The Science Journal of the American Association for Respiratory Care

2006 OPEN FORUM Abstracts

Impact of Vapotherm Recall On Patient Care in the NICU


Terrell Ashe, RRT, Rose Dennis MS RRT RN, Cathy Grady RRT RN Clinical Manager, Respiratory Care Services.  Athens Regional Medical Center, Athens, GA Rose Dennis MS RRT RN, Cathy Grady RRT RN

Introduction:  The Vapotherm 2000i device was recalled due to a possible association with Ralstonia bacteria colonization.  Approximately 5000 devices used on approximately 120,000 patients per year where removed from over 800 US medical centers. In October 2005 CDC reported in the MMWR the Vapotherm 2000i as a possible associated risk factor.  CDC also recommended as part of their report that users follow manufacturer's instructions for use and cleaning.  We routinely cleaned our Vapotherm devices per instructions and we did not have cases of contamination.  Nevertheless, our hospital and patients felt the impact of the recall in that all Vapotherm devices were returned to the manufacturer.  We report here on that impact. 

Method:
An internal audit was conducted measuring patient admission days, ventilator days, nCPAP days, and VAP cases.  The time period was approximately five months prior to the recall (Dec-May 05) and the same five months (Dec - May 06) post recall. 

Results:
  The number of ventilator days and nCPAP days increased.  We had one case of VAP during the recall period measured.  See in Table 1.

                                                     Table 1

  Admission Vent Days nCPAP Days VAP Vapotherm Days
Vapotherm 116 80 4 0 360
Recall 132 155 112 1 0

Discussion:  In our hospital we recognized no increase infection rates during Vapotherm use.  We understand that mechanical ventilation and nCPAP present certain iatrogenic risk to the patient and we aim to wean from these devices seeking less invasive treatment.  The recall of the Vapotherm clearly lead to an increase in ventilator and nCPAP days.  Among the recall patients we had one case of VAP whereas during the five month period prior to the Vapotherm recall we report 0 cases of VAP. 

Conclusion:
  We are able to measure an increase use in both mechanical ventilation and nCPAP that would appear directly related to the recall of the Vapotherm 2000i device.


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