Health and the Information Highway Division, Health Canada
New advances in minimal access or keyhole operative techniques are changing the face of surgery. Recent innovations now make it possible to perform minimal access surgery in a greater number of specialty areas. Minimal access surgical techniques require a much smaller incision (hence the word keyhole surgery) than the traditional open procedures and therefore require a much shorter recovery time and a shorter hospital stay. Many minimal access surgical procedures can be performed as day surgery and do not even require an overnight stay in the hospital. With minimally invasive surgery comes quicker recovery times, fewer complications, less scarring and improved health. Stemming from the reduced risk and trauma inherent in these procedures, consumers are placing increasing amounts of pressure on trained surgeons and adequately equipped operating rooms; these procedures are often not available to Canadians living in geographically remote areas of the country.
To meet this need, The Centre for Minimal Access Surgery (CMAS) has been established as a state-of-the-art, multidisciplinary technological education and research center, designed to increase the awareness and understanding of, and to support the research and development of, these specialized techniques.
The Centre for Minimal Access Surgery, located at St. Joseph's Hospital in Hamilton, was launched in collaboration with the Department of Surgery within the Faculty of Health Sciences at McMaster University in October 1999, and has since achieved national and international recognition for its educational and research accomplishments. The achievements to date include the successful development and implementation of a number of minimal access surgical courses, which have assisted more than 540 surgeons from across the country in adopting these new techniques in the areas of General, Gynecological, Pediatric and Thoracic Surgery. In addition, the Centre received a $1.2 million dollar grant from the MRC and the Ontario Ministry of Health and Long Term Care for research in the use of laparoscopic surgery for the treatment of heartburn.
CMAS utilizes an integrated video-conferencing system that permits high quality, rapid transfer of multi-feed video data of surgical procedures from an operating room to the classroom setting. These video feeds are accompanied by a two-way audio connection for immediate interaction between the learners and surgeons. This set-up allows training surgeons to gain a realistic perspective of minimal access procedures and to identify some of the difficulties commonly associated with them.
The Centre for Minimal Access Surgery also has the capacity to facilitate the learning of physicians in remote locations in Canada. This allows the increase of competence and scope of treatment in these remote areas. The capability to engage in real-time telementoring was made feasible for CMAS through state-of-the-art multimedia videoconferencing equipment. With this videoconferencing system, CMAS has the ability to broadcast or receive data from any ISDN-connected operating room or classroom in the world.
The CHIPP award allowed CMAS to build on its successes, including the expansion of its educational and training opportunities in the area of undergraduate education, to implement telementoring, and to move into the next phases of surgical intervention using telerobotics. CMAS is now able to increase the accessibility of Canadians in geographically remote areas to minimal access surgical procedures and to support and train those surgeons practicing in these remote areas thus encouraging their recruitment and retention.
Community Surgeons, with the assistance of an expert surgeon using the surgical interventional applications of telementoring and/or telerobotics, will be able to perform less invasive laparoscopic operations. Through the use of a telecommunications network designed to support this type of mission critical telehealth application the expert surgeon can be hundreds of kilometers away.
This project is known as the Surgical Support Network. It was developed by the Centre for Minimal Access Surgery, located at St. Joseph's Healthcare Hamilton and supported by McMaster University's Faculty of Health Sciences.
In September of 2001 Professor Marescaux and his team at IRCAD carried out a successful transatlantic telerobotic cholecystectomy on a 68-year-old female patient. The operating surgeon was in New York in a telecommunications office and the patient was in Strasbourg, France. The patient preparation and port placement was conducted by a group of experienced surgeons in Strasbourg under the supervision of Professor Joel Leroy, who also activated the electro-cautery on voice command from the operating surgeon in New York. The surgery was performed with a prototype of Zeus Telerobot (Computer Motion, California) not equipped with micro-wrist. Patient selection, preparation and follow-up was performed by the operating surgeon Professor Marescaux who had flown to New York for the surgery and returned back to Strasbourg following the surgery. A number of lessoned were learned from this historical event.
A number of questions were still left unanswered:
The primary aim of the project was to create a Surgical Support Network feasible that could be utilized to support rural and remote community surgeons via teleassistance from expert surgeons thousands of kilometers away. This support should be accessible on a commercially available network and adaptable to various communities.
This application would be used to enable the surgeons to perform a variety of complex laparoscopic procedures, which have in the past necessitated the transfer of the patient to tertiary centers.
This network would not only provide technical surgical skill support to the community surgeon, augmenting their training in advanced laparoscopic procedures, but also encourage research participation and assist in the recruitment and retention of these surgeons in rural and remote community hospitals.
In addition, the Surgical Support Network evaluated a number of other important questions such as:
The Centre for Minimal Access Surgery received funding for the Canadian Government to evaluate the feasibility of telesurgery in a remote part of Canada using a telerobot.
Stanton Regional Hospital in Yellowknife was originally selected for the following reasons:
Due to unforeseen human resource and management circumstances at Stanton Regional Hospital in Yellowknife we were unable to set up the telesurgical program in this location.
As an alternate choice North Bay General Hospital was selected to participate in both the telementoring and as the first telesurgical site in the program. North Bay fulfilled many of the above criteria but as the program progressed we discovered many other qualities that were beneficial to the feasibility program and the creation of a Surgical Support Network. These will be outlined further in this report.
