Cause of Device-Related Incident
*Not stated

Clinical Specialty or Hospital Department
Anesthesia; CCU / ICU / NICU; Clinical/Biomedical Engineering; Emergency Medicine; OR / Surgery

Device Factors
*Not stated

Document Type
Frequently Asked Questions (FAQ)

External Factors
*Not stated

Mechanism of Injury or Death
Embolism (gaseous or particulate); Infection

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

UMDNS
Warmers, Blood/Solution [10-447]

Inspection Frequency for Blood/Solution Warmers



FAQ [Health Devices Oct 1996;25(10):392]

Hospital: How often should blood/solution warmers be inspected?

ECRI: The American Association of Blood Banks (AABB) addresses intervals for quality control (QC) testing of equipment and reagents commonly used in blood banks in the sixth edition of its Accreditation Requirements Manual. In Appendix 3, AABB states

The frequency of QC testing should be determined by each facility for each piece of equipment in use, using the manufacturer's instructions, if available, and consistent with CLIA '88 [Clinical Laboratory Improvement Amendments] and FDA [U.S. Food and Drug Administration] requirements. One should begin with frequent testing to establish potential failure intervals and then select a reasonable schedule for testing that will ensure detection of malfunction and continued optimal function.(1)

In its listing of "suggested testing frequencies" in this Appendix, AABB specifies quarterly testing of blood/solution warmers. In contrast, in the third edition of our Health Devices Inspection and Preventive Maintenance (IPM) System, we specify that, under most circumstances, annual inspection of these devices is adequate. When we updated our blood/solution warmer IPM procedure in 1995, we recommended an annual inspection interval because our reviews of the medical literature and our searches of the ECRI Problem Reporting Network and Health Devices Alerts databases did not reveal any recurrent problems or maintenance issues on any brand of warmer. Also, with appropriate documentation, an annual interval would be in accordance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requirements.

Clinical engineering departments should analyze the documentation for the warmers they service to determine if shorter inspection intervals (e.g., semiannual, quarterly) are indicated. However, it is not likely that inspection frequencies greater than twice a year would be warranted for these devices. Note that some warmers may require routine maintenance (e.g., changing the water in water baths) more frequently, but this upkeep can typically be performed by users and is not considered preventive maintenance to be performed by clinical engineering personnel.

Note

  1. American Association of Blood Banks (AABB). Accreditation requirements manual. 6th ed. Bethesda (MD): AABB; 1995.

UMDNS Term

Warmers, Blood/Solution [10-447]


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