Project 2

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As a general rule, you should be 18 years or older. You must also have normal kidney function. There are some medical conditions that could prevent you from being a living donor. These include having uncontrolled high blood pressure, diabetes, cancer, HIV, hepatitis, or acute infections.

These parameters are considerd or test done during the kidney transplant.

figure-6.

1. Living kidney donation is the best option for people who need a new kidney.

Many living donors don’t want their loved ones to wait months or even years for a kidney on the national transplant waiting list. Transplant surgeons have successfully performed living kidney donation surgeries since the 1950s. In fact, donating a kidney is the most common living organ donation.

2. Living kidney donation is safe.

If you are healthy, donating a kidney won’t make you more likely to get sick or have major health problems. Like any surgery, the procedure does have some risks. But overall, living kidney donation is safe. In most cases, donating a kidney will not not raise your risk of kidney disease, diabetes, or other health problems.

3. You don’t have to be related to someone to donate a kidney to them.

In fact, one in four living organ donors is not biologically related to the recipient (the person who receives a donated organ). Spouses, in-laws, close friends, church members, and even members of the same community can all be living donors.

It's true that family members have a higher chance of being a good match. But living donor transplants are more successful compared to kidneys from deceased donors because these kidneys come from living donors.

4. You don’t need both of your kidneys to stay healthy.

It might surprise you to learn that your body doesn’t need two kidneys to perform an important job—removing waste and regulating your metabolism. After donating, your remaining kidney will take on the work of both kidneys.

5. Your blood and tissue type must be compatible with your recipient’s.

Besides being healthy, living donors must have compatible blood and tissue types with the kidney recipient. The transplant team will perform tests to see if your blood and tissues are compatible (are a healthy match) with the kidney recipient. If they aren’t, our living donor program can also educate you about the paired donation program.

6. You will have tests, screening, and evaluation to make sure you're a good match.

The transplant team will perform psychosocial and medical tests to help ensure you will stay healthy after your donation. Some tests you will have include:

• blood tests,
• urine tests,
• imaging exams, and
• cancer screenings.

7. Your hospital stay will be short and you can get back to work fairly quickly.

Most living kidney donors stay in the hospital for zero to one day. Depending on what you do for work, you can return to work as soon as two weeks or as late as eight weeks after your surgery. You also shouldn't lift anything heavier than 10 pounds for the first six weeks after your surgery.

8. You can still have a baby.

Donating a kidney won’t make it harder for you to get pregnant or deliver a baby. Living kidney donation doesn’t cause fertility problems in women or men. Still, women should wait one year after donating a kidney before they get pregnant. This gives your body plenty of time to heal.

9. You can talk to someone who's donated before.

Our living kidney donor program can help you speak with someone from our program who has donated a kidney. Donors often find it’s helpful to talk with another donor about their experiences.

10. You don't need to live in the same location as your recipient.

You can live anywhere in the country. Most of your testing can be done at a lab or hospital near your home. Your surgery will take place at the University of Utah Health. There are also organizations that can help you pay for travel costs.

Objective: To provide a step-by-step overview of the University of Florence technique for robotic living donor nephrectomy (LDN), focusing on its technical nuances and perioperative outcomes.

Methods: A dedicated robotic LDN program at our Institution was codified in 2012. Data from patients undergoing robotic LDN from 2012 to 2019 were prospectively collected. All robotic LDNs were performed by a highly experienced surgeon, using the da Vinci Si robotic platform in a three-arm configuration. In this report we provide a detailed overview of our surgical technique for robotic LDN. The main objective of the study was to evaluate the technical feasibility and safety of the technique, including perioperative surgical complications rate and mid-term functional outcomes.

Results: Overall, 36 patients undergoing robotic LDNs were included in the study. Of these, 28 (78%) were left LDNs. Median (IQR) donor pre-operative eGFR was 88 (75.6–90) ml/min/1.73 m². In all cases, robotic LDN was completed without need of conversion. The median (IQR) overall operative time was 230 (195–258) min, while the median console time was 133 (IQR 117-166) min. The median (IQR) warm ischemia time was 175 (140–255) s. No intraoperative adverse events or 90-d major surgical complications were recorded. At a median (IQR) follow-up of 24 months (IQR 11-46), median (IQR) eGFR patients undergoing in living donor nephrectomy was 57.4 (47.9; 63.9) ml/min/1.73 m².