It was initially believed that an existing Ontario network created and run by the Provincial Agency Smart Systems for Health (SSH) could support telementoring and telerobotics over their existing info structure. Unfortunately, after many months of negotiation and lobbying on behalf of CMAS it was confirmed that the SSH was not prepared to participate in our program. The mandate for this network did not include these types of telehealth applications.
As a result, CMAS approached Bell Canada to provide a network, which could support such a program. Details of this network are included in Appendix 1 of this report. This network is a commercially available IP-VNPE network that was developed to support high security programs such as the banking and finance industries.
Listed below are the networks that are available and a brief description of each.
VPN is a network that is based on a shared network infrastructure, yet offers the customer the same policies and performances as a private network. VPN's can be delivered over the internet or over a private shared network. VPN's can be built over many different underlying technologies such as Frame Relay, ATM and IP (including internet), although they have long existed in the voice market.
Meshed Intranets and scalability: Private IP VPNs have limited configuration problems and provide end-to-end quality of service. Frame relay and ATM are difficult to scale, as configuring a large number of PVC's can be time-consuming and costly. Internet VPNs only offer best effort service.
Performance: Private IP VPNs services are best suited to support an assortment of applications, they allow for multiple classes of service across a single IP infrastructure. They also make it possible to offer Service Level guarantees from customer premise to customer premise.
Higher level of security: In comparison with IP VPNs offered over the internet, private IP networks provide segregation o f customers over an IP back bone rather than only encrypting traffic.
IP VPN Enterprise is a managed service that gives the customer control over performance and the capability to support applications both today and in the future. IP VPN solutions provide businesses with the foundation for the total next generation communications solution. It puts business customers in control by converging connectivity, content and commerce onto a single easy to manage high-speed network.
Classes of Service: IP VPN Enterprise features three Classes of Service (CoS) with specific Quality of Service parameters for each. These Classes of Service are differentiated, among others, by the delay and packet loss experienced by the associated traffic they can experience. Scalability: IP VPN Enterprise can scale to meet the needs of an organization, regardless of size, interworking and meshing the network design is no longer a problem since the service is always a layer 3 solution from customer premise to customer premise. IP VPN Enterprise allows new sites to be added seamlessly.
Flexibility: The Class of Service and Bandwidth on Demand capabilities address changing needs such as seasonal fluctuations and business growth, while the extranet capability addresses the need to establish new network relationships, which mirror new business relationships. The IP VPN Enterprise solutions can be rapidly and easily configured to add/delete communication links with partners, suppliers and customers, therefore is capable to keep up with the rapidly varying needs of a company.
Optimal Use of Network: IP VPN Enterprise offers better traffic management over the WAN than traditional Layer 2 services. At layer 3, all traffic can be identified, prioritized and forwarded based on customer-selected class of service to ensure mission critical data gets through.
Access Fees: The following access fees are based on our Service Level Agreement (12Mbps - 10Mbps NRT & 2 Mbps)
| Wan Monthly | BW (Mbps) | Monthly /Mbps | Total Monthly |
|---|---|---|---|
| ATM access and port | 12 | $4,500 | |
| 12 Mbps Standard | 12 | $200 | $2,400 |
| 2 Mbps Priority for 10 days | 2 | $800 | $533.00 |
| 10Mbps NRT for 10 days | 10 | $1,200 | $4,000 |
| PE Cost | $1,050 | ||
| Total WAN Cost | $12,483 | ||
| Prices will vary depending on bandwidth and SLA | |||
ISDN (Integrated Services Digital Network) is a set of standards for digital transmission over ordinary telephone copper wire as well as over other media. ISDN is generally available from your phone company in most urban areas in the Canada, The United States and Europe.
A Circuit-switched network is a type of network in which a physical path is obtained for and dedicated to a single connection between two end-points in the network for the duration of the connection. ISDN and ordinary voice phone service is circuit switched. The telephone company reserves a specific physical path to the number you are calling for the duration of your call. During that time, no one else can use the physical lines involved.
There are two levels of service: Basic Rate Interface (BRI), intended for the home and small enterprises, and the Primary Rate Interface (PRI), for larger users. Both rates include a number of B-channels and a D-channel. Each B-channel carries data, voice and other services. Each D-channel carries control and signaling information.
The Basic Rate Interface consists of two 64 Kbps B-channels and one 16 Kbps D-channel. Thus, a Basic Rate user can have up to 128 Kbps service. The Primary Rate Interface consists of 23 B-channels and one 64 Kbps D-channel in the United States or 30 B-channel and 1 D-channel in Europe (1.5 Mbps and 2 Mbps respectively).
Access fees for ISDN are similar to your home telephone service. You pay a monthly fee to your service provider for the use of your telephone and you can use it as often as you like. If you make a long distance call you pay a small per minute user fee.
