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To Reuse or Not to Reuse Disposables … that is the Question!

While some surgeons wouldn’t consider reusing disposable tools, others in developing countries are doing so out of potential necessity. This is because reusing single-use instruments may help doctors treat their patients at lower costs.

In countries like India, where the nominal per capita income in 2017 was $1850, reducing treatment costs is essential. “In vitreoretinal surgery, the cost of consumables is a significant percentage and consequently drives the patient’s surgical package,” said Dr. Abhishek Kothari, director and chief vitreoretinal surgeon at the Pink City Eye and Retina Institute in Jaipur, India.

A package for vitreoretinal surgery in India costs between $500-1200 (USD), while a single-use vitrectomy consumable pack costs around $300-400, noted Dr. Kothari. Besides the pack, other items such as forceps and silicone oil may also be used in surgeries, so costs can go up to approximately $500. This can make the procedure unviable for the healthcare provider.

As such, the ‘reuse’ approach is followed in large scale, Dr. Kothari said, from large high-volume institutes to smaller private practices, to make vitreoretinal surgery more affordable.

“Almost every single hospital in Southeast Asia implements this reuse practice, but there is no scientific study or research on its safety,” he said. “Every single hospital in India uses single use consumables more than once, and from what I have gathered from my friends in other neighboring countries like Pakistan, Afghanistan, Bangladesh and Nepal, they all do it. I have visited some African countries, and they do it too. It’s not a choice here, it’s a necessity given the economics.” 

He said some surgeons in the more affluent west also do this, but the instruments are sent to professional reprocessing units. “When a surgical set is reused, the consumables cost comes down significantly. This enables us to provide treatment at affordable costs and gives us leeway in extending the benefit of treatment to socio-economically weaker patients,” explained Dr. Kothari. 

Reusing tools also reduces waste in many cases – for example, when a surgeon needs to open a complete pack for a silicone oil removal when a cutter is not needed. Reusing instruments also reduces the amount of non-biodegradable plastic waste that is generated for each surgery, thereby saving plastic waste from ending up in landfills or in oceans.

The argument against reuse

On the other hand, Dr. Diva Kant Misra, an ophthalmologist at Sri Sankaradeva Nethralaya, India, says: “To state it simply, disposable surgical items are supposed to be disposed after a single use . .  so, re-using them goes against the basic principle of ‘disposable’ instruments.”

However, Dr. Misra acknowledges that the financial burden of vitreoretinal procedures is at times unbearable for patient: “Reusing disposable items is a desperate attempt by the treating surgeon to make the procedure affordable for the patients.”

And while there are financial advantages to reusing disposables, Dr. Misra says there are also safety disadvantages.

“The reuse of instruments always poses a considerable threat to patient’s safety in terms of cross infection, including blood borne diseases,” he explained. “The devices are not designed to be reused; thus, the patient’s safety is also is also threatened by malfunction and breakage linked to reuse.”

So, what’s the main concern for reusing disposable surgical tools? According to Dr. Misra, it’s the ever-present risk of endophthalmitis. Therefore, he cautions that the proper sterilization of surgical instruments is vital for safety of these procedures.

“Sterilization is a tedious procedure involving collection, cleaning, disinfection, sterilization, packaging, transportation and storage – and this gives a lot of room for damage and loss,” he explained. “Retina surgeries are extremely delicate procedures requiring high degrees of precision and control. The wear and tear occurring due to reuse and repeated sterilization may affect the high quality and precision that is desired from these instruments.”

Dr. Misra adds: “Disposable instruments are supposed to save costs and be safer for the patient by doing away with the sterilization process and by removing the risk of suboptimal sterilization.”

A study in sterilization

The question remains, however, as to how safe the practice is, and whether there are risks for the patients. 

“The reuse of disposable surgical instruments is quite prevalent in developing countries like India, so much so that every surgeon that I know regularly reuses disposable instruments,” said Dr. Misra. “Though no peer reviewed published data exists which would guide us in making the best decision, but at times the best decision might be unaffordable to the patient.”