Conclusions: In our experience, robotic LDN is technically feasible and safe. The use of robotic surgery for LDN may provide distinct advantages for surgeons while ensuring optimal donors' perioperative and functional outcomes.

• Introduction

Live kidney donors are healthy individuals who intentionally undergo major surgery to improve the well-being of another individual; as such, maximizing the donor safety during this procedure is of paramount importance.

Several surgical techniques have been described for living donor nephrectomy (LDN), including open, pure or hand-assisted laparoscopic, natural orifice transluminal endoscopic surgical (NOTES) and robotic approaches (1–4).

In this view, minimally invasive techniques are increasingly being performed worldwide with the aim to further limit the morbidity of surgery for the donors while ensuring optimal grafts for kidney transplantation (5). While laparoscopic living donor nephrectomy (LDN) has become a common procedure in most Transplant Centers and has been shown to be associated with shorter hospital stay, less pain, and faster recovery as compared to open surgery (6, 7), the use of robotic surgery in this setting might further improve its perioperative outcomes providing distinct benefits for both donors and surgeons (1). This is mainly due to the advantages of the robotic platform as compared to standard laparoscopy (improved ergonomics, Endowrist technology, magnification and 3D vision). Consequently, robotic LDN has been implemented and is being increasingly performed at referral Centers with expertise in both living donor kidney transplantation and robotic surgery (8–10), with excellent outcomes, comparable to those of pure laparoscopic LDN (1).

In this report we provide a step-by-step overview of the University of Florence technique for robotic LDN, focusing on its technical nuances and perioperative outcomes.

• Patients and Methods

Development of a Codified Robotic Living Donor Nephrectomy Program

A preliminary living donor kidney transplant program was set at our institution in 2002.

Between 2002 and 2011, 17 open living donor transplantations were performed. Of these, 15 LDNs were performed with an open approach while two with a pure laparoscopic approach.

In 2012, a well-codified robotic surgical program for LDN was established; this was followed by standardization of the surgical technique and development of a well-defined surgical team.

The transition to robotic surgery for performance of LDN occurred taking advantage of the progressive experience gained by our team in the field of open kidney transplantation (>650 from 1991) and robotic urologic surgery (for the treatment of prostate, bladder and kidney cancer).

A dedicated surgical team for robotic LDN was defined, including a surgeon who was highly skilled in robotic surgery and kidney transplantation (S.S.), bedside assistants experienced in laparoscopic surgery (urologists in training were allowed to assist together with a senior consultant), as well as highly skilled anesthesiologists and operating room nurses and support staff. This team remained essentially unchanged over the years.

• Patients and Dataset

After Institutional Review Board approval, data from patients undergoing robotic LDN from 2012 to 2019 were prospectively collected in an a priori developed web-based dataset.

All robotic LDNs were performed by a highly experienced single surgeon (S.S.). Since 2016, both LDN and kidney transplantation were performed in a twin operating theater, specifically designed to reduce the cold ischemia time during living-donor kidney transplantation (11–15).

Since 2017, kidney transplantation from living donors was also routinely performed with a robotic technique, introduced at our Center (11, 13, 15, 16) following a standardized program developed in collaboration with the European Association of Urology (EAU) Robotic Urology Section (ERUS) group (12, 14, 17, 18). At the beginning of our experience, RAKT was reserved for living donor kidney transplantation; afterwards, it was extended to deceased donors kidney transplantation following a well-codified framework (11).

Pre-operative assessment of living donors, as well as post-operative management and follow-up after LDN, were performed according to the latest EAU and KDIGO Guidelines (6, 19).

Donor candidates were evaluated by a multidisciplinary team. Donors had to be at least 18 years old and underwent a comprehensive pre-operative evaluation, including physical examination, laboratory tests, and psychiatric assessment.

