Thanks to improvements in sterilization techniques, device design, and production techniques, the single-use medical instruments market, or “disposable” medical instruments market, has been able to develop and thrive. Overall, patient outcomes have gotten better as a result of these developments. Unfortunately, the healthcare industry as a whole has adopted the practice of reprocessing and reusing medical devices that were originally designed for a single patient in a single treatment. These instruments are intended for one-time usage during a specific surgical procedure. There can be no doubt about the reality that the danger this method poses to patients is one that medical device makers cannot afford to dismiss. There is no denying the obvious risk to patients that come with reusing single use instruments, despite the fact that “saving money” and “reducing medical waste” are two of the most prevalent excuses for doing so.
In this post, we’ll go over some of the dangers of recycling single use instruments, as well as some of the ways that medical device producers might limit the reuse of their electrically powered tools to reduce waste.
Inherent Dangers of Reusing Previously Used Surgical Equipment Once Only
Devices that “are designed for use on a single individual within the context of a single diagnostic or therapeutic treatment” are considered “single use instruments” by the Food and Drug Administration (FDA). It is not made to be reprocessed, therefore it can’t be sterilized or cleansed before being used on another person. In contrast, a reusable gadget is “one that health care staff can reprocess and utilize on several patients at once.” The notable absence of a citation for:
Why does it matter so much to make a distinction between these two?
The Food and Drug Administration (FDA) makes it very clear that one of the most serious problems that can arise from reprocessing a single use instruments and treating it as if it were a reusable device is the following: When it comes to reusable equipment, the OEM either provides the user with validated step-by-step reprocessing instructions or the methods for reprocessing the item are generally recognized and acknowledged. However, the OEM of a device meant for single use does not consider the feasibility or security of reprocessing the item for a second use.
1. Risk of Spreading the Disease
Furthermore, the FDA recognizes two basic categories of risks that exist whenever a patient receives reprocessed or reused disposable medical equipment. Some examples of such worries are becoming sick and having a bad performance. Reusing a single-use instruments poses a threat of spreading the disease it was originally designed to treat. The greatest cause for alarm is presented by so-called “critical equipment” that comes into touch with blood or other generally sterile tissue. Infection is a real concern for everyone who receives a reprocessed disposable device because of the likelihood that it was not thoroughly sterilized or processed before it was used again.
2. The Risk of Subpar Results
The risk of subpar results here is symbolized by the potential for a breakdown to occur during the operation of the equipment. A device must be able to withstand a certain number of sterile solution washes and in-person patient use before it needs to be replaced. A single use instruments has only been put through limited testing to ensure that it would work as expected for that single application. If a gadget has only been tested on one patient, there is a chance that it won’t work well when used on another. This is due to the fact that the gadget has only been tested for a single application.
Dangers of Reprocessing
Please refer to Guidance for Industry and FDA Reviewers: Reusing Disposable Medical Devices for more information on the dangers of reprocessing and reusing single use instruments. This paper was created for use by those in the healthcare field and those conducting FDA reviews. Analyze the Priority Scheme for Single-Use Device Reprocessing and Reuse Recycling and reusing one-time-use items “[Recycling and Reusing One-Time-Use Devices]”
Other methods to Reduce the Cyclical Reuse of Medical Instruments
There are steps device manufacturers can take to limit the number of times their products are reused, even as the FDA moves forward with legislation to restrict the reuse of specific devices and ease the concerns stated above. A few examples of such behaviors are: While designing energy-driven items, engineers might include use-limiting technology if they pay special attention to the connection problem.
There have been many innovations in use-limiting technology, but we’ll focus on the three most popular types: mechanical use-limiting, single-wire electric limiting, and radio-frequency identification limiting. Use-limiting techniques that employ a physical barrier, like a wire or a switch, are known as mechanical use-limiting (often known as “RFID”).
Limits to its Utility Imposed by Mechanics
Mechanical utilization limiters are designed to physically disable a connector once it has been used.
An example of a product with a mechanical use-limiting system (or MULS, for short) is a retractable ballpoint pen, which features an internal mechanism that prevents the tip from expanding once the pen has been retracted. The phrase “mechanical use-limiting system” is sometimes shortened to “MULS.”
The patented MULS is a good example of an electromechanical usage-limiting system because its use is increased mechanically through mating and un-mating. Since it causes a change in conductivity (open or short), it effectively prevents the device from being reused. This prevents the gadget from serving its intended purpose.
