Single

Eye (2023)Cite this article

1642 Accesses

3 Altmetric

Metrics details

Does reusing single-use devices increases the risk of endophthalmitis? This issue has received much attention in relation to cataract surgery instruments. Commonly reused single-use devices include the phacoemulsification pack (cassette with probe tip and sleeve), incisional knives, cannulas, cystotomes, and leftover ophthalmic viscosurgical devices (OVDs). Though there is evidence that residual material in reused phacoemulsification probes may contribute to endophthalmitis, no conclusive research comparing the sterility of reusable versus disposable equipment exists [1, 2]. Advocates of single-device reuse in cataract surgery are driven by the belief that reuse will reduce the overall cost. A cost-benefit analysis comparing the use of single-use versus reusable devices during cataract surgery was reported by Panagiota Naoum et al. [3]. Contrary to popular belief, they demonstrated that reusing single-use devices in cataract surgery is not cost-effective. Reusable instrument failures, poor cleaning and sterilisation, and surgical delays are difficult to quantify; nevertheless, the expenses of disposable instruments may be predicted.

Shanmugam et al. found rates of postoperative endophthalmitis with reused instruments for vitreoretinal surgery comparable to those with a single use in a multicentric survey. However, the study's generalizability is limited by its retrospective design and lack of a clear definition of endophthalmitis.

In August of 2000, the FDA issued a guidance document concerning the reprocessing of single-use medical devices by third parties or hospitals. In this guidance document, the FDA states that hospitals and third-party reprocessors will be considered "manufacturers" and will be regulated similarly [4]. A repurposed single-use device must meet the same regulatory requirements as when it was initially manufactured. Similarly, the Medicines and Healthcare Products Regulatory Agency in the United Kingdom does not recommend the reuse of single-use devices because it can compromise their safety, performance, and efficacy, as well as place patients and staff at unnecessary risk [5]. Joint Commission International (JCI) establishes stringent requirements for hospitals contemplating reusing single-use medical devices and supplies. The standards include procedures, monitoring, and follow-up on adverse patient events that may be associated with this practice [6]. Additionally, the WHO has provided recommendations for the reuse of single-use devices. It proposes that reusable devices with small lumens, such as fine cannula and cutters, should be classified as single-use and not be reprocessed and reused. Additionally, according to the recommendation, a written policy and procedure on single-device reprocessing should be present in the healthcare organisation [7].

A reprocess/reuse committee should oversee central reprocessing, infection control, biomedical engineering, and cost accounting in any hospital with reprocessing plans. This committee should consist of physicians, infection control officers, microbiologists, nurses, and administrators. The internal committee needs to assume accountability for the safety and procedure issues.

In a typical VR procedure, hollow tubing and cavities are employed in consumables like cassettes, vitrectomy probes, and connecting tubing in addition to solid instruments like trocar-cannula, endo illuminators, and laser probes. The wear and tear of solid instruments and the risk of contamination from those with hollow lumens pose a challenge.

The performance of a single-use device may be compromised if reprocessing alters its characteristics to the point where it no longer conforms to the original manufacturer's specifications. Certain device-manufacturing materials can absorb or adsorb certain chemicals, which can then leach out of the material gradually over time. There is a report of ILM forced fracture that occurred during ERM peeling, presumed to be due to loss of spring action because of repeated use after ethylene-oxide (ETO) sterilisation [8].

The performance of reused vitreous cutters tends to reduce over the number of reuses. The resulting improper cutting or aspiration could cause iatrogenic complications during the surgery. Likewise, a reused scissor or forceps may not perform the desired task during surgery with precision and accuracy. Using SEM, Kothari et al. found microscopic surface changes on the trocar [9]. Nevertheless, the theoretical significance or relevance of these microscopic surface changes is debatable, and they should not pose a safety risk. Other risks involved with the reuse include the introduction of a foreign particle in the eye, reduced cutting or grasping performance, path leaks, or obstruction leading to reduced fluidics performance.

The instruments tend to have fatigue-induced failure and fracture during each reuse cycle. It is also difficult to clean the long narrow lumens and acute angles associated with many instruments used in VR surgeries. Endotoxins are the breakdown products of Gram-negative bacteria. They can pose a significant risk if a device has a high bacterial load after use that cannot be adequately removed by cleaning. Even if cleaning and sterilisation eliminate bacteria, the sterilisation process will not deactivate the toxins.