A computed tomography (CT) angiogram and a renal scan with Tc 99m -DTPA (technetium-labeled diethylenetriaminepentacetate, a renal tubular function tracer) were performed by Institution protocol to evaluate both the donor's renal vascular anatomy and the split renal function.

The choice between right and left robotic LDN was always taken after a careful assessment of the donor's vascular anatomy (i.e., presence of multiple vessels and/or renal anomalies), split renal function at pre-operative renal scan, and surgeon's preference. No contraindication was set a priori regarding the use of right-sided kidneys.

Estimated Glomerular Filtration rate (eGFR) was calculated with the Chronic Kidney Disease Epidemiology Collaboration formula (20).

• Robotic Living Donor Nephrectomy: The University of Florence Technique

Robotic LDN was performed with a transperitoneal access using the da Vinci Si robotic platform (Intuitive Surgical Inc., Sunnyvale, CA, USA) in a three-arm configuration according to established principles (9).

The step-by-step overview of our surgical technique for left and right robotic LDN is provided in the Supplementary Video.

Step 1: Patient Positioning and Port Placement

After general anesthesia, the patient was placed in the right 70° lateral decubitus, for left nephrectomy, or in left 70° lateral decubitus for the right kidney (1, 9).

Port placement was performed according to the principles employed for radical nephrectomy for oncological reasons. In case of right LDN, one additional trocar (5 mm) was placed for liver retraction.

Our technique involves the use of two robotic arms, a 12 mm trocar for the camera and two assistant ports (5 and 12 mm, respectively) (Figure 1).

Initially, the Pfannestiel incision used for kidney extraction was performed when the kidney was completely free from all surrounding tissues (i.e., just before ligation and section of the renal vessels) (Figure 1A). More recently, we opted for placing the GelPOINT^TM hand-assisted device immediately during port placement (at the beginning of surgery) in order to both achieve a quick access for kidney extraction and to switch to a hand-assisted laparoscopic procedure in case of emergency (Figures 1B,C).

The GelPOINT device is placed at the level of the Pfannenstiel incision, with a 12 mm laparoscopic assistant port placed within the Gelseal cap. This port is used to maintain the pneumoperitoneum pressure using the AirSeal device.

After section of the renal vessels, just before kidney extraction, a 15 mm endobag is introduced inside the abdomen through the GelPOINT device by creating a hole in the Gelseal cap while maintaining the 12 mm port in place for the assistant.

Step 2: Identification of the Retroperitoneal Anatomic Landmarks of Dissection

The procedure began with the medialization of the colon along the line of Toldt. Then, the classical retroperitoneal landmarks were identified (psoas muscle, ureter, and gonadal vein).

On both sides, after the medialization of the gonadal vein, the ureter was lateralized and freed from all surrounding tissues. Following the gonadal vein, the renal hilum was identified (Figure 2A).

Step 3: Isolation and Dissection of the Renal Hilum and the Kidney

Once the renal hilum was identified, the renal vein and artery (and all potential accessory vessels) were carefully isolated. The ascending lumbar vein was routinely identified on the left side, isolated and transected.

On the left side, the adrenal vein was always carefully dissected and ligated with two Hem-o-Lok clips (Figure 2B). Any additional gonadal or lumbar vessels were also controlled in order to free the entire length of the renal vein.

On the right side, the renal vein is shorter but there is usually no need to control the adrenal, gonadal, and lumbar veins as they drain directly into the inferior cava vein.

After hilar dissection, the kidney was entirely mobilized and isolated from the perirenal fat tissue.

During this step, a key point is the preservation of the so-called “golden triangle,” namely the space between the ureter, the lower pole of the kidney and the renal vein. Preserving this space is indeed thought to ensure an adequate vascularization of the ureter, potentially reducing the risk of ureteral ischemia.

Step 4: Management of Renal Vessels

Once the whole kidney was isolated, two Hem-o-lok clips were placed at the level of the distal ureter (at the level of its crossing with iliac vessels), which is then sectioned.