Looking for answers – and for cost-effective patient solutions – Dr. Kothari conducted a study* to scientifically assess safety and other issues in reusing single-use tools and disposables in vitreoretinal practice.

A typical vitreous surgery includes the use of solid instruments like trocar-cannula sets, endoilluminators, laser probes and consumables with hollow tubing and cavities, such as cassettes, vitrectomy probes and connecting tubing. 

Cassettes and tubing that handle potentially contaminated fluid need to be cleaned thoroughly so that organic matter is not left inside the cavities. These then need to be sterilized with a process that ensures efficient microbial kill on the surface, as well as throughout the inner cavity, along the complete length of the tubing.

In the study, trocar cannula sets are subjected to enzymatic and ultrasound cleaning to remove all organic material from the surface. They are then dried and packed before being sterilized by ethylene oxide (EO) sterilization. Endoilluminators, laser probes and diathermy cables are wiped repeatedly with 98 percent alcohol before drying and packaging for EO sterilization. Cassettes and tubing of vitrectomy probe and other tubing are lavaged with 98 percent alcohol to inactivate contaminants and dissolve organic matter, and subsequently lavaged with sterile distilled water. 

Thorough drying of the cassette and tubing is needed to ensure effectiveness of sterilization and this is achieved by forcing pressurized nitrogen through the tubing to force out fluid, followed by a period of drying before packing and EO sterilization.

To ascertain the microbial safety of the instruments, cultures were obtained from the surfaces of trocars, endoilluminators, laser probes, cassettes and vitrectomy probes.

Lavage fluid was also obtained from the instruments and subjected to microbiology.

“The cultures did not reveal any growth,” noted Dr. Kothari. As the tubing and cavities could be a source of endotoxin despite being sterile, fluid throughputs from them were subjected to bacterial endotoxin testing (BET) by the Limulous Amoebocyte Lysate (LAL) test, which is used to certify endotoxin safety of solutions meant for parenteral use.

Electron microscopy was also used to assess degradation of trocar tips after reuse. The results of the study showed that a total of 25 cultures of both aerobic and anaerobic from instrument surfaces and fluid lavages did not reveal any growth.

Endotoxin was not detected in any of the 18 specimens of fluid lavages subjected to BET-LAL testing. Electron microscope imaging of the trocar tips revealed “minimum change in morphology” for two to three uses.

The study noted that “there was some degradation and deformation of the trocar tip beyond third use, however, and significant distortion in the tip morphology of the trocars used five times to create sclerotomies”.

The study also included cases such as macular holes, epiretinal membranes and vitreous hemorrhage in the clinical chart review.

Out of a total of 126 eyes that underwent 23-gauge surgery for the above indications, 35 eyes underwent surgery with new instruments while the rest underwent surgery with reprocessed tools.

There was no difference in the incidence of endophthalmitis, or unusual post-operative inflammation, sclerotomy-related breaks or iatrogenic retinal detachments between the two groups. 

“However, there was a higher need for sutures to seal sclerotomies in the reuse group,” noted Dr. Kothari. “Thus, standard and meticulously adhered to protocols of reprocessing can ensure the availability of instruments that are safe for reuse.”

The performance of most components of a vitrectomy instrument pack does not degrade over three to four reuse cycles, he said. He cautioned however that sharp edges of trocars can wear out with repeated use and may need replacement after two to three uses, or at the first sign of increased tissue resistance. Continuous monitoring of the reprocessing practices and the sterilization technique is crucial to ensure sterility. 

The degradation of reused instruments, like trocars, is also a concern for Dr. Misra. “We would all want to use high-end cutting-edge equipment to effectively and safely to treat our patients, but that is not always possible,” he shared. “We should adopt a strategy which balances both the worlds: We should limit the reuse of disposable equipment to one or two times, and they should be sterilized using standard and strict protocols.”   

