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How single-use devices, customised packs and preloaded IOLs could save time and money (1)

Howard Larkin

Posted: Thursday, November 1, 2018


With ageing populations exploding demand for cataract surgery and straining healthcare budgets, the need for increasing efficiency in cataract surgery grows more urgent every day.

At the ESONT Annual Meeting 2018 Alcon sponsored an educational session moderated by ESONT board member Margarita Acebal on how single-use devices, customised surgery packs and preloaded IOLs could significantly improve operating room efficiency and even save money – all while supporting optimal patient outcomes and experience. (1,2,3,4,12)

Milenko Stojković MD, PhD, Head of Clinic for Eye Disease of the Clinical Centre of Serbia and Professor of Ophthalmology at the University of Belgrade Faculty of Medicine, knows first-hand the challenges of reusing medical devices designed for single use. He recently treated three patients for toxic anterior segment syndrome (TASS) traced to remnants of ethylene oxide used to sterilise phaco fluidics tubing designed for single use.

Medical devices marked by the single-use symbol (left) are not intended to be reprocessed; Custom-Pak® Surgical Procedure Packs combine all products necessary for each surgical procedure

Prof Stojković believes the tubing was not left long enough to allow remaining ethylene oxide to evaporate. But manufacturers, understandably, do not make recommendations for sterilising single-use items, leaving providers with the burden of developing procedures on their own, mandatorily based on inadequate degree of evidence. “It’s just a wild guess you need to leave [the tubing to dry] for three days. It may be five, it may be four or seven, so it’s really dangerous to do this,” he said.

Reuse of single-use products and use of various cleaning agents were shown to be significant TASS contributing factors in a large international study. Other reuse-related TASS causes include endotoxins from ultrasonic baths and residual lidocaine, viscoelastics and benzalkonium chloride from topical anaesthetics and antibiotics from previous surgeries. (5)

“While TASS is one of the most feared cataract surgery complications, it is far from the only reuse-related problem,” Prof Stojković noted. He has treated endophthalmitis cases, including several related to lint from reused compresses that have infected surgical wounds.

Inadequate cleaning of phaco irrigation/aspiration instruments may also risk endophthalmitis. (6)

“Surgical difficulties due to damage is another risk of instrument reuse,” Prof Stojković noted. He cited two studies suggesting phaco tips should be used only once.

A recent study found reuse increased torsional phaco time and energy in hard cataracts. Another found deteriorated cutting edges and deposition of biological material on reused tips. (7,8)

“Steam and vapour sterilisation also can damage and dull knives, scissors and forceps, often rendering them incapable of performing precise surgical tasks, such as constructing self-sealing incisions,” Prof Stojković added.

“Still, budget and supply shortages push many centres to reuse single-use devices,” Prof Stojković said. But considering the financial and human cost of resulting complications, any potential savings could be illusory. “There is a good reason to use these devices only once,” he concluded.

Customised surgical procedure packs can help to improve many aspects of cataract surgery, including increasing efficiency in the operating room (OR), easing compliance with regulations and reducing costs related to packaging waste. (1)

Including all essential items for surgery in a single package may also lower total costs by reducing storage space, as well as staff time spent on materials handling, sterilisation and OR setup.

“The advantages offered by pre-packaged surgical kits for cataract surgery are well known in my OR practice,” said Cristina Vatovec, scrub nurse at the Eye Clinic, University of Trieste, Italy. Using Alcon Custom-Pak® increases efficiency at virtually every step.

Surgical kits comply with all European Union laws, regulations and Eucomed guidance, (4) including listing indications and providing references stickers for tracing by patients and hospitals. “This significantly reduces staff effort for tracking multiple individually packaged devices, and because items are used only once, it reduces time spent re-labelling reused devices,” Ms Vatovec said.

Customised packs reduce staff time – and the risk of staff errors – for handpicking several items before surgery. “This helps prevent waste and delays, and may lead to safe and efficient intra-operative management of the procedure,” Ms Vatovec noted. Removing items from a single sterile container instead of opening 20 or more individual packages reduces setup time and OR turnover time as well.

“Including all items for surgery in a single pack helps train newly hired nurses in learning skills rather than gathering items and opening packages,” Ms Vatovec added. Customised packs cut down on inventory ordering, check-in, verification and management time. For a practice doing 3,000 surgeries annually, they can eliminate 50,000 or so packages, reducing waste and waste management costs significantly. (9)

Ms Vatovec has found manufacturers very co-operative when it comes to customising surgical kits. “The key is to ensure that the kits include everything that’s needed and nothing that isn’t,” she said.

Continuous review by surgeons and nurses is required to ensure kit contents keep up with new surgical techniques and emerging practice requirements. The packs are personalised to meet the specific needs of the surgical team, and components are packed in the order the customer specifies, called sequencing, creating efficiency in the operating room.

