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AAMI Sterilization Standards Meeting Update

By Jason Pope, Senior Scientist

The AAMI Sterilization Standards Week was held in Baltimore MD in March of 2017.  This set of meetings provides the opportunity for the various AAMI sterilization standards working groups to come together and provide input on numerous industry standards and guidance documents that relate to the sterilization of medical devices. One of the groups that had the opportunity to meet was ST/WG 43 – Hospital Steam Sterilizer Working Group.

During the meeting of ST/WG 43, a discussion occurred relating to the drying times recommended for healthcare steam sterilizers and the drying times listed by medical device manufacturers for device sterilization instructions. The drying times from sterilizer manufacturers are listed in the FDA Guidance Document for reprocessing of medical devices in health care settings and in AAMI TIR12.  Representatives of multiple sterilizer manufacturers were involved in the discussion and expressed a desire to change the way the documents list the drying times for steam cycles that are commonly available in healthcare settings.

Sterilizer manufacturers explained that the listed drying times was determined by sterilizer manufacturers for specific loads, devices, and test packs used in sterilizer development and validation.  The idea that the drying times, listed in the aforementioned documents, should be considered by medical device manufacturers as minimum times was discussed, with working group members indicating that medical device manufacturers may find that longer drying times are appropriate for their products during validation testing.

Several working group members expressed concern that the drying times listed in the FDA guidance document and AAMI TIR12 are being interpreted by medical device manufacturers and healthcare workers as being exact values that may not be lengthened. Discussion participants indicated that this interpretation of listed drying times is concerning if specific medical devices and loading configurations require longer drying times to ensure adequate moisture removal for device storage stability.

Nelson Laboratories has observed that the US FDA has cleared medical device submissions with drying times that exceed those listed in the FDA guidance document and AAMI TIR12. The drying time that a manufacturer includes in their device sterilization instructions should match the drying time determined by validation testing.  It is impossible for sterilizer manufacturers to perform validation testing of a steam sterilizer in a manner that encompasses all current and future device types used in a healthcare setting to care for patients. A medical device design may have characteristics that require the drying to exceed the minimum drying times outlined by sterilization manufacturers.

Due to the removal of commonly available steam sterilization cycles from the most current revision of ANSI/AAMI ST79, a desire was expressed in ST/WG 43 to add the cycle tables to ANSI/AAMI ST8 – Hospital Steam Sterilizers. Many working group members expressed the opinion that this document, written for sterilizer manufacturers, was a good home for this cycle information. Many members felt that the addition of this information to ST8 should be accompanied by verbiage clarifying that the listed drying times are to be considered minimum times, the goal being to prevent medical device manufacturers and healthcare personnel from misinterpreting the drying time information to be unalterable and to help them recognize that longer drying times may be needed for specific device types and sterilizer loads.  Additionally, clarifying verbiage will let device manufacturers and end users know that drying times should never be shortened from the minimum listed times.

The Hospital Steam Sterilizer Working Group recently decided to revise AAMI ST8 and plans to meet in the Fall of 2017.  Nelson Laboratories will have a representative in attendance at that meeting and will be providing updates after the meeting is held in Baltimore.

To learn more from our industry experts, attend one of the Nelson Laboratories’ three-day Science of Sterilization Validation seminars. Click HERE to view the upcoming seminars.

Cleanroom Renovation Complete

At Nelson Laboratories, our values hinge on quality, service, and expertise. Our quality systems and world-class facilities are part of what elevates us in the MedTech industry.

We recently completed a two-year renovation to our state-of-the-art ISO Class 5 cleanroom. This space is where we perform important product sterility testing.

“I commend our product sterility team and laboratory management for the great coordination and management of this project,” said Jeff Hone, Vice President of Quality at Nelson Laboratories. “This puts us in a state of compliance with our cleanroom that will serve us for years to come.”

