by Lawrence F. Muscarella, PhD
Surveyors for the Centers for Medicare and Medicaid Services (CMS) routinely advise health-care facilities to adhere to the labeling of reusable medical instruments (Hillman, 2016). This labeling routinely includes the manufacturer’s recommendation, if not the requirement, to use enzymatic detergents prior to sterilization to clean reusable ophthalmic instruments used to perform cataract and other intraocular surgeries. A joint statement released in December 2015 does not endorse this cleaning recommendation, however, notwithstanding the reusable instrument’s labeling (ASCRS, AAO, & OOSS, 2015). This joint statement was approved by the American Society for Cataract and Refractive Surgery (ASCRS), the American Academy of Ophthalmology (AAO), and the Ophthalmic Outpatient Surgery Society (OOSS).
Instead, these three organizations have concluded that enzymatic detergents should not be required to clean intraocular surgical instruments (Hillman, 2016). This stance is based on a concern that residues of the enzymes used in these detergents could remain on the surfaces and in the lumens of these surgical instruments after cleaning and incomplete water rinsing, potentially elevating the risk of toxic anterior segment syndrome – or TASS (Hillman, 2016).
A fourth organization, the American Society of Ophthalmic Registered Nurses (ASORN), did not approve the December 2015 joint statement, questioning the merit of its conclusions (ASORN communication). ASORN continues to advise adherence to the device’s labeling, which may include use of an enzymatic detergent to enhance cleaning effectiveness. Presenting as sporadic cases or outbreaks, TASS is an acute, sterile inflammation of the anterior segment of the eye that can result in blindness.
Muscarella, Lawrence F. (2018, Winter). PhD. Insight, 43, p. 26.