Introduction
Healthcare activities that include instrumentation or manipulation of mucosal tissue or normally sterile sites can place patients at risk of infectious and other complications. Within the orbit of the eye, the globe and supporting structures are relatively vulnerable to external environmental conditions and exposures. The use of ophthalmic devices, drops, ointments, and other medical products for diagnosis or treatment and the manipulation of tissue can increase the likelihood of eye infection and other adverse events.
Outbreaks of infectious organisms and clusters of adverse events have been noted in the ophthalmic setting. For example, there have been outbreaks of epidemic keratoconjunctivitis associated with contamination of the ophthalmic clinical environment with adenovirus. Reference King, Johnson and Miller1,Reference Muller, Siddiqui, Ivancic and Wong2 Additionally, eye infections involving a variety of microorganisms from the use of contaminated medical products, such as eye drops, have been reported. Reference Mikosz, Smith and Kim3,4 Postsurgical adverse events can also be seen with common ophthalmologic procedures such as cataract surgery. Reference Edens, Liebich and Laufer Halpin5,Reference Sen, Lalitha and Mishra6 Reusable medical equipment has been implicated in adverse events in eye care settings, Reference Muller, Siddiqui, Ivancic and Wong2 and the most common infection control citations from surveyors in outpatient settings, including ambulatory surgical centers (ASC) performing ophthalmologic procedures, are related to lapses in proper reprocessing of reusable medical equipment. Reference Braun, Chitavi and Perkins7
We reviewed queries to the Centers for Disease Control and Prevention’s (CDC) Division of Healthcare Quality Promotion (DHQP) that were focused on ophthalmologic procedures and settings to identify opportunities to improve infection prevention and control (IPC) practices in these settings.
Methods
CDC/DHQP assists health departments and healthcare facilities with investigations of infection control breaches and outbreaks involving the provision of health care. Internal CDC consultation records received from January 1, 2016, through December 31, 2023, were reviewed to identify those involving ophthalmologic procedures or settings. All queries involving eye care and ophthalmologic and optometric practices and procedures were included. Consultations were reviewed to determine the setting type (eg, inpatient vs outpatient), number of patients affected, organisms identified, nature of IPC breaches, and whether medical products were implicated. Consultations were grouped into categories based on common themes and IPC breaches identified, and respective frequencies were calculated.
This activity was reviewed by the CDC/DHQP Science Office (0900feb822f57ca); data were collected as part of public health investigations, and the project was deemed a non-research activity not requiring Institutional Review Board (IRB) approval. Work was conducted consistent with applicable federal law and Centers for Disease Control and Prevention policy (eg, 45 C.F.R. part 46.102(l) (2), 21 C.F.R. part 56; 42 U.S.C. §241(d); 5 U.S.C. §552a; 44 U.S.C. §3501 et seq.).
Results
We identified 26 consultations among 25 US health jurisdictions, with 2 consultations involving more than 1 jurisdiction. Most consultations (n = 21, 81%) involved outpatient settings, of which 10 (48%) were ASC. Five of the remaining outpatient clinics performed cataract surgery and other procedures but did not have specific ASC designation, while 6 were traditional ophthalmologic and optometric eye clinics not performing invasive procedures. Consultations included the following non-mutually exclusive categories (Table 1) with some investigations involving multiple categories of events: postsurgical adverse events (n = 19, 73%), toxic anterior segment syndrome following cataract surgery (n = 5, 19%), infections following receipt of nonsurgical ophthalmic clinical care (n = 11, 42%), suspected contamination of medications at point of manufacture or during compounding prior to receipt at point of use (n = 8, 31%), medical device reprocessing concerns (n = 8, 31%), improper environmental cleaning and disinfection (n = 8, 33%), mishandling of medications within the clinical setting (n = 3, 12.5%), and events associated with potentially contaminated donor tissue (n = 3, 12.5%). Lapses in general IPC practices, such as poor adherence to hand hygiene recommendations and inconsistent use of standard precautions, spanned across all categories. Overall, half of all consultations (n = 13) identified medical device reprocessing concerns, issues with environmental cleaning and disinfection, or specific breaches in facility-level IPC practices (eg, failed opportunities for hand hygiene, use of single-use medical device for multiple patients). When a consultation included the identification of a pathogen (n = 12, 46%), organisms included bacteria (n = 8, 64%), fungi (n = 3, 25%), and viruses (n = 2, 17%). A total of 243 patients had confirmed ophthalmic infections or adverse events.