During the cleanroom renovations:

  • The isolator testing units were moved to a new, dedicated testing space to allow for more room related to product sterility testing – (additional space for sample processing and storage)
  • The floors were resurfaced with a solvent resistant surface to improve the ability to clean
  • The cleanroom walls were replaced with a high end cleanroom surface which is chemical resistant, easily sanitized and highly durable
  • Two new laminar flow hoods were installed
  • Low particulate construction materials were used to improve particulate interface

If you have any questions, please contact the Sterility Department Section Leader, Jonathan Swenson, at jswenson@nelsonlabs.com.

Jeffery Nelson Contributes on Panel for Biomed Professionals

MedTech innovation leaders gathered at the University of Texas in San Antonio to share their expertise with up-and-coming biomed talent. The Health Cell, a life sciences professional development and advocacy organization, created a pilot workshop series Developing and Clinically Introducing Medical Technologies. The four-part workshop focused on enabling scientists to become entrepreneurs began in October of 2016.

jeff-nelsonPresident of Nelson Laboratories, Jeffery Nelson, participated on a panel during the third workshop held on Monday, January 16, 2017. The focus of this panel was research, product development, manufacturing, verification, and validation.

“The Health Cell concept is a great way to support the growing Med Tech industry sector in San Antonio,” said Jeffery Nelson. “I was impressed by the group and honored to be invited to participate in their learning process.”

The need to educate bioscience professionals spurred the creation of this workshop series,” reported The Rivard Report. “Participants will learn how to develop a medical technology or MedTech device from concept, where patient needs are identified and a market is selected, to product development, testing, and manufacturing, all the way to clinical trials and market introduction.”

The fourth and final workshop in the series will include the topic of financing the pathway followed by a presentation of awards on February, 13, 2017.

More information on upcoming The Health Cell events can be found HERE.

Martell Winters Shares Expertise with University Students

martell_winters_3Martell Winters, consultant and senior scientist at Nelson Laboratories, is now instructing a course at Brigham Young University (BYU) entitled “Industrial Microbiology and Sterilization.” The course is limited to juniors, seniors, and graduate students and is focused on providing a thorough review of microbiology in the medical device industry. For years BYU has provided an excellent education in the department of microbiology and molecular biology. However, it was recognized that a good foundation in industrial microbiology and sterilization microbiology was missing.

Martell worked closely with Dr. Rich Robison (professor and Department Chair) and Hyrum Shumway (graduate student and TA) at BYU to develop a comprehensive curriculum to cover such topics as FDA regulatory requirements, validation concepts, terminal sterilization (including EO, radiation and steam), reusable medical devices, aseptic processing, water treatment, and biological evaluations/biocompatibility. Also incorporated into the course are several company tours to medical device manufacturers, Nelson Laboratories, a water treatment plant and a hospital central processing department. This is an exciting program as it will give students an opportunity to learn from industry experts as well as great preparation for those who want to enter into the medical device/pharmaceutical/sterilization industries.

Martell is an industry leader in microbiology and sterilization and has over 20 years of experience working with companies to improve their processes.  He is also an active committee member of many working groups for multiple regulatory bodies, and has been integral in the creation of multiple standards in place today. His expertise in these areas makes him well qualified to develop and teach this course.

LIVE Webinar: How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance

Register HERE for the three-day live webinar series “How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance” presented by Nelson Laboratories’ experts: Thor Rollins, Sarah Campbell, and Audrey Turley.

This three-day webinar will incorporate the new US FDA guidance on biocompatibility into the three main steps in developing a Biological Safety Evaluation (BSE): Biological Evaluation Plan (BEP), Testing Options, and Biological Evaluation Report (BER). Composed of three one-hour presentations followed by Q&A sessions, the webinar will cover each step in developing a BSE in detail. This webinar will provide insight into regulatory expectations when it comes to evaluating device safety.