The only difference for ISDN is that the long distance call per minute user fees are applied to the total lines used during the call. For example, if you place a video conference call to Toronto for 30 minutes during peak time utilizing 512 Kbps for data transmission.
| Per min/channel | Active channels | Cost per min. |
|---|---|---|
| 0.48 | 8 | 3.84 |
| Call duration (min) | 30 | |
| Total charges | $115.20 |
| Bit rate (KBPS) | Channels |
|---|---|
| 64 | 1 |
| 128 | 2 |
| 256 | 4 |
| 384 | 6 |
| 512 | 8 |
| 768 | 12 |
| 1024 | 16 |
| 1472 | 23 |
Smart Systems for Health (SSH) is publicly-funded and a key component of Ontario Ministry of Health and Long-Term Care's (MOHLTC) information and communications technology strategy. The SSH will enable the secure electronic exchange of personal health information among Ontario's health care providers. The major components of SSH are:
The SSH project also includes the development of data and technology standards and health knowledge and education resources for providers.
The Zeus TS Microjoint (Computer Motion, Santa Barbara, California) was used to provide the telepresence necessary for the telerobotic surgeon in Hamilton, Ontario. It is a three-armed robot and a digital camera (Stryker 988, Stryker Canada, Waterdown Ontario) is used to provide the view for the surgeons.
Founded in 1989, Computer Motion is an ISO 9001 and EN 46001 registered corporation in Santa Barbara, California with offices through out the United States and Europe.
Computer Motion is pioneering the Operating Room of the Future "the intelligent OR" with its expertise in medical computers and robotics. The company develops, manufactures and markets proprietary computer and robotic surgical systems for the operating room, which enhance surgeons' capabilities, improve outcomes and reduce costs.
Computer Motions products include: the AESOP 3000, a voice-controlled endoscope positioning robot, the HERMES Control Centre, a centralized system designed to voice control a series of networked "smart" medical devices, and the ZEUS Robotic Surgical System for new minimally invasive microsurgery procedures.
The above system platforms have now been used in over 100,000 minimally invasive procedures across a broad range of surgical disciplines including general surgery, cardiac, oncology, urology, gynaecology, orthopaedic, thoracic, spinal, and bariatric.
The Zeus system has been used in over 730 procedures around the world with no deaths or serious injuries associated with the malfunctions of the system.
The Zeus system consists of a surgeon control console and three table- mounted robotic arms. The right and left arms replicate the two arms of the surgeon by allowing independent operation of two surgical instruments. The third robotic arm provides the surgeon's vision of the operative field. This arm is based on the AESOP Endoscope Postioner, the world's first FDA-cleared surgical robot.
The Zeus system is designed to allow the surgeon to continuously view both the video scope image and the entire OR environment, including the patient and the OR team. The compact design allows for multiple assistants at both sides of the table. Patient safety is ensured through the use of mirror redundancy technology, which continuously compares the surgeon's intended instrument position with the actual position in three-dimensional space at a rate of up to 1000 times per second.
It takes less than 15 minutes to set-up and drape. The small robotic arms are easily transferred from their storage cart to the OR table rail with minimal effort. Once placed on the rail, the table may be moved or tilted without readjusting or recalibrating the arms. The arms can be positioned away from the sterile field until needed, then quickly moved into position when ready.
The micro-wrist product, which was initially felt to be available in time for this study, was not available. Therefore the same prototype used in the transatlantic surgery between Strasbourg and New York was procured by CMAS for use in the program. A separate robotic system was also purchased by St. Joseph's Healthcare to facilitate the training needed for the both the IT analyst, the expert surgeon, the community surgeon and the nursing staff.
This second robot allowed training to proceed in parallel with the research into the proper network system and the time required to re-develop the space in both institutions to support telerobotics. (See Appendix 2 for the licensing agreement, license (hard copy only) and the detailed description of the telesurgical robot.)
Both the surgical interventional applications outlined below were used to provide support and training to rural and remote community surgeons in the provision of advanced laparoscopic surgical care. In parallel telecommunications, technologies, risk management, general broad based procedures, privacy issues, ethical issues and clinical outcomes were developed, tested and implemented to create a telehealth application that can be adapted to support rural surgeons and the communities in which they practice across the country and eventually around the world.
Telementoring
In telementoring an experienced surgeon (typically in an advanced treatment facility in a major urban center) uses a two-way telecommunications link to guide the remote surgeon during an operation. This allows the remote physician, who may only have had some preliminary training in laparoscopic techniques, to gain confidence and experience under the watchful eye of an expert. Telementoring is used to support the remote surgeon while eliminating the need for travel and increases the mentor's availability to work with several different learning surgeons.
The support network established telementoring sites at both North Bay General Hospital and the Complexe Hospitalier de la Sagamie in Chicoutimi, Quebec. Both of the surgeons at these sites had been trained by CMAS through the laparoscopic training courses the center offers.
Each of these centers had an administration that was supportive of this type of program and saw a value in the training and on-going support required of the menteed surgeons, nursing and allied health professional staff that was willing to be trained in this type of this type of telehealth application.
Over the course of the program from December 2002 to December 31, 2003, 35 cases were telementored.
Steps in establishing the telementoring program
The telementoring program was well received by the rural surgeons, the OR teams and the patients. This type of interventional telesurgical application is the easiest to establish and the most cost effective to date. The cost of the equipment is in accordance with hospital budgets and in order to defray costs, other programs can access the ISDN lines. If a telehealth program currently exists in the institution the current telehealth coordinator can do the line booking necessary to facilitate the telementoring.