Initially, the renal artery was controlled using two Hem-o-lok clips, as previously described (Figures 2C,D) (21). Thereafter, from 2017 onwards, we used the EndoGIA vascular stapler, in line with the FDA warning contraindicating the use of Hem-o-lok clips during LDN (21) (Figure 2E).

The renal vein, as well as accessory arterial or venous vessels, were ligated using either the EndoGIA vascular stapler or two Hem-o-Lok clips, according to the caliber of the vessel and/or surgeon's preference (Figure 2F).

After section of the ureter and the renal vessels, the assistant surgeon introduced the 15 mm endobag through the Gelseal cap and easily removes the kidney together with the cap keeping warm ischemia time to a minimum.

Hemostasis is then achieved, and a drain is placed in the renal fossa. The kidney is then prepared for transplantation at the back table.

• Post-operative Management

Our standard enhanced recovery after surgery (ERAS) pathway for LDN included (a) early patient monitoring in a dedicated “recovery room” by the anesthesiologic staff for 4–6 h, with early removal of the nasogastric tube (at the end of surgery); (b) use of low-molecular-weight heparin subcutaneously (enoxaparin 4000 U), started on post-operative day 1, to prevent deep vein thrombosis; (c) removal of the surgical drain on post-operative day (POD) 1; (d) early patient mobilization (i.e., patients were placed out of bed for 2–3 h the day of surgery, had a ward ambulation at least twice a day on POD 1 and 2 until complete physical rehabilitation); (e) management of post-operative pain with intravenous drugs (i.e., paracetamol 1.0 g three times a day, ketorolac 30.0 mg IV two times a day) for 24–48 h after surgery, then oral analgesic therapy as clinically indicated.

Results

Overall, 36 robotic LDNs were performed at our Center by a single surgeon during the study period.

• Donor and Graft Characteristics

The pre-operative clinical characteristics of the donors, including Charlson Comorbidity Index (CCI) (22), ASA score (23), are shown in Table 1.

Overall, the median (IQR) age was 55 (47–61) years and median (IQR) BMI was 25.6 (23.1–28.5) kg/m².

One patient had a history of prostate cancer treated at our center 8 years before living donor nephrectomy with robotic-assisted laparoscopic prostatectomy (RALP). Oncologic follow-up was negative (PSA < 0.01).

Median (IQR) pre-operative creatinine was 0.8 (0.7–0.95) mg/dL and median (IQR) pre-operative eGFR was 88 (75.6–90) ml/min/1.73 m².

Overall, 4/36 (11%) patients had a graft with two arteries and 1/36 (3%) had a kidney with two veins. For kidney transplantation, these cases were handled as follows: in one case, robotic kidney transplantation was performed with two separated arterial anastomoses to the external iliac artery; in the remaining three cases of multiple graft arteries, a single anastomosis was performed to the external iliac artery during robotic kidney transplantation after extracorporeal ex-vivo vascular reconstruction of the two arteries using a “pantaloon” technique; finally, in a case of a right-sided graft with two renal veins we performed a separated venous anastomosis to the external iliac vein during robotic kidney transplantation.

• Intraoperative Outcomes

Perioperative outcomes after the procedure are shown in Table 2.

In all cases, robotic LDN was completed without need of open conversion.

The median (IQR) overall operative time (from patient entry to exit from the operating theater) was 230 (195–258) min, while the median console time was 133 (IQR 117-166) min. The median (IQR) warm ischemia time was 175 (140–255) s.

Overall, 28/36 (78%) patients underwent left living donor nephrectomy.

No intraoperative adverse events were recorded in our series and no patients needed transfusions during or after the procedure. Overall, the median (IQR) length of hospitalization was 6 (5–7) days.

The figure-3, figure-4, figure-5. shows the transplantation of kidney by using the robotic surgery.

Da Vinci robot assisted surgery during transplantation of kidney

21st century has seen a boom in the medical industry with several new technologies being invented to treat complicated diseases. Da Vinci robot assisted surgery being one of them. This type of surgery has proved advantageous for both surgeons and patients for the treatment of numerous complicated diseases, including kidney related surgeries.

