reusable medical devices

Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes

Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes including FDA, ISO, USP, and MDRs.

The experts at Nelson Labs are teaming with MD+DI to bring a live three-day webinar event that provides manufacturers of medical devices and pharmaceutical products with the most up-to-date regulatory updates, trends, and anticipated changes (including FDA, ISO, USP, and MDRs). Online registration is currently available on the MD+DI website. Many of those speaking contribute to committees that provide global guidance to safeguard patient health; each webinar will offer 15 minutes for audience questions with these experts. Details for each webinar are as follows:

OVERVIEW DAY 1

Title: Assessing Biocompatibility for Medical Devices: Updates, Trends, and Anticipated Changes

Date: Tuesday, 26 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:

This presentation will discuss the recent and upcoming changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices. The presentation will include:

  • Discussion about how biocompatibility assessments are affected by the recent updates to the ISO 10993-1 document and the new European MDRs.
  • Anticipated changes to ISO 10993-18. Since the use of chemistry in the biocompatibility assessment of medical devices is gaining traction, the document that outlines how to use chemical characterization for these assessments is undergoing major revisions.
  • An overview of changes that are expected with the acceptance of in-vitro irritation testing.
  • A thorough review of the impact of the recently finalized ISO 18562 standard which specifically targets respiratory contact devices.

Presenters:

Thor Rollins, B.S., RM (NRCM)
Director, Toxicology and E&L Consulting

Matthew R. Jorgensen, PhD
Chemical and Materials Scientist

OVERVIEW DAY 2

Title: Sterilization Methodologies and Packaging Integrity Testing: Updates, Trends, and Anticipated Changes

Date: Wednesday, 27 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:
Sterilization methodologies and packaging integrity testing are necessary to ensure patient safety. The sterilization portion of the webinar series discusses recent and upcoming changes to regulatory documents and standards such as:

  • Changes that impact steam, radiation, hydrogen peroxide, and ethylene oxide sterilization modalities.
  • What to expect in the new ISO document for hydrogen peroxide sterilization.

As part of the packaging presentation key points regarding the new European MDRs will be reviewed, including:

  • How medical device manufacturers can collect and document objective evidence of compliance for their packaging, look at designs that prevent microbial contamination at the point of use, and justify that the package is suitable for current use.
  • An introduction to a new leak-testing technology, Mass Extraction, that demonstrates container closure integrity in a non-destructive and rapid manner, will be presented. This new test meets the deterministic requirements as outlined in the newly published USP chapter 1207.

Presenters:

Martell K. Winters, B.S., SM (NRCM)
Director, Scientific Competency

Jason Pope, B.S., ASQ CQA
Senior Scientist

Wendy Mach, RM (NRCM), CQA (ASQ)
Packaging Section Leader

OVERVIEW DAY 3

Title: Cleanliness Testing for Medical Devices: Updates and Trends

Date: Thursday, 28 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:

This presentation will cover the latest updates and current trends for medical device cleanliness testing. This webinar will include:

  • A review of the upcoming and highly anticipated orthopedic implant cleanliness ISO document.
  • A discussion about the testing considerations for certain additive manufacturing processes.
  • Guidance updates for reusable device validations.
  • An update regarding the reprocessing of single-use devices.

Presenters:

Alpa Patel, B.S., RM (NRCM)
Senior Scientist

Alexa Tatarian
Study Director III

Paul L. Littley, B.S.E
Consulting Manager

Endoscope Sampling Kit Now Available

With their flexibility and complex components, endoscopes present unique cleaning and disinfecting challenges. Endoscope manufacturers, regulatory bodies, and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. The concern over endoscope reprocessing has been so great that regulatory bodies, such as the Center for Disease Control (CDC), have developed guidelines to prevent the spread of communicable diseases through the use of endoscopes. The FDA is currently working on a guideline.

DSC_3179With patient health in mind, Nelson Laboratories and HealthMark Industries developed an Endoscope Sampling Kit for the random testing of duoendoscopes in compliance with the CDC guidelines. Everything necessary to collect and send a sample from a reprocessed endoscope for testing to determine the presence or absence of objectionable microorganisms will be provided in the kit offered by Healthmark. The sample will be sent by the healthcare facility to Nelson Laboratories for independent testing of the sample for the presence of any microorganisms. If present, the organisms will be identified and quantified.

