AAMI

Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing

For over a decade, Nelson Laboratories has been hosting educational seminars called The Science of Sterilization Validation. The aim of these three-day seminars has been to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and, thereby, achieve more efficient, accurate, and effective testing outcomes.

As the needs of our customers have evolved, we have continuously updated our seminars to meet those changing needs.  To better align with the new, more comprehensive agenda, Nelson Labs is re-naming the seminar to: Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing. The program will continue to be RAPS and ASQ approved for 12 RAC and 1.2 ASQ credit hours and may also qualify for AAMI credit hours. Courses are taught by Nelson Labs’  and SteriPro’s scientific experts. Highlights include, but are not limited to:

  • Introduction to Microbiology & Sterilization:
    The introduction offers attendees an opportunity to brush up on the basics of sterilization, microbiology, and important industry terms.
  • Ethylene Oxide Sterilization Validation:
    Learn how to develop, optimize, and validate a successful ethylene oxide sterilization process that delivers the necessary sterility assurance level and ensures repeatability.
  • Biocompatibility / ISO 10993:
    With 24 possible categories, the biocompatibility testing experience can be intimidating. We will help you understand the testing requirements of ISO 10993 and how to choose the correct test methods for your product.
  • Chemical Characterization / E&L Assessments:
    This topic will help you understand the analytical chemistry strategies that can be used to characterize device materials and evaluate extractable/leachable compounds.
  • Packaging Overview / ISO 11607:
    Focused on the requirements outlined in ISO 11607, this subject will help you understand packaging validations and how to successfully navigate the package testing arena.
  • Radiation Sterilization Validation:
    Attendees will learn how to perform radiation validations, review bioburden data, deal with sterility test failures, and understand the various radiation options (gamma, electron beam, and X-ray).
  • Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices:
    Our experts will teach attendees the information and processes involved in the validation of healthcare device reprocessing instructions. Highlights include discussion of the guidance documents, standards, industry trends, and the acceptance criteria.
  • Cleaning Validations for Newly Manufactured Devices and Single Use Implants:
    The importance of manufacturing clean devices will be discussed, and how cleanliness should be evaluated in addition to the sterility and biocompatibility of a device.

The full seminar is appropriate for professionals who are new in their role as well as for MedTech veterans. Lectures are presented by industry-leading experts and include case studies, hands-on activities, Q&A, and one-on-one time with the speakers. 100% of post-seminar survey respondents have expressed that they would recommend the seminar to a colleague or friend.

Visit the Seminar page on the Nelson Labs’ website to learn more about the next seminar near you.

For more information regarding our seminars, contact the Nelson Labs’ marketing department: marketing@nelsonlabs.com.

U.S. ISO Certified Experts Announced

 

Thor Rollins, Michelle Lee, and Audrey Turley have been accepted as U.S. experts to four working groups in the Biological Evaluation ISO Technical Committee 194: WG5 (Cytotoxicity – Thor), WG8 (Sensitization and Irritation – Michelle), WG9 (Effects on blood – Michelle), and WG6 (Genotoxicity, Carcinogenicity, and Reproductive Toxicity – Audrey). This placement allows participation in the annual ISO meetings to discuss changes to the ISO 10993 and movements surrounding the approach to biocompatibility of medical devices. These meetings have recently been closed, and only those that are nominated and accepted by the co-chair of the respective working groups are allowed to attend and participate in the international annual meeting. Meet the experts:

Thor Rollins started his career at Nelson Laboratories as the study director over cytotoxicity testing. He is familiar with the test procedure and can speak to its application to medical devices providing a deep knowledge of all the complexities that can occur in cytotoxicity testing. Thor frequently works with clients who run into issues with cytotoxicity and need help mitigating patient risk.

Michelle Lee has been highly involved in several ISO round robins over the last few years including a Hemolysis, Complement, and currently an in vitro irritation round robin. Nelson Laboratories have been the top testing laboratory involved providing input on sample type, sample preparation, and protocol development for these projects. Michelle is also working to develop an in vitro sensitization assay using 3D human tissues.

Audrey Turley was one of the key personnel in bringing the in vitro chromosomal aberration assay in-house at Nelson Laboratories. Once the test was validated, she stepped in as the study director for the next six years. Currently, Audrey is working as a technical consultant to help clients perform risk assessments to address carcinogenicity risks.

Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance. P.S. What Happened to the Microbiologists?

Did you miss MD&M Texas? Check out the Tech Theater presentation given by Nelson Laboratories scientist Martell Winters. As biological and tissue products and combination products become more prevalent, new questions are often asked related to microbiology that are different from those asked for traditional medical devices.  As these questions become more common, additional guidance is necessary for the industry.  Much of this additional guidance will be added to the new version of the ISO bioburden standard, 11737-1.  Some of this information must be added due to the lack of microbiological expertise in the industry.  However, when the information is added it will not be easily understood by non-microbiologists, meaning that some understanding must be present to fully appreciate it. Following are some main points to be added to the standard which will be discussed in the Tech Theater presentation.  Also some discussion will be provided regarding the microbiological expertise in the medical device industry.