Kidneys play an important role in the functioning of human body system. We all know that they are two small bean-shaped organs located behind the abdomen and above the waist. Its main role is in processing blood, regulating blood pressure, maintaining calcium levels, and removing wastes, toxic substances, and excess fluids from the body. Kidney related disorders include:

• Bladder Problems
  • Ureter Blockage
  • Kidney Cancer and
  • Kidney stones

In case when both the kidneys get damaged, “kidney transplantation” takes place.

With the help of robotic surgery the doctors are able to conduct operation with much precision that was never before possible earlier. The Da Vinci Surgical System is the state-of-the-art technology helping doctors to provide several benefits concerning kidney surgery, including less complication during operation, controlling of kidney cancer, less pain & scarring, relatively low blood loss, low risk of infection, faster recovery, and comparatively less expense because stay in hospital is much shorter.

The pencil-thin four arms of robot holing camera in one hand and surgical instruments in other three are able to operate through a patient’s body in such a precise manner compared to traditional open surgery that it is helping surgeons to gain expertise in kidney or kind of urological surgeries like never before. Though the robot is performing the operation but actually it’s the surgeon who is in total control of the machine. Sitting behind the console, the surgeon provides instruction to the robot to move its arms for conducting the operation and its every move is monitored thoroughly. A well trained person is required to provide instructions to the robot but overall the Da Vinci assisted Robotic Surgery has made the operation of complicated diseases much easier.

So it’s advisable that if a patient is suffering from a complex kidney ailment then he/she should opt for Robotic Surgery, as this will help them to return back to the day-to-day activities of their life in a faster manner.

Posted in Kidney Surgery, Robotic kidney surgery, Robotic SurgeryTagged kidney cancer, kidney cancer surgery, kidney stone surgery, kidney surgery, kidney tranasplanation, robotic kidney surgeryLeave a commentfigure-7 is shows that the da vinci robotic system.Figure-8 and figure -9 shows the block diagram of da vinci system.Figure-10 shows that the flow chart of kidney transplantation.AI based robotic surgery.

In the last two decades, major advances in surgery have been facilitated by advances in the field of bioengineering, biotechnology and medical instrumentation. These have led to major patient benefits such as reduced perioperative morbidity and shorter hospital stay in all surgical specialities, in part due to the introduction of minimally invasive and robotic surgery [1]. Over the last half century, renal allotransplantation has developed as a superior renal replacement therapy compared with established dialysis methods [2, 3], becoming the gold-standard treatment for the majority of patients with established renal failure. In recent decades there has been significant progress in immunosuppressive therapies [4, 5] and advances in post-transplant management of recipients, resulting in improved graft and patient outcomes [6]. However, the surgical technique of allograft implantation has remained largely unchanged since the first successful living donor open kidney transplant in identical twins in 1954 [7]; the open surgical approach has stood the test of time. As with any major open surgical operation, open kidney transplant (OKT) is associated with morbidity such as post-operative pain, surgical site infection (SSI), delayed mobilization, significant time to return to daily activities and long-term complications such as incisional hernia. Transplant recipients with a high body mass index (BMI) face higher incidences of these inevitable risks of undergoing renal transplantation. These patients have higher rates of wound infections, hernia, associated poor graft outcomes [8, 9] and, on occasion, they may not be considered for renal transplantation. To address these issues, transplant teams have explored newer surgical techniques with the aim of further improving patient outcomes following surgery. The advent of robotics and its integration into surgical practice have revolutionized several areas of complex surgical enterprise. Some transplant teams have also incorporated robotic technology into various areas of transplantation, including donor nephrectomy. In this review we provide a contemporary overview and update on robot-assisted kidney transplantation (RAKT).

