Education

FTIR in Assessment of Medical Devices

By: Adam B. Brigham, B.S.; Matthew R Jorgensen, PhD

Fourier transform infrared (FTIR) analysis is a popular analytical tool for material screening. The technique works because each different type of molecular bond in a molecule vibrates differently, and there is often a set of molecular vibrations that involve the entire molecule that form a characteristic “fingerprint.” When measuring a molecular substance, it is possible to identify an organic substance by comparing its FTIR spectrum to a library. In cases where a substance is a mixture of molecular components, FTIR would not be the best option because a separation technique (e.g. chromatography) would need to take place before identification could occur. However, there are many cases for which FTIR analysis is a fast and inexpensive option.

FTIR can be a useful first step as an aid in the identification of an unknown residue. Even if an exact identification is not possible (e.g. in the case of mixed residue), FTIR can often help identify the class of compound which can assist in unknown investigations or process monitoring. For example, if high residual manufacturing material was found on a device, FTIR could be used as an investigational tool to help identify the source. If FTIR was unable to find a conclusive library comparison match, additional testing would need to take place.

FTIR shines when comparing two or more materials in-hand. For example, when particulates are found on a device, it may be necessary to attempt particle identification so that the source can be found and eliminated. Other analytical chemistry techniques would fail at this task, because the amount of particulate material is too small to analyze. FTIR can be conducted through a microscope so that the “fingerprint” of a single particle can be collected. This spectrum can be compared against potential contaminants (e.g. paper, fibers from clothing, or materials unique to the device manufacture), or a library of materials which can greatly narrow the possibilities.

There are also cases where the question being asked is, “does a certain process change my material?” FTIR is a great resource for polymer characterization. Depending on the nature of the material and process, it may be possible to pinpoint what the change is. For example, oxidation of a polymer is clearly indicated by the introduction of carbon-carbon double bonds. If the details of the change are not derivable, it can at least detect if a change has occurred. Perhaps a manufacturer considers changing the radiation dose for their material; they can measure the original device and a device irradiated at the new level comparatively to see if anything is different.

Any FTIR study relevant to medical devices should be carefully thought through and designed with expertise. Simply ordering of a single test without a specific objective in mind will be marginally useful. With smart design – powerful conclusions can be made.

2017 Mid-year Thought Leadership Update

The experts at Nelson Laboratories have been busy in 2017. They have participated on committees, spoken at domestic and international industry events, written whitepapers, published articles, and hosted webinars. We have compiled the list below to share some of our educational assets:

WHITEPAPER

WEBINARS

TECH THEATER

THIRD-PARTY PUBLISHED ARTICLES

To register for our three-day Science of Sterilization Validation seminar, visit the Seminar page on our website.

WISE Committee Showcases STEM Careers

WISEThe Nelson Laboratories’ Women in STEM Education (WISE) committee recently participated in the San Juan County Sixth Annual Career Fair hosted by Junior Achievement of Utah. Tina May, Dani Silva, Jessi Beck, and Dayna Clarke are part of the WISE committee which is comprised of 17 women scientists and leaders at Nelson Laboratories who are committed to bringing the passion for STEM careers to youths of all ages.

Nelson Labs was one of over 30 vendors that visited Whitehorse and Monument Valley High Schools to teach children from grades 7-12 about career opportunities that are available for them after graduation.

“We love to participate in events like this and share our enthusiasm for science careers with students who wouldn’t normally have the opportunity to learn about these options,” said Tina May, co-chair of the WISE committee and senior director of laboratory operations at Nelson Laboratories.

There was a lot of traffic and interest at the Nelson Laboratories’ booth. The hands-on activities demonstrated to the kids that science can be cool, and they were able to take part in some of the testing protocols that are used in the laboratory. For instance, teaching the kids about aseptic technique for putting on surgical gloves was a big hit. Once they put on the gloves and held their hands under a special light, they were able to see how effectively they followed the procedure for gloving up. This also taught them why the technique is important for sterile environments.

“This experience was amazing as we got the chance to get to know many bright, young people who were genuinely excited to learn about our company and to have fun,” said Dayna Clarke, radiation study director at Nelson Laboratories. “We were also awestruck by the natural beauty of the formations of the Bluff and Monument Valley landscapes.”

