Fluorescence-guided surgery and intervention - An AAPM emerging technology blue paper.

Fluorescence-guided surgery (FGS) and other interventions are rapidly evolving as a class of technologically driven interventional approaches in which many surgical specialties visualize fluorescent molecular tracers or biomarkers through associated cameras or oculars to guide clinical decisions on pathological lesion detection and excision/ablation. The technology has been commercialized for some specific applications, but also presents technical challenges unique to optical imaging that could confound the utility of some interventional procedures where real-time decisions must be made. Accordingly, the AAPM has initiated the publication of this Blue Paper of The Emerging Technology Working Group (TETAWG) and the creation of a Task Group from the Therapy Physics Committee within the Treatment Delivery Subcommittee. In describing the relevant issues, this document outlines the key parameters, stakeholders, impacts, and outcomes of clinical FGS technology and its applications. The presentation is not intended to be conclusive, but rather to inform the field of medical physics and stimulate the discussions needed in the field with respect to a seemingly low-risk imaging technology that has high potential for significant therapeutic impact. This AAPM Task Group is working toward consensus around guidelines and standards for advancing the field safely and effectively.

Does Image-Guided Surgery Reduce Complications?

Image-guided surgery (IGS) is progressively used in endoscopic sinus surgery (ESS), and surgeon comfort with the technology has increased. It remains a challenge to determine if the use of IGS in ESS leads to a reduction in surgical complications and improved outcomes. Current literature does not show a clear reduction in surgical complications. The routine use of IGS in ESS as a deterrent to medicolegal liability is not substantiated by recent reported data. There are particular situations in which IGS may be helpful, but its use is likely not required for routine ESS and seems best left to surgeon discretion.

Patient-specific instruments: industry's innovation with a surgeon's interest.

PURPOSE: The aim of this study was (1) to survey the orthopaedic companies about the volume of patient-specific instruments (PSI) used in Europe and worldwide; (2) to survey a group of knee arthroplasty surgeons on their acceptance of PSI and finally; (3) to survey a medico-legal expert on PSI-related issues. METHODS: Seven orthopaedic implant manufacturers were contacted to obtain their sales figures (in volume) of PSI in Europe and worldwide for the 2011 and 2012 period. During the Open Meeting of the Belgian Knee Society, a survey by a direct voting system was submitted to a selection of knee surgeons. Finally, a number of medico-legal 'PSI-related' questions were submitted to an adult reconstruction surgeon/legal expert. RESULTS: The total volume, for all contacted companies, of PSI in Europe for 2012 was 17,515 total knee arthroplasty (TKA) and 82,556 TKA worldwide. Biomet (Warsaw, USA) was the number one in volume, both in Europe as worldwide with their Signature system. Biomet represented 27 % of the market share in PSI worldwide. Stryker preferred not to reply to the survey because of the FDA class 1 recall on ShapeMatch cutting guides. Eighty per cent of the Belgian knee surgeons expressed a great interest in PSI and especially, for 58 % of them, if it would increase their surgical accuracy. They valued it even more in unicompartmental arthroplasty, and 55 % was ready to use single-use instruments. Surprisingly, 47 % of surgeons thought it was the company's responsibility if something goes wrong with a PSI-assisted case. The medico-legal expert concluded that PSI is a complex process that exposes surgeons to new risks in case of failure and stated that companies should not produce surgical guides without validation of the planning by the surgeon. CONCLUSION: Patient-specific instruments is of great interest if it can proof to increase the surgical accuracy in knee arthroplasty to the level surgeons are expecting and if in the same time it would make the surgical process more efficient. LEVEL OF EVIDENCE: V.

Legal and ethical issues in robotic surgery.

