sarantos

8 Medical Packaging Game Show Do you know your stuff related to aseptic presentation of sterile packages and related topics?

9 Game Show question 1 True or False Shelf life is a guarantee that items will remain sterile until the expiration date.

10 Game Show answer 1 Shelf life is a guarantee that items will remain sterile until the expiration date. False

11 Game Show question 2 True or False A stained package can be used if the package is dry and if it passes visual inspection for seal and package integrity.

12 Game Show answer 2 A stained package can be used if the package is dry and if it passes visual inspection for seal and package integrity. False The contents of wet or stained packages may have been subject to strike-through which occurs when liquids soak through a barrier. Strike-through provides for passage of microorganisms; contents must be considered contaminated.

13 Game Show question 3 True or False Drapes serve as a barrier to prevent the passage of microorganisms between sterile and non-sterile areas.

14 Game Show answer 3 Drapes serve as a barrier to prevent the passage of microorganisms between sterile and non-sterile areas. True

15 Game Show question 4 True or False Heavy, awkward, or sharp items should be gently dumped onto the sterile field.

16 Game Show answer 4 Heavy, awkward, or sharp items should be gently dumped onto the sterile field. False These items should not be tossed onto the sterile field because they may roll off the edge or displace other items or penetrate the sterile barrier. These items should be opened on a separate table or stand or be received directly by the scrub person.

17 Game Show question 5 True or False On peel-open packages, contents should be slid out over package edges to present the contents to the sterile field.

18 Game Show answer 5 On peel-open packages, contents should be slid out over package edges to present the contents to the sterile field. False The flaps on peel-open packages should be pulled back, not torn, to expose the sterile contents. The contents should not be permitted to slide over the edges. The inner edge of the heat seal is considered the line of demarcation between sterile and unsterile.

19 Game Show question 6 The illustration shows: a. Aseptic technique b. Aseptic dump c. Aseptic transfer

20 Game Show answer 6 The illustration shows: a. Aseptic technique b. Aseptic dump c. Aseptic transfer C. Aseptic transfer---removing a sterile article from an opened package via a sterile, gloved operator. The operator must be cautious not touch his/her gloved hand to any unsterile area.

21 Game Show question 7 Aseptic opening is opening a package without contaminating the contents. The most common reasons for contamination are: a. Generation of unsterile fibers or particles during the opening process which settle on the contained product b. Attached pieces or fragments on the unsterile exterior of the package which fall or curl inward and contaminate the contents c. Package design that prevents easy access and removal of the contents in an aseptic manner. d. A and B e. A and C f. B and C g. A, B and C

22 Game Show answer 7 Aseptic opening is opening a package without contaminating the contents. The most common reasons for contamination are: a. Generation of unsterile fibers or particles during the opening process which settle on the contained product b. Attached pieces or fragments on the unsterile exterior of the package which fall or curl inward and contaminate the contents c. Package design that prevents easy access and removal of the contents in an aseptic manner. d. A and B e. A and C f. B and C g. A, B and C G---A, B and C

23 Game Show question 8 True or False The scrub nurse or person ensures a sterile transfer to the sterile field.

24 Game Show answer 8 The scrub nurse or person ensures a sterile transfer to the sterile field. False---the circulating person ensures the sterile transfer

25 8 questions---how did you do?

26 References Essentials of Perioperative Nursing, Third Edition, Cynthia Spry, 2005 Surgical Technology Principles and Practice, Sixth Edition, Joanna Kotcher Fuller, 2013 Berry and Kohn s Operating Room Technique, Seventh Edition, Lucy Jo Atkinson, 1992

27 Join us! Medical Device Packaging Technical Committee of IoPP Contact Eric Carlson Only requirement is membership in IoPP