Medical device reprocessing includes mechanical, chemical and/or electrical processes. [Photo courtesy of Cardinal Health Sustainable Technologies]
Medical device reprocessing is a key focus for Cardinal Health’s Sustainable Technologies business, which collects and cleans single-use devices for safe re-use under FDA standards.
Reprocessed devices keep medical waste out of landfills while offering significantly lower costs than brand-new products for hospitals and other healthcare customers, according to the Association of Medical Device Reprocessors.
Meg McClanahan, chair of the Association of Medical Device Reprocessors Board and global portfolio director for Cardinal Health’s Sustainable Technologies business, offered some advice for designing medical devices for reprocessing.
Previously: Cardinal Health expands single-use device reprocessing facility
What advice can Cardinal Health share to help medical device engineers and designers make products that are more easily and effectively reprocessed for re-use?
Meg McClanahan is global portfolio director for Cardinal Health’s Sustainable Technologies business. [Photo courtesy of Cardinal Health]
McClanahan: “Medical device engineers and designers should take into consideration the entire lifecycle of the device, including the desired number of times the device will be reprocessed and re-used and the various conditions the device will be exposed to over time.
“The design of the device and its use environment play key roles in determining suitability for reprocessing. How robust are the materials to additional use and decontamination techniques such as mechanical, chemical and electrical? Are there desired features omitted due to the cost in a single-use model, but that could become attractive over several uses through reprocessing?
“In development, the engineer may want to include the reprocessing cycle(s) into the Design Failure Mode and Effect Analysis (DFMEA) and Use Failure Mode and Effect Analysis (UFMEA) analyses for identifying failure modes of the initial use versus repeated use.
“Other considerations include material selection such as biobased materials or sustainable packaging materials, user friendly design (enabling easy disassembly for multiple components, for example), overall manufacturing process, or a sustainable sterilization/disinfection process.”
What kind of medical devices are best suited to reprocessing, and what is it about them that makes them good candidates — and vice versa for devices that aren’t suitable for reprocessing?
McClanahan: “Devices best suited for reprocessing are robust enough to withstand multiple uses without losing functional performance and can be effectively cleaned without posing a risk of infection to the patient. Devices that aren’t suitable for reprocessing would not be capable of meeting these requirements.”
What medical device materials/components are best for reprocessing, and which should be avoided?
McClanahan: “Medical device materials should have an expected life based on the design, which includes the physical and chemical properties of the materials. These materials also need to be compatible with the steps in the reprocessing cycle: exposure to chemicals/temperature/moisture, etc. Avoid materials that will degrade and lose performance over the entire device lifecycle.”
What regulatory standards are unique to devices that can be reprocessed?
McClanahan: “We recommend organizations consult their legal and regulatory teams and experts for such standards. A non-exhaustive list to begin a review would include:
- ANSI/AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
- FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- FDA Guidance: FDA Medical Device User Fee and Modernization Act (MDUFMA) of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
What are some best practices for designing devices that can be reprocessed?
McClanahan: “Always consider the robustness of the materials, the compatibility of those materials with different cleaning agents and high-level disinfection or sterilization processes, the type(s) of soil and mechanical forces the devices will encounter during their intended use, ways to reduce cost, waste or landfill impact, or ways to reduce greenhouse gases.”
Related: How medtech giant Cardinal Health is prioritizing sustainability