Terumo Cardiovascular Systems

Terumo’s Perfusion Clinical Specialist team is another demonstration of Terumo’s commitment to the perfusion community:

Fully-resourced team:

For a decade, Terumo has continued to increase the number of Clinical Specialists on its team—they can respond more quickly and focus more fully on the needs of each customer.

Years of experience:

The team has 150 years of combined clinical, technical and scientific expertise.

Hundreds of O.R.s visited annually:

Their knowledge is based on practical experience.

Full-time focus:

All Terumo Clinical Specialists are dedicated full-time to the clinical support of Terumo products. They provide clinical input during new product development, support clinical trials and laboratory studies, and design training programs.

No other manufacturer provides the same depth and breadth of clinical support. 1

Question of the Quarter

 

    • April 2010

      Is there a national standard parameter for measuring the quality of the cell saver product? It would be "nice" to measure free hemoglobin, and lipid concentration, or heparin concentration, but these cannot be measured easily.

    • At present time there is no agreed upon “national standard” for testing parameters in perioperative blood salvage. The American Association of Blood Banks (AABB) offers guidelines.

      Section 5.1.2 Quality Control, states that each program is responsible for quality control, establishing their own parameters for reagents, equipment and methods as expected. These test results should be reviewed and corrective action taken when appropriate.

      The quality control program should specify the type and frequency of testing. It is up to the user to select which criteria to test and record. The AABB provides the following list as examples: hematocrit, color of the waste line, heparin concentration, albumin removal, free hemoglobin removal, and potassium removal. It may be important to note that in the near future, samples from pre-wash versus post-wash may be required to show adequate device function.

      For each test that has been chosen, a range of acceptable values should be established. Standard operating procedures should be in place when a chosen test value falls out of range: What to do to investigate, identify, and correct the problem. Then a process for re-validation of the offending device or procedure should be established, once corrective measures have been taken.

      All of this should be recorded in a log book of some kind that the user can produce on demand for accreditation purposes.

       

1. This describes the Terumo Perfusion Clinical Support Team in the United States.