REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY

Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study

Fifty Years of Innovation in Plastic Surgery

© 2016 The Korean Society of Plastic and Reconstructive Surgeons.Background Innovation has molded the current landscape of plastic surgery. However, documentation of this process only exists scattered throughout the literature as individual articles. The few attempts made to profile innovation in plastic surgery have been narrative, and therefore qualitative and inherently biased. Through the implementation of a novel innovation metric, this work aims to identify and characterise the most prevalent innovations in plastic surgery over the last 50 years. Methods Patents and publications related to plastic surgery (1960 to 2010) were retrieved from patent and MEDLINE databases, respectively. The most active patent codes were identified and grouped into technology areas, which were subsequently plotted graphically against publication data. Expert-derived technologies outside of the top performing patents areas were additionally explored. Results Between 1960 and 2010, 4,651 patents and 43,118 publications related to plastic surgery were identified. The most active patent codes were grouped under reconstructive prostheses, implants, instruments, non-invasive techniques, and tissue engineering. Of these areas and other expert-derived technologies, those currently undergoing growth include surgical instruments, implants, non-invasive practices, transplantation and breast surgery. Innovations related to microvascular surgery, liposuction, tissue engineering, lasers and prostheses have all plateaued. Conclusions The application of a novel metric for evaluating innovation quantitatively outlines the natural history of technologies fundamental to the evolution of plastic surgery. Analysis of current innovation trends provides some insight into which technology domains are the most active

The cruciform drain: a technical note on the surgical management of cystic lesions of the sella

Background: The postoperative recurrence of cystic lesions of the sella is frequent and may require further surgery for re-drainage. / Objective: To tackle this problem, we propose to insert a small cross-shaped drain coursing from the cyst lumen to the suprasellar cistern. At this early stage of innovation, the technique is primarily intended for patients who present with a recurrence. / Methods: The cruciform drain is fashioned from the tip of a ventricular catheter and is inserted under endoscopic vision. We retrospectively reviewed the pre- and postoperative records of patients in whom this technique was implemented. / Results: A cruciform drain was placed in five patients since the introduction of the technique into our practice in 2018. The use of the cruciform drain did not impact upon the expected surgical workflow nor was it associated with adverse intraoperative events, but three patients did develop a postoperative CSF leak that was successfully treated in all cases. None of the patients showed re-collection of their cysts on early radiological follow-up. / Conclusion: The cruciform drain is intended to prevent the renewed build-up of cystic fluid by allowing it to flow through and around the drain into the subarachnoid space. We have modified our repair protocol in response to the observed high CSF leak rate, as a basis for further development of the technique. Studies involving long-term follow-up will also be required to assess its efficacy in reducing cyst recurrence

Quantifying innovation in surgery

Objectives: The objectives of this study were to assess the applicability of patents and publications as metrics of surgical technology and innovation; evaluate the historical relationship between patents and publications; develop a methodology that can be used to determine the rate of innovation growth in any given health care technology. Background: The study of health care innovation represents an emerging academic field, yet it is limited by a lack of valid scientific methods for quantitative analysis. This article explores and cross-validates 2 innovation metrics using surgical technology as an exemplar. Methods: Electronic patenting databases and the MEDLINE database were searched between 1980 and 2010 for “surgeon” OR “surgical” OR “surgery.” Resulting patent codes were grouped into technology clusters. Growth curves were plotted for these technology clusters to establish the rate and characteristics of growth. Results: The initial search retrieved 52,046 patents and 1,801,075 publications. The top performing technology cluster of the last 30 years was minimally invasive surgery. Robotic surgery, surgical staplers, and image guidance were the most emergent technology clusters. When examining the growth curves for these clusters they were found to follow an S-shaped pattern of growth, with the emergent technologies lying on the exponential phases of their respective growth curves. In addition, publication and patent counts were closely correlated in areas of technology expansion. Conclusions: This article demonstrates the utility of publically available patent and publication data to quantify innovations within surgical technology and proposes a novel methodology for assessing and forecasting areas of technological innovation

Surgical Video Motion Magnification with Suppression of Instrument Artefacts

Video motion magnification can make blood vessels in surgical video more apparent by exaggerating their pulsatile motion and could prevent inadvertent damage and bleeding due to their increased prominence. It could also indicate the success of restricting blood supply to an organ when using a vessel clamp. However, the direct application to surgical video could result in aberration artefacts caused by its sensitivity to residual motion from the surgical instruments and would impede its practical usage in the operating theatre. By storing the previously obtained jerk filter response of each spatial component of each image frame - both prior to surgical instrument introduction and adhering to a Eulerian frame of reference - it is possible to prevent such aberrations from occurring. The comparison of the current readings to the prior readings of a single cardiac cycle at the corresponding cycle point, are used to determine if motion magnification should be active for each spatial component of the surgical video at that given point in time. In this paper, we demonstrate this technique and incorporate a scaling variable to loosen the effect which accounts for variabilities and misalignments in the temporal domain. We present promising results on endoscopic transnasal transsphenoidal pituitary surgery with a quantitative comparison to recent methods using Structural Similarity (SSIM), as well as qualitative analysis by comparing spatio-temporal cross sections of the videos and individual frames

An Exit Strategy for Resuming Nonemergency Neurosurgery after Severe Acute Respiratory Syndrome Coronavirus 2: A United Kingdom Perspective

