Reuse of Single-Use Devices in Endourology: A Review

Abstract

Introduction:

Single-use medical devices (SUDs) are labeled for single use only, but rising health care costs along with the absence of visible deterioration in the quality of SUDs after one use have led to their reprocessing and reuse. In the past, SUDs mainly consisted of equipment such as guidewires and catheters. However, SUDs have now expanded to flexible endoscopes and energy devices that are much more expensive. Reuse of such devices raises concerns of infection transmission, safety, and lack of effectiveness. We reviewed the disinfection process, cost benefits, potential harms, and legal status of the reuse of SUDs in endourology.

Materials and Methods:

PUBMED, Embase, and the Cochrane Library databases were searched for articles published between 1970 and March 2023 that reported the reuse of SUDs using the search terms “reuse”; “single-use device”; “disposable medical devices”; “reprocessing of single-use device”; “endourology”; and keywords related to cost, safety, sterilization, and legal status. Online resources were found using Google search engines. Articles on cost savings, device malfunction, disinfection, or legal status in different countries were reviewed.

Results and Conclusions:

Reusing SUDs has financial, environmental, and practical advantages. The potential savings on medical expenses is the most compelling argument for reprocessing disposable devices. Reusing medical equipment also contributes to the reduction of toxic biodegradable waste. However, there is a scarcity of data on the safety and efficacy of reused SUDs. For patient safety and to avoid complications, the practice must be regulated with established reprocessing standards.

Introduction

Endourologic procedures are among the most common surgeries performed in urology. It has been one of the most rapidly progressing specialties: a growth that has been possible singularly because of the advancements in technology and armamentarium. These include endoscopes that have a smaller caliber, better vision, and greater maneuverability; energy sources that are more powerful but also more precise and flexible; and accessories such as wires, sheaths, and baskets that enhance the reach of these instruments and the safety of the procedures.¹

All these, of course, come with an increased cost. These include capital expenditure for the equipment and recurring costs for disposable or single-use accessories. Over the past few years, there has been a further change with some expensive equipment, such as flexible endoscopes, which were earlier reusable in multiple patients also becoming disposable. The shift to disposable devices is neither new nor unique to urology. Such changes have occurred regularly in all spheres of medicine such as gloves, gowns, drapes, syringes, and needles, which are now routinely disposable were reused not too long ago.

The change occurred because of improved quality of disposable products, easier inventory management, reliability of sterility, and consistency of quality.² However, this was potentially associated with increased costs and an environmental impact related to their packaging and disposal.² Counterarguments against these concerns were the higher capital and maintenance costs of reusable devices and the environmental impact of their washing and sterilization.³

Disposable devices are typically labeled as single-use devices (SUDs) by the manufacturers. There are legal liabilities associated with reusing such devices in another patient.⁴ Inadequate disinfection of SUDs may jeopardize patient safety and result in the transmission of infection from patient to patient. There are concerns regarding the safety of reprocessed SUDs and their ability to perform as well as new devices.⁵ The issue of cost–benefit also needs to be evaluated scientifically since the cost of reprocessing and restocking SUDs may potentially negate any savings.

The reuse of SUDs continues to be studied scientifically and practiced routinely, particularly in regions where patients pay out of pocket for surgeries and can save money by allowing the reuse of SUDs.⁶ We reviewed the current literature for the disinfection process, cost benefits, potential harms, and the legal status of reusing SUDs in endourology.

Methods

To assess the status of the reuse of SUDs in endourology, we reviewed PUBMED, Embase, and the Cochrane Library databases for articles published from 1970 to March 2023 that reported the reuse of SUDs. Search terms included “reuse”; “single-use device”; “disposable medical devices”; “reprocessing of single-use device”; “endourology”; and keywords related to cost, safety, sterilization, and legal status. In addition, Google search engines were used to identify additional materials and information online. These were supplemented by manually searching bibliographies, full text, and articles published in English. Articles were considered for review if they reported outcomes related to cost savings, malfunction of devices, disinfection process, or legal status in different countries.

