Ocular Cosmetics: Public Safety Problem or Harmless Products?

PURPOSE: This perspective explores the safety profile of ocular cosmetics and explores the role ophthalmologists can play in mitigating potential ocular harm from unsafe products. METHODS: N/A. RESULTS: Cosmetics and personal care products represent a large industry that is currently unregulated in any meaningful way. Products intended for use around the eyes carry a risk of serious side effects including contact dermatitis and bacterial infection. Currently, legislation has been proposed to change regulation to provide more meaningful oversight of cosmetics. CONCLUSIONS: Ophthalmologists are often the first to recognize patterns in harmful products intended for use around the eye and can help mitigate potential future ocular harm by reporting adverse events to the Food and Drug Administration and by advocating for cosmetic regulation change.

[Measurement of Quality with Routine Data]. / Qualitätsmessung aus Routinedaten.

There is a growing interest in quality measurement in the healthcare sector. Hospitals in Germany are obligated to participate in measures for external quality assurance and they must establish an internal quality management system. In addition to the legal requirements, measurement of quality is also possible with routine data. Suitable sources are the ICD system or unstandardized information from treatment documentation. The selection of suitable quality indicators is necessary to interpret the data. Complications or achievement of surgical objectives can be suitable quality indicators. Analysis of procedures or the assessment of waiting time are also possible indicators. Our first data concerning waiting time show that with increasing use of an electronic patient guidance system, the waiting time decreased in our outpatient department. Assessment of quality indicators from routine data enables a continuous measurement of quality over a long period. Measures to increase quality can easily be checked. Routine data also provide the possibility to participate in a public reporting of quality indicators.

[ISO 9001:2015 Certification in Quality Management]. / Zertifizierung des Qualitätsmanagements nach DIN EN ISO 9001:2015.

Quality management improves the structures, processes and results of organizations of all kinds. Many practices and clinics have their existing quality management system certified according to ISO 9001, (e.g., to check their own quality management system or to obtain a testimonial against third parties). The latest version ISO 9001:2015 contains some changes, both structurally and in terms of content. These changes can be met with reasonable efforts. An ISO 9001:2015 certification represents a value for your organization, but these advantages are often not directly measurable.

[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]. / Rahmenbedingungen zur Sammlung von "Real-Life"-Daten am Beispiel der Augenklinik der Universität München.

Background The importance of evaluating real-life data is constantly increasing. Currently available computer systems better allow for analyses of data, as more and more data is available in a digital form. Before a project for real-life data analyses is started, technical considerations and staff, legal, and data protection procedures need to be addressed. In this manuscript, experiences made at the University Eye Hospital in Munich will be shared. Materials and Methods Legal requirements, as found in laws and guidelines governing documentation and data privacy, are highlighted. Technical requirements for information technology infrastructure and software are defined. A survey conducted by the German Ophthalmological Society, among German eye hospitals investigating the current state of digitalization, was conducted. Also, staff requirements are outlined. Results A database comprising results of 330,801 patients was set up. It includes all diagnoses, procedures, clinical findings and results from diagnostic devices. This database was approved by the local data protection officer. In less than half of German eye hospitals (n = 21) that participated in the survey (n = 54), a complete electronic documentation is done. Fourteen institutions are completely paper-based, and the remainder of the hospitals used a mixed system. Conclusion In this work, we examined the framework that is required to develop a comprehensive database containing real-life data from clinics. In future, these databases will become increasingly important as more and more innovation are made in decision support systems. The base for this is comprehensive and well-curated databases.

Medicolegal pitfalls of cataract surgery.

PURPOSE OF REVIEW: To provide a general overview of medicolegal issues that may arise before, during, and after cataract surgery. RECENT FINDINGS: The Department of Health and Human Services Office of Inspector General has designated ophthalmology as an auditing target, an unusual step to take for an entire specialty. Ongoing False Claims Act litigation may provide greater clarity on billing Medicare for a premium intraocular lens patient's return to the operating room and charging for an intervening exam when performing cataract surgery on both eyes. SUMMARY: Ophthalmologists should continue to follow basic principles that help decrease medicolegal risk. These include a thorough informed consent discussion before surgery and accurate and contemporaneous documentation. When complications arise, surgeons should handle them in accordance with best practices and refer patients appropriately. Problems can arise from inattentive postoperative care, so ophthalmologists should train staff members on handling of patient calls. Implementing safety protocols for intraocular lens implantation and asking for legal advice when considering certain types of financial arrangements are also prudent. Cataract surgeons also should follow guidelines for billing noncovered services carefully.

In the eyes of the law: malpractice litigation in oculoplastic surgery.

PURPOSE: To assess characteristics associated with various outcomes of malpractice litigation, resulting from injuries sustained during oculoplastic procedures. METHODS: The Westlaw legal database (Thomson Reuters, New York, NY, U.S.A.) was used to obtain jury verdicts and settlements. Pertinent data were extracted from 69 malpractice cases litigated from 1988 to 2012 involving oculoplastic procedures, including alleged cause of malpractice, outcome, and defendant specialty. RESULTS: The most commonly litigated surgical procedures were blepharoplasty (63.8% of total) and brow lift surgery (11.6%). The most commonly alleged complications included excessive scarring (24.6%), lagophthalmos (24.6%), visual defects (23.2%), and exposure keratitis (21.7%). Plastic surgeons were the most commonly named defendants (46.4%), followed by both comprehensive ophthalmologists and fellowship-trained ophthalmic plastic surgeons (17.3% each). A defense verdict was held in 60.9% of cases, a plaintiff verdict in 31.9% of cases, and a settlement was reached in 7.2% of cases. Blindness, cranial nerve injury, and the allegation of a permanent deficit increased the likelihood of a case being resolved with payment to the plaintiff (Fisher exact tests, p < 0.05). CONCLUSIONS: Most litigated oculoplastic malpractice cases were resolved in favor of the defendant, while settlements and plaintiff decisions averaged $455,703. Blepharoplasty constituted two-thirds of cases, with the most frequently cited associated complications being unsightly scarring, lagophthalmos, and visual deficits. An alleged lack of informed consent (30.4%) or the need for additional surgery (39.1%) was present in a considerable proportion of cases, emphasizing the importance of a detailed informed consent and clear communication preoperatively regarding patient expectations.

