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Regulatory and Design Considerations for Automatic Cell Washers

Posted on Mar 26, 2024 by Colleen Holtkamp

A person using a cell washer

Pre-transfusion testing refers to the laboratory tests required to ensure compatibility between a patient’s blood and a transfusion of donated blood. This process includes patient identification, sample collection and labeling, and laboratory testing to determine the patient’s blood type and screen for unexpected antibodies.

In addition, compatibility of the donor and recipient’s blood must be determined by crossmatch. The pre-transfusion testing process is completed when a compatible blood product has been identified for transfusion to the patient.

For pre-transfusion tube testing, a cell washing system can improve operational efficiencies compared to manual methods. The cell washer dispenses and decants the saline required for washing processes, saving time and effort by automating the hands-on steps associated with using a centrifuge.

As manufacturers refine their portfolios and cell washers are more difficult to come by, Helmer Scientific continues to support our customers by offering the UltraCW®II Automatic Cell Washing System. The UltraCW®II saves time and effort by automating the manual steps associated with pre-transfusion tube testing.

It is important for an automatic cell washing system to meet regulatory requirements. The Food and Drug Administration (FDA) identifies a cell washer as an automated cell-washing centrifuge for immunohematology used to separate and prepare cells and sera for further in vitro diagnostic testing.

The FDA regulatory classification for these devices is Class II, which requires Section 510(k) premarket notification of intent to market the device. The UltraCW®II has 510(k) clearance from the FDA.

The UltraCW®II is also recognized by the AABB Standards-Compliant Products Program. This program provides assurance that products for the blood community comply with standards. Products that achieve this recognition have been thoroughly reviewed by AABB and confirmed as adhering to the AABB Standards relating to equipment, process control, and document control.

Design features important for the functionality and ease of use of an automatic cell washer include:

  • The ability to create and customize programs
  • Digital calibration for precise control of saline volume
  • A design that enables the saline supply to be placed below the unit, eliminating the need for staff to lift the saline
  • A low profile that enables blood bank staff to work in an ergonomic and comfortable position
  • A cleaning procedure that does not require excessive downtime


To learn more about important considerations for selecting a cell washer, review our Best Practices Guide for Automatic Cell Washing Systems.

Download the Guide »

Colleen Holtkamp

Written by Colleen Holtkamp

Helmer designs, manufactures, and markets specialized medical and laboratory equipment to customers in more than 125 countries. With an extensive background in Helmer products, Colleen’s focus is on the Clinical Laboratory and Blood Bank segments.

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