Tackling the challenge of needless surgical waste in ophthalmology

Unofficial AI-generated summary based on the public title and abstract. Not an official translation.

🔬研究者:医療廃棄物削減の研究課題と、感染管理ガイドラインの科学的根拠の必要性を示す。

🏢実務担当者:眼科手術における廃棄物削減の具体的な方策（カスタムパック削減、リユース検討）の参考になる。

🏛政策担当者:規制が廃棄物削減を妨げる事例を示し、エビデンスに基づくガイドライン策定の重要性を示す。

In a survey of North American cataract surgeons conducted by the Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force and published in 2020, 93% felt that operating room (OR) waste was excessive and should be reduced.1 In this issue, a new ESCRS survey shows a similar consensus within Europe (Chang et al., page 341).2 This begs the question: if more than 1500 ophthalmic surgeons from 2 major continents are nearly unanimous in this opinion, why do we continue to waste so much and how can we surmount this problem? Can a root cause analysis of this complex predicament suggest strategies to pursue? A Need for Education Changing long-established behavior and practices requires us to understand the importance and urgency of doing so. In these 2 surveys of ophthalmologists' attitudes toward OR waste, 43% of North American and 32% of European cataract surgeons said that they were completely unaware of the environmental impact of the healthcare system and of surgical waste.1,2 A 2019 report from Health Care Without Harm estimated that the healthcare sector is responsible for 4.4% of all global greenhouse gas emissions; 71% of these emissions come from the manufacture, use, and disposal of healthcare supplies.3 If the global healthcare sector was a country, it would be the fifth largest emitter in the world.4 The healthcare system accounts for nearly 10% of greenhouse gas emissions in the United States, where it is the second largest contributor to landfills after the food industry.5,6 ORs account for a major share of the total emissions and waste from the healthcare sector.7 Amid the pandemic of the century, the World Health Organization declared in 2021 that climate change is the single biggest health threat facing humanity.8 Poorer countries and communities will disproportionately bear the burden of poor air quality and food and water shortages.9 Climate change also compromises eye health.10 According to the International Agency for the Prevention of Blindness (IAPB), the climate crisis will disrupt eyecare delivery and inequitably increase many eye diseases, such as blinding infections, in the most vulnerable populations.11 Although ophthalmologists are specialists, we are also physicians who should be concerned and alarmed by these forecasts. In 2021, the National Academy of Medicine launched the Action Collaborative on Decarbonizing the U.S. Health Care Sector.12 That same year, IAPB declared a climate emergency and called on our profession to take action.11 Because our specialty has the highest procedural volumes, ophthalmology has a compelling opportunity and obligation to lead efforts within medicine to make our essential services more sustainable.13 Simple and immediate steps to reduce waste, such as eliminating infrequently used custom-pack items or recycling paper and plastic packaging, might be implemented if more ophthalmologists and nurses understood the detrimental impact of healthcare's contribution to greenhouse gas emissions.7,14 Infection Control Guidelines: Recommendations or Requirements? Organizations that accredit and license surgical facilities are charged with safeguarding patients from healthcare-associated complications and infections. Universal OR infection control recommendations are typically developed by guidelines committees within organizations such as the Centers for Disease Control and Prevention (CDC) or the Association of Perioperative Registered Nurses (AORN) in the United States. Many scientifically proven recommendations should be mandatory requirements. Others, based on the opinions of experts without peer-reviewed studies, might better serve as guidance or suggestions. Regulatory and licensing bodies, however, may decide to mandate and enforce these recommendations that are more eminence than evidence based. In 2015, AORN recommended wearing bouffant head covers and long-sleeved surgical jackets in the OR, and The Joint Commission subsequently began enforcing these AORN recommendations as compulsory requirements. However, a study of more than 34 000 inpatient surgeries at the University of Alabama found that these regulations, which cost more than $300,000 annually to comply with, did not lower the rate of surgical site infection.15 Expert opinions are subject to bias, and in this case, the assumption of greater safety was contradicted by the evidence. Another issue is that universal infection control guidelines are applied to all surgeries by default. However, it stands to reason that some measures (eg, many environmental infection control guidelines) required for orthopedic or thoracic surgery would be unnecessary for ophthalmic procedures, which are relatively clean. In the United States, compulsory guidelines to prevent airborne microbial cross-contamination include disinfecting the OR countertops between cataract surgeries and discarding multi-dose vials of