Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.

Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors onsite, ensuring efficient utilization of resources and the efficiency of inspection process. The objective of this research is to examine and document the shared encounters involving remote inspections and evaluations carried out by SFDA from 2020 to 2022. This will be achieved through the evaluation of the accuracy of document evaluation and the extent to which the objectives of smart GxP inspections were met. Data were collected from local and international smart inspections reports conducted by SFDA between 2020 and 2022, covering medical device manufacturers, pharmaceutical manufacturing sites, warehouses, accreditation offices, scientific offices, and food manufacturing facilities. The results indicate that smart GxP inspections were effective in achieving visit objectives, showing a high degree of document evaluation accuracy. The findings of this study support the use of smart GxP inspections as a valuable alternative to on-site inspections, offering a practical solution to regulatory compliance during the pandemic and beyond. Although the SFDA recognizes the usefulness of smart inspections in upholding regulatory oversight in the face of various challenges, it does not endorse the complete replacement of conventional on-site inspection methods. The SFDA acknowledges significant limitations associated with the current technological resources used in remote regulatory assessments, and these limitations will be explored in the relevant sections.

The Impact of Cybersecurity Practices on Cyberattack Damage: The Perspective of Small Enterprises in Saudi Arabia.

Small and medium-sized enterprises represent the majority of enterprises globally and yet have some difficulties in understanding the impact that cybersecurity threats could have on their businesses and the damage they could do to their assets. This study aims to measure the effectiveness of security practices at small-sized enterprises in Saudi Arabia in the event of a cybersecurity attack. Our paper is among the first research papers to measure the effectiveness of cybersecurity practices and the threat posed by cybersecurity breaches among small enterprises in the event of cybersecurity attacks. A total of 282 respondents participated, all of them representing small-sized enterprises in Saudi Arabia. The study applies multiple regression tests to analyze the effectiveness of 12 cybersecurity practices in three aspects: financial damage, loss of sensitive data, and restoration time, at small enterprises. The findings indicate that having an inspection team and a recovery plan may limit the financial damage caused by cybersecurity attacks on small enterprises. The results also show that cybersecurity awareness, knowledge of cybersecurity damage, and professionals' salaries were related to the loss of sensitive data. Furthermore, the results indicate that contact with cybersecurity authorities and having an inspection team have statistically significant effects on restoration time.

Levels of public awareness regarding cervical spine injury and the suitable first aid response among adults in Saudi Arabia.

OBJECTIVES: To evaluate the level of public awareness regarding cervical spine injuries among adult residents of the Kingdom of Saudi Arabia (KSA). METHODS: This descriptive cross-sectional study was carried out between June and November 2020. It involved structured questionnaires, collecting information on participant socio-demographic characteristics, first responder training status, and the awareness of cervical spine trauma and suitable first aid response. RESULTS: A total of 4914 respondents (age, 31.6 ± 11.8 years) completed the survey. Most participants (75.2%) reported road traffic accidents as a risk factor for cervical spine injury. Moreover, 79.4% of the participants reported that cervical spine injury may be accompanied by damage to the spinal cord. Motor and sensory disability, and trouble breathing were recognized as complications associated with cervical spine injuries by 52.1%, 39%, and 28.8% of the participants, respectively. Fewer than one in 3 participants was aware of cervical spine trauma or the suitable first aid response. CONCLUSION: Public awareness regarding cervical spine trauma is poor among the KSA residents, although most study participants were aware trauma victims should be immobilized at the site of the accident until the arrival of an emergency response team.

del Nido Cardioplegia in Adult Patients: A Propensity-Matched Study of 102 Consecutive Patients.

BACKGROUND: Paediatric del Nido cardioplegia (DNC) has been tested in selected populations of low-risk adult patients. This study examined its use in an unselected medium-to-high-risk adult population and compared the results with a propensity-matched population that received intermittent warm blood cardioplegia (IWBC). METHODS: Data from the last 1,000 consecutive adult patients who underwent a variety of surgical procedures under cardioplegic arrest with the use of IWBC or DNC between 2016 and 2018 were propensity score matched on preoperative clinical and demographic variables. Two (2) main populations were 102 patients who received DNC and another set of matched 102 patients from a total of 1,000 patients who received IWBC, along with a subgroup with an ejection fraction (EF) ≤40% (EFDNC vs EFIWBC). Postoperative outcomes were mortality, peak troponin T, postoperative EF%, and aortic cross-clamp time. RESULTS: There were no preoperative differences amongst the groups in the main cohort (Euroscore II: DNC 4.1±8, IWBC 4.0±7; EF%: DNC 47±10, IWBC 47±11) and in the subgroup (EF%: EFDNC 32±6%, EFIWBC 32±6%; p=0.45). There were also no differences in three of the outcomes. A significant postoperative improvement was noticed in the EF% in the DNC (32±6% 95% CI 29-34 to 39±12 95% CI 34-44; p=0.001) in the EFDNC group. CONCLUSIONS: This initial experience of del Nido cardioplegia proved to be effective in a variety of challenging pathologies in adult populations.

Complications of 411 laparoscopic urological procedures: A single surgeon experience.

OBJECTIVES: The aim of this study is to review the complications of laparoscopic urological procedures performed using a single surgeon during a 12-year period. MATERIALS AND METHODS: From June 2004 to May 2017, a total of 411 abdominal urological procedures were performed using the author. They included 250 varicocele ligations, 94 nephrectomies (simple, partial, radical, and nephroureterectomy), 34 adrenalectomies, 22 renal cyst ablation, and 11 pelvic lymph node dissections. Operative and postoperative complications were reviewed and analyzed. The results were analyzed using Chi-squared tests for statistical analysis. RESULTS: A total of 55 complications out of 411 procedures occurred in 26 patients with a total complication rate of 13.4%, 19 were major (4.6%), and 36 were minor (8.8%). Mortality occurred in two patients (0.5%). Conversion to open surgery was done in 5 patients (1.2%) to manage uncontrolled bleeding. Major intraoperative complications included vascular injuries (2.2%), injuries to the diaphragm (0.5%), bowel (0.7%), and pancreas (0.5%). Major postoperative complications included urine leak (0.2%) and pelvic lymphocele (0.2%). Minor intraoperative complications included bleeding during trocar access (4.4%) and subcutaneous emphysema (0.7%), whereas minor postoperative complications included atelectasis (1.2%) and ileus (2.2%). CONCLUSIONS: Even though the complications rate in this series was comparable to those of other studies in the literature, yet it remains higher than that of open surgery. The continuing advances in laparoscopic techniques will reduce the complication rate and will pave the way for laparoscopy to replace most currently practiced open surgical urological procedures.

Peritoneal Dialysis in Adult Patients with Permanent Suprapubic Catheter: A Single-Center Experience and Literature Review.

BACKGROUND: The aim of this paper was to review the feasibility of peritoneal dialysis (PD) in the presence of a permanent suprapubic catheter over a long follow-up period. METHODS: Twelve patients with automated PD and permanent suprapubic catheters were studied for complications over a period of 10 years. RESULTS: In all 12 patients, PD went smoothly. Two of our patients required removal of the PD catheter due to peritonitis. The overall rate of exit-site infection throughout the study was 41.7/patient-month and the difference between patients 60 years or older and those 25 years or younger was not significant (p = 0.3673). The overall peritonitis rate for all patients was 38.3 episode/patient-month, and none of the patients with ventriculoperitoneal shunt (VPS) had peritonitis. All patients with episodes of infection responded well to the proper antibiotics. CONCLUSIONS: The available data supported the feasibility of PD in patients with permanent suprapubic catheters; however, a greater number of patients with a longer follow-up period need to be studied to support our results.

Hydroxychloroquine-induced hypoglycaemia in non-diabetic renal patient on peritoneal dialysis.

Hydroxychloroquine (HCQ) is a commonly used drug for the treatment of systemic lupus erythematosus (SLE). Renal involvement is common in SLE. We present a 25-year-old woman with lupus nephritis on peritoneal dialysis whose lupus was quite silent for almost three years, and secondary to HCQ she developed severe hypoglycaemic episodes, which were completely resolved after stopping HCQ.

Acute Kidney Injury in Critically Ill Patients: A Prospective Randomized Study of Tidal Peritoneal Dialysis Versus Continuous Renal Replacement Therapy.

Few studies have discussed the role of peritoneal dialysis (PD) in managing acute kidney injury (AKI) in critically ill patients. The present study compares the outcome of AKI in intensive care unit (ICU) patients randomized to treatment with tidal PD (TPD) or continuous venovenous hemodiafiltration (CVVHDF). One hundred and twenty-five ICU patients with AKI were randomly allotted to CVVHDF, (Group A, N = 62) or TPD, (group B, N = 63). Cause and severity of renal injury were assessed at the time of initiating dialysis. The primary outcome was hospital mortality at 28 days, and secondary outcomes were time to recovery of renal function, duration of stay in the ICU, metabolic and fluid control, and improvement of sensorial and hemodynamic parameters. No statistically significant differences were observed between groups in regard to patients' characteristics. The survival at 28 days was significantly better in the patients treated with TPD when compared to CVVHDF (69.8% vs. 46.8%, P < 0.01). Infectious complications were significantly less (P < 0.01) in the TPD group (9.5%) when compared to the CVVHDF group (17.7%). Recovery of kidney function (60.3% vs. 35.5%), median time to resolution of AKI and the median duration of ICU stay of 9 days (7-11) vs. 19 days (13-20) were all in favor of TPD (P < 0.01). This study suggests that there are better outcomes with TPD compared to CRRT in the treatment of critically ill patients with AKI.

The Phantom of Metformin-Induced Lactic Acidosis in End-Stage Renal Disease Patients: Time to Reconsider with Peritoneal Dialysis Treatment.

♦ OBJECTIVE: Metformin continues to be the safest and most widely used antidiabetic drug. In spite of its well-known benefits; metformin use in end-stage renal disease (ESRD) patients is still restricted. Little has been reported about the effect of peritoneal dialysis (PD) on metformin clearance and the phantom of lactic acidosis deprives ESRD patients from metformin therapeutic advantages. Peritoneal dialysis is probably a safeguard against lactic acidosis, and it is likely that using this drug would be feasible in this group of patients. ♦ MATERIAL AND METHODS: The study was conducted on 83 PD patients with type 2 diabetes mellitus. All patients were on automated PD (APD). Metformin was administered in a dose of 500 - 1,000 mg daily. Patients were monitored for glycemic control. Plasma lactic acid and plasma metformin levels were monitored on a scheduled basis. Peritoneal fluid metformin levels were measured. In addition, the relation between plasma metformin and plasma lactate was studied. ♦ RESULTS: Mean fasting blood sugar (FBS) was 10.9 ± 0.5 and 7.8 ± 0.7, and mean hemoglobin A1-C (HgA1C) was 8.2 ± 0.8 and 6.4 ± 1.1 at the beginning and end of the study, respectively (p < 0.001). The mean body mass index (BMI) was 29.1 ± 4.1 and 27.3 ± 4.5 at the beginning and at the end of the study, respectively (p < 0.001). The overall mean plasma lactate level across all blood samples was 1.44 ± 0.6. Plasma levels between 2 and 3 mmol/L were found in 11.8% and levels of 3 - 3.6 mmol/L in 2.4% plasma samples. Hyperlactemia (level > 2 and ≤ 5 mmol/L) was not associated with overt acidemia. None of our patients had lactic acidosis (levels > 5 mmol/L). Age ≥ 60 was a predictor for hyperlactemia. No relationship was found between plasma metformin and lactate levels. ♦ CONCLUSION: Metformin may be used with caution in a particular group of ESRD patients who are on APD. Metformin allows better diabetic control with significant reduction of BMI. Information on the relationship between metformin and plasma lactate levels is lacking. Peritoneal dialysis appears to be a safeguard against the development of lactic acidosis in this group of patients.

Iatrogenic submucosal tunnel in the ureter: a rare complication during advancement of the guide wire.

BACKGROUND: Inserting a guide wire is a common practice during endo-urological procedures. A rare complication in patients with ureteral stones where an iatrogenic submucosal tunnel (IST) is created during endoscopic guide wire placement. OBJECTIVE: Summarize data on IST. DESIGN: Retrospective descriptive study of patients treated from from October 2009 until January 2015. SETTING: King Fahd Hospital of the University, Al-Khobar, Saudi Arabia. PATIENTS AND METHODS: Patients with ureteral stones were divided to 2 groups. In group I (335 patients), the ureteral stones were removed by ureteroscopy in one stage. Group II (97 patients) had a 2-staged procedure starting with a double J-stent placement for kidney drainage followed within 3 weeks with ureteroscopic stone removal. MAIN OUTCOME MEASURE(S): Endoscopic visualization of ureteric submucosal tunneling by guide wire. RESULTS: IST occurred in 9/432 patients with ureteral stones (2.1%). The diagnosis in group I was made during ureteroscopy by direct visualization of a vanishing guide wire at the level of the stone (6 patients). In group II, IST was suspected when renal pain was not relieved after placement of the double J-stent or if imaging by ultrasound or intravenous urography showed persistent back pressure to the obstructed kidney (3 patients). The condition was subsequently confirmed by ureteroscopy. CONCLUSION: Forceful advancement of the guide wire in an inflamed and edematous ureteral segment impacted by a stone is probably the triggering factor for development of IST. Definitive diagnosis is possible only by direct visualization during ureteroscopy. Awareness of this potential complication is important to guard against its occurrence. LIMITATIONS: Relatively small numbers of subjects and the retrospective nature of the study.

Symptomatic cycling Cushing disease managed by simultaneous bilateral laparoscopic adrenalectomy in a 11-year-old boy.

We report symptomatic cycling Cushing disease in a 11-year-old boy that was managed with simultaneous bilateral laparoscopic adrenalectomy. Positioning and the surgical technique have been fully described. Excellent results were achieved. Recent application of laparoscopic adrenalectomy for various adrenal pathology is highly effective and offers better results than open surgery. Post-operative recovery after laparoscopic technique is significantly shorter than the open technique.

Laparoscopic adrenalectomy: 10 years experience.

PURPOSE: Laparoscopic adrenalectomy is considered the standard technique for the surgical removal of the adrenal gland. Shorter length of stay, decrease in postoperative pain and reduced complication are all the advantages of the laparoscopic approach. This report is about a 10-year single experience with laparoscopic adrenalectomy. MATERIALS AND METHODS: A total of 34 lateral transperitonial laparoscopic adrenalectomies were performed. 24 right-sided lesions and 10 left-sided lesions were removed. The indications for surgery were aldosteronoma in 20 patients and nonfunctioning adenoma in 10 patients, and 1 child underwent bilateral adrenalectomy for bilateral adrenal hyperplasia. RESULTS: All except one had successful laparoscopic adrenalectomy. Complication occurred in one patient who required open conversion because of bleeding. In addition, one patient suffered a pancreatic injury where the patient was managed conservatively. The average operative time was 2 hours and 30 minutes and the hospital stay was 2.5 days. CONCLUSION: Laparoscopic adrenalectomy is technically feasible and reproducible. Lateral transperitoneal approach offers advantages including better visibility and easy access to other organ systems. There is always a learning curve for the urological laproscopy.

Ureterovaginal fistulas: The role of endoscopy and a percutaneous approach.