For maximum efficiency, pack needs should be planned in advance and co-ordinated with the manufacturer to ensure timely delivery. In case of dropped items, extra supplies of individual items should be kept on hand.

“Uniform packs have made a significant contribution to our surgery centre’s efficiency,” Ms Vatovec said.

The UltraSert® Pre-loaded Delivery System
is designed to safeguard cataract surgical
outcomes by protecting every detail of IOL delivery

Loading intraocular lenses (IOLs) into injectors is one of the most complex and challenging surgical preparation steps. “Using preloaded IOLs reduces stress on staff, reduces risk of lens haptic positioning problems, reduces risk of scratches on the IOL optic and may reduce overall surgery time,” said Cristina Garcia Gutiérrez, scrub nurse at Hospital Miguel Servet, Zaragoza, Spain.

Manually loading IOLs into injectors “is difficult and it should be a walk in the park”, Ms Garcia Gutiérrez said. “Switching to the preloaded Alcon UltraSert® IOL system has eased the problem in my centre, reducing preparation time, lens delivery and unfolding time and total procedure time, as well as staff costs,” she added.

Ms Garcia Gutiérrez cited a study of 220 procedures comparing three preloaded and one manual delivery system. The preloaded systems reduced effort in surgery, and the UltraSert® preloaded delivery system also resulted in less wound stretch and less induced corneal astigmatism one day after surgery than the others. (10)

Similarly, an ex vivo study of porcine eyes showed some variation in ease of use among six preloaded insertion systems, with UltraSert® scoring easy on all parameters. (11)

“Preloaded IOLs are much more likely to deliver the lens correctly into the capsule,” Ms Garcia Gutiérrez noted. An internal Alcon study found preloaded IOLs were inserted with the leading haptic correctly positioned 98% of the time. (12) “In my experience for the last three years we have been using the Alcon preloaded IOLs, it has been even better than that,” she reported.

Preloaded lenses eliminate one of the most difficult training tasks, Ms Garcia Gutiérrez said. “It’s hard to teach a new colleague to fold the lens without touching it.” Eliminating the task could increase efficiency by avoiding the need to bring in an experienced nurse to load the injector, or delaying surgery to have the surgeon do it.

Using IOL injectors may also reduce the risk of endophthalmitis compared with forceps insertion. (13)

“Considering that preloaded IOLs save time, training and the risk of improperly inserted or damaged IOLs, using them is not a difficult choice,” Ms Garcia Gutiérrez said. “Preloading reduces stress and leaves more time for the patient and that is what it is all about.”

The ophthalmologic market has been facing an increasing amount of business funded through public tenders as healthcare budgets come under heavier pressure to control costs: as such, it’s more than important to look into products and solutions that can increase efficiency and ensure better workflow, ultimately driving cost reduction.

Assessing the impact of single-use devices and customised surgical packs on every aspect of patient outcomes and clinic management is essential to understand the broad scope of efficiency, effectiveness and cost savings benefits they may provide. (1,2,3,4,12)

All opinions are based on healthcare professionals’ own clinical experience

1 Gonzalez T et al. Operating Room Time Savings with the Use of Splint Packs: A Randomized Controlled Trial. Arch Bone Jt Surg 2016; 4(1): 10-15
2 MHRA Regulating Medicines and Medical Devices; Single-use medical devices implications and consequences of reuse, Dec 2013
3 Report on the issue of the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC; Brussels, 27.8.2010
4 EUCOMED White Paper on the reuse of single use devices; Dec 15, 2009
5 Cutler Peck CM et al. Toxic anterior segment syndrome: common causes. J Cataract Refract Surg 2010; 36(7): 1073-80
6 Leslie T et al. Residual debris as a potential cause of post-phacoemulsification endophthalmitis. Eye (Lond). 2003 May;17(4):506-12
7 Demircan et al. The Impact of Reused Phaco Tip on Outcomes of Phacoemulsification Surgery. Current Eye Research 2016; 41(5): 636-642.
8 Cecchini P et al. Chemical and physical analysis of phaco handpiece tip surfaces before and after cataract surgery. J Cataract Refract Surg 2017; 43(8):1107-114
9 Luthe R. The Leader of the Pack: Pre-packaged surgical kits make for a smoother and more profitable surgery. Ophthalmology Management March 1, 2009
10 Mendicute J et al. Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system. Clin Ophthalmol 2018; 12:1495-1503)
11 Nanavaty MA et al. Evaluation of reloaded intraocular injection systems: Ex vivo study. J Cataract Refract Surg 2017; 43:558-563
12 Alcon Data on File. TDOC-0053876 (July 11, 2017)
13 Weston K et al. An 8-year retrospective study of cataract surgery and postoperative endophthalmitis: injectable intraocular lenses may reduce the incidence ofpostoperative endophthalmitis. Br J Ophthalmol 2015;99(10):

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