However, as regulations are continuously becoming more stringent, Dr. Misra advises that uncertain surgeon dispose of items after a single use, wherever possible, as the ideal solution.

Addressing the cost of vitreoretinal surgery

It’s critical to counsel patients if they choose to allow surgeons to use reprocessed instruments to reduce their costs.

“Though it may be ideal to utilize new sets of consumables for every case, most of us lack such utopian settings,” said Dr. Kothari. “A significant cost reduction can well be achieved without compromising on surgical safety and quality. This can bring down overall surgical costs and increase the affordability of vitreoretinal surgery for the vast majority of our patients.”

For Dr. Misra, he says that a holistic approach should be taken to make treatment more cost-effective for patients. “Correct surgical decision is the very first step toward making vitreoretinal surgery more cost-effective,” he explained. “Whenever indicated, a scleral buckle may be less expensive than a vitrectomy for retinal detachment repair; similarly, a pneumatic retinopexy may be a cost-effective option in the right case.”

In addition, he says that planning the surgery and aligning the subsequent follow-ups with the patient’s schedule may bring down the financial burden associated with traveling and loss of work hours. 

Further, Dr. Misra says using indigenously developed instruments and equipment can help lower the cost drastically. “Using them and helping indigenous companies in refining their products is a worthwhile investment for future cost-cutting,” he concluded.  

* Kothari, AR. Re-using disposables in vitreoretinal practice. Newsletter of the Vitreoretinal Society of India, March 2018. pg 24-26

Dr Kothari

Dr. Abhishek R. Kothari, MS, FMRF, FICO, FRCS

Dr. Abhishek R. Kothari, MS, FMRF, FICO, FRCS, completed his undergraduate medical education from Coimbatore Medical College and ophthalmology residency from S.M.S. Medical College, Jaipur. He completed a fellowship in vitreoretinal surgery at Sankara Nethralaya, Chennai and worked at the world renowned Aravind Eye Care System in India. He has presented several research papers and has won prestigious awards at national and international fora (including The All India Ophthalmologic Society Academic Research Committee Award 2007, S Natarajan All India Ophthalmologic Society award for best paper in Retina in 2009, the International College of Ophthalmology Merit Award 2009, the Best paper in the All India Ophthalmologic Society Retina 2010, The Natarajapillai Award 2010, Asia Pacific Vitreoretinal Society Merit award 2010, the Rajasthan Ophthalmic Premier League Award 2012 and many others). He has also delivered numerous presentations in various national and international conferences. Dr. Kothari has published several papers and is the chief editor of a textbook on vitreoretinal surgery (Principles and Practice of Vitreoretinal Surgery, Jaypee Brothers, New Delhi), besides having authored several chapters in other textbooks. He is actively working on automated image recognition in OCT images using artificial intelligence/deep learning techniques, and has interests in the economization of high quality healthcare. He has trained several Indian and overseas vitreoretinal fellows.  Email: dr.a.kothari@gmail.com.

Dr. Diva Kant Misra, DO, DNB, MNAMS, FVRS

Dr. Diva Kant Misra, DO, DNB, MNAMS, FVRS has completed his long term Vitreo-Retina Surgery fellow from Sri Sankaradeva Nethralaya. He holds the post of General Secretary, Young Ophthalmologists Society of India & Chief Editor, Young Ophthalmologists Times. He is the recipient of various Ophthalmic awards like, APAO Achievement Award, Bangkok 2019, Best of IJO Award 2017-18, Ophthalmic Hero of India 2017 & 2018, KOS International Travel Grant 2019, Busan, The Yasuo Tano Award from Asia Pacific Academy of Ophthalmology, Singapore in 2017 and The APVRS Tano Award 2018, Malysia  and other national & state level awards. He has published extensively (26 publications (Indexed & Non Indexed) and book chapters) and has presented in conferences held at various and has presented in conferences held at various international and national forums. He has been an invited faculty in various international forums like EURETINA, APAO & AAO. Email: divakant@gmail.com.

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