PURPOSE: The aim of the study was to evaluate the minimal invasive approach and endourological techniques in managing the iatrogenic ureterovaginal fistula. The etiology and the diagnostic tools were also looked at. PATIENTS AND METHODS: A retrospective study was conducted on 20 patients with ureterovaginal fistulas. The main causes for these were gynecological and obstetrical procedures. In all cases, the diagnosis was based on clinical presentation, intravenous pyelography, and cystoscopy. Various therapeutic methods were used. Eleven patients were treated by the endoscopic placement of a ureteral stent and 13 patients (including four with failed initial ureteral stent insertion) received ureteral reimplantation. Of these, two patients were treated by the Boari flap method, six by Psoas hitch, four by simple ureteric reimplant, and one by transureteroureterostomy. RESULTS: Of the 11 patients treated by the endoscopic placement of a ureteral stent, 7 (64%) were successfully managed with this treatment alone. The remaining 4 (36%) also had open surgery. A total of 13 patients (including the 4 initially treated with endoscopic placement) underwent successful ureteric reimplantation. Routine cystoscopy revealed that 2 of the 20 patients (10%) had a concurrent vesicovaginal fistula. CONCLUSION: A ureterovaginal fistula is a rare but a relatively frequent complication of pelvic surgery. We recommend a minimal invasive approach including ureteric stent insertion as primary management and routine cystoscopy to rule out an association of a vesicovaginal fistula.

Retrograde upper-pole calyceal access for percutaneous nephrolithotripsy of stones in the lower-pole calyx.

OBJECTIVE: To present the results of upper calyceal access during percutaneous nephrolithotripsy (PCNL) for stones in the lower calyx, as PCNL is considered the most effective minimally invasive surgery for managing lower calyceal stones, with percutaneous access either directly to the lower calyx or through an upper or middle calyx. PATIENTS AND METHODS: The study included 76 patients with single (51) and multiple (25) stones in the lower calyx, and stones in the lower calyx plus renal pelvis (six) and associated pelvi-ureteric junction obstruction (PUJO, five). They were managed by PCNL using retrograde access through the upper-pole calyx in addition to laser endopyelotomy for the PUJO. RESULTS: The mean duration required for establishing the retrograde nephrostomy tract was 14.4 min, and for completing the procedure was 40 min. The mean fluoroscopy exposure time was 3.2 min. Access from the upper calyx allowed easy and rapid advancement of the nephroscope to the lower calyx. The stones varied in size, at 10-25 mm. Stones were cleared completely in 70 of the 76 patients (92%); the stone-free rate was 100%. The residual stone fragments (2-4 mm) in the remaining six patients (8%) were considered insignificant. Complications were minor in four patients (5%), and included pleural effusion in two, bleeding in one and an arteriovenous fistula in one. CONCLUSIONS: Upper-pole calyceal access for PCNL provides easy and effective clearance of stones in the lower calyx. This access should be considered for PCNL of single or multiple stones in the lower calyx.

Minimally invasive treatment of ureterovaginal fistula: A review and report of a new technique.

BACKGROUND: An iatrogenic ureterovaginal fistula (UVF) can be a consequence of difficult pelvic surgery. The patient must endure a long wait before having major surgery to reconstruct the injured ureter. Reports that address the minimally invasive treatment of UVF are limited, and are reviewed here. We introduce the concept of using a Memokath™ 051 stent (PNN A/S, Hornbaek, Denmark) as a promising minimally invasive approach for UVF. METHODS: We used PubMed, Science Direct, Google and the Cochrane Library to assemble appropriate evidence-based reference reports. The keywords used for the search were: 'Memokath', 'stent'; 'ureterovaginal fistula' and 'ureteral injury'. The review showed 42 relevant articles published up to September 2011. RESULTS: Ureteric stenting consistently stopped the vaginal leak of urine. The long-term results were not encouraging after removing the JJ stents at 3 months after insertion. Most patients had a recurrence of the vaginal leak of urine. The outcome was different with the Memokath stent, that remained in situ for a duration far exceeding that of the JJ stent. The Memokath stopped the vaginal leak of urine with no episodes of urinary tract infection and no evidence of stent migration. CONCLUSION: Long-term ureteric stenting has two advantages, in that it facilitates urine flow through the ureteric strictured segment down to the bladder, and it stops urine leakage along the fistula. It further promotes the resolution of the ureteric stricture and healing of the fistula. A duration of 3 months was inadequate when a JJ stent was used, whereas longer periods are possible with the Memokath stent. The optimum stenting period required for complete healing of a UVF remains to be defined. Long-term Memokath ureteric stenting can be an effective alternative and minimally invasive approach to conventional surgical repair in selected cases.