Results and Discussion

Reuse of SUDs has to be evaluated in terms of the process required for making SUDs fit for reuse, potential harms, and benefits of such reuse. The major harm would be the transmission of infection or failure of the device to perform to the same level as originally intended. The potential benefits would be decreasing costs and environmental impact.

Reprocessing of endoscopic devices and accessories

SUDs are designed to be used once and discarded.⁷ A reusable medical device can be used on the same or different patients, multiple times with proper cleaning and reprocessing. Reprocessing is the validated process to make a previously used or contaminated medical device fit for subsequent use.⁸

The practice of reusing SUDs began in the late 1970s to reduce expenses.⁹ Reprocessing of devices is intended to remove soil and contaminants while disinfecting or sterilizing the equipment. When reprocessing medical devices, it is to be assumed that they will be contaminated with the most resistant of microbes. In addition, it is essential to maintain the resilience and functionality of the device during reprocessing.

Reprocessing involves cleaning, disinfection, and sterilization of the equipment that includes steps such as disassembly, cleaning, checking, testing, packing, relabeling, and sterilization. A repurposed SUD must comply with the same regulations as the original device before it can be used on another patient.¹⁰

Classification for medical devices

The U.S. Food and Drug Administration (FDA) considers a medical device to be “sterile” if it has undergone processing to achieve a sterility assurance level of 10⁻⁶ or a one-in-a-million chance of a nonsterile occurrence. This level of sterility cannot be achieved through high-level disinfection.¹¹ FDA-approved Spaulding's classification labels medical devices according to the infection risk level associated with their use in health care facilities. Medical devices are classified into three risk categories: critical, semi-critical, and noncritical.^12,13

Devices that come in contact with a break in the mucous membrane or enter a sterile body cavity or vascular system are categorized in the critical or high-risk category, and only sterilization is recommended. This category includes rigid endoscopes, ureteral catheters, and double-lumen ureteral stents. Devices that come in contact with a mucous membrane or nonintact skin are semi-critical or intermediate risk categories, and either sterilization or high-level disinfection is recommended. Most endourologic instruments, such as noninvasive flexible endoscopes, cystoscopes, ureteroscopes, nephroscope, and guidewires, come under this category. Devices that come in contact with intact skin are of the noncritical or low-risk category and require disinfection only, such as the endoscopy camera.

Steps in sterilization

The bioburden on rigid endoscopes, after use, ranges from 10¹ to 10⁴ colony forming units (CFUs) per device and the bioburden in the channels of flexible endoscopes has been reported to be 7.0 × 10⁹ CFUs.¹⁴ Cleaning removes 4 logs of microorganisms from clinically used endoscopes and experimentally contaminated endoscopes.^15,16 For these reasons, decontamination/cleaning is universally recommended as a key component of sterilization and disinfection processes.¹⁷

In most cases, used medical devices carry a relatively low bioburden of microorganisms. Nystrom and colleagues¹⁸ reported that after use, 62% of the instruments were contaminated with <10¹ CFU organisms, 82% with <10² CFU organisms, and 91% with <10³ CFU organisms. More than 98% of the devices had <10¹ CFU organisms after being washed in an instrument washer, with none having >10² CFU organisms. Previous studies reported that the bioburden on the inner and outer surfaces of rigid lumen medical devices ranged from 10¹ to 10⁴ CFU organisms per device, and 83% of the devices had a bioburden of <10² CFU organisms after cleaning.^18,19 The steps involved in the sterilization of endoscopic instruments are given in Table 1.²⁰

Table 1.

