Disinfection of outpatient ophthalmic devices: a critique of “semicritical” designation

Ophthalmic devices used in outpatient clinics are undergoing scrutiny by regulatory agencies and hospital infection control groups. Applying a nearly century-old classification for disinfection and sterilization of reusable devices and instruments, they are faulting ophthalmologists for not using high-level disinfection (HLD) listed in newer manufacturer instructions for use. By this classification, A-scan and B-scan ultrasound probes, fundus and laser contact lenses, and gonioscopy lenses are grouped with other “semicritical” devices, such as gastrointestinal endoscopes, laryngoscope blades, and anorectal manometers, and therefore require sterilization or HLD. HLD, however, varies by geographic region, compatibility with material, and disinfectant availability. Because HLD necessitates turnover time, clinics must buy more devices to maintain patient volume. Therefore, manufacturers have no incentive to develop sustainable or reusable devices. Most important, however, none of the ophthalmic devices in question has been associated with spread of infection. In short, the mandate for HLD seems to be arbitrary, reactive to perception of possible infection risk from classification of the eye as a “mucous membrane,” and devoid of evidence that HLD decreases risk of infection transmission relative to current cleaning and disinfection methods. In the manner that the Ophthalmic Instrument Cleaning and Sterilization Task Force Regulatory raised concerns that regulatory agencies arbitrarily were imposing costly infection control measures for intraocular ophthalmic surgery without evidence that they improved patient safety, a similar task force is needed to address regulatory HLD mandates for clinic devices used in tens of millions of patient encounters for decades without infection transmission.