Disinfection Validation Services

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STEMart Launches Disinfection Validation Services
for Reusable Medical Devices STEMart, a
U.S.-based provider of comprehensive services for
all phases of medical device development, is
pleased to announce that it offers Disinfection
Validation Services for reusable medical
devices. These services are designed to ensure
that products meet FDA's disinfection validation
requirements and patient safety. Cleaning
validation services must be performed on reusable
instruments, trays, surgical kits and similar
items that have been used in patient care.
Manufacturers of reusable medical devices must
provide reprocessing instructions describing
cleaning, disinfection and sterilization and
prove that these procedures are
effective. Medical Device Disinfection
Validation is used to verify the manufacturer's
description of the disinfection steps to
demonstrate the effectiveness of the
microbicidal process. Disinfection validation
studies should focus on "worst case" scenarios
to show that end users can reliably disinfect
devices when instructions are followed. STEMart
now offers Disinfection Validation Services for
reusable medical devices to ensure customer
products meet FDAs disinfection validation
requirements and patient safety. The validation
processes are in compliance with AAMI TIR12,
ANSI/AAMI ST58, ISO 15883 series, ISO 17664, and
FDA guidance documents. STEMart will not only
help customers validate specific programs, but
also advise them on the design and creation of
protocols for their reusable devices. STEMart
now offers Disinfection Validation Services for
reusable medical devices to ensure that customer
products meet FDA requirements for disinfection
validation and patient safety. These validation
processes comply with AAMI TIR12, ANSI/AAMI
ST58, ISO 15883 series, ISO 17664 and FDA
guidance documents. STEMart not only assists
customers with the validation of specific
programs, but also consults with them on the
design and creation of protocols for their
reusable devices. Disinfection refers to the use
of physical or chemical methods to kill
microorganisms, usually accomplished through
chemical disinfectants or thermal disinfection.
Validation of chemical disinfection is performed
in a variety of ways to support high-level,
intermediate-level and low-level disinfection,
depending on the required disinfection leverage.
The level of disinfection is determined by the
category of the device (critical, semi-critical,
or non-critical). These validations require that
the device be inoculated with bacteria and then
immersed in a liquid chemical disinfectant
solution. Finally, any remaining bacteria are
extracted from the device and grown on plates in
a manner similar to a bioburden test. The other
type of disinfection, thermal disinfection,
utilizes hot water from 60C to 95C (140F to
203F). The level of thermal disinfection depends
on the contact
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time and temperature. If you are looking for
professional disinfection validation services for
your reusable medical devices, or would like to
know more about STEMart's medical device
development service, please visit
https//www.ste-mart.com/. About
STEMart STEMart is an industry-leading eCommerce
platform incorporated with an extensive global
footprint and a broad portfolio of more than
10,000 products. It aims to provide better lab
materials, medical instruments and consumables,
excellent technologies, and high-quality
services to global customers in the fields of
science, technology, and engineering, from the
discovery stage upward to the manufacturing
process. STEMart is dedicated to enhancing
research and biotech production with simpler and
safer protocols in order to access better health
worldwide.