Steps of Sterilization of Endoscopic Instruments

Dismantling	Separating the component of the instruments.
Precleaning	Removal of gross soiling by blood/body fluid.
Cleaning	Manual or mechanical with water, detergent, or enzymatic products.
Drying	Using an air blower or oven, if compatible.
Packaging	In instrument trays or baskets for sterilization.
Loading	Instruments are kept in perforated trays.
Sterilization	Varies with instrument type and availability of the sterilization process.
Storage	Packaging material porosity and storage conditions affect how long a sterilized instrument can be kept.
Monitoring	Mechanical, chemical, and biologic indicators evaluate sterilization status.

The complexity of modern endoscopes has increased the difficulty of sterilizing them. Sterilization reduces the risk of infection, with a sterility assurance of 10⁻⁶ being achieved. Most endoscopes, including rigid, fiber optic, and chip-on-tip digital flexible endoscopes, can be sterilized with hydrogen peroxide. Although ethylene oxide (ETO) can be used for many instruments, the preparation time is longer. Despite its widespread use, glutaraldehyde acts only as a high-level disinfectant. In a retrospective analysis of plasma sterilization for endourologic procedures, Parikh et al.²¹ discovered that the hydrogen peroxide gas plasma technology-based system is highly effective and safe for sterilizing heat-labile instruments such as semirigid, flexible, and chip-on-the-tip endoscopes and other endourology equipment.

In comparison with the available literature, they discovered a statistically significantly lower septicemia rate among patients undergoing ureteroscopy (URS) and/or retrograde intrarenal surgery. There were no reported health risks associated with plasma sterilization. There was no damage to the endoscopes or instruments. Potential sterilization procedures for different endourologic devices are listed in Table 2.

Table 2.

Sterilization Process for Endourologic Instruments

Instruments	Sterilization process
Camera head	ETOS, HPS, GHD
Light and high-frequency cables, transurethral resection loop	ETOS, HPS
Energy probe, metal forceps, working element	Autoclave, ETOS, HPS
Rigid endoscopes	Autoclave, ETOS, HPS, GHD
Flexible endoscopes	ETOS, HPS, GHD
Sheaths	Steam, autoclave, ETOS, HPS, GHD
Guidewires, stone baskets; laser fiber	ETOS, HPS, GHD
Fascial dilators, balloon dilators	ETOS, HPS
Morcellator, Ellik evacuator	ETOS, GHD

ETOS = ethylene oxide sterilization; HPS = hydrogen peroxide gas plasma sterilization; GHD = 2% glutaraldehyde high-level disinfection.

Advantages of reuse of SUDs

Cost efficacy

Calculating costs per use depends on several factors other than simply the purchase price of the equipment. For reusable devices, this includes the number of times it is used, the costs of repairs, and the reprocessing charges. The number of uses varies with the surgeon, procedure, and maintenance among other variables. Thus, calculating actual costs is not easy.

Afane and colleagues²² compared the average number of uses before the need for repair between reusable digital ureteroscope and reusable fiberoptic ureteroscope and concluded that an average number of uses is 21 times in digital ureteroscope as compared with 6–15 times for a fiberoptic ureteroscope. Kramolowsky and colleagues²³ conducted a cost analysis of flexible ureteroscope repairs and recommended that replacing a flexible ureteroscope instead of repairing may be financially sound after a certain number of uses.

According to a recent review, purchasing costs for reusable flexible URS (F-URS) ranged from US$ 13,611 to 85,000, whereas a single-use F-URS costs between US$ 800 to 3,180 depending on the country and device brand.²⁴ Yitgin and Karaköse²⁵ studied efficiency, safety, and cost analysis after repeated use of disposable F-URS and they reported cost savings with the use of disposable F-URS. Purchasing costs of the devices were $ 14,400 for reusable F-URS and $ 1,800 for disposable F-URS with 10 h limit in disposable F-URS.

The authors stated that reusing disposable F-URS reduces costs without increasing complication rates and is safe, effective, and cost-effective without increasing the frequency of infections. Another study found that the entire operating room time was shorter in the disposable F-URS group, and the time was stated to be cost-effective.²⁶ Although there is little data on costs from developing countries, it is expected that the cost per use of reused SUDs is lower in these regions. This is because of lower manpower costs and thus lower reprocessing expenses.

