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.

AAMI STERILIZATION STANDARDS MEETING UPDATE

By Emily Mitzel, MS

On March 20-23, 2017, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Committee Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers, and FDA.  It is important for industry experts to participate in these meetings to ensure the standards and technical informational reports reflect current industry changes and trends, and to make sure the standards are written scientifically.

In addition to the satisfaction of positively impacting global health, participating on these committees allows me to stay up to date with the standards and understand what is trending in the industry. The clients I work with benefit because I can make sure they are meeting current and future regulatory requirements.

Highlights from the meetings include:

  • Working Group 93. TIR 30: 2011. This document needs to be updated to reflect current standards and published documents. A task committee, which included me, was established to determine the updates.
  • Working Group 40. ST79. This group finished reviewing all comments. It was noted that the document has been placed on AAMI public review but still needs to be placed on ANSI public review, and this could drive public review comments that will need to be discussed.
  • Working Group 13. ISO 15883 series. I provided an update from the February 6-8, 2017 interim meeting of ISO/TC 198/WG 13. Comments are still being resolved on ISO/DIS 15883-4, Washer-disinfectors – Part 4: Requirements and tests for washer -disinfectors employing chemical disinfection for thermolabile endoscopes, and that work will continue in April. The majority of this group’s time was spent on ISO 15883-5, Washer-disinfectors – Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy. Substantial changes and additions were made to the document during the February meetings that required discussion. ISO/CD 15883-5 is out for ballot and comment until April 2017. It was also reported that there will be a major revision to ISO 15883-1, Washer-disinfectors – Part 1: General requirements, terms and definitions and tests to begin soon.

In April, I will be attending the ISO meetings as a U.S. delegate. The standards that will be discussed at this meeting are ISO 17664, ISO 15883-1, ISO 15883-4, and ISO 15883-5.

Complete EN 13795 Suite of Tests Offered by Nelson Laboratories

The European standard, EN 13795, addresses the barrier properties, cleanliness, and strength of surgical drapes, gowns, and clean air suits used to protect patients from secondary infections in the surgical suite. The standard was approved in 2011, updated in 2013, and is the current standard today.

Nelson Laboratories is proud to announce that we are able to perform the eight tests required to meet the EN 13795standard. The addition of Hydraulic Burst Test and Resistance to Dry Microbial Penetration Test in 2016 completed the suite of tests offered by Nelson Laboratories to help manufacturers meet the requirements of the European standard. The following tests have been certified by ANAB to meet the requirements of ISO/IEC 17025:2005:

  • HPT220 Resistance to Dry Microbial Penetration
  • HPT210 Resistance to Wet Bacterial Penetration
  • BIO220 Bioburden
  • PSA120 Particle Shed Analysis
  • HPT110 Hydrostatic Pressure
  • HPT230 Hydraulic Burst Test
  • PHY150 Tensile Test, Dry
  • PHY155 Tensile Testing

Manufacturers of surgical drapes, gowns, and clean air suits who will be marketing their products in Europe need to make sure their product offerings meet the requirements outlined by EN 13795. Additionally, meeting the requirements of this standard is important for manufacturers who are looking to obtain the CE label for their products.

For more information, contact Nelson Laboratories’ Protective Barriers department ProtectiveBarriersStudyDirectors@NelsonLabs.com.

Nelson Laboratories’ Experts Receive SOT Award

During the annual Society of Toxicology (SOT) meeting in Baltimore, Maryland, Michelle Lee and Audrey Turley from Nelson Laboratories were two of eleven authors awarded Best Overall Abstract for “Round Robin Study to Evaluate the Reconstructed Human Epidermis (RHE) Model as In Vitro Skin Irritation Test for Detection of Irritant Activity in Medical Device Extracts”. This abstract resulted in a poster presentation on the results of a worldwide collaboration to demonstrate the application of an in vitro skin irritation method for medical devices.

SOT_AwardThe acceptance of this method could significantly reduce the animal testing needed when determining the biocompatibility of medical devices. The initiative to reduce animal testing has primarily been led by Europe, but US regulatory bodies are adopting the initiative as well.

The irritation test is based on exposing RHE to device or material extracts, then performing a viability assay (using an MTT assay) where limits have been established to determine irritation potential based on an adopted method for chemicals from OECD 439: In Vitro Irritation: Reconstructed Human Epidermis Test Method.

Nelson Laboratories has been involved with this project long before it came to SOT, through our membership on the ISO working group for irritation. We have worked in conjunction with medical device manufacturers for this round robin. Look for a review of the official publication for this groundbreaking work in the near future.

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.

Nelson Laboratories Science Council

By Martell Winters

I am very excited for this new stage of Nelson Laboratories. For many years I have envisioned that the replacement of Dr. Jerry Nelson would be more than just a single person. The replacement needed to be a small group of highly qualified individuals to help drive the science of Nelson Laboratories.

The Nelson Laboratories Science Council had its first meeting yesterday to confirm the regular participants and discuss the charter and membership qualifications. We have a clear vision of how we will be working together to help expand the knowledge within Nelson Laboratories.

“As we continue to expand as a global leader in microbiological testing services, our scientific expertise is a differentiator for us as a company,” said Jeff Hone, Vice President of Quality at Nelson Laboratories.  “I am so excited to be working with this wonderful group of scientists to expand our scientific knowledge.”

I will serve as the chair of the council, with Tonya Morris as the vice-chair. The regular members of the council are as follows:

  • Martell Winters (Chair; AAMI/ISO participant and co-chair, liaison to AATB standards committee)
  • Tonya Morris (Vice-chair; AAMI/ISO/PDA participant)
  • Thor Rollins (AAMI/ISO participant)
  • Wendy Mach (USP Expert Committee, AAMI/ASTM participant)
  • Michelle Lee (AAMI/ISO/ASTM participant)
  • Alpa Patel (AAMI/ASTM participant)
  • Emily Mitzel (AAMI/ISO participant and co-chair)
  • Dennis Ransom (Master Scientist – Nelson Laboratories)

I look forward to working with this excellent group as we help to improve the science of the 10 Nelson Laboratories facilities, and as we interact in our industry.

science-council