The American Society for Dermatologic Surgery Association (ASDSA) released a new policy position aimed at increasing patient safety related to medical devices for patients with all skin types.
“Inaccuracies resulting from diverse skin tones in pulse oximeter readings and other medical devices create risks for patients and can delay access to needed treatments and possibly result in poor outcomes,” says ASDSA President Vince Bertucci, MD, FRCPC. “ASDSA members, who are all board certified dermatologists and experts in treating the skin, call on the FDA and other policymakers to address issues of medical device safety in patients of all skin types.”
Some of the new ASDSA patient safety recommendations include:
- Creating increased public and physician awareness of the limitations of medical devices, specifically pulse oximetry, of potential erroneous readings in patients with diverse skin tones.
- Providing patients with enhanced instructions for using medical devices where diverse skin tones could be impacted.
- Stating the accepted ranges of values that are normal, borderline, or overly concerning / emergent for medical devices, like pulse oximeters, for patients with all skin types.
- Calling for further research to develop all medical devices, specifically pulse oximetry devices, with all skin types included, and incorporating newer technologies to improve device performance.
- Requiring that the FDA set heightened minimum performance standards for pulse oximeters, to account for patients with diverse skin types.
- Asking that the FDA reclassify and directly regulate over-the-counter pulse oximetry devices, which are currently designated as not for medical use.
To read the full position statement, visit asds.net/Portals/0/PDF/asdsa-position-statement-medical-device-safety.pdf.