Inspiring the next generation of scientists is an important mission, and the WISE committee is comprised of dedicated individuals who volunteer their time and talents to spread the word about STEM education and careers.

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.

Flexible Endoscope Surveillance Testing Webinar Now Available

AlpaPatelLast week, Alpa Patel, Senior Scientist at Nelson Laboratories, and Kaumudi Kulkarni, Manager of Research and Development at Healthmark Industries, hosted the live webinar Endoscope Microbial Surveillance Testing Made Easy. The webinar was attended live by infection prevention professionals, sterile processing professionals, nurse managers, laboratory professionals, and others who work in healthcare facilities and wanted to learn more about performing surveillance on endoscopes.

The webinar discusses the outbreaks that have been in the news over the past few years regarding contamination of flexible endoscopes, and the benefits of performing endoscope surveillance in a healthcare facility. An explanation of the organisms of concern is provided which allows Patel and Kulkarni to review the options for positive growth of the organisms. Basic tests methods for surveillance of flexible endoscopes are covered.

The 44 minute webinar is now available on-demand. If you would like to watch the webinar, follow this LINK.

For more information, contact Alpa Patel at apatel@nelsonlabs.com.

Reprocessing Single-Use Devices

By Emily Mitzel & Paul Littley

Some devices that are marketed and validated for single use are now being used multiple times in clinical settings. To save money and to comply with green initiatives, hospitals are moving towards using third-party reprocessed single-use devices (SUDs). However, reusing devices intended for single use can be dangerous without the correct validations and instructions for reprocessing in place.

single-use-blog-post-1Post-market validations need to occur to reuse devices intended for single use. Since there are no reprocessing instructions for use (IFU) for SUDs, cleaning and sterilization processes must be developed and validated to ensure patient safety.

FDA and other regulatory bodies have some guidance documents and are creating more to make sure SUDs can be appropriately cleaned, disinfected, sterilized, and tested for functionality. A test plan, justification, and acceptance criteria should be written to conform to regulatory trends.

FDA is hosting a public workshop, Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, in October and has started a draft document to help regulate and provide guidance to this industry.

There are many items that need to be addressed to successfully reprocess SUDs.  The experts at Nelson Laboratories provide the following services to help third-party reprocessors with their process validations:

  • Cleaning process and parameter development including validation
  • Disinfection process and parameter development including validation
  • Sterilization cycle development including validation
  • Packaging validations for device sterile barrier systems in preparation for sterilization, transportation, and shelf life
  • Family grouping of devices for validation
  • Environmental Monitoring (EM) program involving review of current program, gap analysis, and development of EM sampling plans
  • Assessment of current water systems design and status, including: determination of the appropriate type of water, gap analysis, and testing to ensure compliance to the water grade specified
  • Training program development or review; which includes reprocessing techniques, EM sampling, etc.
  • Regulatory compliance consultation; which includes regulatory responses, audit support, and on-site process inspection and evaluation with written assessment as appropriate

single-use-blog-post-2Third-party reprocessing offers healthcare providers a way to maintain the highest quality patient care, while also achieving significant cost-savings and reducing medical waste.  This is only possible if all regulatory requirements are fulfilled and the devices are reprocessed for safely for subsequent patient use.  This savings has been reported to be millions of dollars in supply costs and millions of pounds of waste diverted from landfills.

US FDA recommends using the guidance from Medical Device User Fee and Modernization Act of 2002, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, and Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA. Medical Device and Diagnostic Industry published Reprocessing Single-Use Devices: Why Does the Debate Continue?  The Association of Medical Device Reprocessors (AMDR) website has a lot of information such as Regulatory Position Statements and Letters and International Regulations.  Health Canada published an update in 2015 on Reprocessing of Single-Use Medical Devices which includes the policies and practices appropriate for each Canadian jurisdiction.

Validated cleaning, disinfection, and sterilization processes combined with validated functionality testing can ensure patient safety when reusing single-use medical devices.

Please contact Nelson Laboratories Experts for your consulting needs:

Emily Mitzel: emitzel@nelsonlabs.com

Paul Littley: plittley@nelsonlabs.com