The kit is a turnkey solution and an important “safety check” for hospitals to make sure their endoscope cleaning and disinfecting processes are working.

Important Considerations for Reusable Medical Endoscope Processing and Reprocessing

Endoscope processingEvery year Nelson Laboratories tests and validates thousands of medical devices. One particular family of reusable medical devices, endoscopes, can present unique challenges for manufacturers and  healthcare reprocessing facilities. Responding to recent attention on reusable endoscopes, particularly the reusable duodenoscopes being blamed for two Los Angeles patient deaths and an increase of Healthcare Acquired Infections (HAIs), Nelson Laboratories has compiled a suite of educational resources detailing important reusable medical endoscope processing and reprocessing considerations.

“All scopes require careful thought and consideration before validation testing and FDA submissions are conducted,” said Emily Mitzel, Nelson Laboratories Consulting Manager, specializing in reusable medical device validations. “The reprocessing instructions need to be accurate for different regions of the world and must be usable in a variety of different healthcare facilities’ reprocessing programs. Healthcare facilities need to ensure staff is properly trained on cleaning procedures and that technicians understand the importance of cleaning difficult locations multiple times when visual inspections are not adequate.”  Effective reprocessing of endoscopes and other reusable medical devices will help minimize the prevalence of healthcare acquire infections.

Nelson Laboratories offers the following information and resources for reusable medical device manufacturers and healthcare facilities reprocessing reusable devices:

  • Comments on “Reprocessing Guidance for Industry and FDA Staff,” issued March 17, 2015 – Learn more about how the FDA’s new guidance document (issued March 17, 2015) differs from their 2011 draft guidance. Read full story >
  • Healthcare Reprocessing of Medical Devices and Human Factors Debrief – Complex reusable medical device designs and other device enhancements that do not take human factor considerations into account may make it difficult, or even impossible, for hospitals to clean, disinfect, and sterilize reusable devices effectively. Watch webinar >
  • Validating Cleanliness Taking Human Factors Into Effect – Medical device manufacturers are expected to provide clearly understandable reprocessing instructions with their medical devices. Nelson Laboratories recommends validating reprocessing with a conservative approach to ensure a safety buffer is built in to account for human factors. Read more >
  • Successful Medical Device Cleaning Validation: What You Need to Know – Validating cleaning instructions for reusable medical devices is an important milestone on the path to obtaining FDA clearance. Get the detailed information you need to know about medical device cleaning validations with this complimentary white paper. Download white paper >
  • Functionality vs. Simulated-Use Testing in Device Reprocessing – The FDA has said that if a medical device is to last 100 cycles, it needs to be validated to 100 cycles. Likewise, endoscopes need to be tested for a buildup of soil. Testing for these two different conditions is very similar, but looks for very different results based on human factors. Read more >
  • Standardization of Test Soils for Reusable Endoscopes – Scientists at Nelson Laboratories actively participate with the ASTM committee and writing the ASTM standard that is slated to standardize test soils for reusable medical device testing, making it easier and more cost effective to develop and validate cleaning instructions. Learn more >

For additional information on requirements for processing and reprocessing of reusable endoscopes and other medical devices, manufacturers can contact Nelson Laboratories at sales@nelsonlabs.com, or 801-290-7502.

In addition to reusable device validation testing, Nelson Labs offers quarterly assessment or qualification tests to help healthcare facilities assess the human factors and cleanliness of their endoscope reprocessing facility. Nelson Laboratories’ Technical Consulting group is also available to provide manufacturers and healthcare facilities technical support at every phase of the product life cycle.

Comments on “Reprocessing Guidance for Industry and FDA Staff,” issued March 17, 2015

By: Emily Mitzel, B.S. M.S. RM (NRCM), healthcare reprocessing expert, Nelson Laboratories

The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance.  Based on the content and addition of Appendix E, this appears to be a response by the FDA to recent issues with endoscope reprocessing.  It is, however, important to note that many of the concepts highlighted in the new guidance document have been incorporated in current Technical Informational Reports and Standards, industry practice, and laboratory tests for years, and this guidance reaffirms FDA recommendations and expectations.