• THE TRADITIONAL SURGICAL APPROACH TO RENAL TRANSPLANTATION

For >60 years, kidney transplantation has been traditionally performed through an open oblique or ‘J-shaped’ incision in the lower lateral abdomen. The exact incision length and position is dependent upon surgeon preference, patient body habitus, BMI and prior transplant history among others. The most common incision used is the oblique or curvilinear incision known as the ‘pelvic Gibson incision’ [10, 11]. Running parallel to the inguinal ligament, the incision extends medially to the midline, 2 cm above the pubis and laterally to the anterior superior iliac spine. The abdominal muscles beneath the incision are divided in the direction of the incision and retracted. The ‘J-shaped’ or ‘hockey stick’ incision has become increasingly popular for kidney transplantation, with its pararectal position continued medially to the midline above the pubic symphysis, allowing division and retraction of the ipsilateral rectus muscle. The kidney graft is placed extra peritoneally, with end-to-side anastomosis of the renal vein and artery to the external iliac vein and artery, respectively (Figures​(Figures 1 1 and ​and12).2). Following successful reperfusion of the graft, the ureter is anastomosed to the bladder, creating a ureteroneocystostomy (Figure 13). This technique has remained unchanged for many years and provides a reliable method of access and implantation, with good results that are widely reproducible [12, 13]. In selected individuals a transperitoneal approach through a midline or paramedian incision is used if the standard iliac approach could prove problematic [14]. Situations in which this is helpful are in third and subsequent transplants and in paediatric recipients.

Despite the standardization and safety of this approach, it is well recognized that open abdominal incisions carry significant morbidity. They are associated with longer wound healing times, higher levels of post-operative pain and the need for higher doses of analgesia, prolonged recovery and hospital stay, incisional hernia as well as inferior cosmetic outcomes compared with minimally invasive surgical approaches [15–18]. Morbidity of open surgery is higher in patients with a high BMI, diabetes mellitus, smokers, renal failure and, importantly for transplant patients, immunosuppressive medication, most specifically steroids.

Minimally invasive surgery, favoured for its lower morbidity, has made significant technological advances and now plays a role in almost all forms of abdominal surgery [19]. It affords patients improved perioperative outcomes, including shorter hospital stay, reduced post-operative pain, lesser rates of wound infection and superior cosmetic results [20]. Minimally invasive surgery already plays a role in renal transplantation, with variations of laparoscopic donor nephrectomy becoming established as the gold-standard worldwide [8, 9]. The 6–10 cm incision required for minimally invasive donor nephrectomy allows safe donation with significant benefits for living donors [10, 11, 15, 19, 20]. For the implantation of grafts, various minimally invasive approaches have been explored to minimize the complications associated with the OKT approach.

To minimize wound-related morbidity, smaller open incisions of 7–10 cm have been trialled with limited success [21, 22]. Utilization of minimally invasive incisions requires careful patient selection, favouring those with lower BMI, thereby precluding its use in patients who may attain the greatest benefit. OKT through smaller incisions also increases the difficulty of already challenging vascular anastomoses, the most crucial technical component of a kidney transplant. The difficulty in balancing a minimally invasive cosmetic incision with a safe, effective vascular anastomosis, in conjunction with a restrictive patient cohort, has led to limited practice.

Following success with laparoscopic donor nephrectomy, attention inevitably moved towards attempting laparoscopic graft implantation. Rosales et al. [23] reported the first case of laparoscopic kidney transplantation (LKT) in 2010, also employing a smaller 7-cm incision to allow the graft to be placed in the abdomen. Modi et al. [24] demonstrated no difference in estimated glomerular filtration rate (eGFR) at 1 and 12 months between kidneys from single donors transplanted open and laparoscopically, respectively. However, operative and anastomotic times in the laparoscopic group were significantly longer. Modi et al. [25] also reported outcomes of 72 laparoscopic living donor transplants with successful outcomes. The LKT group required significantly lower quantities of morphine equivalent analgesia in the first 24 h post-operatively due to the minimally invasive incision. While eGFR was significantly less in the LKT group at days 7 and 30 post-operatively, no difference was observed between LKT and OKT at 3, 6, 12 and 18 months. Patient survival was also similar between the two groups, at 94.1% and 94.7%, respectively, at 22.3 months of follow-up. While the outcomes are comparable between OKT and LKT, the authors acknowledge the steep learning curve (LC) and need for further prospective randomized studies with large patient numbers to evaluate the actual benefits of LKT over OKT.

