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Recommended Identification Measures If Particulates Are Detected

Fig. 3 – HIAC Royco 9703 Particle Counting System that is used to size and count particles present in a solution.
If particulates are detected, further investigation of recovered particulate matter may be required to determine where they originated or at what step in the manufacturing process the particulates occurred. (See Figure 2) Manufacturers seeking additional information about the particulates recovered during testing can choose a variety of options to further identify possible sources of contamination including:

  • Microscopic particle investigation for visual inspection of particulate matter.
  • Fourier transform infrared spectroscopy (micro-FTIR) scan using an analytical test to determine the composition of recovered solid material—not just quantity and size of particulates, but qualitative identification against known materials in the database.

Data obtained from particulate testing is typically in the form of “particles-pertest- sample” depending on the equipment and lab that performs the testing. Particles-per-test-sample or particles-perdevice is a measure of the total particulate load of that sample and theoretically, how much particulate matter will be exposed or introduced to the patient. (See Figure 3)

For example, a guide wire may be tested via a worse-case, tortuous path using a microcatheter and hemostatic valve as accessories. If the wire was exercised within the microcatheter (contained within the model), then the microcatheter is flushed, the extract produced would, theoretically, contain the amount of particulate that could be exposed to a patient during use. As mentioned earlier, the health risks to patients associated with this potential particulate exposure is what concerns regulatory agencies.

Choosing Wisely: Finding a Third-Party Laboratory with Expertise and Experience in Particulate Testing of Cardiovascular Devices

Establishing acceptance criteria and testing for particulate matter can be a daunting task; therefore, identifying a qualified third-party laboratory with whom to partner is strongly recommended. The following criteria should provide helpful guidance for selecting a laboratory partner for your cardiovascular device particulate testing:

  • Years of experience working with manufacturers of cardiovascular devices, such as stents, catheters, guide wires, and active implantables.
  • Expertise in writing appropriate test protocols and preparing clinically relevant study designs including validation of the test method using appropriate test controls.
  • Comprehensive knowledge of, and even participation in the development of, relevant international standards and experience with regulatory guidance documents.
  • Capability to perform further investigation of recovered particulate matter to identify source and consult on solutions.

It is important to stress that decision makers at cardiovascular device manufacturers are advised to incorporate third-party particulate testing of their devices into their product development schedules and postmarket monitoring processes. Failure to do so can result in problems ranging from complications in obtaining regulatory clearance and delayed product launch to postmarket quality and serious patient safety issues. With some understanding of the importance of particulate testing and a partnership with a carefully chosen third-party laboratory, however, device manufacturers will be well positioned to reduce the risk of these problems occurring and to maintain good control and oversight of their cardiovascular products and manufacturing processes.

This article was written by Ryan Lunceford, Particulates Department Manager, CQIA (ASQ), Nelson Laboratories, Salt Lake City, UT. For more information, Click Here.

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