AATB

Martell Winters Recognized at AATB

By Alyessa D’Ewart, MPC

martellMartell Winters, senior scientist at Nelson Laboratories, received the Jeanne Mowe Distinguished Service Award by the American Association of Tissue Banks on Wednesday, September 21, 2016. Martell was chosen to receive this award due to his contributions to the tissue banking and transplantation industries. He is an active committee member of many working groups with AATB, and currently serves as the AATB liaison to the AAMI Radiation Working Group. Martell has also made great contributions to the radiation sterilization standards for human tissue-based products.

“I am honored to receive this award,” Martell said. “I have enjoyed working with the members of AATB, and look forward to continuing to contribute to the tissue industry.”

About the award from AATB’s website: “The Jeanne C. Mowe Distinguished Service Award recognizes an individual who has made a significant contribution in tissue banking or transplantation, whether in research, education, or laboratory improvement, or who has served the Association or the field of tissue banking. The individual should have demonstrated leadership qualities and a consistent willingness to lend his or her expertise to the Association and/or to his or her peers. The recipient shall be a member in good standing of the Association.”

Nelson Laboratories Scientist Provides Clarification on Tissue Bank Cleaning Validations

Alpa Patel, Nelson Laboratories Senior Scientist - Healthcare Reprocessing

Alpa Patel, Nelson Laboratories Senior Scientist – Healthcare Reprocessing

Nelson Laboratories, Inc. Alpa Patel, senior scientist in healthcare reprocessing, presented at the annual American Association of Tissue Banks (AATB) meeting last month on the topic of Equipment Cleaning and Disinfection Validations, something she calls, “the tissue industry’s compliance challenge.

Highlighting regulatory issues and solutions for process validations at tissue banking facilities, Patel noted, “Because tissue is an emerging industry they have had less experience with validations than other MedTech service providers and may not know what to expect.”  However, recent regulatory attention on the cleaning, disinfection, and sterilization validations for the equipment and supplies used to process tissue is changing that.

“While the FDA does not clearly state the requirements for these validations, recent trends have shown that companies that state they adhere to the American Association of Tissue Banks (AATB) standard may be required to have a validation plan in place.” said Patel. “And although the Good Tissue Practices (GTP’s) do not specify these validation practices, there is good reason for tissue banks to acquire them.”

Intimately involved in assisting some of the world’s premier tissue banks in establishing their validation plans, Patel recommends tissue banks review whether or not an equipment validation plan is in place and take appropriate measures to ensure compliance sooner rather than later since:

  • Regulators have begun auditing some tissue banks.
  • Facilities that did not have validation data to support the cleaning, disinfection and sterilization of their equipment have been issued observations.

Patel reminds us “The real value of a process validation for equipment used in tissue processing is that  validated cleaning, disinfection, and sterilization processes help ensure the absence of cross contamination between donors during tissue processing.”

To learn more read Equipment Cleaning, Disinfection, and Sterilization Validations – The Tissue Industry’s Compliance Challenge!, and Importance of Cleaning and Sterilization Validations, Even When They May Not Be Required.

You may also contact Nelson Laboratories at www.nelsonlabs.com, 800-826-2088, or sales@nelsonlabs.com.

Are Your Tissue Banking Processes Validated?

Equipment Cleaning Disinfection & Sterilization Validations ǀ Nelson Laboratories, Inc.

Equipment Cleaning Disinfection & Sterilization Validations ǀ Nelson Laboratories, Inc.

“Equipment process validations are becoming one of the tissue banking industry’s most pressing regulatory compliance concerns. Until recently, the tissue industry has enjoyed a comparatively less regulated environment than medical device manufacturers and other medtech service providers. But a surge of regulatory attention focused on validations begs the question; do equipment and supplies used to process tissue need cleaning, disinfection, and sterilization validations?

– Alpa PatelNelson Laboratories, Inc. Senior Scientist
Healthcare Reprocessing

This September, Nelson Laboratories, Inc. Senior Scientist Alpa Patel will be co-presenting with MTF’s Joel Osborne at the annual American Association of Tissue Banks (AATB) Meeting. Their breakout session, Equipment Cleaning and Disinfection Validations (September 18, 2014, 1:45 – 2:30 pm), will highlight regulatory issues and provide solutions for the tissue industry’s latest compliance challenge – process validations.

Alpa Patel will be teaching about process validation and how this long-standing medtech industry practice now impacts tissue banking facilities. Joel Osborne will highlight how facilities can avoid regulatory scrutiny by getting their cleaning and disinfection validation plans in place.

Course topics include:

  • Why cleaning and disinfection validations are vital
  • When to validate, and what is involved
  • Consequences of ignoring your validation plan

Nelson Laboratories will have consultants available to AATB Conference participants at their booth (#14) to answer any questions about tissue process validation and other tissue testing related matters.

2014 AATB Meeting
Date ǀ September 16 – 20, 2014
Location ǀ Hilton San Diego Bayfront 1 Park Boulevard San Diego California 92101
Booth ǀ #14

Breakout Session
Course ǀ Equipment Cleaning and Disinfection Validations
Presenters ǀ Alpa Patel, Nelson Laboratories, Joel Osborne, MTF
Date ǀ September 18, 2014
Time ǀ 1:45 – 2:30 pm

To learn more about tissue process validation, Alpa recommends you read Equipment Cleaning, Disinfection, and Sterilization Validations – The Tissue Industry’s Compliance Challenge!, and Importance of Cleaning and Sterilization Validations, Even When They May Not Be Required. You may also contact Nelson Laboratories at www.nelsonlabs.com, 800-826-2088, or sales@nelsonlabs.com.