History of ultrasound in obstetrics and gynaecology from 1971 to 2021 on occasion of the 50 years anniversary of EFSUMB.

Diagnostic ultrasound in obstetrics and gynaecology has experienced a fantastic evolution during the past seven decades. Initial steps with A-mode technology were followed by B-mode and B-mode real-time imaging, then by Doppler and colour Doppler ultrasound, and finally by 3D/4D ultrasound. Other evolutionary steps were the development of high-resolution transabdominal and transvaginal transducers providing high quality images in the first, second and third trimesters of pregancy, as well as in gynaecology and breast imaging.The progression from two-dimensional (2D) to three-dimensional ultrasound (3D) and 3D real-time imaging (4D) has brought new options in displaying anatomical structures. In comparison with CT or MRI, it is not a static but functional technique, cheap and safe, and applicable at any time.

Reliability and validity of pelvic floor muscle strength assessment using the MizCure perineometer.

BACKGROUND: The purpose of this study was to clarify the reliability and validity of pelvic floor muscle (PFM) strength assessment using the MizCure perineometer in healthy women. METHODS: Twenty healthy women (age 20-45 years) participated in this study. The vaginal pressure measured using the MizCure and validated Peritron perineometers were repeated during PFM contraction in the supine and standing positions. All women were evaluated twice by examiners 1 and 2. Following the measurements in the first session (Test 1), they were repeated after an interval of between 2 and 6 weeks (Test 2). Within- and between-session intra- and inter-rater reliabilities in vaginal pressure were analyzed using intraclass correlation coefficients (ICC) (1, 1) and (2, 1), respectively. Validity was assessed by Pearson's product-moment correlation coefficient and Spearman's rank correlation analysis. RESULTS: Within-session intra-rater reliabilities for both examiners 1 and 2 for all vaginal pressures in Tests 1 and 2 were 0.90-0.96 for both perineometers. Between-session intra-rater reliability for the MizCure was 0.72-0.79 for both positions for examiner 1, and 0.63 in the supine position and 0.80 in the standing position for examiner 2. Inter-rater reliability for Test 1 was 0.91 in the supine position and 0.87 in the standing position for the MizCure. The vaginal pressures using the MizCure and Peritron were significantly associated with the supine position (r = 0.68, P < .001) and the standing position (rs = 0.82, P < .001). CONCLUSION: MizCure perineometer is a validated tool to measure PFM strength in both supine and standing positions in healthy nulliparous women.

Vaginal Energy-Based Devices.

This clinical consensus statement on vaginal energy-based devices (EBDs) reflects statements drafted by content experts from the American Urogynecologic Society's EBD writing group. The American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus.

Impact of Obesity on Surgeon Ergonomics in Robotic and Straight-Stick Laparoscopic Surgery.

STUDY OBJECTIVE: Work-related musculoskeletal symptoms (WMSs) are reported to be increasing in surgeons performing minimally invasive procedures. Therefore, we investigated the use of inertial measurement units (IMUs) and electromyography (EMG) sensor recorders to record real-time information on the muscle movement/activity required to perform training exercises in simulated in normal and high body mass index (BMI) models. DESIGN: Prospective study. SETTING: University hospital. PARTICIPANTS: Four consultant gynecologic oncology surgeons experienced in complex straight-stick (SS) laparoscopic and robotically assisted (RA) surgery. INTERVENTIONS: Three exercises (hoops onto pegs and wire chase) using SS and RA surgery on 2 abdominal models: normal BMI and high BMI. MEASUREMENTS AND MAIN RESULTS: We measured time to complete exercise and surgeon muscle movement/activity. The time to complete all exercises was significantly lower for RA surgery as compared with SS laparoscopy (p <.05 or better). The movement of the surgeons' core was significantly greater in high BMI SS laparoscopy compared with normal BMI SS laparoscopy for exercises 1 and 2 (p <.001). Muscle usage, as determined by EMG peak, was significantly higher in normal BMI SS laparoscopy and even higher in high BMI SS laparoscopy but was generally flat for all normal and high BMI RA surgery exercises (p <.05 or better). CONCLUSION: Detailed real-time information can be collected through IMUs/EMG sensors. Our results indicate that RA surgery requires less surgeon movements and muscle activity to complete tasks compared with SS laparoscopy, particularly in a high BMI model. The implications of these results are that RA surgery in high BMI patients may therefore have less physical impact on the surgeon compared with SS laparoscopy and may result in lower WMS rates.

The Morcellation "Debate" and the FDA 510(k) Process-A Call for Further Reform.