Environmental impact

In addition to economic savings, reuse can reduce hazardous biodegradable waste that is produced when medical devices are disposed of, which will decrease environmental footprint. Owing to its positive effects on the environment, reprocessing has been recognized as a leading green purchasing strategy. Manufacturing, repairing, and cleaning of endourologic instruments, such as flexible ureteroscopes, use a significant amount of energy, contributing to the environmental impact of CO₂ emissions.²⁷ The use of fossil fuels to cause climate change is a major threat to the environment on a global scale.^28,29 The U.K. National Health Service emits 20 million tons of greenhouse gases annually and contributes 25% of all public-sector emissions.³⁰

Davis et al.³¹ compared the carbon footprint or the environmental impact of reusable and single-use flexible ureteroscopes and reported a per-case lifecycle carbon footprint of 4.47 kg of CO₂ for reusable ureteroscopes vs 4.43 kg of CO₂ for single-use ureteroscopes. In another study, Hogan et al. compared the carbon footprint of reusable vs single-use flexible cystoscopes based on waste production with estimated carbon emissions to be 4.23 kg of CO₂ (IQR 4.22–4.24) per case vs 2.41 kg of CO₂ (IQR 2.40–2.44), respectively, suggesting that SUDs have a significantly lower impact on the environment in terms of carbon footprint.³² Similar lower impact of SUDs was reported by Boucheron and colleagues in a retrospective analysis of >1500 cases.³³

However, data on the environmental impact are variable among studies. Kemble and colleagues compared environmental impact and carbon footprint of reusable vs single-use flexible cystoscope and reported that per case total estimated carbon footprint was 0.53 kg CO₂ and 2.40 kg CO₂, respectively, with lower environmental impact of reusable cystoscopes.³⁴ Some of the discrepancies could be because of variations in methodology and techniques used to assess environmental impact, and more data, particularly on reuse of SUDs, would be required.

Potential risks of reprocessed devices in endourology

Reprocessing of reusable endoscopic equipment has been associated with persistent contamination, and evidence of clinical infection in some cases. It has been found that devices with narrow lumen or interlocking parts are more likely to trap debris that cannot be easily removed during cleaning, and that failure of terminal processing to disinfect or sterilize such devices increases the risk of disease transmission.³⁵

Data on the reuse of flexible endoscopes

Legemate et al.³⁶ investigated the frequency of preoperative and persistent microbial contamination of reprocessed flexible ureteroscopes and the relationship between contamination and cumulative ureteroscope use. They found microbial contamination in one-eighth of the flexible ureteroscopes after high-level disinfection reprocessing. Uropathogens were found to be the source of contamination in 2.3% of all procedures. Only on rare occasions was a reusable flexible ureterorenoscope contaminated with uropathogens.

The effectiveness of sterilization for flexible ureteroscopes was studied by Ofstead and colleagues³⁷ They reported that discoloration, fluid residue, foamy white residue, scratches, and channel debris were all visible on every ureteroscope manually cleaned and sterilized with hydrogen peroxide gas. All ureteroscopes were found to be contaminated during testing (microbial growth 13%, adenosine triphosphate 44%, hemoglobin 63%, and protein 100%). By reprocessing guidelines, they advocated for regular audits of reprocessing procedures and the use of cleaning verification tests and visual inspection.

Even when institutional reprocessing protocols were created to be consistent with guidelines, a recent prospective study showed multiple instances of contamination. This may be because of problems with reprocessing as well as ureteroscope defects. Institutions that strictly adhere to guidelines are still worried about contamination, and this has led to the promotion of disposable devices.³⁸

Lee and colleagues³⁹ reported post cystoscopy infections and device malfunctions in reprocessed flexible cystoscopes. They analyzed the MAUDE (The Manufacturer and User Facility Device Experience) database data between January 2015 and December 2020 and discovered 335 adverse events associated with flexible cystoscopes. Infection (n = 121), mechanical malfunction (n = 6), and allergic reaction (n = 1) were the most common causes of adverse events. In 29 of the infections, the same organism grew in both the device and the patient. Five infectious outbreaks were discovered, and each outbreak was traced back to a single cystoscope.