injectable drugs after a single use in the OR. However, multiple studies prompted by the COVID-19 pandemic concluded that the risk for cross-contamination from aerosolized pathogens during phacoemulsification is exceedingly remote.16–21 This underscores the need for more research to ascertain which universal infection control policies do or do not lower the endophthalmitis risk. The widely accepted use of short-cycle instrument sterilizers for cataract surgery is another example of why we need infection control guidelines that are specific to ophthalmology. In 2014, the Centers for Medicare and Medicaid Services (CMS) ruled that immediate use steam sterilization, the replacement term for flash sterilization, was not acceptable for routine surgical instrument sterilization.22 In response, the OICS task force, comprised of representatives from ASCRS, the American Academy of Ophthalmology (AAO), and the Outpatient Ophthalmic Surgery Society (OOSS), was established to develop specialty-specific guidelines for the cleaning and sterilization of ophthalmic surgical instruments.23 A study conducted by the task force determined that short-cycle instrument sterilization and unwrapped settings were appropriate for sequential same-day ophthalmic cases when performed in compliance with U.S. Food and Drug (FDA)-approved sterilizers.24 As a result of discussions with the OICS task force, the CMS continues to allow short-cycle sterilization for ophthalmic instruments.25 Because tissue contamination of cataract surgical instruments is usually insignificant, the guidelines also discouraged routine use of enzymatic cleaners because of the unique risk for toxic anterior segment syndrome posed by introducing microscopic detergent residue into the anterior chamber.23 Surgical Manufacturing Industry Most ophthalmologists want manufacturers to offer more reusable options for surgical supplies, drugs, devices, and instruments.1,2 Most are also willing to reuse single-use ophthalmic devices reprocessed by third parties, although this is rarely an option at present. Survey respondents most frequently cited profit motive and liability protection as factors driving the surgical manufacturing industry toward single-use products. Another commonly cited problem was the lack of environmental considerations in product design and packaging. The largest surgical manufacturers in ophthalmology have heeded these concerns and committed to reducing product emissions and waste. Some are targeting carbon neutrality across their global operations. Governmental directives, such as the European Union (EU) taxonomy regulations, are accelerating corporate prioritization of environmental goals. On the other hand, onerous and costly regulatory approval processes often impede the ability of manufacturers to mitigate carbon emissions through improved surgical product design and packaging. For example, simply reducing the amount of plastic packaging may require a manufacturer to revalidate the safety and efficacy of the medical device following this change. Meanwhile, the new EU Medical Device Regulation (MDR) policy has introduced stricter requirements and is forcing manufacturers to recertify many previously approved devices. Increasingly stringent certification requirements may hamper or imperil responsible corporate efforts to decrease surgical waste and emissions. Regulatory Enforcement of Device Manufacturers' Instructions for Use Regulatory agencies, such as the EU MDR and the FDA, require manufacturers of medical instruments and devices to provide detailed instructions on how to clean, disinfect, and/or sterilize these items. These instructions for use (IFU) also specify whether an item can be reprocessed and reused. These recommendations are not always based on scientific evidence. Because manufacturers may be required to revalidate the safety and efficacy of a product that has been reprocessed, it is generally much easier to obtain commercial approval for a single-use indication. Specifying single use may also reduce product liability. As an example, some companies label their titanium phacoemulsification tips single use, whereas others allow multiple uses. In a study performed at the Moran Eye Center (Salt Lake City, Utah), we could not identify any significant ultrastructural differences between brand new tips and single-use tips that were used multiple times in a testing model.26 This is consistent with the absence of any clinical evidence that reusing phacoemulsification tips is unsafe. The 2009 U.S. Recovery Act funded increased ambulatory surgery center (ASC) oversight and inspections by the CMS. That same year, the CMS issued a new set of ASC Conditions for Coverage, including many compulsory infection control measures.27 CMS surveyors were instructed to “Determine whether the ASC re-uses devices marketed for single use, and if so, does it send them to an FDA-approved vendor for reprocessing?” The new guidelines specified that only devices approved by the FDA for reprocessing could be reused and that this must be done by an FDA-approved re

• openalex https://doi.org/10.1097/j.jcrs.0000000000001175first seen 2026-08-02 18:05:40 · last seen 2026-08-02 18:07:21