IMPORTANCE: Few gynecologic surgeons understand the mechanism by which surgical instruments are approved for human use and marketing or do they appreciate the central role they play in postmarket surveillance and reporting after instruments have come to market. OBJECTIVE: Using the experience with the uterine morcellator, this review will detail the Food and Drug Administration (FDA) system for approving surgical instruments and the potential pitfalls of this process. EVIDENCE ACQUISITION: Literature review and public documents from the FDA. RESULTS: The FDA 510(k) approval process for surgical instruments relies largely on postmarket surveillance as exemplified by the uterine power morcellator, which was approved before sufficient evidence was available regarding its potential harms. CONCLUSIONS: The current system currently transfers the responsibility of ensuring safety and efficacy to the public, patients, and providers. To minimize potential harm, the FDA needs to incorporate a greater standard of evidence into its framework for the approval and regulation of medical devices. The burden of these requirements should be borne at least in part by the companies bringing equipment to market. RELEVANCE: It is incumbent on all surgeons to be vigilant in their objective critical assessment of new instrumentation and report their outcomes after they come to market.

Experiencias adquiridas por los residentes de Ginecología y Obstetricia en la instrumentación obstétrica del parto / Experiences acquired by Gynaecology and Obstetrics residents regarding delivery obstetrics instrumentation

Introducción: Los obstetras siempre han tratado de sujetar la cabeza del feto de la manera más segura posible para acelerar el parto y reducir el difícil trabajo de la mujer. La historia del uso de instrumentos obstétricos para facilitar el parto (ya sean fórceps o espátulas) es una parte pintoresca y particular de la historia de la medicina. Objetivos: Identificar la experiencia adquirida por los residentes en la instrumentación obstétrica. Métodos: Para cumplir los objetivos propuestos se revisó el plan temático de la residencia de Ginecobstetricia y posteriormente fueron seleccionados los aspectos referidos al tema en estudio. Resultados: Los resultados encontrados a partir de las encuestas realizadas y los datos aportados por los tutores de formación y la revisión de los libros de partos aportaron el nivel de aprendizaje de los residentes. Conclusiones: Se aprecia en los estudiantes demora en la aprehensión de los conocimientos relacionado con la instrumentación obstétrica(AU)

Introduction: Obstetricians have always tried to hold the fetus head as safely as possible to accelerate delivery and reduce the women's difficult work. The history of usage of obstetric instruments to facilitate labor (whether forceps or spatulas) is a colorful and particular passage in the history of medicine. Objectives: To identify the residents' acquired experience regarding the obstetric instrumentation, for which we decided to determine their received practical theoretical training. Methods: In order to meet the proposed objectives, we reviewed the system of contents for the Gynecology residence and, thereafter, we selected the aspects regarding the subject under study. Results: The results obtained from the surveys conducted and the data provided by the training professors and the review of delivery books contributed to the residents' level of learning. Conclusions: The students show delay in the apprehension of knowledge regarding obstetric instrumentation(AU)

Assessment of Obstetric and Gynecologic Food and Drug Administration Device Approvals and Recalls.

STUDY OBJECTIVE: To evaluate and compare the recall rates of obstetric and gynecologic devices approved via the Food and Drug Administration's 510(k) and premarket approval (PMA) processes. DESIGN: A retrospective observational study (Canadian Task Force classification II-2). SETTING: Clinical settings in the United States that use obstetric and gynecologic devices. SUBJECTS: Two thousand two hundred forty-nine Food and Drug Administration-approved obstetric and gynecologic devices that were recalled between November 1, 2002, and December 31, 2017. MEASUREMENTS AND MAIN RESULTS: The class of device, class of recall, date of recall, and original approval process were obtained for each device. These were compared against the total number of approved devices during this time period in the PMA and 510(k) processes. Recall proportions of each process were calculated and compared. A total of 685 devices were approved via the PMA process, and 1564 devices were approved via the 510(k) process in the observed time period. Of these, 1.17% of the PMA-approved devices and 15.98% of the 510(k)-approved devices were recalled (p < .001). There was an overall increase in absolute device recall numbers over time in the 510(k) process, whereas the number of recalls in the PMA process did not change with time. CONCLUSION: The recall event rate for the 510(k) approval process is 13.6 times the rate for the PMA approval process for obstetric and gynecologic devices. Analysis of the results suggests improper device risk classification, inappropriate assignment of the approval process, increased device malfunctions, recalls by the 510(k) process and, therefore, increased risk to patients by these devices. This warrants a call for improvement and increased scrutiny in the 510(k) approval process for devices used in obstetrics and gynecology.

Motion control skill assessment based on kinematic analysis of robotic end-effector movements.

