The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to reprocessing medical devices in
The document provides an overview of the applicable regulatory requirements and highlights the most important aspects to be considered by the parties involved. It is important to mention that due to its legal nature, the guidance does not introduce new rules and requirements itself but provides additional recommendations and clarifications on the matter. As explicitly stated by the Agency, an alternative approach could be applied, provided such an approach complies with the respective regulatory requirements and has been approved by the authority in advance.
General Considerations for Reusable Medical Devices
First, the present document outlines the most important aspects to be considered by medical device manufacturers in the initial design stage. In particular, the authority states that manufacturers of reusable devices should consider device designs that facilitate easy and effective cleaning, as well as any necessary disinfection or sterilization by the users. The FDA further states that in the case of complex design, such procedures could be more complicated. Since the design of a reusable medical device impacts the ease and effectiveness of its cleaning, this aspect should be considered by the medical device manufacturer at the very first stage of the development process. For instance, the elements that complicate reprocessing could be replaced with single-use elements. Additionally, the manufacturer can develop and provide device-specific cleaning accessories created to ensure the effectiveness of cleaning a particular device.
According to the guidance, medical device manufacturers should duly implement all the measures necessary to ensure the safety of multiple-use medical devices in terms of risks associated with reprocessing such devices between uses to be conducted in healthcare settings. In this context, the manufacturer shall provide detailed enough and clear instructions for reprocessing after use. Such instructions should be included in the labeling of medical devices. It is stated that in the labeling, manufacturers should identify for users the materials and equipment, including reprocessing supplies with part numbers, if applicable, that will be needed to reprocess the device. Additionally, the labeling of a multiple-use medical device should contain the requirements on parameters for reprocessing. It is important to mention that not only medical device manufacturers but end-users are also responsible for ensuring the safety of medical devices subject to reprocessing: in particular, they should follow the instructions provided by the manufacturer and ensure they are using the materials and equipment indicated by the manufacturer.
Apart from the aforementioned requirements, medical device manufacturers are also required to maintain the Device Master Record and/or Design History File, together with documentation regarding the testing performed for the purpose of validating the effectiveness of the reprocessing methods described in the appropriate instructions supplied with the device. The regulatory requirements the Device Master Record and Design History File should meet are set forth by regulations 21 CFR 820.181 and 21 CFR 820.30(j) accordingly.
General Considerations for Reprocessing Instructions in Device Labeling
The document further describes in detail the concept of reprocessing and the particular way in which medical device manufacturers should provide the instructions on reprocessing to users, including the scope of information to be communicated.
As defined in the present FDA guidance, reprocessing stands for validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. The main purpose of such processes is to clean the device and to inactivate microorganisms in order to reduce the risks associated with cross-contamination, which usually appears when a single medical device is used for more than one patient.
It is stated that reprocessing of a multiple-use medical device usually takes place close to the place where the device is used and includes the following consequent steps:
- Point-of-Use Processing. According to the document, the process commences at the point of use and includes the initial cleaning steps to be taken in order to facilitate further processing.
- Thorough Cleaning. As the next step, the multiple-use medical device should be subject to rigorous cleaning, which should be performed in a special place. The authority also states that for certain medical devices, for which the risks related to contamination with pathogens are less relevant, this step could be sufficient for the device to be treated as ready and fit for further use.
- Disinfection or Sterilization. However, if the device in question could be subject to contamination with pathogens, additional disinfection or sterilization should be required before the device is used for the next time for the same or another patient.
The Agency also provides a simple chart visualizing the process described above (Figure 1).
The authority additionally emphasizes that cleaning, disinfection, and sterilization are different processes and should not be confused with each other.
- Cleaning stands for the process whose purpose is to physically remove soil and contaminants by using the appropriate methods, equipment, and agents. According to the guidance, cleaning should:
- Minimize the soil transfer from one patient to another or between uses in a single patient;
- Prevent accumulation of residual soil through the product’s use life; and
- Allow for successful subsequent disinfection/sterilization steps.
- Disinfection and sterilization are the processes intended to inactivate microorganisms, so the methods and agents used should fit this purpose. The Agency also refers to special recommendations on disinfection and sterilization provided in separate sections of the present guidance.
As mentioned, the guidance also describes how the instructions for reprocessing a multiple-use medical device should be reflected in its labeling. According to the guidance, when developing such instructions, the manufacturer shall consider the following:
- Recommendations related to labeling provided in device-specific guidance documents issued by the Agency. In this context, the present document refers to the FDA’s Guidance Document Database.
- Technical Information Reports (TIRs) developed by the Association for Advancement of Medical Instrumentation (AAMI) provide additional information that could be used in the context of the matter, including AAMI TIR12 and AAMI TIR30.
- The FDA-recognized version of AAMI/ANSI ST81 Sterilization of medical devices – information to be provided by the manufacturer for the processing of resterilizable medical devices.
- FDA-recognized test methods.
- Applicable clinical practice guidelines and recommendations.
In summary, the present FDA guidance outlines the responsibilities of the parties involved in operations with medical devices in terms of cleaning, disinfecting, and sterilizing multiple-use medical devices between uses. The document provides additional clarifications on applicable regulatory requirements for labeling for such products in terms of instructions for reprocessing to be provided by the manufacturer in order to ensure the safety of a device.
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