For reusable medical devices, it is critical to have adequate, validated reprocessing Instructions for Use (IFU). Medical devices can harbor microorganisms that can spread to patients by the caregiver, by the patient touching a contaminated surface, or by the actual medical device during a procedure. Over the last ten years, there has been increased scrutiny on reprocessing instructions after a number of outbreaks resulting from inadequately reprocessed duodenoscopes – some infections resulting in patient death. These outbreaks led to investigations by the CDC and FDA, discovering that the complexity of the devices make it very difficult to adequately clean, and therefore disinfect, the duodenoscopes at the source of the outbreaks. While not all devices are as complex as a duodenoscope, it remains critical to validate reprocessing IFU.
According to the U.S. FDA, 21 Code of Federal Regulations (CFR) 801, the labeling for medical devices shall provide adequate directions for preparation for use. In March 2015, FDA provided a guidance document titled “Reprocessing Medical Devices in Health Care Settings: validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.” This document provides guidance to manufacturers in the complex process of writing instructions for reprocessing and validating these instructions. For a successful validation process, the best practice is to design the device for effective cleaning and decontamination. The more complex the device, the more difficult these processes can become. As a reprocessing validation is often one of the final steps before FDA submission, failure to consider cleaning and decontamination in the design stage can lead to submission delays or may even require device redesign.
In the 2015 guidance, the FDA laid out six criteria for reprocessing instructions. These criteria are straightforward, but critical to keep in mind while developing your reprocessing IFU. Developing these instructions are the first step in preparation for a reprocessing validation. The general flow of reprocessing includes a pre-cleaning step, followed by either disinfection or sterilization. Important items to consider while developing reprocessing IFU include the type of detergents, disinfectants, or sterilization processes, device design challenge points (stickers, lumens, seams, etc.), and reprocessing accessories (if applicable).
- Labeling should reflect the intended use of the device.
- Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
- Reprocessing instructions should indicate the appropriate process for the device.
- Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
- Reprocessing instructions should be comprehensive.
- Reprocessing instructions should be understandable.
Common cleaning agents are enzymatic detergents; however, nonenzymatic (surfactant based) detergents also can be effective cleaning agents. There are also combination cleaning/disinfecting products available, where the surfactants or detergents aid in the cleaning portion and the disinfectant can kill microorganisms. It is important to note that when using a combination product, the FDA still considers cleaning and disinfection to be separate steps and expects the cleaning validation to evaluate only the cleaning steps, and the disinfection validation to evaluate only the disinfection steps. The selection of cleaning products should be something the user can easily access for purchase. For example, if the user of the device will be cleaning it in their home, instructions using a detergent and/or disinfectant that can be purchased at a local drug store or convenience store is appropriate. If a device is used in a dental office, instructions should indicate use of agents readily available in the dental field.
Selection of decontamination procedures should be chosen based on the level of decontamination required. Devices are classified into three classifications based on the criticality of what area in the body the device will contact. This classification will determine the level of decontamination necessary. The classifications defined by Spaulding are described as Critical, Semicritical and Noncritical items.
- Critical items are devices that enter any sterile body cavity, for example, surgical instruments, cardiac and urinary catheters, and implants. According to the CDC, critical items require decontamination via sterilization.
- Semicritical items include devices that enter mucosal membranes or nonintact skin, for example, flexible endoscopes such as a colonoscope, dental devices, or internal ultrasound probes. These semicritical devices require minimally high-level disinfection if they come in contact with mucosal membranes, or intermediate-level disinfection for devices that may contact nonintact skin or blood for a brief period of time.
- Noncritical items are devices or equipment that may contact intact skin, but not mucous membranes, such as blood pressure cuffs, stethoscope, or monitoring systems. These devices currently require low-level disinfection.
Other factors to consider in developing reprocessing IFU include (but are not limited to) the type of water to be used, rinsing procedures, and reprocessing accessories. The type of water to be used for cleaning, rinsing, and final rinsing after disinfection needs to be listed in the IFU. AAMI TIR34 lists the types of water recommended based on the intended use of the device and for each step in the process. The incorrect water choice can contribute to device malfunction, endotoxin contamination and/or ineffective reprocessing. As high levels of endotoxin can lead to toxic reaction in patients, critical water should be used to rinse devices that could introduce endotoxin into a patient. Cleaning procedures often use tap water for the washing step; however, some manufacturers choose to use critical water for all cleaning steps. The final rinse for cleaning should be based on what the next step in the IFU is – for disinfection, a tap water rinse may be sufficient, however, for sterilization, the final rinse should be performed using critical water as sterilization processes do not remove any remaining dead cells.
All reprocessing accessories should be clearly listed in the IFU to instruct the user how to perform the process. These accessories include brushes (with size and bristle type specifications), wipers/cloths, syringes, tubing, attachments, and bins. Additionally, solution temperatures for detergents, rinse water, and/or disinfectant should be specified. Clear direction on how to protect the device from water ingress should also be given.
Once the IFU has been finalized, validation testing can begin. Manufacturers should select an appropriate sample size to determine statistical significance for the validation. Currently, it is recommended that a minimum of three replicates be performed, however this recommendation varies by device type, and often, more replicates are needed to support the evaluation of reprocessing instructions. In a cleaning validation, several different parameters will need to be defined, in addition to the sample size. These include determining clinically relevant test soils, soil dry times to represent worst case drying, test markers to quantify soil removal, inoculation sites, simulated use conditions, worst-case processing, and visual inspection methods. For disinfection or sterilization validations, the test organism(s) need to be determined (based on the level of decontamination required), as well as the method, packaging for sterilization, and the soil load accompanying the bacterial inoculum.
In addition to performing GLP medical device reprocessing validations, Analytical Lab Group offers non-GLP studies designed to evaluate the efficacy of your IFU prior to validation. These studies can be used throughout your design process, using early prototypes to determine whether your device can be effectively cleaned and disinfected prior to design finalization.
About Analytical Lab Group
Analytical Lab Group is an industry leader in the specialty contract lab space and comprises FDA-registered and EPA-regulated laboratories across the United States, with facilities in San Francisco, Minneapolis and Boston. Our team is focused on Helping Protect Life® through infection prevention, with the most comprehensive testing solutions in the antimicrobial, pharmaceutical, medical device, biotech and healthcare spaces. Our facilities are GLP/cGMP compliant, FDA registered, DEA licensed, and ISO/IEC 17025:2017 accredited.