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Bill West

Sysmex XW-100 Waived CBC Analyzer

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Good Morning,

  Has anyone looked into this product? We're an outpatient organization with several medium-sized clinics and small school based health centers, doing non-waived testing at 3 sites (3-part diff CBCs only). We're considering this for one of our lower volume sites where the expected utilization won't justify the added regulatory overhead of upgrading our CLIA certificate. Interested to see if anyone has decided to use this yet, and what restrictions they put on its use in-house. The FDA press release states as part of its Intended Use that it is not for patients under 2 yrs of age (easy to follow), and that it is not intended "to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients". Having trouble determining what else the FDA includes in that category besides oncology and critically ill - simple iron deficiency? - sickle cell disease/trait?

BW

 

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20 hours ago, Bill West said:

Good Morning,

  Has anyone looked into this product? We're an outpatient organization with several medium-sized clinics and small school based health centers, doing non-waived testing at 3 sites (3-part diff CBCs only). We're considering this for one of our lower volume sites where the expected utilization won't justify the added regulatory overhead of upgrading our CLIA certificate. Interested to see if anyone has decided to use this yet, and what restrictions they put on its use in-house. The FDA press release states as part of its Intended Use that it is not for patients under 2 yrs of age (easy to follow), and that it is not intended "to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients". Having trouble determining what else the FDA includes in that category besides oncology and critically ill - simple iron deficiency? - sickle cell disease/trait?

BW

 

That FDA press release caveat seems strange.  Why don't you see if you can get a customer list from Sysmex and then call and ask how they are being used at similar facilities.  You will want to talk to current users in any event.

Scott

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Thank you for asking for clarification and further information.  As noted, The XW-100 is contraindicated for critically ill patients.  CMS defines a critical illness or injury as one which “acutely impairs one or more vital organ systems such that there is a high probability of imminent or life-threatening deterioration in the patient’s condition.” (Medicare Claims Processing manual, Chapter 12, Section 30.6.12A.).

Additionally, the XW-100 is not for use in a clinical area which cares for only critically ill patients, such as intensive care units. However, in some environments, physicians will encounter critically ill patients as well as those who are not. In those cases, it is important for the physician to follow the IFU and only use the XW-100 for patients who are not critically ill. Use in critically ill patient populations is not only contraindicated, but is likely to result in suppression of a large portion of the results.

Please also visit www.sysmex.com/xwsafety to learn more.

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