INTRODUCTION: Substantial healthcare resources have been diverted to manage the effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, and nonemergency neurosurgery has been effectively closed. As we begin to emerge from the crisis, we will need to manage the backlog of nonemergency neurosurgical patients whose treatment has been delayed and remain responsive to further possible surges of SARS-CoV-2 infections. METHODS: In the present study, we aimed to identify the core themes and challenges that will limit resumption of a normal neurosurgical service after the SARS-CoV-2 pandemic and to provide pragmatic advice and solutions that could be of utility to clinicians seeking to resume nonemergency neurosurgical care. We reviewed the relevant international policies, a wide range of journalistic and media sources, and expert opinion documents to address the stated aims. RESULTS: We have presented and discussed a range of factors that could become potential barriers to resuming full elective neurosurgical provision and important steps that must be completed to achieve pre-SARS-CoV-2 surgical capacity. We also explored how these challenges can be overcome and outlined the key requirements for a successful neurosurgical exit strategy from the pandemic. CONCLUSION: The performance of nonemergency neurosurgery can start once minimum criteria have been fulfilled: 1) a structured prioritization of surgical cases; 2) virus infection incidence decreased sufficiently to release previously diverted healthcare resources; 3) adequate safety criteria met for patients and staff, including sufficient personal protective equipment and robust testing availability; and 4) maintenance of systems for rapid communication at organizational and individual levels

Attitudes of Patients and Their Relatives Towards Artificial Intelligence in Neurosurgery

BACKGROUND: Artificial Intelligence (AI) may favorably support surgeons but may result in concern among patients and their relatives. OBJECTIVE: To evaluate attitudes of patients and their relatives towards the use of AI in neurosurgery. METHODS: In this two-stage cross-sectional survey, a qualitative survey was administered to a focus group of former patients to investigate their perception of AI and its role in neurosurgery. Five themes were identified and used to generate a case-based quantitative survey administered to inpatients and their relatives over a two-week period. Presented AI platforms were rated appropriate and acceptable using 5-point Likert scales. Demographic data was collected. A Chi Square test was performed to determine whether demographics influenced participants' attitudes. RESULTS: In the first stage, 20 participants responded. Five themes were identified: interpretation of imaging (4/20; 20%), operative planning (5/20; 25%), real-time alert of potential complications (10/20; 50%), partially autonomous surgery (6/20; 30%), fully autonomous surgery (3/20; 15%). In the second stage, 107 participants responded. The majority felt appropriate and acceptable to use AI for imaging interpretation (76.7%; 66.3%), operative planning (76.7%; 75.8%), real-time alert of potential complications (82.2%; 72.9%), and partially autonomous surgery (58%; 47.7%). Conversely, most did not feel that fully autonomous surgery was appropriate (27.1%) or acceptable (17.7%). Demographics did not have a significant influence on perception. CONCLUSIONS: The majority of patients and their relatives believed that AI has a role in neurosurgery and found it acceptable. Notable exceptions remain fully autonomous systems, with most wanting the neurosurgeon ultimately to remain in control

Automatic generation of operation notes in endoscopic pituitary surgery videos using workflow recognition

Operation notes are a crucial component of patient care. However, writing them manually is prone to human error, particularly in high pressured clinical environments. Automatic generation of operation notes from video recordings can alleviate some of the administrative burdens, improve accuracy, and provide additional information. To achieve this for endoscopic pituitary surgery, 27-steps were identified via expert consensus. Then, for the 97-videos recorded for this study, a timestamp of each step was annotated by an expert surgeon. To automatically determine whether a step is present in a video, a three-stage architecture was created. Firstly, for each step, a convolution neural network was used for binary image classification on each frame of a video. Secondly, for each step, the binary frame classifications were passed to a discriminator for binary video classification. Thirdly, for each video, the binary video classifications were passed to an accumulator for multi-label step classification. The architecture was trained on 77-videos, and tested on 20-videos, where a 0.80 weighted-F1 score was achieved. The classifications were inputted into a clinically based predefined template, and further enriched with additional video analytics. This work therefore demonstrates automatic generation of operative notes from surgical videos is feasible, and can assist surgeons during documentation

Implementation of duty of candour within neurosurgery: a national survey and framework for improved application in clinical practice

INTRODUCTION: Statutory duty of candour was introduced in November 2014 for NHS bodies in England. Contained within the regulation were definitions regarding the threshold for what constitutes a notifiable patient safety incident. However, it can be difficult to determine when the process should be implemented. The aim of this survey was to evaluate the interpretation of these definitions by British neurosurgeons. MATERIALS AND METHODS: All full (consultant) members of the Society of British Neurological Surgeons were electronically invited to participate in an online survey. Surgeons were presented with 15 cases and asked to decide in the case of each one whether they would trigger the process of duty of candour. Cases were stratified according to their likelihood and severity. RESULTS: In all, 106/357 (29.7%) members participated in the survey. Responses varied widely, with almost no members triggering the process of duty of candour in cases where adverse events were common (greater than 10% likelihood) and required only outpatient follow-up (7/106; 6.6%), and almost all members doing so in cases where adverse events were rare (less than 0.1% likelihood) and resulted in death (102/106; 96.2%). However, there was clear equipoise in triggering the process of duty of candour in cases where adverse events were uncommon (0.1-10% likelihood) and resulted in moderate harm (38/106; 35.8%), severe harm (57/106; 53.8%) or death (49/106; 46.2%). CONCLUSION: There is considerable nationwide variation in the interpretation of definitions regarding the threshold for duty of candour. To this end, we propose a framework for the improved application of duty of candour in clinical practice