Justifying Family Groupings to Maximize Value
for Cleaning and Sterilization
Nick Workman and Emily Mitzel • Nelson Laboratories
Orthopedic and surgical implant device manufacturers could be spending more time and money
on testing than necessary by not considering family grouping when validating the
cleaning and sterilization processes that
occur at healthcare facilities. Cleaning and
sterilization validations help ensure patient
safety and minimize healthcare-acquired
infections, corrective actions, and recalls.
Device manufacturers can use worst
case or family grouping for the validations
of cleaning and sterilization processes that
occur at a healthcare facility unless the device is very unique and specialized. These
devices must be individually validated.
Cleaning Validation Family Grouping
Performing a cleaning validation aids manufacturers in complying with international
and U.S. standards and guidance documents, current good manufacturing practices, and quality systems regulation. To evaluate the effectiveness of the cleaning process,
residual testing is performed to identify the
presence of markers after cleaning is complete. Protein, hemoglobin, total organic
carbon, bacterial endotoxin, bioload reduction, and detergent residuals are some of the
tests available to measure the efficacy of the
cleaning process. Recommended acceptable
levels of each marker are provided in AAMI
TIR30:2011, and the results of residual testing will help determine whether a device is
appropriately clean. The most recent U.S.
Food and Drug Administration (FDA) guidance recommends testing at least two fully
quantitative markers for validating manufacturers seeking marketing clearance for their
devices. The cleaning markers chosen to be
tested should reflect what the device would
come in contact with during clinical use.
To save time and money, manufacturers
can choose to family group the devices for
validation and comply with FDA guidance.
There are three main approaches to evaluat-
ing whether family grouping for cleaning is
appropriate for the medical devices a manu-
facturer is validating—device use, material
type, and size and challenge features.
Device Use: If the devices have similar use
during surgical procedures, they may qualify
for family grouping. An example of this is
drill bits. Devices can be grouped by their
function, use, and degree of patient contact
based on intended use. Similarly config-
ured devices or parts used for generally the
same purpose and that contact comparable
amounts of human tissue, blood, mucus, etc.
may be grouped together for validation.
Material Type: If a group of devices are
made out of the same metals and soft ma-
terials, they could qualify for family group-
ing. One example of this is the parallel graft
knife handle. Devices are made from mate-
rials ranging from metal to ceramic to poly-
mers, and sometimes, a mix of several ma-
terials. Each of these materials holds onto
residue differently and, therefore, should be
grouped accordingly. For instance, an all-
titanium device requires different cleaning
considerations than a polymer device with
silicone parts and other soft plastics. In ad-
dition, devices that are 3D printed present
unique considerations for cleaning in that
they are typically very textured and porous,
and thus, more likely to hold onto residue.
Size and Challenge Features: Medical
devices of similar size and challenge fea-
tures may be grouped together as a fam-
ily. An example of this is catheters, which
require cleaning procedures to ensure the
narrowest lumen is thoroughly cleaned.
The considerations that are employed in
this type of grouping include components
and product design and size.
An important aspect of the validation of
the cleaning process after the manufactur-
ing process includes using worst-case clean-
ing parameters and worst-case contamina-
tion similar to the manufacturing process.
Another option for determining pro-
duction variability uses a validation process
in which a range of parameters is exam-
ined. For example, if a device is cleaned
using between 1/8 and 1.0 oz./gallon of de-
tergent, then the validation might include
a bracketing validation using the least con-
centration and the highest concentration
Simulated contamination dwell time after
exposure to test soil.
Manual cleaning using standard medical