Innovations in sterilization techniques, device design, and manufacturing processes have enabled the single-use (“disposable”) medical device market to evolve and expand to improve patient outcomes worldwide.
Unfortunately, the reprocessing and reuse of single-use medical devices has become a prevalent practice throughout the healthcare industry.
Though the reasons for reusing single-use devices range from “lowering costs” to “reducing medical waste” one thing is clear: The risk this practice presents to patients cannot be ignored by medical device companies.
In this blog post, we’ll discuss some of the risks involved with reprocessing single-use devices and how medical device companies can prevent the reuse of their energy-driven products.
The risks of reprocessing single-use surgical instruments.
According to the FDA, a single-use device is one “intended for use on one patient during a single procedure. It is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient.”
A reusable device, on the other hand, is one “that health care providers can reprocess and reuse on multiple patients.”
Why is this distinction important?
As the FDA makes clear, one of the biggest issues with reprocessing a single-use device and treating it like a reusable device is:
For a reusable device, the OEM provides the user with validated step-by-step reprocessing instructions or the methods to reprocess for reuse are commonly known and accepted. However, the OEM of a single-use device does not consider safety and effectiveness issues related to reprocessing the device for reuse.
Further, the FDA outlines two broad categories of risk that come from reprocessing and reusing disposable devices: the risk of infection and the risk of inadequate performance.
The risk of infection is the risk of disease transmission from reusing a disposable device.
This risk is greatest among “critical devices” that come into contact with blood or normally sterile tissue.
If devices are not properly processed or sterilized, any patient who is subjected to a reprocessed disposable device is at risk of infection.
The risk of inadequate performance is the risk that the device will experience a form of failure during use.
Every device is designed to withstand a certain number of uses and sterilization cycles.
The manufacturer of a single-use device has only validated that it will perform without failure for one use.
When a device that has only been validated for one use is reused, it presents a risk of inadequate performance to the patient.
For additional information on the risks associated with disposable device reprocessing and reuse, please consult the Guidance for Industry and FDA Reviewers: Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme.
Options for limiting the reuse of single-use medical instruments.
Though the FDA is moving forward with methods to prevent the reuse of certain devices and mitigate the risks mentioned above, there are steps device companies can take to limit the reuse of their devices.
By focusing on the interconnect solution during the device development process, engineers can incorporate use-limiting technology into their energy-driven products.
Though many advancements have been made in the realm of use-limiting technology, we’ll talk about three of the most common forms: mechanical use-limiting, single wire/electric limiting, and radio frequency identification limiting (“RFID”).
Mechanical use-limiters physically prevent a connector from being used again.
A pen with a built-in mechanical feature that prevents the tip from being extended after it has been retracted is an example of a product with a mechanical use-limiting system (“MULS”).
ATL’s patented MULS is an example of an electromechanical use-limiting system as it is incremented mechanically by mating and un-mating while also creating a change in conductivity (open or short) to disable the device from being reused.
Single wire/electric limiting.
A single wire/electric limiter uses a signal and a fuse to prevent reuse.
When a cable is connected, the capital equipment sends a high current through one of the pins to “blow” the fuse.
If the cable is used again, the cable registers a reduced voltage which the capital equipment can be programmed to recognize and prevent from using again.
Unlike MULS and single wire/electric limiting, RFID limiting does not utilize a connector or pin to prevent reuse.
Instead, an RFID chip is embedded into the connector shell that tracks and communicates the number of times the connector has been used to the capital equipment.
If the reading is above the approved limit, the capital equipment can be programmed to prevent the device from working.
For a more in-depth view of the use-limiting technologies available, download our free eBook, The Critical Nature of Use-Limiting Technology in Medical Connector Assemblies.
Selecting the right use-limiting technology for your energy-driven device.
Selecting a use-limiting method for your energy-driven device depends on a variety of factors.
If you are applying use-limiting technology to a connector that must survive a set number of cycles, but you are not updating the capital equipment, an MULS may be your best fit.
If you are looking for anti-counterfeit protection as well as use-limiting ability, and you have the capacity to design the capital equipment around it, RFID may be your best option.
If you’re looking for a low-cost option for a single-use device, simple wire/electric limiting may be right for you.
Finding the right solution for your energy-driven device requires an in-depth understanding of interconnect technology and the different use-limiting methodologies that exist, so we recommend speaking with an expert.
To learn more about the different types of use-limiting technology and how they can help you protect your next energy-driven device, download our free eBook, The Critical Nature of Use-Limiting Technology in Medical Connector Assemblies.