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Features

Particulate Testing of Cardiovascular Devices

Fig. 2 – Study Director analyzing particulate matter under a microscope.
As particulate testing of cardiovascular devices varies by device type and manufacturer, no standardized acceptance criteria have been established. Therefore, it is advisable for a manufacturer to identify an unbiased, third-party laboratory with whom to partner to create acceptance criteria specific to their device. (See Figure 1) In creating this criteria there are three major steps of the process that generally remain constant:

Step 1: Create a protocol. Incorporate a vascular model (where applicable). Working closely with the third-party lab facility, the manufacturer and lab collaboratively write a test protocol incorporating a vascular (or “tortuous”) model mimicking arterial conditions to which the device will be subjected during testing (simulated use conditions).

Step 2: Perform method validation. The laboratory will validate the test protocol per the FDA’s Class II Special Controls Guidance Document mentioned previously. The purpose of the validation is to show that any particulate matter exposed to the vascular model is recoverable in the analysis.

Step 3: Test the device. Testing varies by device type but there are commonalities across devices. For instance, testing should typically include:

  • Associated accessories per your regulatory agencies’ preferences—to see if the interaction of devices and accessories causes particulates to slough off during use.
  • Simulated use conditions for each device type that will accurately mimic how the device is used clinically.
  • Human factors associated with practitioner and patient that may result in unintended use or mishandling of the device during procedures that may contribute to additional particulates.

Step 4: Ongoing Monitoring. Particulate testing is strongly advised during both premarket product development and also for postmarket monitoring and quality purposes.

Establishing Acceptance Criteria

For medical devices there are few standards published providing clear guidance for particulate matter on devices, with the exception of EN 45502. Therefore, the manufacturer has the primary responsibility to establish standardized acceptance criteria for their specific cardiovascular device and its intended use. Often the manufacturer’s acceptance criterion is based on standards that don’t necessarily apply to cardiovascular devices, but contain specifications for particulate matter of other products in the vascular pathway (i.e., USP ). However, some regulatory bodies frown upon leveraging these standards to determine acceptance of a product that does not fit within that standard’s scope, such as applying the USP specifications for particulate matter in injections to a medical device.

A recommended best practice as outlined in ANSI/AAMI TIR 42 suggests obtaining comparative data on particulate matter from a predicate device. If the data from the legally marketed device or predicate is comparable to the test device, the manufacturer has reasonable assurance of patient safety and may use this data to justify its establishment of acceptance criteria values. Action and alert limits can then be established based on the acceptance criteria and the percentage of the maximum limit that the manufacturer is willing to accept during routine production monitoring.

Postmarket Surveillance

The value of particulate testing for the device manufacturer in the postmarket environment includes monitoring of the manufacturing processes and techniques and the amount of residual material being generated. Lot-release testing helps determine whether the packaging and handling processes for devices are adequately clean. It also helps the manufacturer assess changes or variance in the manufacturing process to set alert and action limits to avoid costly product recalls or adverse clinical outcomes.

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