Telerobotics
Steps in establishing the telerobotics program
Telerobotics uses cutting-edge virtual-reality technology to translate a surgeon's natural finger, hand and wrist movements into the movements of a robot, located in the next room or across the country.
The purpose of telerobotics is to increase the accessibility of minimal access surgical intervention to remote communities where a specialized surgeon is not available. Recent advances in technology make it possible for a surgeon to provide complete laparoscopic surgical intervention from a distance of over a thousand kilometers away. Using a three-armed robot to seamlessly and directly translate the surgeon's natural hand, wrist and finger movements allow a surgeon in an urban hospital to operate on a patient in a remote location.
Telerobotics comes in two forms:
The telerobotics feasibility study was established between North Bay General Hospital and St. Joseph's Healthcare Hamilton. There were many reasons for changing our direction in terms of partnering sites as stated in our original proposal. These will be detailed in section 3.3, Unreached Goals.
Please see attached research paper "Establishment of the World's First Telerobotic Remote Surgical Service" (Appendix 3) and "The Impact of Latency on Surgical Precision and Task Completion during Telerobotic Surgery". (Appendix 4)
A telecommunications info structure was tested and proven successful in supporting critical the telehealth applications of telementoring and telerobotics.
This telecommunications network was established between North Bay General Hospital and St. Joseph's Healthcare Hamilton. It is used for both telementoring and telerobotics.
The establishment of a telementoring program to both North Bay and Chicoutimi were successful and proved to have great benefit to the rural surgeon and ultimately their patients. 35 cases were telementored and then evaluated and the program is now an on-going service to both of these communities.
The following is a sampling of the advanced laparoscopic procedures were telementored successfully:
The world's first hospital-to-hospital telesurgery was performed on February 28, 2003. To date 24 telesurgical cases have been performed successfully between the two institutions.
The following are a sampling of the types of advanced procedures performed telerobotically:
The contributing factors to the successful completion of our program were:
At the outset of the project it was decided that Yellowknife would be the first community to participate in both the telementoring and telerobotic applications. Due to telecommunication difficulties, the fact that land based telecommunications were not the only mode of networking to Yellowknife caused a concern. The cost and the development that would be needed to adapt a networking system, which would incorporate land-based, satellite and possibly microwave was prohibitive to the project.
Also human resource and administrative issues were a concern in Yellowknife. The institution was running with only one general surgeon and the CEO and the some of the administrative team were relieved of their duties and the institution was involved in major restructuring.
The language barriers and the cross-jurisdictional networking issues that existed between Ontario and Quebec were obstacles in terms of time it would take to overcome them. To the project constraints there was not enough time in the project to over come these issues so it was decided that Chicoutimi would participate only in the telementoring application in this first phase (CHIPP funded) of the program.
Due to the above factors North Bay was selected as the site to participate in both telementoring and telerobotics. It was fortunate as the site had a keen surgeon both knowledgeable in laparoscopic techniques and technological innovations and he was well respected by his administration and the patient population.
North Bay is a regional hospital in Northern Ontario and the OR's were already set up for laparoscopic procedures so the expense for capital equipment was not necessary. The only expenses necessary were for the cabling necessary for the network and some upgrades to the teleconferencing equipment to support the program. The OR team and IT staff were supportive and willing to train to participate in the program.
The ability to establish a telecommunications network to support the applications was also seen as feasible. At the outset it was believed that the Ontario Provincial Smart Systems for Health Network would be used to support the program. The SSH was already connecting the two institutions and it was a matter of access to increased bandwidth and security measures.
The access to the SSH network turned out to be the second obstacle faced by the program. After lengthy lobbying and presentations to SSH and even the Ministry of Health it was decided that SSH did not have the mandate to facilitate our applications. It would require a regulation change at the Ministry level and a change of service provider for SSH to provide us with a network of the proper bandwidth and security level. The time it would take to make these changes was not feasible so the program researched another network option.
CMAS and St. Joseph's Healthcare approached Bell Canada and they agreed to work together to develop a network similar to SSH but one that was commercially available and could support our applications. Bell saw this as an opportunity to develop further business for their network and CMAS was given the opportunity to utilize a network that would satisfy all of the needs that both the telementoring and telerobotic applications required including security, redundancy and privacy.
The acceptance of the program by the patient population in North Bay was an additional success that was outside of the feasibility study. Our ability to set up a clinical program offering telementoring and telerobotics to North Bay was seen as a positive addition to Dr. McKinley's practice by both Dr. McKinley and his patients. The information gained through our relationship with North Bay along with new telehealth readiness assessment tools developed by the Health Telematics Unit, Faculty of Medicine; University of Calgary (Appendix 5) will assist CMAS in establishing telementoring and telerobotics in Chicoutimi and other expansion sites in the future.
Not applying readiness rules prior to the site selection portion of the program was a contributing factor in our obstacles listed previously. If the readiness rules were applied to each site prior to selection some of the hurdles experienced would have been obvious far sooner. In terms of the time frame given to CMAS to complete the program and the number of people working on the project also contributed to the lack of readiness planning given to the sites prior to selection.
