For 20 years, reprocessed single-use devices have been seen as an exception, an odd and complicated version of a single-use device. There is no such thing as a “reprocessable device”, only a device that due to market imperfection and regulation by exception, has become the step-child of the single-use device. Healthcare doesn’t consider the unique characteristics of a reprocessed device in its vocabulary, and this is suboptimal for all: patients, healthcare providers, manufacturers and reprocessors.
Healthcare distinguishes between two types of devices: “Reusable” devices and “single-use” (disposable) devices. By definition
- Reusable devices are designed and manufactured with the intent that they should be re-used. The manufacturer includes cleaning and other re-use considerations in its 510(k) and provides cleaning instructions to the hospital. Making the reusable device ready for another use is the responsibility of the hospital, following manufacturer instructions.
- Single-use (disposable) devices are not designed and manufactured to be re-used. Often, they are made out of material that disallows this, or the complexity of the devices makes it impossible to clean and reuse them safely. Therefore, the manufacturer does not address re-use and cleaning in their 510(k) and they are marketed based on the idea that after one use they are discarded. In the past, some hospitals have cleaned and re-used disposable devices due to financial constraints and the obvious opportunity to save money. This produces considerable patient risk and should never happen.
In the past, some hospitals have cleaned and re-used disposable devices due to financial constraints and the obvious opportunity to save money. This produces considerable patient risk and should never happen.
It seems logical: Either you can re-use a device or you can’t. The decision is made by the manufacturer based on their design and knowledge of technology as well as clinical use. This is a very reasonable system. However, between these two categories, a third type of devices has emerged that is not just a step-child of the single-use device, but a new category that has its own unique characteristics in terms of design, cleaning, and responsibilities. Its emergence is caused by a technological and economical gap between reusable and single-use devices: Some disposable devices seem sturdy enough to reuse – and the high cost difference between reusable and disposable devices incites unregulated reuse.
- Reprocessable devices are a limited number of devices designed for a single-use that when cleaned and readied for reuse by a FDA controlled organization and following strict guidelines can be re-used for a limited number of times. The manufacturer does not carry responsibility for the device in re-use, rather the reprocessor does, acting as its “manufacturer”. Hospitals cannot perform the role of the reprocessor, but must work with external, specialized organizations.
February’s whitepaper from Innovative Health details the process of obtaining a 510(k). It reveals just how much work it takes to get clearance to market a reprocessed device. The reprocessor must do everything the original manufacturer does to get 510(k) clearance – and several things that go beyond the manufacturer's responsibilities - including reverse engineering the device, studying how the device is changed with use, determining what needs to be done to make it ready for another use, demonstrating ability to clean used devices, and testing every single device before releasing them to hospitals for another use.
Reprocessable devices are neither “reusable” nor “disposable”. They are devices with limited, regulated reuse, when reprocessed by a specialized company.
Why does it matter? Recognizing the reprocessable device as its own category enables every actor in the market to better realize its potential:
- Patients and clinicians would better understand that these are not devices associated with bigger risk, but with lower costs
- Hospitals would be able to better plan for and manage cost-per-use and to make more informed choices when selecting suppliers
- Reprocessors would avoid confusion with reusable devices and with the unsafe practice of hospital-based reprocessing
- Manufacturers would be able to gain a competitive advantage from launching reprocessable devices – a better deal for the hospital than single-use devices
From a regulatory standpoint, a reprocessed single-use device is simply a single-use device. However, from a user and manufacturer perspective, it is a category on its own.
Click below to discover Innovative Health's latest white paper, Developing a 510(k) To Achieve FDA Clearance for Reprocessing of Single-Use Devices
