Medical Design Briefs - June 2022 - 6

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Advances in manufacturing technologies are fostering an age of unprecedented innovation in the development
of reusable medical devices and instruments. As designers develop smaller, more- complex,
and increasingly intricate devices, however, manufacturers must not overlook the importance of
ensuring that such products can be effectively cleaned and disinfected before being reused. In fact,
appropriate cleaning processes must be validated by the manufacturer before a reusable product can
be released into the marketplace. To find out more about the expertise required to establish safe processes
for cleaning and disinfecting reusable medical devices, MDB recently spoke with Elizabeth Sydnor,
Director of Microbiology Medical Device Testing for Eurofins Medical Device Testing (Lancaster, PA).
MDB: What characteristics define a
reusable medical device?
Elizabeth Sydnor
Director of
Microbiology Medical
Device Testing
Eurofins Medical
Device Testing
Elizabeth Sydnor: The term encompasses
any device that is intended to
be used more than once. Most attention,
however, is paid to the products
that must be cleaned, disinfected, or
sterilized between uses. Common examples
include a wide range of surgical
instruments, from stainless steel retractors
and forceps to endoscopes and
drill guides for orthopedic implants.
MDB: Are such instruments typically cleaned by hospital
staff between surgeries?
Sydnor: After use, devices that will be reused for another
surgery are sent to the hospital's central sterile supply department,
where they are cleaned, disinfected, and sterilized. This
is one of the most important steps to ensure patient safety
and reducing the potential risk of cross contamination between
patients.
MDB: Is it the responsibility of the hospital to validate these
processes?
Sydnor: No. It is the responsibility of the device manufacturer
to provide a validated cleaning, disinfection, and or sterilization
method. Once the manufacturer has an FDA approved method,
the product's instructions for use (IFU) is provided to the hospital
to execute the cleaning instructions between each use. It's
the hospital's responsibility to ensure that they are precisely
following the instructions provided by the manufacturer. This is
a critical step because each validated cleaning method is unique
to the specific medical device.
MDB: What FDA regulations should be followed to validate
reusable medical devices?
Sydnor: The FDA's guidance document, " Reprocessing Medical
Devices in Health Care Settings: Validation Methods and
Labeling, " is a good source of information to gain insight into
the validation of reprocessing methods for reusable devices.
However, a new standard, ANSI/AAMI/FDS ST98, " Cleaning validation
of health care products - Requirements for development
and validation of a cleaning process for medical devices, " will
be the overarching standard that will shape cleaning validations
6
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MDB Inside Story Eurofins 0622_1.indd 6
moving forward. This standard is anticipated to release sometime
in 2022.
MDB: How does a company go about validating a method for
reprocessing its instruments?
Sydnor: The process involves inoculating a device with an artificial
contaminant known as a soil and then testing the device
for cleanliness after it has undergone a well-defined cleaning
method. The choice of a particular soil is based on the application
of the device, and is a synthetic formulation of proteins,
acids, and lipids meant to simulate the environment where
the device will be used, which may be blood-filled, mucosal, or
gastric. Validation should be conducted under worst-case conditions,
including inoculation of the device at a site identified as
the most challenging location for cleaning.
MDB: Instruments used in orthopedic procedures can involve
nearly a dozen different trays, each filled with a dozen
or more instruments or trial implants. Does the manufacturer
need to validate its reprocessing protocol for each
part, or for the entire instrument set?
Sydnor: In instances where a surgical tray is categorized as a
medical device, cleaning validation is required on the tray and
instruments. However, regulators will accept the bundling of
products if a sufficient justification can be provided for treating
items as a single family of products. In such a case, data for a
worst-case example, or perhaps for a bracketed set of trays and
devices, can then be applied to an entire set of trays devices.
A typical example might be a set of trial implants, or a set of
reamers that vary only in diameter or length.
MDB: How can you establish equivalence between different
detergents for cleaning? Should the selected detergent be
recommended in instructions for use (IFU), or is it only required
to describe the type of detergent?
Sydnor: Overall equivalence can be established through the
detergent type. (e.g., enzymatic). The type of detergent should
be included in the IFU document. The brand used can be referenced
also, but this is not required. Process residuals should be
detected by the device manufacturer. The product and material
could vary, which would prohibit detergent manufacturers from
establishing acceptable process residuals data.
To find out more about Eurofins Medical Device Testing, visit
www.eurofins.com.
www.medicaldesignbriefs.com
Medical Design Briefs, June 2022
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5/26/22 1:40 PM

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Medical Design Briefs - June 2022

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