Our inability to access Yellowknife via land based telecommunications alone initiated a relationship with the Canadian Space Agency (CSA) and Telesat to develop a feasibility study to test the capability of a satellite link up to support telementoring and telerobotic surgical applications. Currently CMAS, St. Joseph's Healthcare Hamilton, North Bay General Hospital and the CSA are developing an agreement and series of experiments to support this application.
The amount of media the project garnered was an additional success and helped to keep the momentum of the program moving forward. To date the Public Relations and Marketing Department of St. Joseph's Healthcare estimates the dollar value of the public relations to be in the range of $2.5 million dollars. (Appendix 6, initial media list).
The publication of two articles, the Establishment of the World's First Telerobotic Remote Surgical Service and the Impact of Latency on Surgical Precision and Task Completion during Telerobotic Surgery (Appendix 3 & 4) has also given the program added scientific and academic recognition.
This momentum and the experience gained through the telementoring and telerobotics program allowed CMAS's Dr. Mehran Anvari and Dr. Craig McKinley to participate in early experiments on surgery in space. The experiments involved both the Canadian Space Agency (CSA) and The National Aeronautics and Space Administration (NASA) took place at the Houston Space Centre on the KC-135 zero gravity airplane. The primary purpose of the experiments was to look at the effect of zero gravity on completion of laparoscopic tasks. They used simulated environments to test the ability of the surgeon, an astronaut, and some technical staff who'd been trained to perform a variety of laparoscopic skills under zero gravity conditions. From these experiments and the relationships established a multi-lateral medical operations taskforce made up of the medical directors of various space agencies on telerobotic surgery and its implication for space.
Further collaboration with CSA and NASA continue to be developed through the NEEMO project, which is now in its first phases of preparation. This program will involve the testing of telehealth supporting technologies and equipment such as diagnostic imaging technology and telerobotics in a harsh environment. This environment will be the Aquarius Habitat located under water in the Florida Keys. It will be 14-day missions that will have both a research and educational component.
Further participation in high-level telecommunication conferences such as the International Telecommunication Union (October 2003), at the invitation of Industry Canada, promoted the telementoring and telerobotic application, commercialization opportunities and the applications ability to assist third world countries in the training and mentoring of their physicians.
CMAS also received a Showcase Ontario 2003 Diamond Award for Innovation and Technology by the Ontario Government. Following Showcase Ontario, CMAS was awarded the Distinction Gold Medal Award at GTECH week in Hull, Quebec in October of 2003. The federal government presented this award for Innovation and Technology on a national scale.
Further presentations followed on an international level as Dr. Mehran Anvari was invited to speak and present his telehealth applications at a workshop during the Nobel Week Summit in Sweden in December 2003.
Even with these high profile awards and invitations to speak CMAS still struggles with the issue of sustainability and the promotion of our application and its benefits to rural communities within Canada is a goal which is of the highest a priority. Unfortunately it is the economics of the program, which is holding back potential funding agencies, both Provincially and Federally from supporting the expansion of the program.
As stated in Draft 3 of the NIFTE Framework of Guidelines published by the Federal Government an economic return on investment should not be the only priority, "The return on investment for telehealth activities needs to be viewed from a societal perspective, in addition to an organizational perspective. This return on investment may be seen as the ability to serve more individuals or seen as a savings distributed among patients and a number of organizations, as well as the primary service. These returns are not necessarily going to be seen by the organization providing the services as an expense savings, particularly where the telehealth application required a sizable up-front investment"1
From this information and the inability to fund this as a clinical program in Ontario CMAS learned a valuable lesson:
Telerobotic surgery and this type of mission critical telehealth application represents a paradigm shift in the delivery of surgical care-it is a revolutionary, rather then an evolutionary transformation. As with other previous transformational changes in medical practice, such a laparoscopic surgery, it may not be readi8ly accepted - yet.
Telerobotic surgery, and the use of robotics in education and surgical support represent a revolutionary shift for the future and will establish a significant position in the surgical world providing substantial benefits to the medical field and patients both nationally and internationally and world wide.
Telesurgery is a vehicle for expanding accessible, quality and responsible health care practice into areas where expertise does not currently exist. It may take some years for telerobotic surgery to gain full acceptance, however, the clinical practice and technology has been introduced, proven and met with complete success. Like any innovative and revolutionary clinical practice, once established and proven cost effective it has the potential to become mainstream.
Realizing this and with the resulting feed back from various provincial and federal groups around our program and the following limitations of the NIFTE Guidelines:
CMAS has put forward a funding proposal to Canada Health Infoway (Appendix 9) that would spear head a program of economic evaluation over three telementoring and telerobotic hubs in an academic center and in turn each would support a rural community hospital as CMAS did with North Bay. The cost effectiveness evaluation program would involve a sophisticated analysis of the cost/benefits of minimal access surgery directly influenced through the training and telerobotic expertise of CMAS and expanded through telesurgery. It would establish the development and evaluation of tools, technology and standards that can support the provision of quality healthcare in Canada through this type of telehealth platform.
