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Are you required to perform reprocessing validations for all your devices?

It is important that all reprocessing instructions included in the Instructions For Use document are validated to ensure patient safety and minimize healthcare-acquired infections; however, validating the reprocessing instructions for every device is a costly affair. Luckily, when an array of devices presents similarities in design, materials, and other factors, this may provide an opportunity to establish product families. Chose the most difficult to reprocess device from these product families as a worst-case representative, or master product, for the purpose of minimizing reprocessing validation efforts. In that way, the validation data for the worst-case representative can cover devices that present an equivalent or lesser reprocessing challenge[1] [2] [3]. It is important that supporting information for the justification of the worst-case device is well documented1.

A prerequisite to performing a family grouping is that all devices of one product family must share the same reprocessing instructions2. Additionally, the medical device manufacture must demonstrate commonality (equivalent or lesser processing challenges) in device materials, design features, and intended use, including clinical soil exposure2.

Device materials

If a group of devices are made of the same metals and soft materials, they could qualify for family grouping. Devices are made from materials ranging from metals to polymers, and sometimes, a mix of several materials. Each of these materials have different texture, porosity, or affinity properties to chemical residuals during processing and, therefore, should be grouped accordingly.

Design features

In addition to device materials, a master product can be chosen from a product family if the design features of the less difficult to reprocess devices are assured to be less challenging to reprocessing than the master device1. Factors to take into consideration are cannulation or lumen length and diameter, the presence of mated surfaces, device configuration/design, and surface area.

Intended use

If the devices have similar intended use during surgical procedures, they may qualify for family grouping. Devices can be grouped by their function, use, and degree of patient contact based on intended use. Similarly configured 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.

In addition to the considerations outlined above, it is important to note that master products are process specific2. Depending on the device design features and materials, one device in a family may qualify as the greatest challenge to cleaning, whereas a different device may qualify as the greatest challenge to disinfection, and yet another device may qualify as worst-case for steam sterilization2. Especially for the selection of a worst-case device for steam sterilization, extra considerations must be considered in addition to the ones outlined for cleaning or disinfection. Whereas devices are usually processed for cleaning or disinfection individually, steam sterilization will often be conducted by placing several devices in a tray and as such, the worst-case representative for steam sterilization could very well be a worst-case tray configuration. Moreover, the worst-case representative for steam sterilization is selected based on whichever device/tray configuration presents the biggest challenge for steam penetration resistance. To evaluate steam penetration resistance, device design and materials must be taken into account as well as the additional considerations outlined below.

Weight

The weight of a device will influence several factors related to steam sterilization such as heating time, cooling time, drying time, and the amount of condensate and its effect on steam penetration. Device weight must therefore be considered in selecting a worst-case representative for steam sterilization[4].

Sterile barrier system and/or packaging system

Packaging must be a part of the evaluation as well. Packaging systems vary from single wrapping/ pouching, to double wrapping, or to a combination of two or more systems which will affect steam penetration resistance4.

In conclusion

Devices that are processed through the same reprocessing instructions may be grouped in families based on features such as device design, device materials, and intended use. These features will help determine a worst-case representative to perform the validation. With the successful validation of the master products, the other devices in the product family that present equal or lesser challenges to reprocessing will be considered validated as well. It is important to note that the master product must be evaluated for each process. As such, the device selected for cleaning will not necessarily be worst-case for steam sterilization due to the fact that different considerations are taken into account. A thorough justification for the selection of the master product(s) must be provided.

[1] Food and Drug Administration, 2015 “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”

[2] AAMI TIR12:2020 “Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers”

[3] ISO 17664:2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices.

[4] ISO 17665-3:2014(R)2016 Sterilization of health care products – moist heat – guidance on the designation of a medical product to a product family and processing category for steam sterilization

Alpa Patel

Alpa Patel

B.S., RM (NRCM)
Principal Scientist

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 18 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a principal scientist at Nelson, involves overseeing test method validations for reprocessing, writing standard test...

Lise Vanderkelen

Lise Vanderkelen

PhD
Pharmaceuticals and Microbiology Expert

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...