Despite the successes of Modi et al. [25], LKT has not been widely adopted, likely due to the challenges of performing vascular anastomosis with laparoscopic instruments and two-dimensional vision, causing loss of hand–eye coordination and the long instruments amplifying natural tremor and carrying a fulcrum effect, as well as poor ergonomics promoting surgeon' fatigue [26]. These technical difficulties are unlikely to change and therefore LKT is likely to remain in a few highly specialized centres with extensive expertise. This poses a challenge to larger prospective randomized multicentre studies required to robustly assess the potential benefits of LKT versus OKT.

• RAKT

Minimally invasive surgery has been enhanced by the introduction robots (Figure 14), which has a well-established role across several surgical specialties. A robot offers more dexterity, increased geometric accuracy, enhances the abilities to measure surgeon performance and reduces tremors and fatigue.

The da Vinci surgical system (Intuitive Surgical, Sunnyvale, CA, USA) is the most widely used robotic system in many surgical specialities and has demonstrated significant clinical benefits to patients over the last two decades [27, 28]. The three-dimensional views restore hand–eye coordination, with wristed instruments and tracking of movements thousands of times per second providing tremor filtration and scaled motion. These features provide significant operative advantages over laparoscopic surgery, particularly when the operative field is narrow and deep and fine dissection and microsuturing are required [28], as with the intrapelvic anastomoses of kidney transplantation. Seeking the benefits provided by the robot, several groups have pioneered robot-assisted donor nephrectomy and renal transplantation [29–32], with a significant reduction in surgical complications and graft outcomes compared with OKT. The first robot-assisted kidney transplant was performed in France in 2001 [33], when a cadaveric kidney was transplanted into a 26-year-old male using the da Vinci robot by a remote surgeon in another hospital, with an assistant in the operating theatre. While this ground-breaking achievement demonstrated the feasibility of RAKT, the authors commented that the operative time was greater than standard OKT and the cost of the procedure was extremely high.

Seven years later, Giulianotti et al. [29], from Chicago, performed the first full RAKT in a 29-year-old female with a BMI of 41 kg/m² via a 7-cm midline incision. The outcome was excellent, with immediate graft function, no perioperative complications and the patient safely discharged at day 5 with normal renal function. In 2011, Boggi et al. [30] reported the second European case of RAKT, a successful living-donor transplant from a 56-year-old mother to her 37-year-old daughter. The success of these pioneering single-case reports was built upon by a number of safety and feasibility studies [34, 35], which provided improved methods of robotic positioning, access and use of regional hypothermia and graft cooling for implant. Vascular anastomoses take longer when performed robotically, leading to longer warm ischaemic times (WITs), which are known to partially compromise renal function when >30 min [36]. A phase 2a innovation study [35] introduced the technique of RAKT with regional hypothermia provided by a reproducible technique that allows cooling of the graft through a wrapped gauze filled with ice slush, delivered intraperitoneally during implant, creating safe regional hypothermia (see supplementary video). The benefits of RAKT have been reproduced since [31, 32, 37–40] and the results confirmed by the large prospective multicentre studies of the European Association of Urology: Robotic Urology Section (ERUS)–RAKT working group [41–44]. These reported experiences suggest RAKT achieves comparable patient and graft survival outcomes as compared with OKT, with the added benefits of minimally invasive surgery [45, 46]. The ERUS–RAKT group [42] is currently the largest international collaborative on RAKT, with 10 centres across Europe maintaining a prospective dataset of >300 patients undergoing RAKT [35]. Their recent update demonstrates good surgical and functional results, comparable with those of OKT [47].

IEC 60601 FOR MEDICAL ELECTRICAL EQUIPMENT

With the publication of IEC 60601-1:2005 + A1:2012 + A2:2020, otherwise known as IEC 60601-1 (Edition 3.2), medical device manufacturers must be aware of the varying regulatory transition periods worldwide. Based on past experience with previous transition periods of international standards worldwide, it can be concluded that, as well for the Amendment 2:2020 of IEC 60601-1, a transition period will be given of 3-4 years minimum in the most countries and regions. However, it is also possible that very few countries will require standard compliance with the predecessor standard (edition 3.1) for longer times.

In the general standard of IEC 60601-1 are 78 issues addressed by the amendment 2:2020. Further 32 issues are addressed by several collateral standards such as IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-10, etc. Beyond that referenced standards are either completely new or significantly updated, e.g. IEC 62133-2, IEC 62366-1:2015+A1:2020, IEC 62368-1:2018, ISO 14971:2019. The particular standards IEC 60601-2-XY are planned to be published within 2 years until August 2022, or if the responsible part 2 standard committee will not keep the date, it will be published by the IEC Central Office in a formal way only (update of referenced standards only).

WHAT IS IEC 60601-1 (EDITION 3.2).

IEC 60601 is a series of technical standards that ensure the safety of medical electrical equipment. IEC 60601-1 (Edition 3.2) deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to ensure that no single electrical, mechanical, thermal or functional failure shall pose an unacceptable risk to patients and/or operators. It is assumed that public health authorities in many countries recognise IEC 60601-1 (Edition 3.2) as a pre-requisite for the commercialisation of electrical medical equipment. IEC 60601-1 (Edition 3.2) is the newest published general standard with around 1500 single specific requirements. The requirements are often recognised as State-Of-The-Art (SOTA) and are required to be met in different markets around the globe.

WHY IS IT IMPORTANT.

IEC 60601-1 (Edition 3.2) will probably become a widely accepted standard in the U.S., Canada, the EU, Japan, Brazil, Russia, and Australia. Some major import countries and regions (e.g. EU and Australia) for such equipment are required to take into account the state-of-the-art (SOTA) requirements why newer IEC/ISO standards cannot be ignored after their typically given transition period of 3-4 years will be expired. To avoid being denied entry into these and other markets, manufacturers should ensure that their products comply with both the Edition 3.1 and 3.2 of the standard.

IEC 61010 FOR IVD MEDICAL ELECTRICAL EQUIPMENT

IEC 61010-1 is the general standard for safety requirements for electrical equipment for measurement, control and laboratory use.

Electrical equipment for laboratory refers to

• Equipment that measures, indicates, monitors, inspects, or analyses materials, or is used to prepare materials
• In vitro diagnostic (IVD) equipment including self-test IVD equipment to be used in the home
• Inspection equipment to be used to check people or material during transportation

The IEC 61010-1 standard includes, but is not limited to, requirements regarding electrical hazards, mechanical hazards, the spread of fire from the equipment, as well as laser sources and sonic and ultrasonic pressure. The standard IEC 61010-2-101 is also applicable for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. This standard adds further product-specific requirements for in vitro diagnostic (IVD) medical equipment to the general standard such as biohazards and hazardous chemical substances.

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TÜV SÜD Product Service offers a full suite of testing and certification services for this standard that can be provided at our state-of-the-art facilities or on-site at your premises.

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WHY CHOOSE TÜV SÜD

With over 700 dedicated medical health and services experts situated in major markets worldwide, TÜV SÜD is one of the largest Notified Bodies in the world and the only one to have its own clinical expert team. We also have a dedicated Regulatory Foreign Affairs & Clinical Department to monitor developments in regulations for medical health services and devices globally.

With the widest range of accreditations, we possess an in-depth understanding of international standards and the medical health services sector. In addition to regulatory and quality assurance expertise, TÜV SÜD’s experts are also skilled in advanced medical device assessments for functional and software safety, especially related to essential performance.

YOUR BENEFITS AT A GLANCE

• Save time and money - by ensuring your product is compliant to both editions in your first prototype, thereby avoiding costly delays in redesign.
• Minimise risk - with redesign development right from the beginning.
• Benefit from global support - with engineers in your local markets that speak your language and are capable of conducting tests and audits.
• Work with a single-source partner - that is an internationally recognised testing body with a strong presence in major markets worldwide.