The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issues guidance dedicated to premarket notification submissions for arthroscopy pump tubing sets intended for multiple patient use.
Definition of Arthroscopy Pump Tubing Sets
The new guidance published by the FDA covers devices intended to deliver irrigation fluid to the surgical site. As usual, during arthroscopic procedures, healthcare professionals can use one source of irrigation fluid several times for different patients. In such a case, the source itself remains the same while tubing systems could be replaced. This creates a significant cross-contamination risk since fluids could move in the opposite direction via the same tubing system (“backflow” is the term widely used to describe such situations). The agency informs that numerous reports confirm that using the same systems for several patients leads to a significant increase in disease transmission risk.
The document describes the approaches medical device manufacturers could use in order to reduce the risk associated with using the same device for multiple patients and covers the most important aspects related to design and testing. At the same time, the agency emphasizes that the only way to exclude any risk is to use one arthroscopy pump tubing set per one patient.
It is important to outline that arthroscopy pump tubing sets are assigned to Class II medical devices under risk-based classification. An applicable regulation covers all arthroscopes in general, describing them as electrically powered devices intended to be used during surgical procedures to make the interior visible. The guidance covers the devices themselves as well as accessories. The agency recommends using similar definitions in documents filed in the course of premarket 510(k) submission and in labeling.
The terms “single-use devices” and “disposable” describe a device that should be used only for one single patient while it is allowed to use such a device to make several insertions for the same patient during one procedure. The document also clarifies other important concepts, such as:
- 24 Hour Use / Day Use – a special label used to mark the devices that could be used for 24 hours.
- Backflow-prevention valve (or “one-way valve”) – a special element designed to prevent the system from the movement of fluids in the opposite direction (from the patient) leading to the risk of contamination.
- The consumable device is a device that should be used only once or during a limited period of time upon expiring of which it should be replaced.
- Cross-contamination – a situation in which hazardous microorganisms could be transferred from one patient to another.
- Irrigation system – the device intended to irrigate the surgical site, composed of the fluid container, tubing systems, valves and containers.
The document also provides other definitions, such as multiple patient use, reprocessing, reusable medical device and single-use devices since they are also important in order to describe certain aspects related to the regulation of arthroscopy pump tubing systems.
Recommendations for Arthroscopy Device Manufacturers
The guidance provides detailed recommendations related to filing the premarket 510(k) submissions for devices subject to the arthroscopy device regulatory framework. These recommendations include the following:
- It is necessary to supply the device accompanied by the information on the use, including the use time. This information could be expressed either in hours or in the number of procedures.
- The device should be identified with the regulation number and product code.
- The documents filed during the application process should contain a detailed description of all components of the device, including ones intended to be used for several patients and other elements intended to mitigate the risk of cross-contamination. It is also advised to provide images necessary to describe the structure of a device, also to provide information about its most important features together with a comparison to other similar devices already available on the market, and on the consensus standards applicable to the device. In particular, it is advised to describe in detail the backflow-prevention valve, providing information about maximum flow rate, mechanisms and design, composition and materials used, maximum back pressure and other important characteristics. The manufacturers should also provide information regarding all connectors and tubing used, including their type, configuration and physical dimensions.
- It is recommended to provide information regarding risk management systems utilized on all steps of the medical device’s lifecycle, including the description of measures taken to identify risks and reduce them.
- Due to the fact that the systems covered by the guidance include elements that contact directly with the patient, it is recommended to supplement the submission with the biocompatibility information for all patient-contacting materials. At the same time, it is allowed to make references to other devices with the same composition that are already present on the market, and also to the FDA-recognized consensus standards. If there is no similar existing device, it may be necessary to perform the biocompatibility testing and risk assessment.
- The medical devices of this type and all their components should be sterilized and their packaging should ensure the sterility of the device during its whole shelf life. It may also be necessary to perform shelf life testing to confirm that the device remains functional.
- Since some of the arthroscopy pump tubing sets could be used multiple times, it is necessary to provide information on the procedures to be taken to properly clean the devices after each application.
- All devices containing the label “non-pyrogenic” should meet the appropriate requirements related to the presence of bacterial endotoxins and/or chemicals.
- It is required to describe the whole set of measures aimed at the prevention of cross-contamination, including the design of the device, the information included in labeling, and also testing conducted to confirm that all prevention systems perform as intended by the manufacturer. For example, the device should have at least one backflow-prevention valve that should be properly tested to ensure its effectiveness.
Thus, the manufacturer shall take all measures necessary to reduce the risk of cross-contamination to the lowest extent possible. As it was already mentioned above, the only way to completely exclude the risk associated with using the same device for different patients is to use it only for one patient instead.
Non-Clinical Performance Testing and Labelling
The manufacturer must perform non-clinical performance testing in order to confirm that the device operates in a safe and efficient manner, and also to validate all the information and statements included in labeling.
Due to the nature of arthroscopy pump tubing sets and risks associated with using them, testing should include:
- Bench testing,
- Backflow-prevention valve testing,
- Microbial ingress testing.
It is also advised to include complete test reports in the 510(k) submission together with the proposed labeling. In accordance with applicable requirements, the labeling of such devices should provide users with the sufficient information necessary to use the device in a safe and effective manner, including the indication of potential hazards and side effects. Due to the specific risks associated with using arthroscopy pump tubing sets, the labeling should also include the notification on existing cross-contamination risk appearing when using the device for more than one patient.
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