Personally, if one intends to reuse a single-use device, it is preferable to reuse solid devices rather than those with cavities or tubing. However, if single-use instruments are reused, it is critical to indicate the recycling policy in the surgical consent form. Patients should be given the option of using either a new disposable pack or a recycled pack. In conclusion, the multi-use cost-effectivity may be inversely proportional to safety and instrument fatigue and may fall below manufacturer/regulatory standards. Ophthalmologists have been driven to practise the reuse of single-use instruments due to the financial implications of doing surgery for less cost in a developing country while paying equipment purchase costs comparable to those in a developed one. There is an increase in carbon emissions from clinical and non-clinical waste due to the usage of single-use disposable equipment. Thus, promoting minimal waste generation, recycling, and the use of reusable materials and equipment has the potential to reduce environmental risks. So, instead of dismissing it out of hand, perhaps one could consider a rational course of action. Developing a plan for the reuse of VR equipment would probably benefit from more prospective operational studies in this area.

Leslie T, Aitken DA, Barrie T, Kirkness CM. Residual debris as a potential cause of postphaco-emulsification endophthalmitis. Eye. 2003;17:506–12.

Article CAS Google Scholar

Baskaran M, Rao SK, Kumar PJ, Vijaya L, Madhavan HN. Postphacoemulsification endophthalmitis—role of residual debris in the handsets used for surgery. Eye. 2005;19:115–116.

Article CAS Google Scholar

Naoum P, Palioura S, Naoum V, Nomikos N, Bachtalia K, Zisis K, et al. Cost–benefit analysis of single versus repeated use of single-use devices in cataract surgery. Clin Ophthalmol. 2021;15:1491–1501.

Article Google Scholar

Guidance 1 on Enforcement Priorities For Single-Use Devices Reprocessed by Third Parties and Hospitals. J Clin Eng. 2000;25: p 341–9.

Medical Devices Agency. Single‐use medical devices: implications and consequences of re‐use. Med Devices Agency Device Bull. 2000;4:1–9.

Google Scholar

Joint Commission International Accreditation Standards for Hospitals, 6th Edition. (Joint Commission Resources, Oak Brook, Illinois, USA, 2017).

Decontamination and Reprocessing of Medical Devices for Healthcare Facilities. World Health Organization and Pan American Health Organization (2016).

Roy M, Roy S, Maiti A, Yadav N. Intraoperative breakage of a reused 25-guage ILM peeling forceps. Int J Retin. 2021;4:178.

Article Google Scholar

Kothari A. Re-using the disposables in vitreoretinal practice. The Official Newsletter of theVitreoretinal society -India (36-38, March 2018).

Download references

Shri Bhagwan Mahavir Vitreoretinal Services, Sankara Nethralaya, Chennai, Tamil Nadu, India

Rajiv Raman & Chetan Rao

Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand

Paisan Ruamviboonsuk

Retina Center of Ohio, Miami, Voluntary Assistant Clinical Professor, Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA

Suber Huang

Department of Ophthalmology, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA

Tarun Sharma

You can also search for this author in PubMed Google Scholar

You can also search for this author in PubMed Google Scholar

You can also search for this author in PubMed Google Scholar

You can also search for this author in PubMed Google Scholar

You can also search for this author in PubMed Google Scholar

RRN; contributed to the conception, design, and wrote manuscript of the study. RRN, CR, PR, and SH drafted the work and TS substantively revised it. All authors reviewed the manuscript. RRN; takes the responsibility for the contents of the article.

Correspondence to Rajiv Raman.

The authors declare no competing interests.

Publisher's note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Reprints and Permissions

Raman, R., Rao, C., Ruamviboonsuk, P. et al. Single-use versus reuse of instruments in ophthalmic surgery. Eye (2023). https://doi.org/10.1038/s41433-023-02431-0

Download citation

Received: 29 December 2022

Revised: 14 January 2023

Accepted: 27 January 2023

Published: 08 February 2023

DOI: https://doi.org/10.1038/s41433-023-02431-0

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative