Let’s throw everything away…except the patient and the surgeon
Single-use cataract surgery comes with several safety and quality attributes.
Over the past 5 years, I have developed an all single-use instrument cataract surgery (ASUICS) custom pack. The surgical instruments contained in the pack are the only instruments used to prepare the surgery tray. I regularly use it for cataracts up to Lens Opacities Classification System III (LOCS III) grade 4.1
Before discussing the contents of this custom pack, let us consider the possible advantages of single-use instruments in cataract surgery. Such discussions are usually based on three factors: risk, cost and the waste materials produced.
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Prof. Gangolf Sauder
Cleaning any instrument that has a canular structure, even when the manufacturer’s instructions are thoroughly followed, has the potential to leave microscopic remains lodged inside that could pose a genuine threat to patients or at least worsen outcomes.
In Germany, the Commission on Hospital Hygiene and Infection Protection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) suggest mechanical cleaning of reusable instruments or surgical equipment prior to sterilisation.2
The small inner lumen diameter of phacoemulsification and irrigation/aspiration handpieces does not permit mechanical cleaning with a brush, so compressed air or flushing with water or solvents is required. However, this is far less thorough than a brush. In the United States, the Food and Drug Administration’s guidelines recognise that instruments with lumens that are not freely accessible, i.e., they have sharp angles or are too small to permit access with a brush, may pose a challenge to adequate reprocessing.3
Related: Study examines pairing phacoemulsification with implantation of stents
Using only single-use instruments abolishes the potential risk of infection transmission.4 Prophylactic intracameral antibiotics may seem to be a simple solution to the issue, but they have a significant drawback in that they contribute to emerging antimicrobial resistance.5
Other drawbacks include, but are not limited to, inefficacy due to dilution; contamination during preparation; toxic anterior segment syndrome; corneal endothelial toxicity; haemorrhagic occlusive retinal vasculitis; and toxic effects on the retina.6
Related: Considering antibiotics use in postoperative endophthalmitis
Although disposable instruments are generally considered to be more expensive, reusable instruments have hidden costs including those incurred from reprocessing, maintaining an autoclave facility, cleaning microbicides and instruments for disinfection, packaging and human resources. In addition, there are unexpected expenses such as accidental damage/repair, maintenance and the need to update them from time to time, to keep pace with technological breakthroughs.
Another factor to consider is that investment in non-single-use instruments may have limited the advancement of techniques. For example, reducing the calibre of an instrument may make it no longer practical to clean and reuse a sufficient number of times. Thus, reducing the diameter may effectively mean that all instruments are usable only a very limited number of times.
Single-use instrument tray used for nanosecond laser cataract surgery.
The custom ASUICS pack includes a nanolaser handpiece; a microscope handle cover; a phacoemulsification cassette; an eyelid retractor; scissors; a side-port blade; a syringe with physiological solution; a syringe; a hydrodissection cannula; a cystotome holder; two ophthalmic viscosurgical devices; a two-sided modified Neuhann chopper; a pre-bent cystotome; separate irrigation and aspiration devices; and surgical drapes. The scissors and chopper are made of titanium and could in principle be reused, but when we finish each procedure everything is thrown away.
Weighing up pros and cons
An illustration of the key advantages of reusable instruments vs all single-use instrument cataract surgery. Although I found that that balance was in favour of single-use, surgeons should decide for themselves, taking into consideration individual circumstances and patient outcomes. (Images courtesy of Prof. Gangolf Sauder)
Now that an ASUICS pack is available, surgeons should evaluate if this option is right for them and, above all, the best choice for their patients. I decided in favour of single-use instruments several years ago, having evaluated the pros and cons of reusable vs single use.
The key pros for single use include the ability to rapidly integrate updated technology without having to take a loss for outdated purchased instruments, the elimination of the risk of passing organic material from patient to patient—especially probable when having to clean a tubular instrument—the elimination of sterilisation costs, and, specific to nanolaser photofragmentation, the reduced loss of endothelial cells postoperatively.7,8
Cons include the increased cost per procedure and the increase in waste products produced, including both packaging and instruments.
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I weighed up that the balance was more than tipped towards a single-use solution. This decision was reinforced by the rapid evolution of handpieces, which has increased the holding potential and the cataract grade that can be successfully treated without an increase in cost. This technique still has a significant margin for future developments.
This decision also allows me to offer procedures for both eyes on the same day. After completing the first procedure, the patient is moved to another operating room where a new ASUICS pack is used for the second eye.
I have found that this option is becoming more popular with younger, active patients who must travel to my centre. The shorter recovery time required with a nanolaser procedure also favours this option.
Although biomedical waste is an important consideration, I believe the most pressing factors in deciding between recycling instruments or using a single-use pack should be the risk/spread of infection and the quality of the outcome. Delaying the implementation of new technology in order to complete the work cycle of a reusable instrument should not be accepted under any circumstances.
References
1. Sauder G, Ruf E, Moedl S, Thyzel R. Nanosecond laser cataract surgery in LOCS III Grade 4 and 5: A case series. Asia Pac J Ophthalmol (Phila). 2017;6:425-428.
2. Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut (RKI) und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM). Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. Bundesgesundheitsbl. 2012;55:1244-1310.
3. FDA. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff. 2017:1-77.
4. Walker P. Pediatric adenoidectomy under vision using suction-diathermy ablation. Laryngoscope. 2001;111:2173-2177.
5. Schwartz SG, Flynn HW Jr, Grzybowski A, et al. Intracameral antibiotics and cataract surgery: endophthalmitis rates, costs, and stewardship. Ophthalmology. 2016;123:1411-1413.
6. Flynn HW, Batra NR, Schwartz SG, Grzybowski A. Antibiotic stewardship. In: Flynn HW, Batra NR, Schwartz SG, Grzybowski A, eds. Antibiotic Stewardship in Endophthalmitis in Clinical Practice. Cham, Switzerland: Springer International Publishing; 2018:171-172.
7. Tanev I, Tanev V, Kanellopoulos AJ. Nanosecond laser-assisted cataract surgery: Endothelial cell study. J Cataract Refract Surg. 2016;42:725-730.
8. Mastropasqua L, Mattei PA, Toto L, et al. All laser cataract surgery compared to femtosecond laser phacoemulsification surgery: corneal trauma. Int Ophthalmol. 2017;37:475-482.
Gangolf Sauder, MD
E: prof.sauder.charlottenklinik@gmail.com
Prof. Sauder has been the managing director and chief physician of the Charlottenklinik für Augenheilkunde in Stuttgart and a professor in the Department of Ophthalmology of the University of Mannheim since 2006. He has no financial interests in any of the products mentioned.
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