The provincial and Federal governments were not ready for or willing to fund a clinical program involving this type of mission critical telehealth application so we have repackaged our information and are setting out on path of research and evaluation keeping in mind the above information and the following strengths of this program:
"As telehealth and the public appetite for health information and access to care resources becomes internationalized, it seems clear that the need for international agreement on relevant standards will become increasingly urgent. It is my view that this represents a significant opportunity for Canada"2
"My impression is that Canada remains weak relative to the US in regards to the entrepreneurial side of telehealth. My impression is that despite the significant amount of telehealth activity in Canada, we continue to import telemedicine software and hardware for the US"3
The contributing factor to all of the above successes was the fact that the program was so innovative and ultimately very successful. There are various implications of this type of application and the technologies involved in supporting it.
This application has the ability to be applied in space in terms of supporting a flight team through medical emergencies while in space. The technology developed to support this application could ultimately be commercialized and have a positive economic impact.
The application itself has proven to be successful over a commercially available network, which opens doors to our industry partners Bell Canada in terms of emerging markets. This also applies to the CSA and their ability to utilize their technology for the good of Canadians, which has recently been identified as a priority to this group.
Due to the uniqueness and innovativeness of the program it has a great potential to garner media attention, which in turn provides the momentum that, a program such as this needs.
In terms of unreached goals, the fact that we could not connect with Yellowknife to provide both telementoring and telerobotics was on of the biggest. The fact that a readiness audit in terms of telecommunications, the cost, the availability and types of telecommunications that existed, was not performed contributed to the fact that we did not reach this goal. Other factors such as the human resource issues and the restructuring that was taking place at the time in Yellowknife were out of our control and the time it would have taken to wait out the issue would have been unfeasible.
Now that the issues regarding the types of telecommunications available to reach rural and remote regions in Canada such a Yellowknife have been identified and the obstacles outlined, a research and feasibility study, as mentioned previously, has been established with the CSA.
It is felt that satellite link ups can provide the type of telecommunications needed to support telehealth applications such as ours to these communities in the future. This program has been developed as a separately funded project as our CHIPP funds could not support it.
This inability to link up with Yellowknife was at first seen as a terrible blow to our program. However, as we continued developing our relationship with North Bay we discovered in terms of feasibility this site was ultimately the best for the following reasons:
As this was initially established as a feasibility study to prove that telementoring and telerobotics could be conducted over a commercially available network some parameters needed to be in place to ensure patient safety, institutional and industry liability and surgeon liability.
The fact that Bell assisted in the development of this network between North Bay and Hamilton, they participated as a full partner both in the research of the network and the provision of the lines. This allowed them to come up with safety protocols and measures that they felt would protect the patient, the surgeons and themselves. This type of partnering eliminated some of the liability issues that exist when a service provider is strictly a vendor. During this partnership CMAS, St. JOSEPH'S Healthcare, North Bay General Hospital and Bell came up with an agreement that was unique to a telecommunications provider and could stand as a template for future mission critical telehealth applications such as this.
In terms of patient safety and ethics approval by both institutions it was established that the surgery could and would take place without injury to patient if the telecommunications lines or the telerobotics technology failed. The fact that Dr. McKinley and Dr. Anvari had already developed a collegial relationship was a key factor. Dr. McKinley had previously taken part in various laparoscopic courses at CMAS and was trained in some advanced procedures and was highly skilled at performing the procedures open. Therefore if an issue occurred with either the telecommunication lines or telerobotic equipment the procedure would continue either laparoscopically with telementoring assistance or in an open manner. This information was put in the information sheet provided to patients that were recruited to participate in the program.
Dr. McKinley and Dr. Anvari, due to past training, had already established a collegial relationship and we found this to be a very important aspect to the telementoring and telerobotic surgery. The mentee must be open and willing to accept support and advice and the mentor must be able to provide it in a way that is both supportive and collegial.
This type of telehealth application is not designed to take the place of a surgeon but to ultimately assist and train that surgeon in advanced laparoscopic cases so as to continue to provide quality and accessible care to their patients in the rural and remote communities.
The administration of North Bay General Hospital was very willing to participate in a program such as this s the working relationship developed between the two institutions was excellent.
The OR team at the North Bay General welcomed the training in the robotics and an established relationship between the nursing teams continues today.
The ability of Dr. McKinley to participate in the research efforts and the various new programs such as the KC-135 and the NEEMO project has eliminated any feeling of professional isolation that may have developed working in a regional community hospital. This could be applied to any community surgeon working in a rural or remote institution that may participate in a program such as this. Professional isolation has been identified is one reason small communities have a problem recruiting and retaining surgeons.
| Document /Product Name | Available in Paper and/or Electronic Form | Licence Fee Required for use (Yes/No) | Previously Provided to Health Canada (Yes/No) | Appendix Name /Number |
|---|---|---|---|---|
| Partnership Agreements | Paper /electronic form | No | Yes | Partnership Agreement /Appendix 7 |
| Evaluation templates | Paper /Electronic form | No | Yes | Evaluation template Appendix 8 |
| Patient Information sheet | Paper /electronic form | No | Yes | Patient Information sheet Appendix 10 |
| Patient consent form | Paper /Electronic form | No | Yes | Patient Consent form Appendix 11 |
Telementoring
In the provision of telementoring it was found that both locations, North Bay and Chicoutimi found benefit in terms of surgical support during an advanced laparoscopic case. Please the evaluation report on this program for statistics.