Table 1. Categories and examples of CDC consultations (n = 26) for investigations involving ophthalmic settings or procedures, United States, 2016–2023
Note: A. fumigatus, Aspergillus fumigatus; A. xylosoxidans, Achromobacter xylosoxidans; B. cepacia, Burkholderia cepacia; CDC, Centers for Disease Control and Prevention; E. coli, Escherichia coli; E. meningoseptica, Elizabethkingia meningoseptica; EPA, Environmental Protection Agency; FDA, Food and Drug Administration; IPC, infection prevention and control; K. oxytoca, Klebsiella oxytoca; LASIK, laser-assisted in situ keratomileusis; M. abscessus, Mycobacterium abscessus; M. chelonae, Mycobacterium chelonae; P. lilacinum, Purpureocillium lilacinum; P. aeruginosa, Pseudomonas aeruginosa; S. aureus, Staphylococcus aureus; S. maltophilia, Stenotrophomonas maltophilia; S. mitis, Streptococcus mitis; S. pneumoniae, Streptococcus pneumoniae; S. pyogenes, Streptococcus pyogenes.
a Categories are non-mutually exclusive.
b MMWR Morb Mortal Wkly Rep 2017;66:811–812, https://doi.org/10.15585/mmwr.mm6630a3.
c Recalls, Market Withdrawals, & Safety Alerts > United Exchange Corp Issues Voluntary Nationwide Recall of Family Care Brand Eye Wash Due to Microbial Contamination (archive-it.org), https://wayback.archive-it.org/7993/20180126102114/https://www.fda.gov/Safety/Recalls/ucm519583.htm.
Discussion
Preventable observed and potential harms associated with medical device reprocessing deficiencies and improper environmental cleaning and disinfection, among other factors, were noted in this review of CDC consultations involving ophthalmic care and settings. These identified IPC concerns in ophthalmic settings may be addressed by heightened attention to education and training related to environmental cleaning and medical device reprocessing. Increased emphasis on, and awareness of, the critical role of environmental cleaning and disinfection of surfaces may be particularly beneficial given multiple reports of eye-clinic-associated transmission of environmentally hardy organisms such as adenovirus. Reference King, Johnson and Miller1,Reference Muller, Siddiqui, Ivancic and Wong2 Additionally, more specific training, with refresher training as necessary and performance audits, with monitoring and documentation, is important for those performing medical instrument and device reprocessing and those charged with the preparation and use of medical products and treatments.
The American Academy of Ophthalmology (AAO) has issued a comprehensive document, “Infection Prevention in Eye Care Services and Operating Areas and Operating Rooms—2012,” that provides guidance on standard precautions, cleaning, disinfection and sterilization procedures, and other topics relevant to maintaining a robust IPC program. 9 This document relies heavily on guidance and recommendations from the CDC, the Association of Professionals in Infection Control and Epidemiology, the National Institute of Occupational Safety and Health, and others. The update of the AAO document tailored to the unique aspects of ophthalmologic settings and practice and consistent implementation and practice of the AAO recommendations could have a substantial impact in improving IPC practices and reducing adverse outcomes in the ophthalmic setting.
Our review has several limitations. First, consultations with the CDC/DHQP are voluntary, and the findings summarized here may not be generalizable to all investigations involving ophthalmic settings across the country. Each state’s decision to request CDC assistance likely depends upon many factors, including the health department’s experience with response to similar situations, available personnel and areas of expertise, and competing priorities from other public health needs. Second, the CDC does not always receive complete follow-up information (eg, details regarding onsite observations, including those related to specific reprocessing concerns or breaches in IPC practices) for each investigation for which it is consulted. Third, healthcare investigations do not always include formal epidemiologic studies, and most investigations do not identify a single, definitive IPC failure responsible for transmission. However, onsite observations and environmental sampling are often suggestive of potential transmission routes. A formal outbreak reporting system for outpatient settings, including those focused on ophthalmic practices and settings, could clarify the nature and frequency of IPC issues of greatest concern to help inform targets for prevention efforts.
A review of consultations to the CDC/DHQP involving ophthalmic settings and practices found documented and potential patient harms associated with a variety of suboptimal practices. Enhanced education, training, and auditing of healthcare personnel and the use of IPC guidance specific to this setting could improve patient outcomes and decrease the likelihood of adverse events. Additionally, good manufacturing practices and safe handling and adherence to pharmacy standards during compounding will decrease the likelihood of patient contact with contaminated ophthalmic products. 10
Acknowledgments
The authors appreciate the work of the members of the DHQP Prevention and Response Branch Outbreak Response Team and the Epidemic Intelligence Officers, as well as the health departments and other institutions, who contributed to the investigations reviewed in this study.
Financial support
None.
Competing interests
All authors report no competing interests relevant to this article.
Disclaimer
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC.
