by Eric F. Shaver, PhD
The last five years have seen increased focus on the importance of adequately reprocessing reusable medical equipment. One medical device specifically – duodenoscopes – has garnered much of the attention due to the challenges associated with its’ complex design. In fact, this year alone the FDA has sent out two Safety Communications about duodenoscopes; one dealing specifically with instructions.
According to the FDA Reprocessing Guidance, “reprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use” (p. 5). It should be noted that reprocessing is only required for medical equipment that will be reused and not for equipment that will be disposed of after one use.
An integral aspect of successful reprocessing is designing instructions that allow for reprocessed devices to be subsequently used without harming the health and safety of patients or healthcare providers.
In our experience working with medical device manufacturers, we’ve observed several issues that negatively impact the ability of intended users to safely and effectively complete the steps necessary to reprocess medical equipment. Based on those observations, we’ve identified some steps medical equipment companies should take to increase the likelihood of designing adequate reprocessing instructions. They include:
Utilize a user-centered design process to develop reprocessing instructions.
All too often we see manufacturers that have rushed to develop reprocessing instructions late in the product development process. This often results in inadequate instructions that are challenging for intended users to understand and implement. Using a user-centered design process can often overcome many of the challenges associated with developing instructions. This would consist of developing the instructions from the perspective of how they will be used by reprocessing personnel.
Work closely with engineering to develop instructions that (1) pass cleaning process validation and (2) can be used by reprocessing staff.
We often see reprocessing instructions that were designed with a test laboratory in mind instead of the actual staff responsible for reprocessing the medical equipment. This can result in overly complex instructions that are difficult to comply with in a real-world environment. Manufacturers need to design instructions that meet the needs of both groups.
Simplify the instructions as much as possible.
There is no need to make instructions more complex than necessary. In fact, doing so often results in instructions that are not usable. Make sure to tailor the language to the intended users and minimize jargon or unnecessary technical terms.
Add visuals of the process.
Appropriately designed visuals demonstrating the process (pre-cleaning, cleaning, disinfection / sterilization, drying, and storage) can go a long way toward increasing the understanding of those who will be performing the reprocessing. Of course the visuals must be understandable by the intended audience. Including poorly constructed and confusing visuals will be worse than providing text-only instructions.
Attempt to standardize reprocessing instructions with similar medical equipment.
Manufacturers should remember that their medical equipment is not the only equipment that a healthcare system has to reprocess. Consider whether the instructions for similar types of medical devices or even competitors’ products, could be adapted for your medical equipment. Requiring healthcare systems to use a different process, when a similar process would have sufficed, increases the likelihood that reprocessing of your medical equipment will not be performed incorrectly.
Users have a tendency to conflate cleaning and disinfecting.
We’ve witnessed on many occasions users conflate cleaning and disinfecting, with the result being that the former is skipped to focus on the latter. This can result in medical equipment that is not adequately reprocessed. Manufacturers should make it clear in the instructions that cleaning and disinfecting are both important and skipping cleaning for disinfecting is unacceptable. Moreover, manufacturers should explicitly state the consequences of failing to adequately clean before disinfecting.
Wet environments and paper IFUs don’t mix.
Many manufacturers provide paper reprocessing instructions. But the typical reprocessing environment is wet and messy. Unfortunately, this can render paper instructions useless after a short period of time? We recommend providing the reprocessing instructions in a water-resistant format (i.e., laminated) that allows for continual use in a wet environment without degradation.
Provide electronic reprocessing instructions (to allow for easy integration in healthcare system SOPs).
Many healthcare systems reproduce the medical equipment reprocessing instructions and put them in their SOPs. Make electronic versions (i.e., Adobe Acrobat) of instructions available so that healthcare systems don’t have to electronically recreate them. Doing so will help prevent recreation errors that might negatively impact reprocessing.
Test early; test often.
We’ve suggested many tips for improving the effectiveness of medical equipment reprocessing instructions. Prior to commercialization, manufacturers need to validate that users can safely and reliably reprocess the manufacturers equipment. We recommend testing prototype instructions early in the development process in order to allow for sufficient time to make changes prior to attempting to validate the final version. Using an iterative process will increase the likelihood of a successful validation study and decrease the chances of unwanted delays in getting equipment to market due to poorly designed instructions.
Need assistance designing, developing, and testing reprocessing instructions for your medical equipment? We’re here to help!