Telementoring was proven a successful tool in the provision of surgical care and support in this program and therefore has the ability to:
Telerobotics
With the proven success of telerobotics over a commercially available telecommunications network access to this type of surgical support is readily available.
During the course of the program we have noticed that the patient population is looking at this type of application as a positive experience and they see the benefits having an expert surgeon provides. The program officially ended on December 31, 2004 but the telementoring continues with both sites and more institutions are requesting the services of telementoring.
In terms of telerobotics it is the costs of the robotic equipment that is preventing us from expanding the program currently but we see our Canada Health Infoway application as the next step in the expansion of the telerobotics program.
In terms of new skills development we have found that the IT personnel assisting in the telementoring and telerobotics program should have IT skills as well as some clinical knowledge.
As they help in terms of the network and the connecting and disconnecting of the telecommunications knowledge of the network and the equipment involved is critical. These skills can certainly be gained through training and can be applied to other areas of their jobs especially if other telehealth programs occur within the institution.
In terms of the telerobotics component the IT staff will need know some clinical knowledge and also knowledge of the telerobotic equipment. These skills can also be acquired through training.
Our experienced IT Director with the assistance of the Bell Engineers and the telerobotics manufacturer train and assess the IT staff. The experienced IT person from CMAS has been present at North Bay for all telerobotic cases to date. This is due to the shortage of IT professionals at North Bay not due to the lack of knowledge of their team.
The nursing staff will need to be trained on the instrumentation required for the telerobotics, the care and assembly of the equipment etc. These are all skills that can be learned through training. These skills will also augment their existing training and assist them in accepting and dealing with new innovative technology that is always presenting itself in the OR environment.
The cleaning and sterilizing of the equipment falls to the allied health professional working in the Sterilizing and Processing Department (SPD). Once again training in the equipment and the cleaning and sterilization needs can be acquired through training.
In terms of training and supporting the physician's hands on robotic training occurs at the CMAS OR site.
All of the above professions and their training have been occurring through a mentoring program and training courses offered at CMAS. Our nursing team has hosted the North Bay team here at CMAS and they have experienced robotic cases and mock telerobotic cases. Once this has been done the CMAS nursing team goes to the North Bay site to assist and train. An experienced OR nurse from CMAS is present during the telerobotics cases in North Bay until that team, the physician and the experienced nurse is confident that the team can continue on their own.
The CMAS nursing team runs nursing training courses, which now include robotics and telerobotics 4-5 times per year.
The training available to the SPD group is offered at CMAS courses, which occur 4 -5 times a year. The initial training for the first telerobotic cases was done both here at CMAS at the North Bay General Hospital much like the nurses were initially trained.
To date no new positions were created, as the current volume of cases does not support such a step. However, as telementoring and telerobotics increases in popularity there will be a requirement for an increase in support staff with the unique skills identified above.
Due to the uniqueness of the program, the in-kind support element that CHIPP encouraged, and the limited funds available all of the nursing, IT and surgical staff accepted these new duties as extras to their current workload. This required a commitment from the existing staff and both institutions and their administration. With this increase in workload also came increased job satisfaction as the new innovation offered an opportunity to participate in a "worlds first" and also the ability to acquire new skills.
During the course of the program we did not find a resistance to change. However, we feel in communities that are not as open to participating in new innovative programs, as North Bay was, "readiness for change" audits would have to be conducted with the community, the institutions, the surgeons and their patients. The readiness tools mentioned earlier in the report would assist in this type of audit.
In terms of privacy and protection of patient information we have followed the procedures set out by both participating institutions in terms of patient records. Obviously, a patient record is created at the institution where the surgery is taking place. The information of the patient, clinical background and any additional notes associated with the patient that would be relevant to the surgery are transferred down to St. Joseph's Healthcare via fax. This fax machine is located in the telehealth manager's office. A patient record is created at St. Joseph's Healthcare and all the institutions policies and procedures relating to privacy are followed.
As this program promotes education and it involves laparoscopic surgery the surgery itself is taped and stored on a VHS tape of DVD. These copies are stored in a locked cabinet for use in the research project. The patient is well aware of this and it is indicated in both the information sheet and the consent form.
In terms of the environment of the telesurgical procedure itself, the North Bay OR falls under the institutions policies and procedures relating to patient privacy, the robotic room at St. Joseph's healthcare is located in the OR area of the hospital and it to falls under the institutions guidelines. This room is treated as if it was a working OR.
We did not see any reason for a privacy impact assessment, as we don't feel the patient's privacy is effected by this feasibility study, as it would be affected by undergoing any laparoscopic procedure.
We did not find that any privacy or confidentiality rules either helped or hindered our programs success of the ability of the healthcare professionals to perform their duties or provide service.
Patient consent and information sheets were discussed with the most responsible surgeon, Dr. McKinley, as these were his patients. As he had a relationship with the patient this was the best way to undertake this process. It is also the process that is followed in any laparoscopic procedure.
Dr. McKinley would answer any questions that patient had and if a consultation with Dr. Anvari was needed or requested by the patient it was arranged via videoconference prior to the surgery. Both a paper consent and information sheet was provided to the patient and the consent form was to be signed prior to surgery. A copy of this consent form was also sent to St. Joseph's Healthcare and put in the patient record prior to Dr. Anvari participating in the surgery.
