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The Anesthesiology and Respiratory Therapy Devices Panel (the Panel) met on Friday, May 13, 2005 in Gaithersburg, MD, to make recommendations (no voting) to the Food and Drug Administration (FDA) on issues regarding pulse oximetry. Pulse oximeters are devices intended to noninvasively measure arterial oxygen saturation and pulse rate. The issues discussed include the differences between transmittance and reflectance pulse oximetry, the validation of pulse oximeters intended for use in neonates, and the over-the-counter (OTC) clearance of pulse oximeters. The Panel membership for this meeting consisted of seven anesthesiologists, one nurse practitioner, an industry representative, and a consumer representative.
The FDA presented the review process for pulse oximeters and how these devices are regulated. This included a review of the non-invasive pulse oximeter guidance, and current recommendations not included in the guidance. Additionally, FDA presented information available in ISO 9919, a new pulse oximetry standard, and clinical background information that the Panel should consider when providing their recommendations.
The FDA was followed by Industry stakeholders who presented their views on the issues to be discussed. Industry speakers presented the following views:
- Pulse oximeters intended for use in neonates should be validated on adults and that no degradation factor should be added to the validated accuracy specification.
- There are no fundamental differences between reflectance and transmittance pulse oximetry.
- It would be beneficial to the public to allow clearance of OTC pulse oximeters.
The Industry presentations were followed by a formal presentation by one open public speaker. This individual believed that pulse oximetry performance in neonates should be validated by use of convenience sampling. Additionally, he stated that the currently provided specification, Arms (root mean square accuracy), does not adequately disclose to a user the performance of a pulse oximeter.
Following the above presentations, the Panel deliberated the questions provided by FDA. After deliberations, the panel offered final recommendations on these questions. The Panel recommended the following:
- There are no fundamental technological differences between transmittance and reflectance pulse oximeters. However, pulse oximeter variability in clinical performance (sensor location, patients) does exist. A pulse oximeter should be validated in each location it is intended for use.
- The 1% neonatal degradation factor, which is added to the saturation accuracy specification validated with healthy adults, should be dropped. Pulse oximeters intended for use in neonates should continue to be validated in healthy adults; however, clinical performance of the oximeter in neonates should be reported in the labeling. The device labeling should more fully disclose how the accuracy specifications were obtained.
- The Panel could not reach a recommendation regarding the clearance of OTC pulse oximeters. The Panel expressed concerns regarding misuse of oximeters and discussed benefits of greater patient empowerment. However, the Panel felt that the lack of data regarding this issue did not allow a recommendation to be made and suggested that user studies are considered to gauge the need for user education and improved labeling.
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