The following highlights some of the ways the new guidance document differs from the May 11, 2011, version (Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling). For the complete document, visit www.fda.gov.

The majority of changes to the document include rewording, new information, and additional details about content highlighted in previous iterations of the 2011 draft guidance. These changes include expanded endoscope reprocessing guidance in Appendix E.

Appendix E.  Devices for which a 510(k) Should Contain Data to Validate Reprocessing Instructions

One of the biggest changes to this document is the addition of Appendix E, which is entitled, “Devices for which a 510(k) Should Contain Data to Validate Reprocessing Instructions.”  This new appendix focuses on endoscopes of all types and it highlights:

  1. Specific medical devices that FDA has identified, which pose a greater likelihood of microbial transmission, and represent a high risk of infection in the event they are not adequately reprocessed. Devices listed in the appendix include the Product Code, Device Name, and Regulation Number.
  1. Reprocessing instructions not only need to be validated, the validation data must be equivalent or better than predicate devices.
  1. Considerations for most scope models and accessories are now included.
  1. Specific guidance for laparoscopic instruments, accessories, and design features are also included (see Table 1).

Section IV. General Considerations for Reusable Medical Devices
Part A. Design of Reusable Medical Devices

This new section addresses the FDA’s concern about the, “evolution towards more complex, reusable medical device designs that are more difficult to reprocess.”  It specifically talks about the need for medical device engineers to think about the cleaning, disinfection, and sterilization reprocessing instructions when designing medical devices.  FDA recommends engineers consider including flush ports and cleaning accessories made for the device.  This is also mentioned in a number of other sections of the revised guidance.

Additional References to Current Guidance, Technical Informational Reports, and Standards

Many additional references were introduced to the guidance.

  • Section B. 3. contains a reference to ANSI/AAMI ST81/Ed.1, “Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices” as well as a couple of other pertinent references.
  • Section C. 2. specifies many FDA and AAMI guidance documents on human factors that are relevant to how healthcare facilities manage and process reprocessed medical devices.
  • Section F. includes a reference to the newly published AAMI TIR34: 2014, “Water for the reprocessing of medical devices,” which is an important consideration for ensuring the correct water quality is used in all steps of reprocessing in the clinical setting.

Quantitative Residual Markers

FDA has now specified that at least two quantitative residual markers should be tested in a cleaning validation.  These tests should measure clinically meaningful levels of the clinically relevant test soil and be measured against predetermined endpoints.  While Nelson Laboratories has recommended testing two quantitative residual markers for cleaning validations for many years, this is the first time FDA has incorporated this number it into their guidance document.

Visual Inspection

Of key importance is the language related to visual inspection of reprocessed devices.  A couple of changes the new document makes to the suggested validation process include the addition of visual inspection of the inside of the device and definition of additional positive and negative controls.

  • Section VIII. 3. A. specifies that visual inspection of both external and internal surfaces should be performed during validation.
  • Section VIII. 3. B. specifies device and sample controls of both positive and negative controls. This does not really change how Nelson Laboratories currently performs these validations.

For more information about the reprocessing of reusable medical devices, please contact Nelson Laboratories’ reusable device testing experts Emily Mitzel, Alpa Patel, or Nick Workman at (800)-826-2088, or servicecenter@nelsonlabs.com.

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Biocompatibility Advancements To Be Showcased At MD&M Minneapolis ǀ Nelson Laboratories

In the midst of an evolving biocompatibility testing and regulatory environment, MedTech professionals face the challenge of staying informed of biocompatibility testing and regulatory trends. Intended to provide MedTech professionals the knowledge and expertise to navigate the challenges inherent in contemporary biocompatibility testing, the upcoming MD&M Minneapolis tradeshow is slated to offer four lectures by Nelson Laboratories biocompatibility expert Thor Rollins.

“Right now we have a very exciting, dynamic, and sometimes challenging biocompatibility testing landscape. I have been on the ISO Committee for almost 12 years and we have never seen as much development in the 10993 standards as we have in the last several years.” Rollins said. “We are in what I would consider the new age of biocompatibility testing.”