The presenters for this three day webinar provide a combined 50 years of experience in their field of expertise. Thor Rollins is a leading biocompatibility expert and has worked closely with medical device companies and the FDA for over 15 years. Dr. Sarah Campbell is a board certified Toxicologist with an extensive 17 year background in practicing and using analytical chemistry for toxicological evaluation. This combination of expertise is important to in order to handle the important aspects of material/chemical characterization and toxicological risk assessment. Audrey Turley has 20 years of experience working in research, laboratory, and test design functions in the medical device industry.

DAY 1: DEVELOP A BIOLOGICAL EVALUATION PLAN (BEP)

The new FDA guidance document for ISO 10993-1 focuses on a risk based approach to biocompatibility. The first step is to develop a BEP. This webinar will go over the thought process and information needed to develop a useful testing plan.

Date: August 30, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Thor S. Rollins, B.S., RM (NRCM)
Senior Scientist

 DAY 2: UNDERSTANDING TEST OPTIONS

Justifying out of testing using chemical characterization vs performing full biocompatibility testing. The first important step in determining the risk of a medical device to a patient is to know and understand your materials and processes. This webinar will go over the steps in evaluating device materials and an extractable/leachable chemical testing needed to demonstrate biocompatibility.

Date: August 31, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Sarah Campbell, PhD, DABT
Toxicologist

DAY 3: SUMMARIZE ALL YOUR FINDINGS IN A BIOLOGICAL EVALUATION REPORT (BER)

The ISO 10993-1 and new FDA guidance document asks you to write a BER to demonstrate that the identified risks have been mitigated. We will go over the information needed and the important points that should be included in the report.

Date: September 1, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Audrey Turley, B.S., RM (NRCM), CBA (ASQ)
Research Scientist

Dr. Victoria Hitchins Remembered at Nelson Laboratories

By Alyessa D’Ewart

Victoria Hitchins, PhD, of the FDA passed away on Friday, June 17, 2016.  Dr. Hitchins was a respected microbiologist who made many contributions to the public health industry.  Emily Mitzel, Technical Consulting Manager at Nelson Labs, worked with Dr. Hitchins for over 11 years.  “Vicki was incredibly smart, personable, down to earth, and caring,” Mitzel said.  “You could always tell when she walked into the room because she greeted and was greeted by everyone.”

After obtaining her master’s and doctoral degrees in microbiology from Michigan State University, and post-doctoral studies at Princeton University and the University of Kentucky, Dr. Hitchins joined the FDA as a research microbiologist with the Center for Devices and Radiological Health.  She was a Captain of the Commissioned Corps of the U.S. Public Health Service for over 30 years; she then retired from the Corps and became the Laboratory Leader of Infection Control and a sterility consultant for the FDA.  Dr. Hitchins’ passion for public health was evident in her work outside the FDA as well.  She served as a consultant for the 2001 anthrax clean up and decontamination in Washington D.C., and participated in the 2005 Hurricane Katrina response as a Commissioned Corps officer.

During her lifetime, Dr. Hitchins authored over 70 papers and articles.  “Vicki was passionate about the research she was working on at the time, and the wheels in her brain were always spinning on the next project,” Mitzel stated.  Her research centered on the safety of medical devices, and the impact cleaning and sterilization processes have on the materials of the devices.  She provided a large contribution in developing methods for detecting bacterial endotoxins on devices and cytotoxicity testing of nanoparticles.

Dr. Hitchins was also a thought leader in the standards development process, and she served on many standards development committees.  She was the co-chair for the AAMI Sterilization Standards Committee as well as the U.S. sub-TAG for WG 16 (pyrogenicity), and was serving as the convener of ISO/TC 194/WG16 (pyrogenicity).  “I’ve worked with her on many standards committees, research projects, and client submissions.  We spoke personally about our lives, and I always enjoyed working with her,” added Mitzel.

Nelson Labs extends their deepest condolences to Dr. Hitchins’ family.  Her contributions and dedication to public health and safety will be missed.