Reprocessing Medical Devices: Approaches and Considerations for Manual Cleaning Validations

Clinical Trials, Drug Discovery and Development, Life Sciences, Medical Device, Medical Device Design, Medical Device Safety and Regulation, Pharmaceutical, Pharmaceutical Regulation ,
  • October 26, 2016

Reusable medical devices (RMD) acquire varying levels of organic residue during clinical use. Prior to re-use, this residue must be removed as failure to effectively clean devices can result in loss of device function(s), the inability to subsequently disinfect or sterilize, and increased patient risk of infection. While the responsibility for ensuring reusable devices are effectively cleaned during reprocessing is shared, it begins with the device manufacturer. Manufacturers are required to provide the end-user with appropriate and validated cleaning instructions for use (IFU), increasingly under regulatory scrutiny.

Official guidance documents such as AAMI TIR12, AAMI TIR30, and the FDA’s Reprocessing Medical Devices in Health Care Setting (2015) provide critical direction and considerations. However, reusable medical designs vary, devices have distinct classifications and clinical applications, and there are multiple reprocessing options. This complexity contributes to some uncertainty in the structure of a validated cleaning procedure and no single study design is appropriate for all device types. Proper selection of the most appropriate methodology is essential for a successful RMD manual cleaning validation

This webinar will assist medical device designers and manufacturers navigate the reprocessing requirements and successfully execute a manual cleaning validation. This program will present various aspects of manual cleaning validation testing: overall considerations, selection of artificial test soil, soil challenge sites and dwell time, cleaning reagents, manual cleaning techniques, rinse requirements, and acceptance criteria. It will also cover life cycle considerations and challenges in the design of an appropriate validation study.

Speakers

Michael Brady, MS, PhD, Director of Microbiology Services, Toxikon Corporation

Dr. Michael Brady is the Director of Microbiology Services at Toxikon Corporation. In that role, he oversees the microbiology testing for medical devices. He is the author of a number of articles and co-inventor on two antimicrobial patent applications. Dr. Brady received his BA in Biology from St. Anselm College, an MS in Biology from the University of Lowell, and a PhD in Molecular Microbiology from the University of Massachusetts Medical School. His graduate research focused on bacterial pathogenesis for a class of enteric pathogens. Prior to joining Toxikon, he conducted pre-clinical development studies for antimicrobial technologies.

Who Should Attend?

Senior level executives involved in regulatory affairs for medical device companies, including those from manufacturing services providers, consulting companies, product development, and financial/investment companies and government.

Relevant job functions include:

  • Engineering – Biomedical, Design, Manufacturing/Production, Packaging, Process, Project, Quality, R&D
  • Manufacturing (Packaging, Process)
  • Project Management
  • Research & Development
  • Regulatory / Compliance / Quality Assurance
  • Sales / Business Development / Marketing
  • Purchasing

The session will also benefit pharmaceutical, biotechnology and dental product manufacturers.

Xtalks Partners

Toxikon 

Toxikon is a preclinical Contract Research Organization (CRO). Located in a state-of- the art laboratory facility in Bedford, Massachusetts, and a second European lab operation in Leuven, Belgium. We contract and partner with biotech, Pharmaceutical and medical device industries to deliver exceptional product development services from concept to final product. Our professional and scientific staff is experienced in a comprehensive range of compound structures, therapeutic agents, and medical devices, including combinations products. We serve over 1,500 customers in more than 41 countries.

At Toxikon, we pledge:

To conduct the highest quality research and testing services in the industry;
To assure you of a clean and comfortable environment when working on-site;
To provide prompt, friendly, and courteous services by a knowledgeable and highly-trained staff;
To be sensitive to special project needs and provide a detailed scope of services to be performed for every study/project;
To deliver studies/projects to sponsor satisfaction, in a timely and efficient manner;
To feature new services that represents the best current technology available;
To respond in a rapid, sensitive, and constructive manner to requests that will enhance your outsourcing experience;
To provide you with an experience that will encourage a continued partnership with Toxikon.

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