Biocompatibility test methods and regulatory behavior have changed dramatically over the last four years. While the future of biocompatibility testing hints at faster, more accurate, cost effective test methods, the contemporary regulatory environment has become increasingly complex. Changes to the ISO standard and diverse regulatory interpretation and application means that merely establishing a testing scheme will be wrought with challenges. According to Rollins, it is not uncommon for regulators to request additional testing beyond the scope of the current ISO 10993 standard. It is these unforeseen complexities that make understanding current biocompatibility testing trends so important for MedTech professionals.

Courtesy of Nelson Laboratories, Thor will be presenting four consecutive biocompatibility testing and compliance focused lectures beginning Thursday October 30th at 10:30 am central time.

MD&M Minneapolis tradeshow participants will be given complimentary access to Mr. Rollins’ three Tech Theater presentations which will include discussion of the Big Three, the power of chemical characterization, and how the new FDA ISO 10993 guidance could affect you.

Thor’s final presentation will focus on the latest FDA trends in biocompatibility testing for cardiovascular devices. This is a conference presentation scheduled to begin Thursday October 30th at 2:45pm. Registration is required.

Half-Day MD&M Biocompatibility Lecture Series:

The Big Three: Cytotoxicity, Sensitization, & Irritation
10:30 am – 11:15 am, October 30th

The Power of Chemical Characterization to Assess Changes in Your Medical Device
11:30 am – 12:15 pm, October 30th

How the New FDA Guidance on ISO 10993 Could Affect You
12:30 pm – 1:15 pm, October 30th

Hemocompatibility and the FDA: The Latest Trends From The FDA
2:45 pm – 4:00 pm, October 30th
Requires MD&M Minneapolis registration. CLICK HERE to register.

Click here to learn more about Thor Rollins MD&M Lecture Series! 

Successful Medical Device Cleaning Validations: What You Need to Know

Validating cleaning instructions for a tray of reusable orthopedic devices is an important milestone on the path to obtaining US and EU clearance. Although the process of validation can seem daunting at first, medical device manufacturers seeking to successfully navigate this process can do so confidently and efficiently if they are armed with knowledge, education, and guidance. To this end, Nelson Laboratories, Inc. recently published Successful Medical Device Cleaning Validations: What You Need to Know, a white paper available for download on QMED.com. This comprehensive overview of medical device cleaning and reprocessing validation highlights what medical device manufacturers need to know, where to start, and with whom to partner.

The following is an excerpt from Nelson Laboratories’ Successful Medical Device Cleaning Validations white paper, providing medical device manufacturers a check-a-box list of questions to help qualify potential lab partners:

As medical device manufacturers search for a testing lab to validate their devices’ cleaning instructions, asking the following questions of potential lab partners can help them best qualify the lab partner:

• Does the lab perform validation tests routinely for medical device clients and is therefore very familiar with this industry and various product types?

• Are the testing lab’s representatives members of applicable standards committees?

• Is the lab willing and able to consult with medical device clients in the early stages of cleaning-instruction creation and revision, especially when the instructions appear too simple or overly complex?

• Does the lab work closely with both the FDA and clients to resolve discrepancies between validation test results and FDA requirements?

• Are the lab personnel experienced and familiar with the full breadth of medical device types and understanding of patient contact and soiling techniques?

If the answer to all of these questions is yes, then the testing lab under consideration is a good candidate for the manufacturer’s validation testing needs.

Medical device companies must do their part to ensure that their devices are cleaned, disinfected, and sterilized properly between patient uses in the healthcare setting. To that end, validated cleaning instructions for medical devices is critical for both obtaining FDA clearance and keeping patients safe. The cleaning process described in a device’s IFU must be easily understood and repeatable in the healthcare facility. An experienced, conscientious lab partner will help medical device manufacturers through each step of the validation process to ensure satisfactory results.

To learn more about performing medical device cleaning validations DOWNLOAD Successful Medical Device Cleaning Validations: What You Need to Know from QMED.com, or visit Nelson Laboratories at www.nelsonlabs.com.

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