Towards regulatory generative AI in ophthalmology healthcare: a security and privacy perspective.

As the healthcare community increasingly harnesses the power of generative artificial intelligence (AI), critical issues of security, privacy and regulation take centre stage. In this paper, we explore the security and privacy risks of generative AI from model-level and data-level perspectives. Moreover, we elucidate the potential consequences and case studies within the domain of ophthalmology. Model-level risks include knowledge leakage from the model and model safety under AI-specific attacks, while data-level risks involve unauthorised data collection and data accuracy concerns. Within the healthcare context, these risks can bear severe consequences, encompassing potential breaches of sensitive information, violating privacy rights and threats to patient safety. This paper not only highlights these challenges but also elucidates governance-driven solutions that adhere to AI and healthcare regulations. We advocate for preparedness against potential threats, call for transparency enhancements and underscore the necessity of clinical validation before real-world implementation. The objective of security and privacy improvement in generative AI warrants emphasising the role of ophthalmologists and other healthcare providers, and the timely introduction of comprehensive regulations.

Clinical negligence in ophthalmology: fifteen years of national health service litigation authority data.

OBJECTIVE: To categorize and understand the reasons behind ophthalmic clinical negligence claims in the National Health Service and how such claims can be avoided. DESIGN: Retrospective analyses of all ophthalmic clinical negligence claims between 1995 and 2009 were carried out. Data were obtained from the National Health Service Litigation Authority through the Freedom of Information Act. Claims were classified according to ophthalmic subspecialty, mean payment per subspecialty, severity, paid-to-closed ratio, and cost. PARTICIPANTS: One thousand two hundred fifty-three ophthalmology-related claims occurring from 1995 through 2009. Of these, 963 claims were closed over the 15-year period. Eighty-four were excluded because of insufficient case data. INTERVENTION: Retrospective analysis of all public sector ophthalmology litigation claims over a 15-year period in England. MAIN OUTCOME MEASURES: Subspecialty pertaining to claim, mean payment per claim, and severity of outcome of clinical incident. RESULTS: Nine hundred sixty-three claims were closed over a 15-year period, of which 67% resulted in payment. The total cost of claims was £32.1 million ($50.3 million), with a mean payment per claim of £33 300 ($52 300). The specialties with the highest mean payment per claim were neuro-ophthalmology and pediatric ophthalmology. Cataract subspecialty had the highest number of claims, accounting for 34% of all claims. CONCLUSIONS: Overall, the number of litigation claims in ophthalmology is low, relative to the high volume of outpatient and surgical workload.

[Requirements for information about medical parameters in the field of ophthalmology].

The authors came to conclusion that modern concept of medical information systems imply the development of electronic case-record using medical archives, results of laboratory and instrumental researches, based on modern information exchange technologies. The main criterion of realisation of this concept is solving of diagnosis problems. All parameters of diagnosis and treatment can be divided into three groups: measurable, observable and calculable. Measurable parameters -parameters, whose quantitative meanings can be measured with the help of special equipment and procedures of ist application. Observable parameters--parameters that can be observed with the help of biomicroscope, fundus-camera, ophthalmoscope and etc. Specific characteristic of these parametrs is not a qualitative evaluation, but quantative description and high level of subjectivity. The third group--parameters that cannot be measured or observed. These parameters can be received computationally or in the process of simulating. These parameters are result of mechanical and mathematical simulation of physiological and pathologic process of visual organ. The authors suggested requirements for ophthalmological workstation.

Law and order of modern ophthalmology: Teleophthalmology, smartphones legal and ethics.

In recent years, new technologies used in the field of ophthalmology have been emerging and developing rapidly. Two major aspects of these advancements are teleophthalmology and smartphones, which have enabled practitioners to achieve optimal outcomes in record time with minimal costs. Several rules and regulations have been applied to these technologies in order to frame them under the appropriate medico-legal ethics, and specialized committees have been dedicated to maintaining their efficacy and avoiding shortcomings. In addition multiple studies and case reports conducted worldwide have assessed them according to specific diseases or global concerns. This review article constitutes an up-to date account of almost all of the applications and medico-legal perspectives of technologies used in ophthalmology in order to summarize and better visualize their advantages and disadvantages.

Retinal haemorrhages in inflicted traumatic brain injury: the ophthalmologist in court.

Child abuse is a significant social and public health problem in many societies. One particular form of physical abuse is inflicted traumatic brain injury (ITBI) - the so-called 'Shaken Baby Syndrome'. One of the key features associated with ITBI is characteristic ocular findings - only observed on fundal examination. It is crucial not to miss the diagnosis of ITBI as there may be implications for the safety of the child. The ophthalmologist is one key contributor to the process required to make the diagnosis of ITBI accurately and on the basis of all the relevant evidence. This article discusses some medicolegal implications of examining a child with retinal haemorrhages in the context of suspected ITBI, with practical advice for the ophthalmologist to be as objective and prepared as possible. The scientific validity of some alternative explanations advanced in court is discussed, with a strong emphasis on the literature.