Whitepaper

WHITEPAPER

Reusable Advices For Reusable Medical Devices eBook

February 22, 2022 | By: Lise Vanderkelen

Ensuring that reusable devices can be properly cleaned, disinfected and/or sterilized is imperative
to ensure patient safety and to minimize healthcare-acquired infections, corrective actions,
and recalls. Regulatory agencies and healthcare facilities are increasingly concerned about
the spread of diseases, including clinically relevant microorganisms, on reprocessed medical
devices. The COVID-19 pandemic has increased that concern even further. Therefore, having
proper cleaning, disinfection and/or sterilization instructions in place that have been validated
to ensure compliance with current regulatory standards is paramount. This is not an easy feat,
however, with many considerations to keep in mind when developing and validating these
reprocessing instructions.

In order to assist our customers with the development and validation of reprocessing instructions
in an ever changing regulatory landscape, Nelson Labs has a dedicated team of experts
actively serving on relevant ISO and AAMI committees capable of helping with every step of the
way. We offer full-range services starting from writing an appropriate Instructions For Use (IFU)
document, selecting worst-case devices that should be validated, and performing the actual
validations in ISO17025 and GLP accredited laboratories.

When performing intake conversations with our clients, it is clear that deciding which
regulatory aspects are applicable to a specific and individual medical device can be challenging.
In our series of advices, we have therefore attempted to summarize the regulatory guidance
that is offered and how it can be applied to a specific medical device. This list is by no means
exhaustive nor does it cover all aspects related to reprocessing validations. Instead, it covers a
selection of frequently asked questions. It is evident that our team of experts remains at your
disposal to answer any questions that remain.

Please, fill in your data below to download the document and I wish you a very interesting reading…

Alpa Patel

B.S., RM (NRCM)
Principal Scientist

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 18 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a principal scientist at Nelson, involves overseeing test method validations for reprocessing, writing standard test...

Lise Vanderkelen

PhD
Pharmaceuticals and Microbiology Expert

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...

Katleen Peymen, PhD

Study Director Healthcare reprocessing and Microbiology

Katleen Peymen received her PhD in Biochemistry and Biotechnology from the Faculty of Science at the University of Leuven (Belgium) in 2019. After her career as a post-doctoral researcher, she started at Nelson Labs Europe in 2020 as a Study Director for Healthcare reprocessing and Microbiology. She is responsible for the study design, analysis and reporting of healthcare reprocessing validations for reusable medical devices, such as cleaning, disinfection, and steam sterilization validations, and is an active member of several International Organization for Standardization (ISO) committees related to healthcare reprocessing.

Jason Pope, B.S., ASQ CQA

Senior Scientist

Jason Pope is a certified quality auditor and specializes in providing consultations for clients about sterilization of reusable medical devices, endoscopes, and pharmaceuticals and general sterilization validation process development. He has over 19 years of experience working in research and development, validation, and routine control of various sterilization processing modalities including, but not limited to, steam, ethylene oxide (EO), dry heat, and H2O2 gas plasma sterilization. His experience includes commissioning of sterilization vessels for clients including IQ/OQ/PQ performance. Jason also specializes in developing sterilization testing protocols for new packaging products prior to regulatory clearance submissions. Jason actively provides advice and guidance relating to product sterilization to clients for various regulatory submissions, including product PMA and 510(k) submissions. This expertise, combined with his active oversight of routine reprocessing sterilization validation projects, keeps him at the forefront of knowledge of regulatory trends and expectations for health care product sterilization. This experience gives him a unique perspective on product sterilization performance and allows him to provide valuable product design input prior to active laboratory testing phases. As a member of the American Association of Medical Instrumentation (AAMI), he plays an active role, in concert with the FDA and regulatory committees, in developing standards and voting on changes to those standards.