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Objectives To identify the potential opportunities and risks around future UK regulatory reform of medical devices. Design A mixed methods approach, comprising a rapid literature review, one-to-one, semi-structured interviews with key stakeholders, a multidisciplinary stakeholder workshop, and a post-workshop survey. Setting United Kingdom. Participants 32 key stakeholders across the medical device sector were identified both from the public and private sectors. Results Opportunities relating to regulatory independence were identified, including the potential to create and implement a regulatory framework that ensures availability of medical devices; innovation and investment potential; and safety to the citizens of the UK. The most significant risks identified included threats to the safety of individual patients and the wider health system arising from the delay in awaiting regulatory approval due to the shortage of approved bodies; and reduced competitiveness of UK market and device manufacturers. Recommendations were identified to mitigate risks, centred on harnessing broader cross-sector collaborations, promoting patient and public partnership, and maximizing international engagement. Conclusions The UK’s medical device sector is at a time-critical juncture to construct a regulatory framework to navigate its exit of Europe and respond to Europe's transition to new medical device regulations whilst also addressing the ongoing demand for rapid approval for new devices in response to the global pandemic. Investment, capacity-building, and international engagement will play a central role in mitigating risks and maximizing opportunities for medical device regulation.

Aim To evaluate changes in corneal higher-order aberrations (HOAs) following epithelium-off accelerated corneal cross-linking (A-CXL) and to explore the impact on visual acuity. Methods In this retrospective case series, 32 eyes of 24 patients with keratoconus (KC) underwent A-CXL. Treatment was delivered at 10 mW/cm2 for 9 min with a total dose of 5.4 J/cm2. The following anterior corneal HOAs: total corneal HOAs, trefoil, secondary trefoil, coma, secondary coma, secondary astigmatism and spherical aberrations were analysed using the Scheimpflug-Placido Sirius (CSO, Italy) corneal topographer at baseline and 12 months following treatment. Multivariate analysis was used to evaluate the independent effect of HOA subtypes on changes in uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA). Results At one year post CXL, UDVA and CDVA were significantly improved, -0.13 ± 0.19 LogMAR (P = 0.0005) and -0.08 ± .0.11 LogMAR (P = 0.0003), respectively. The mean preoperative trefoil, secondary trefoil, secondary coma and secondary astigmatism were 0.95 ± 0.46; µm, 0.20 ± 0.11; µm, 0.29 ± 0.19; µm and 0.42 ± 0.17 µm, respectively. At one year, the mean values decreased significantly to 0.77 ± 0.47 µm, 0.15 ± 0.11 µm, 0.25 ± 0.18 µm and 0.34 ± 0.18 µm, respectively (P P = 0.048; β = 0.67). Conclusion A 9-min protocol of Accelerated corneal cross-linking is an effective treatment in improving corneal HOAs at 12 months follow up, in eyes with progressive keratoconus at one year follow-up. A change in secondary coma had a statistically significant and independent effect on CDVA.

Background Vascular anomalies are congenital lesions of abnormal vascular development, and a primary distinction have to be made between a vascular tumor and a vascular malformation, hemangiomas are considered the commonest vascular tumor, correct diagnosis is imperative for appropriate treatment. In this report, we tried to verify the role of ultrasonography and Doppler examination in the initial diagnosis, the classification of vascular anomalies and in the post-treatment follow-up. Results (main findings) This report included cases of vascular anomalies who attended the interventional radiology department as well as the vascular anomaly clinic in Abo El-Rish hospitals during the period 2019 through 2021. Data of all patients attending the clinic were prospectively examined. Files of 60 cases with vascular anomalies were available for review. The diagnosis of vascular anomalies was done according to their history and characteristic findings at clinical examination as well as U/S and color Doppler examinations, MRI and angiographic studies were done as needed. A significant female predominance was noticed. A significant predominance in the head and neck region was noticed (60%). Treatment was individualized according to each case; propranolol was chosen as the first line of treatment in IH. Intra-lesional steroids injections were done in hemangiomas, and intra-lesional bleomycin was done in venous and lymphatic malformations, endovascular embolization was done in high flow vascular malformations. Conclusion Ultrasound and color Doppler examination were effective and accurate methods in the diagnosis, the classification of superficial soft tissue vascular anomalies, the detection of early complications and in the follow-up after different treatment methods applied, it was also beneficial in the exclusion of non-vascular lesions.

Accurate data regarding the size of the erect penis is of great importance to several disciplines working with male patients, but little data exists on the best technique to measure penile length. While some previous small studies have suggested good correlation between stretched penile length, others have shown significant variability. Penile girth has been less well studied, and little data exist on the possible errors induced by differing observers and different techniques. Much of the published data report penile length measured from the penopubic skin junction-to-glans tip (STT) rather than pubic bone-to-tip (BTT). We wished to assess the accuracy of different techniques of penile measurements with multiple observers. Men who achieved full erection using dynamic penile Doppler ultrasound for the diagnosis of sexual dysfunction or a desire for objective penile measurement were included in the study. Exclusion criteria were penile scarring, curvature, or congenital abnormality. In each case, the penis was measured by one of the seven andrology specialists in a private air-conditioned (21 °C) environment. Each patient had three parameters measured: circumference (girth) of the penile shaft, length from suprapubic skin-to-distal glans (STT), and pubis-to-distal glans (BTT). The three measurements were recorded in the stretched flaccid state, and the same three measurements were then repeated in the fully erect state, following induction of full erection with intracavernosal injection. We analyzed the accuracy of each flaccid measurement using the erect measurements as a reference, for the overall patient population and for each observer. In total, 201 adult men (mean age 49.4 years) were included in this study. Assessing the penis in the stretched and flaccid state gave a mean underestimate of the erect measurement of ~20% (STT length 23.39%, BTT length 19.86%, and circumference 21.38%). In this large, multicenter, multi-observer study of penis size, flaccid measurements were only moderately accurate in predicting erect size. They were also significantly observer dependent. Measuring penile length from pubic bone to tip of glans is more accurate and reliable, the discrepancy being most notable in overweight patients.

Hepatic hydatid cystic disease continues to be a serious health problem and is endemic in Iraq. There are of two types of cysts: noncomplicated and complicated cysts. Open surgery is widely practiced for both types. The aim of this study was to evaluate the clinical features, management, and outcome of surgical treatment in both types of cyst. The study included 150 patients operated on between 1996 and 2014. The patients’ demographic data, location, number, size, type of cysts, surgical procedure performed, morbidity, recurrences, and duration of hospital stay were recorded. There were 102 female and 48 male patients with an age range of 4–70 years. There were more patients with noncomplicated cysts than complicated cysts – 94 and 56 patients, respectively. The complicated disease group had significantly more pronounced clinical presentations (p < 0.001) and higher postoperative morbidity (p < 0.001), and without significant change in recurrence rate (p = 0.059). Mean postoperative hospitalization time for noncomplicated cysts was 3.2 days, and for complicated cysts 5.6 days (p < 0.001). The most common type of hydatid cyst is the noncomplicated type, which has lower complication rates and shorter hospital stay regardless of the management technique of the cyst cavity. Therefore, complicated and noncomplicated cysts should be considered as different forms of the disease entity with different outcomes.

Thirty-six consecutive children presenting to our clinic over 12 months with problematic CVI (mean age 10.8, range 5–16.5 years, SD 3.1) and 156 children (mean age 8.24, range: 4.5–11.6 years, SD 1.92) from seven mainstream primary schools (excluding those with poor reading skills, dyspraxia, autism, and other developmental and behavioural disorders) comprised patients and controls.