I don't believe that our program has influenced or will influence privacy policy or process development in our jurisdiction. The only major concern regarding privacy occurred with the institutions ability to understand how the telecommunications network worked and the ability to secure patient privacy while information was being transmitted. It was discovered through discussions with Bell and the CSA that most privacy violations happen at the beginning or input stage and the output stage of a telecommunications event not while transmitting. Therefore it is imperative that the privacy policies and procedures that are in place within an organization are followed at both institutions. Before entering into a program with an institution it is recommended that a privacy audit is conducted by both the institutions to confirm privacy practices are in place and to a level that is satisfactory to both parties involved.
In terms of the telecommunications transmission it is recommended that research is done into the measures used to ensure patient privacy and these to meet all the requirements of the institution and government regulations.
As stated in the achievements and lessons learned section of this report, this program developed and implemented a mission critical telehealth application. The knowledge gained regarding the application, technology and its implications can be used to devise or assist in the development of policies and procedures relating to many types of telehealth applications that involve the direct care and outcome of patients.
Current telecommunication networks that are in place provincially should be audited in terms of their mandates. It is an economic hardship to ask institutions to develop their own networks to participate in telehealth applications such as ours. There is another group that supports diagnostic imaging, NORAD that also had to develop their own network at a great cost.
If the bandwidth and info structure is currently in place then policies and procedures should be altered to include mission critical telehealth applications such as these. Our program could assist in the development of such mandates, the technological requirements and the adaptability of the network.
The Ontario provincial Government should audit the SSH and assist in the development of a mandate that is inclusive to innovative programs such as telementoring, telerobotics, telediagnostic imaging. The CMAS group continues to lobby the provincial government for these mandate changes.
The implementation of such a mission critical telehealth application that could potentially impact cross-jurisdictional health care provision, such as telementoring and telerobotics, could in parallel, assist in the development of a national licensing structure, fee structure and assist in the development of national standards for telehealth coordinators, program managers, nurses, IT analysts and allied health professionals.
Through the expansion proposal to Canada Health Infoway, CMAS would assist in the development of a national licensing structure, fee structure, and national standards for telehealth coordinators, program managers, physicians, nurses, IT analysts and allied health professionals.
The ability of this program to bring together academic institutions, community institutions, surgeons and industry partners such as Bell Canada, in an innovative application gave the group experience in the development of standards to support telehealth applications that directly impact patient care and outcome such as telementoring and telerobotics. These standards include minimum bandwidth requirements, security and safety measures, minimum equipment standards, ethics support, consent and information sheets, training standards and partnership agreements. All of these tools could be developed to be applicable nationally and across provincial boundaries.
Development of these standards cannot be done in isolation but rather should be developed and adapted in parallel with the expansion of this type of mission critical telehealth application. By doing so the newest developments in technology can be addressed as they are developed and applied, and their implications on standards and policies addressed directly, new advances in the types of services that are developed in terms of other disciplines and other applications such as telepathology and telediagnostics can also be addressed directly.
In this model the applications, technology and the standards, policies and procedures are developed in relationship to one another and the development of a gap between innovations and standards is not created and will not present itself as a hurdle in the future.
The program is currently looking for options to sustain itself. As stated earlier in the report it was felt that an expansion proposal to Canada Health Infoway was an option. In this expansion plan three academic sites and three community hospitals will participate. They will each be in a different province and thus the policies and procedures that are developed will be nationally adaptable.
During this expansion plan the current research into the technology development, network adaptability and satellite feasibility testing will continue.
The biggest barrier we have experienced to date in terms of sustainability is our inability to show economic savings. As with any new innovation in healthcare this program is initially capital heavy, increased volume needs to be established, outcomes measured and new technology developed over a period of time for the economics of it can be proven. The societal and clinical benefits are clear but these benefits alone are not reasons for sustainability in the eyes of the provinces.
Keeping these above factors in mind other areas of sustainability are being looked into, international expansion of the application, industry research in new technology development with CMAS's clinical experience and support, and the defense and space industries are all possible options.
| Methods or Tools | Date | Targeted Audience | Documents or Pres-entations Produced | Ap-pendix Name /Number |
|---|---|---|---|---|
| Conference | Canadian Society of Telehealth Halifax October 2003
ITU World Telecom Conference, Geneva October 2003 Nobel Peace Summit, Sweden December 2003 |
Other telehealth groups, medical institutions and academics
Inter-national countries and industries Inter-national countries |
Power point presentation of the world's first hospital to hospital telesurgery
Physical demonstration of the application PowerPoint presentation of the application and its implications internationally |
See CD |
| Media Events | See media list | |||
| Publications | See media list and attached pieces Appendix 13 | Ap-pendix 13 |
1 NIFTE Framework of Guidelines, Draft3, National Institute for Telehealth, Pg. 23 July 8, 2003.
2 Canadian Strengths and International Opportunities in Telehealth (1999), Observations from G&&-G8 SP4 Forum, November 28-29, London, UK (A report for Industry Canada by the Canadian Society of Telehealth)
3 Canadian Strengths and International Opportunities in Telehealth (1999), Observations from G7-G8 SP4 Forum, November 28-29, London, UK (A report for Industry Canada by the Canadian Society of Telehealth)