BACKGROUND: The performance of robotic end-effector movements can reflect the user's operation skill difference in robot-assisted minimally invasive surgery. This study quantified the trade-off of speed-accuracy-stability by kinematic analysis of robotic end-effector movements to assess the motion control skill of users with different levels of experience. METHODS: Using 'MicroHand S' system, 10 experts, 10 residents and 10 novices performed single-hand test and bimanual coordination test. Eight metrics based on the movements of robotic end-effectors were applied to evaluate the users' performance. RESULTS: In the single-hand test, experts outperformed other groups except for movement speed; in the bimanual coordination test, experts also performed better except for movement time and movement speed. No statistically significant difference in performance was found between residents and novices. CONCLUSIONS: The kinematic differences obtained from the movements of robotic end-effectors can be applied to assess the motion control skill of users with different skill levels.

Overview of high-risk medical device recalls in obstetrics and gynecology from 2002 through 2016: implications for device safety.

The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death. We defined a recall event as a group of unique Food and Drug Administration recalls that share a similar reason for recall and occurred within a 1-month time frame. In total, 7 class I recall events were identified encompassing 83 unique recalls affecting >88,000 medical devices in distribution. Recalls involved a broad range of devices used in women's health including diagnostic assays for chlamydia and gonorrhea, a laparoscopic tissue morcellator, and obstetrical/gynecological surgical kits. Four of 7 (57%) recall events were due to postmarketing problems such as improper packaging and labeling while the remaining 3 (43%) recalls were due to premarketing problems (eg, software issues). Additionally, 3 of 7 (43%) recall events were cleared via the 510(k) pathway, while the remaining were essentially exempt from any form of premarket approval. Two recall events involved sterility concerns of 71 surgical kits used in obstetrics and gynecological surgeries representing the majority of affected devices (78,423) in distribution. Class I medical device recalls are rare but serious events. Most recalled devices in women's health had minimal preapproval regulation and were recalled due to both premarketing and postmarketing reasons. Future regulatory efforts to improve postmarketing surveillance may mitigate the potential impact and frequency of class I recalls, but do not replace the need for a higher burden of proof for both safety and efficacy prior to medical device approval.

A Classical Wooden Vaginal Speculum Mentioned in Old Medical Manuscripts.

The subject of this paper is the story of an ancient medical instrument. This instrument is a wooden vaginal speculum used in classical and Islamic medicine. Its drawings can be found in Abulcasis al-Zahrawi's and Serefeddin Sabuncuoglu's illustrated books of surgery.

Committee Opinion No. 680: The Use and Development of Checklists in Obstetrics and Gynecology.

Checklists are used in medical and nonmedical settings as cognitive aids to ensure that users complete all the items associated with a particular task. They are ideal for tasks with many steps, for tasks performed under stressful circumstances, or for reminding people to perform tasks that they are not routinely accustomed to doing. In medicine, they are ideal for promoting standardized processes of care in situations in which variation in practice may increase patient risk and the chance of medical errors. Checklists also can be used to enhance teamwork and communication. It is a good idea to include frontline individuals who are involved in completing the procedure in the selection and development of the checklist. To be optimally effective, those who create checklists need to carefully plan for their design, implementation, evaluation, and revision. Checklists are valuable cognitive aids to help health care teams provide complete and timely care to patients, but checklists should be only one tool in the armamentarium to ensure that practitioners do the right thing for the right patient at the right time.

Design and testing of a phantom and instrumented gynecological applicator based on GaN dosimeter for use in high dose rate brachytherapy quality assurance.

PURPOSE: High dose rate brachytherapy (HDR-BT) is widely used to treat gynecologic, anal, prostate, head, neck, and breast cancers. These treatments are typically administered in large dose per fraction (>5 Gy) and with high-gradient-dose-distributions, with serious consequences in case of a treatment delivery error (e.g., on dwell position and dwell time). Thus, quality assurance (QA) or quality control (QC) should be systematically and independently implemented. This paper describes the design and testing of a phantom and an instrumented gynecological applicator for pretreatment QA and in vivo QC, respectively. METHODS: The authors have designed a HDR-BT phantom equipped with four GaN-based dosimeters. The authors have also instrumented a commercial multichannel HDR-BT gynecological applicator by rigid incorporation of four GaN-based dosimeters in four channels. Specific methods based on the four GaN dosimeter responses are proposed for accurate determination of dwell time and dwell position inside phantom or applicator. The phantom and the applicator have been tested for HDR-BT QA in routine over two different periods: 29 and 15 days, respectively. Measurements in dwell position and time are compared to the treatment plan. A modified position-time gamma index is used to monitor the quality of treatment delivery. RESULTS: The HDR-BT phantom and the instrumented applicator have been used to determine more than 900 dwell positions over the different testing periods. The errors between the planned and measured dwell positions are 0.11 ± 0.70 mm (1σ) and 0.01 ± 0.42 mm (1σ), with the phantom and the applicator, respectively. The dwell time errors for these positions do not exhibit significant bias, with a standard deviation of less than 100 ms for both systems. The modified position-time gamma index sets a threshold, determining whether the treatment run passes or fails. The error detectability of their systems has been evaluated through tests on intentionally introduced error protocols. With a detection threshold of 0.7 mm, the error detection rate on dwell position is 22% at 0.5 mm, 96% at 1 mm, and 100% at and beyond 1.5 mm. On dwell time with a dwell time threshold of 0.1 s, it is 90% at 0.2 s and 100% at and beyond 0.3 s. CONCLUSIONS: The proposed HDR-BT phantom and instrumented applicator have been tested and their main characteristics have been evaluated. These systems perform unsupervised measurements and analysis without prior treatment plan information. They allow independent verification of dwell position and time with accuracy of measurements comparable with other similar systems reported in the literature.