AIM: With the rapid introduction of revolutionary technologies in surgical practice, such as computer-enhanced robotic surgery, the complexity in various aspects, including medical, legal and ethical, will increase exponentially. Our aim was to highlight important legal and ethical implications emerged from the application of robotic surgery. METHODS: Search of the pertinent medical and legal literature. RESULTS: Robotic surgery may open new avenues in the near future in surgical practice. However, in robotic surgery, special training and experience along with high quality assessment are required in order to provide normal conscientious care and state-of-the-art treatment. While the legal basis for professional liability remains exactly the same, litigation with the use of robotic surgery may be complex. In case of an undesirable outcome, in addition to physician and hospital, the manufacturer of the robotic system may be sued. In respect to ethical issues in robotic surgery, equipment safety and reliability, provision of adequate information, and maintenance of confidentiality are all of paramount importance. Also, the cost of robotic surgery and the lack of such systems in most of the public hospitals may restrict the majority from the benefits offered by the new technology. CONCLUSION: While surgical robotics will have a significant impact on surgical practice, it presents challenges so much in the realm of law and ethics as of medicine and health care.

Are the Brookhill-Wilk patents impediments to market growth in cybersurgery?

BACKGROUND: In the past, many surgeons could practise their craft with little or no knowledge of patent law. But in the world of robotic and computerized surgery, this is increasingly a myopic approach, because the principle means of protecting high-tech surgical instruments is through the application of patent law. The issue is: does the Brookhill-Wilk patent, which covers the performance of remote robotic surgery, impede the growth of cybersurgery? METHODS: Review of the Brookhill-Wilk patent and relevant law. RESULTS: Patent law, which first took its form in the Middle Ages, attempts to balance the rewarding of innovation with the stifling of market growth. Using US patent law as a model, it would appear that the Brookhill-Wilk patent, a particular example of a medical process patent, could inhibit the growth of cybersurgery, as potential sums of money could be demanded by the patent holder from anyone who practises cybersurgery. However, two recent US Supreme Court cases appear to have seriously undermined the validity of a number of medical process patents, including the Brookhill-Wilk patent. CONCLUSION: Based on recent changes in patent law, it is not expected that Brookhill-Wilk patent will hinder the growth of cybersurgery.

The complexity of litigation associated with robotic surgery and cybersurgery.

Litigation after cybersurgery, i.e. remote robotic surgery, will be complex. In addition to being able to sue physicians and hospitals, patients who sustain an adverse outcome after cybersurgery will have the potential to sue the robotic manufacturer and the telecommunications company. Moreover, cybersurgery litigation will involve laws that are generally unfamiliar to healthcare providers. Accordingly, this article examines a lawsuit involving a robotic surgical instrument as a model to suggest where liability traps may arise during the delivery of cybersurgery.

The legal and economic forces that will shape the international market for cybersurgery.

BACKGROUND: Despite the common use of medical devices most health care providers have little understanding how a device alters medical malpractice litigation. Such knowledge will be increasingly valuable as cybersurgery (i.e. remote robotic surgery) becomes routine. METHODS: Review of the laws governing products and telecommunication liability. RESULTS: Litigation after cybersurgery will be complex. In addition to being able to sue physicians and hospitals, patients who sustain an adverse outcome after cybersurgery will have the potential to sue the robotic manufacturer and telecommunication company. Robotics manufacturers can obtain virtual immunity from liability if they elected to place their devices on the market after obtaining [see text]360 per-market approval from the FDA. However, because [see text]360 pre-market approval is expensive and time consuming most medical devices on the market (including the robotic surgical instruments) do not have immunity to products liability. Consequently, after an adverse cybersurgical outcome a manufacturer of a robotic surgical instrument faces liability for failure to warn, design defects, and failure to properly manufacture. As for telecommunication providers, existing law provides them with immunity from liability. CONCLUSIONS: Litigation following cybersurgery will involve multiple defendants who are likely to use "finger pointing" defenses. Accordingly, there will be liability traps associated with providing cybersurgery.

Stereotactic computer assisted navigation: state of the art for sinus surgery, not standard of care.

There are circumstances in which image guidance is clearly useful to facilitate a more complete operation. By confirming the identity of known anatomic structures, a knowledgeable surgeon's understanding of the disease process can improve and only the necessary structures removed. CT guidance is a clear aid to understanding altered anatomy when combined with a thorough analysis of the preoperative CT scan and office nasal endoscopy. It is the combination of this preoperative planning with image guidance that allows a skilled surgeon to operate with confidence. This discussion intentionally did not refer to image guidance as the standard of care, because although this technology is clearly useful, valuable, and helpful in confirming anatomy and performing many procedures, it is not always necessary in achieving a complete operation. Therefore, it should not be considered the standard of care.