These data would suggest that reuse of devices, both reusable and SUDs, is associated with higher risks. However, the detection of organisms through culture techniques does not always result in adverse patient outcomes.

Data on the reuse of guidewires/balloon catheters

Guidewires are among the most used SUDs in endourology. They are among the least expensive equipment but also most amenable to reuse since they are solid and resilient. In contrast, balloon catheters have narrow lumen and depend on elastic properties that may not be sustained on repeated use. The majority of data on reuse of wires and balloon catheters come from cardiology. Reusing balloon catheters may be associated with greater operating difficulty. Gruntzig and colleagues⁴⁰ used balloon dilation for the first time to treat coronary blockage in 1973.⁴¹

Initial success with balloon dilation in treating vascular stricture led to its promotion for use in treating ureteral stricture and studies have reported ureteral stricture can be effectively treated with balloon dilation.⁴² Although studies on the reuse of balloon catheters in endourology are lacking, there is a wealth of published data on the reuse of balloon catheter in percutaneous coronary intervention.

Eiley et al.⁴¹ reported the effects of gas sterilization on the hydrophilic guidewire surface structure, slipperiness, and bacterial growth after one or three sterilizations. They found no bacterial growth after gas sterilization and that light microscopy at 100 × and 400 × magnifications revealed no changes between new and reprocessed wires even though scanning electron microscopy (SEM) revealed various irregular surfaces. Gas sterilization had no effect on the lubricious qualities or surface coating of wires' hydrophilic coating.

Plante et al.⁴³ reported that reused catheters lengthened the angioplasty procedure time with an increased rate of failure to cross the stenosis. Burton and colleagues found an increased complication with the use of reused angioplasty catheters. Some studies have reported altered physical properties and surface morphology of reused balloon angioplasty catheters after reprocessing.⁴⁴

Trudel et al. reported that reused balloon catheters took a longer time to inflate and deflate and were proportional to the number of reuse cycles.⁴⁴ Mussivand and colleagues reported new catheters to have smooth particulate-free surfaces, whereas used balloon catheters had scratches, pits, and debris, and burst balloon catheters had cracks.⁴⁴ Grimandi et al.⁴⁵ found particles burst bubbles, uncoated areas on irradiated reused catheters, cellular elements found on the spiral of guiding catheters, and dried fluid with erythrocytes on the balloon surface.

Long narrow lumen makes reprocessing of angiographic and interventional catheters challenging. Angioplasty catheters must be flushed and suctioned to remove contrast media from the balloon lumen before it crystallizes.⁴⁶ Sterilization with ethylene oxide is the preferred method, but its cytotoxic residuals must be effectively removed. The mechanical integrity of the balloon and the entire pressure system of an angioplasty catheter must be evaluated. Deflated balloons often do not restore their original tight shape and may include organic waste observable by electron spectroscopy.

Avitall et al.⁴⁷ reported deflectable catheters to remain functionally consistent in deflection and torque, as well as electrical integrity up to five times. Tessarolo and colleagues⁴⁸ reported no differences in the radiofrequency ablation effectiveness, and electrode conductivity among catheters that had been reprocessed up to 10 times, even though catheters started to become less lubricious after four cycles. After five reuses, material properties change and the surface roughens, increasing bacterial persistence. This number should be determined by the reprocessing protocol and device type.⁴⁹

Gelamo et al.⁵⁰ concluded that ethylene oxide did not cause morphologic or chemical changes, making it suitable for guidewire coating integrity, but polymer-coated guidewires were unsuitable for ultrasonic cleaning as chemical reaction and mechanical vibration may have caused further deterioration of guidewire coating.