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System. Final order.

The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the gynecologic laparoscopic power morcellation containment system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Integrated System for Monitoring and Prevention in Obstetrics-Gynaecology.

A better monitoring of pregnant women, mainly during the third trimester of pregnancy and an easy communication between physician and patients are very important for the prevention and good health of baby and mother. The paper presents an integrated system as support for the Obstetrics - Gynaecology domain consisting in two modules: a mobile application, ObGynCare, dedicated to the pregnant women and a new component of the Obstetrics-Gynaecology Department Information System dedicated to the physicians for a better monitoring of the pregnant women. The mobile application informs the pregnant women about their status, permits them to introduce glycaemia and weight values and has as option pulse and blood pressure acquisition from a smart sensor and provides results in a graphic format. It also provides support for easy patient-doctor communication related to any health problems. ObGyn Care offers nutrition recommendations and gives the pregnant women the possibility to enter a social space of common interests using social networks (Facebook) to exchange useful and practical information. Data collected from patients and from sensor are stored on the cloud and the physician may access the information and analyse it. The extended module of the Obstetrics-Gynaecology Department Information System already developed supports the physicians to visualize weekly, monthly, or on a trimester, the patient data and to discuss with her through the chat module. The mobile application is in test by pregnant women and medical personnel.

The eponymous Dr James Marion Sims MD, LLD (1813-1883).

Dr James Marion Sims was born in 1813 in Lancaster County, South Carolina. It was while pioneering numerous surgical procedures in Alabama that in 1849 he achieved the outstanding landmark in medical history of successfully, and consistently, repairing vesicovaginal fistulae. Sims soon developed a reputation as a fine surgeon, with new operations and techniques, using novel surgical instruments and his innovative approaches frequently published. Moving to New York City in 1853, he further established hospitals devoted entirely to women's health. Sims was controversial, with flamboyant descriptions of self-confident success, yet they were tempered with sober reflection of failure and loss. Today we remain with the Sims speculum and Sims position, eponymous tributes to his accomplishments as the 'Father of Gynaecology'.

Bits and pieces: the ethics of uterine morcellation.

Intensive media and policy attention has been focused on the ongoing controversy surrounding uterine morcellation in gynecologic surgery. What has been missing from this impassioned discourse is an objective analysis of the ethical implications of uterine power morcellation in gynecologic surgery. This article discusses competing ethical duties of physicians, industry, the U.S. Food and Drug Administration, and the media to develop a more robust and nuanced understanding of informed consent for the use of morcellation in benign gynecologic surgery. Ultimately, as physicians, we must remain steadfast in our dedication to the use of evolving technologies to better patient health in a safe and ethical manner that is well-studied, informed, and implemented with appropriate training and precautions.

Safety aspects and side-effects of ExEm-gel and foam for uterine cavity distension and tubal patency testing.

A state-of-the-art overview of the safety and side-effects of ExEm-gel for uterine cavity distension and ExEm-foam for tubal patency testing is presented. A literature search was carried out using PubMed, textbooks, pharmaceutical databases and reports of toxicity tests. Information on clinical use in humans and experiments in animal models was collected and grouped according to the following components: glycerol, hydroxyethyl cellulose and purified water; subjects included toxicity test, influence on sperm cells, oocytes, blastocyst development, uterine cavity distension, tubal patency testing, pain and obstetric applications. No unknown side-effects of gel or foam, or unexpected concerns about safety, were reported. More information than expected was available on the absence of effects of the components on various human tissues. Although it is difficult to prove that the search is complete, and it is possible that side-effects remain unreported, the combination of glycerol, hydroxyethyl cellulose and purified water is considered to be safe for intrauterine application and tubal patency testing, indicating an optimal risk-benefit ratio in clinical use. The safest strategy, however, is to restrict clinical examinations with gel and foam to the pre-ovulatory phase of the menstrual cycle.

Modification of the pelvic examination simulator for the developing world.

The clinical pelvic exam is a critical examination for external and internal inspection of female reproductive organs. A sensor enabled pelvic examination simulator was developed to provide immediate visual performance feedback. The simulator was modified for rural area usage, where electricity supply and PC display may not be available. We succeeded at replacing key components while maintaining functionality.