MedTech Industry News

Everything from GDP per capita, venture capital, M&A, interesting statistics and more. This may not be all of the news available about MedTech but it will be some of the most interesting and interpretive.

AAMI Sterilization Standards Meetings Update

By: Emily Mitzel, MS

The AAMI Sterilization Standards Meetings were held on 16-18 October 2017.  There were almost 300 medical device manufacturers, FDA personnel, heath care facility personnel, testing laboratory personnel, consultants, and others in attendance.

One item of interest from USFDA/CDRH is that the Office of Device Evaluation (ODE), Office of Compliance (OC), and Office of Surveillance and Biometrics (OSB) are merging into a single structure specified as the Center for Devices and Radiological Health (CDRH) Total Product Life Cycle (TPLC).

A second item of interest is the Accreditation Scheme for Conformity Assessment (ASCA) in which FDA is ensuring testing laboratories are consistent and are complying with current standards. https://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm558632.htm

Medical Device Reprocessing Update:

  • AAMI TIR30:2011 Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices is in the process of review and is being rewritten.
  • ISO/FDIS 17664 – Sterilization of Medical Devices Information to be provided by the device manufacturer for the processing of reusable medical devices last published in 2004 will be publishing a new version (hopefully by the end of 2017).
  • A new document currently titled ISO/NP 22913, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Medical devices not intended for direct patient contact, was approved and will be written.
  • The current draft of ISO 15883-5 – Test soils and methods for demonstrating cleaning efficacy is undergoing a major revision.

The dates of the next AAMI Sterilization Standards meetings are:
19-22 March, 2018
22-25 October, 2018

Sterigenics International and Noxilizer Announce Partnership

Sterigenics International and Noxilizer announce partnership to provide NO2 sterilization for pharmaceutical, biotech and medical device products

Agreement supports customers with global manufacturing networks

October 3, 2017 (Baltimore, MD and Broadview Heights, OH) Noxilizer, Inc. and Sterigenics International LLC announce the signing of a global agreement that will make Sterigenics the exclusive worldwide provider of nitrogen dioxide (NO2) contract sterilization services, as well as feasibility and research studies, to the pharmaceutical, biotech and medical device manufacturing industries.

NO2-based sterilization was first commercialized by Noxilizer in 2012. Customers prefer nitrogen dioxide sterilization for its key advantages: ultra-low temperature (10°-30°C), minimal pressure requirements, no cytotoxic residuals, and fast cycle times (2-4 hours, including aeration). NO2 sterilization opens new avenues for medical device innovation and has been shown to be particularly effective in the sterilization of prefilled syringes, drug-device combination products, and custom implants.

“We are very excited about our partnership with Sterigenics, as together we can rapidly expand NO2 sterilization capability for our customers,” states Lawrence Bruder, President & CEO of Noxilizer. “Noxilizer’s customers will now have large-scale facilities to meet their needs for contract services, redundancy and increasing volumes.”

“Sterigenics is committed to providing our customers with efficient, state-of-the-art sterilization services using the processes best suited to their specific products,” says Philip Macnabb, President of Sterigenics. “We regularly monitor new technologies and are excited to be able to add NO2 processing to our suite of offerings.”

Noxilizer expects to have the first NO2 sterilization systems in place and operational in select Sterigenics’ facilities in the United States and Europe by the end of the year with additional installations to follow. As part of the agreement, Sterigenics will also offer nitrogen dioxide sterilization consulting services to its customers.

Customers will also be able to benefit from the integrated testing services available through Sterigenics International’s Nelson Laboratories business.  “This unique combination of cutting edge sterilization technologies, expert consulting support, and full-service testing services will provide customers with unrivaled support in getting products to market quickly and reliably,” says Jeff Nelson, President of Nelson Labs.

“Sterigenics has set a high standard for matching the needs of its customers with the best available sterilization technologies,” Lawrence Bruder concluded. “Noxilizer shares this commitment to excellence and we look forward to working with the Sterigenics International team as they continue to reshape the market.”

About Sterigenics International LLC:

Sterigenics International LLC, along with its affiliates, is a global leader in outsourced contract sterilization services, laboratory services, gamma technologies and medical isotopes, and the only vertically integrated sterilization company in the world. Operating out of 51 locations in 13 countries across the Americas, Europe and Asia, Sterigenics provides contract sterilization and ionization services for the medical device, pharmaceutical, food safety, and high-performance materials industries. Its affiliate Nordion positions Sterigenics as the world’s largest provider of Cobalt-60 used in the gamma sterilization process as well as medical isotopes used in the diagnosis and treatment of various diseases and cancers. Through Nelson Labs, Sterigenics offers microbiological and analytical testing and consultancy to assist customers in developing and maintaining sterilization solutions in medical devices, tissue/implantable products, and pharmaceuticals and biologics fields. Sterigenics International LLC and its affiliates serve more than 2,500 customers around the world and is owned by private equity firms Warburg Pincus and GTCR. Learn more about Sterigenics at sterigenics.com, about Nordion at nordion.com and about Nelson Labs at nelsonlabs.com.

About Noxilizer, Inc.:

Noxilizer, Inc. provides an ultra-low temperature nitrogen dioxide process that offers many benefits over traditional sterilization and biodecontamination methods. Noxilizer sells sterilization and biodecontamination equipment to pharmaceutical, biotech and medical device manufacturers. Noxilizer’s expert microbiology and material compatibility team is ready to partner to solve sterilization challenges through every phase of the process. Noxilizer, Inc. has offices in the United States and Japan. For more information, please visit: www.noxilizer.com.

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.

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.

ISO Committee Member Announced

erinbakesErin Bakes has been accepted as a U.S. expert to the ISO Technical Committee 150: Implants for Surgery (WG7).  This placement allows participation in the annual ISO meetings to discuss movements surrounding the approach to cleanliness and safety of medical devices and the development of ISO 19227.  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.

Erin Bakes has been with Nelson Laboratories for over ten years.  She has spent eight years as a study director in the chemistry department with a focus on cleaning validations for newly manufactured and single use devices.  She is now the chemistry department manager and continues to consult with clients on their device cleanliness validations.

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.