Kapoor and colleagues⁵¹ proposed in a consensus document of guidance on the reuse of cardiovascular catheters and devices that interventional catheters should not be reused more than three times because of the risk of mechanical integrity and function loss.

Data on the reuse of vessel sealing devices and energy sources

Energy devices form a significant part of the cost of urologic procedures, particularly in minimally invasive surgery. Reusing SUDs could offset much of this cost. However, energy devices may be prone to malfunction on reuse since they have sensitive tips that could get degraded after repeated use.

Mihanović and colleagues⁵² compared the performance of new vs reused Harmonic^® (Johnson & Johnson) scalpel in patients with acute appendicitis who underwent laparoscopic appendectomy and found comparable outcomes in the form of device performance, complications, and surgeon's subjective assessment of device function. Kuvaldina et al.⁵³ evaluated the number of use and sterilization cycles that can be safely applied to a single-use vessel sealing device (LigaSure, Covidien) and reported that after a minimum of 10 cycles, the vascular seal failed because of inadequate tissue apposition.

Quitzan and colleagues⁵⁴ evaluated the performance after reuse and resterilization of an endoscopic 3 mm bipolar vessel sealing device and concluded that reuse/resterilization is safe for up to nine cycles. Chivukula et al.⁵⁵ compared the new with reprocessed vessel sealing devices and found reprocessed devices typically cost 30% less on each device.

Quitzan and colleagues⁵⁴ also reported biologic contamination along with structural damage in the reprocessed devices compared with new devices. In reprocessed devices, significant amounts of residual organic material were seen. SEM analysis of reprocessed devices revealed liquid-patterned residues and diffuse soiling with foreign material. The sterility level of reprocessed devices was <6⁻³. SEM shows cracking and pitting on the plastic jaws, possibly from thermal cycling or harsh reagents. The dispersed presence of glass fibers indicates matrix degradation.

Data on reuse of disposable laparoscopic instruments/trocars

Laparoscopic trocars are available as both SUDs and reusable devices. The reusable devices are made of metal, making it possible to autoclave them for sterilization. Their hollow channels raise a concern about the ability to remove debris and sterilization of nonautoclavable disposable devices. The complexity of disposable trocars may make it more difficult to sterilize than reusable trocars.

Gundogdu and colleagues⁵⁶ reported only 1 bacterial growth in 45 cases using 2% glutaraldehyde used for the disinfection of disposable laparoscopic trocars. DesCoteaux et al.⁵⁷ found 1.8% of wound complications in 816 patients with reused disposable laparoscopic instruments. They concluded effective and safe reuse of disposable laparoscopic instruments without risking increased complications.

Colak et al.⁵⁸ reported the efficacy and safety of reusing disposable laparoscopic instruments in laparoscopic cholecystectomy and found trocar-side infections in 1.6% of patients with single-use disposable laparoscopic instruments and 3.2% with reused disposable laparoscopic instruments. No bacterial growth was found in the trocar samples or the other instrument samples or in the glutaraldehyde solution after a standard cleaning and disinfecting procedure.

Data on the reuse of laser fiber

Chapman and colleagues⁵⁹ studied the cost–benefit of disposable laser fiber with reusable laser fibers in flexible ureterorenoscopy. They reported use of disposable laser fiber decreases the number of laser-damaged ureteroscopes, which decreased repair costs by £ 16,800. Using disposable laser fiber is more economical because it avoids ureteroscope damage that can result from microfractures with repeated laser use. In addition, this will reduce the amount of time and/or resources needed for sterilization.

Legal status of reuse of SUDs

Many countries and associations have guidelines on reuse of SUDs. These are given in Table 3.

Table 3.