  • Low bioburden products
    • How low is low?
    • Why are they different?
  • How should the bioburden test be performed?
    • Review of raw materials/manufacturing process
  • Optimization of bioburden testing
    • Increasing sensitivity (e.g. volume factors)
    • Pooling of bioburden samples
  • Reviewing bioburden data
    • Addressing TNTC values
    • Addressing spreaders/lawns

AAMI Sterilization Standards Meeting Update on Processing of Reusable Medical Devices

Medical-device-cleaingBy Emily Mitzel, Laboratory Manager

On April 14-16, 2014, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers, and the FDA.

Processing of reusable medical devices is an extremely hot topic with manufacturers and regulators.  Many working groups, standards, and technical informational reports are currently being written and revised by the AAMI and ISO committees.  We are very involved in all of the meetings and document updates.

Highlights from the meetings include:

  • AAMI TIR34 – Water for the Reprocessing of Medical Devices – This document will be submitted for final 30-day review this summer.  The categories of water have changed, so medical device manufacturers may want to use these categories in their IFUs as this is the quality of water that the healthcare facilities will use for their reprocessing.
  • AAMI TIR55 – Human Factors for Device Reprocessing – This document is going to ballot for the first time.  It is a great document designed for medical device manufacturers to provide guidance from a human-factors perspective.
  • AAMI TIR63 – Management of medical devices that are not owned by the healthcare facility where they are used – This document is now going to ballot after successfully responding to all of the comments provided for the last meeting.  This document will help manage medical devices that move between healthcare facilities.

ISO Meeting in Australia Updates International Standards for Medical Device Testing and Validation

Tissue testingBy Martell Winters, Senior Scientist, Nelson Laboratories

The International Organization for Standardization (ISO) hosted the Sterilization of Health Care Products Committee meeting (ISO Technical Committee 198) to update the worldwide standards used for testing and validating medical devices.

Australia was the site of this year’s meeting. I attended and served as a delegate from the United States to provide input to several documents. As part of the U.S. delegation, I contributed to discussions surrounding ISO 18362 for aseptic processing as well as ISO 11737-1 for microbiological methods.

ISO 18362 is a document detailing the minimum requirements for manufacturing cell-based health care products which are not terminally sterilized. Before attending the ISO meeting, my fellow U.S. delegates and I met to discuss and submit comments about the current document, and what we would like to see changed. We had mostly editorial comments rather than technical changes to the standard at this meeting.

This standard will help companies navigate the complexities of processing tissues and cells in a way that controls microbial contamination. Tissues and cells often cannot be sterilized by traditional means without affecting their functionality and thus are forced into an aseptic processing scenario.

This ISO 18362 document will go out for a Draft International Standard (DIS) vote. After approvals and edits, and a final vote, the new ISO standard will be implemented.

We also discussed the revision of the standard for testing and validating product bioburden—standard ISO 11737-1.  While we will likely not include any new requirements in this revision, we are adding more guidance to assist manufacturers in setting up tests and interpreting bioburden data.

For example, we are including better guidelines for determining the advantages and disadvantages to pooling multiple samples into one bioburden test when there is low contamination on a device, as opposed to using a different sample for every test.

The revision to the ISO 11737-1 standard is a result of questions we frequently receive from people unfamiliar with bioburden testing. The standard has addressed some of these questions previously but without much or any detail. A new draft of the standard should be sent out for a first review later in the year.

What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Validation Considerations for Managing Human Factors in Reprocessing of Reusable Devices

Emily Mitzel, Laboratory ManagerSterilization-of-reusable-tray

Agenda:

Emily Mitzel will present on reusable medical device cleaning, disinfection and sterilization validations at the 2014 MD&M West Conference. Emily is a Laboratory Manager at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include:

  • Standards that govern medical device reprocessing, which include cleaning, disinfection and sterilization validations
    – Specifically, the new standards associated with human factors
    – Updates from the AAMI/FDA Round Table Discussion
  • Challenges inherent in device design for human factors
  • Considerations for cleaning and sterilization validations relevant to the practices of healthcare facilities
  • New recommendations for manufacturers, Instructions for Use (IFU) documents, etc.
  • Review of the manufacturer’s responsibilities and considerations

Take Away:

• Attendees will gain a better understanding of the central processing personnel who reprocess medical devices and how the ability to clean and sterilize the devices is a factor in the successful reuse of those devices
• Attendees will learn how to answer the question, “How clean is clean?”
– Three specific residual amounts have been agreed upon by the FDA/AAMI/industry and will be presented

Details:

Emily will present for approximately one hour at the Nelson Labs classroom in 208AB on February 12, 2014 at 4:00 PM. She will also present an innovation brief titled “Healthcare Reprocessing of Medical Devices and Human Factors Debrief” on February 11, 2014 from 1:40 PM until 2:10 PM. The innovation brief will be at booth 635 in the Tech Theater.

Register at www.canontradeshows.com/expo/west14/conference-nelson-rsvp.html

Nelson Laboratories website: www.nelsonlabs.com