Legal Status of Reuse of Single-Use Device in Different Countries

Country	Legal status of reuse of single-use devices
USA	40%–50% of U.S. hospitals reprocess SUDs through third parties. 25% of hospitals recycle SUDs.⁶⁰ Hospitals and reprocessors that reuse SUDs must follow the same rules as the original manufacturers. Most hospitals reprocess reusable medical devices while outsourcing single-use devices.⁶⁰
Canada	The federal health care agency recommends reprocessing SUDs only in facilities with a quality reprocessing system. 28% of hospitals reprocess SUDs, and 85% reprocess in-house. 40% have no written policy, and 12% have no incident reporting mechanism.^61,62
South America	In Brazil, Colombia, Chile, and Ecuador, reprocessed SUDs are expensive. In Chile, it is against the law to reprocess medical equipment used for intravenous treatments.⁶³ 97% of hospitals in Brazil recycled SUDs such as cardiac catheters and angiography devices.⁶⁴
Australia	From 2005, Australia only allowed SUD reuse if all reprocessors, including hospitals, met medical device manufacturer regulations.⁶² To prevent patient cross-contamination, the Australian Infection Control Guidelines 2003 recommend disposing of single-use equipment.⁶³
New Zealand	The governing body regulator in New Zealand requires compliance with U.S. regulatory policy or approval under Australian policy before reprocessing a single-use product.⁶⁵
Europe	Nearly every nation in Europe permits reprocessing⁶⁶
Germany	Reprocessing allowed; 40% of hospitals reuse SUDs⁶³
Madrid	Reprocessing allowed; 80% of hospitals reuse SUDs⁶³
Denmark	Reprocessing allowed; 37% of hospitals reuse SUDs⁶⁷
Netherlands, Denmark, Slovakia, Finland	Reprocessing of SUDs is allowed.⁶⁶
Portugal	Third-party facilities for SUD reprocessing are allowed for SUD reprocessing
France	Reprocessing of SUD is not allowed.^68,69
Ireland, Spain, Italy, Czech Republic, Austria, Hungary	Recommendations for the reuse of SUDs were not made.⁷⁰
Estonia, Latvia, Lithuania, Malta, Cyprus, Greece, Poland	There is no legislation.⁶³
United Kingdom	Guidelines for the reprocessing of SUDs were published in 2016. Another guideline regarding the effects and consequences of SUD reprocessing was released in 2018.^71,72
Asia:	The reuse of SUDs is generally not governed by any national regulations. In Asia, third-party reprocessors need to provide their services. Most reuse in Asia takes place at the user-facility level in an unregulated manner.
Arab countries	Reprocessing is prohibited by an informal policy that was adopted by the Saudi Food and Drug Authority (SFDA). No third-party reprocessors; SUDs are reprocessed locally in-house⁶³
Israel	There are no laws or regulations in Israel that specifically address the reprocessing of SUDs. Without any oversight or controls from the federal government, hospitals in Israel are reusing a variety of SUDs.
China	Reusing SUDs is prohibited by the China Food and Drug Administration (CFDA)⁷³
India	Devices must be used in accordance with their labels, according to the Drugs and Cosmetics Act; In-house reprocessing is prevalent in India.²
Pakistan	SUDs reprocessed in-house⁶³
Japan	In Japan, 80%–90% of hospitals recycle SUDs⁷⁴
South Korea	Hospitals frequently refurbish SUDs, despite the fact that recycling of medical waste, including SUDs, is prohibited.⁷⁵
Africa	At the user-facility level, reprocessing is carried out in both Africa and the Middle East. National medical device reuse and reprocessing standards exist in some African countries⁶³

SUDs = single-use devices.

Conclusions

The most convincing argument for reprocessing disposable devices is the potential savings on medical expenditure. Reusing medical equipment may also help reduce the amount of toxic biodegradable waste. However, data on the safety, benefit, and effectiveness of reused SUDs are limited. Regulation of the practice, with established standards for reprocessing, is required for patient safety and to prevent complications.

Authors' Contribution

R.G. contributed to conceptualization, methodology, and writing–original draft preparation; R.K. was involved in conceptualization, methodology, writing–reviewing and editing, and supervision.

Footnotes

Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

Abbreviations Used

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