57 Setting a Research Agenda for Perioperative Systems Design · 2017-10-08 · Setting a Research...

Seminars in Laparoscopic Surgery, Vol 10, No 2 (June), 2003: pp 57–71

When our workgroup assembled to create thiswhite paper, we originally intended to focus

on how the physical infrastructure of the surgicalworkspace supported the surgical procedures thatoccur therein. This scope proved to be less thansatisfactory in complimenting the work of the fourother focus areas. Consequently, we redefined ourmission on several occasions and what arose wasa broad set of issues integrated under a researchframework we called “perioperative systems de-sign.”

Perioperative systems design describes a rationalapproach to managing the convergent flow of pa-tients from disparate physical and temporal start-ing points (frequently home), through the operatingroom (OR), and then to such a place and time(home or hospital bed) where future events per-taining to the patient have no further impact on ORoperations (Figure 1). This process for an individualpatient can be envisioned as a nested set of time-lines: a coarse-grained timeline beginning with thedecision to perform an operation and ending whenthe patient definitively leaves the postoperative ex-perience, and a fine-grained timeline encompassingthe immediate pre-, intra-, and postoperativecourse. At each point, physical infrastructure andwork processes impact the progress of patients

along these timelines. Starting from this construct,perioperative systems design can be conceptualized,studied, and optimized like any industrial processin which many materials, actors, and processes arebrought together in a coordinated workflow toachieve a designed goal.

We will present the current state of the art andtechnology with respect to the perioperativeprocess. We will develop the notion of nested peri-operative timelines, which illustrate how unexpect-ed events pertaining to one patient have effects thatpropagate downstream and frequently affect globalefficiency. We will set out a desired state of periop-erative systems design for the OR of the Future(ORF). Next, we develop a research roadmap (es-sentially a set of specifications) for future researchin perioperative systems design. Finally, we willset forth a research agenda for accomplishing thestated goals.

Current State of Perioperative Systems

Perioperative systems design in today’s OR involvesa complex interaction with (and often reactions to)physical infrastructure, changing technology, andhuman factors. Hospital processes are often definedby facility design, which is an architectural disci-pline rather than a discipline of production systemdesign. Once hospital facilities are built, theprocesses they support are hardwired and difficultto change. Often, processes remain locked-in fordecades due to the capital investment that is re-quired to make changes.

New technology has been introduced primarilyfor intraoperative use; it is not focused on preoper-ative or postoperative processes, or aimed at infra-structure improvements. Often, new technologiesactually disrupt the perioperative process becauseof their complexity and by creating competition forscarce equipment that has to be moved around andset up for use.

Patients and healthcare providers comprise thehuman factor in perioperative systems. The currentperioperative systems tax the cognitive capacitiesof both. To lessen the cognitive burden, systems arecreated which ultimately subject all stakeholders in

57

From the *Massachusetts General Hospital, Boston,Massachusetts; †University of Maryland Medical Center,Baltimore, Maryland; ‡Cleveland Clinic Foundation, Cleveland,Ohio.Address reprint requests to Warren S. Sandberg, MD, PhD, Deptof Anesthesia and Critical Care, Massachusetts General Hospital,55 Fruit St., Clinics 3, Boston, MA 02114. E-mail:[email protected]©2003 Westminster Publications, Inc., 708 Glen Cove Avenue,Glen Head, NY 11545, USA.

Setting a Research Agenda for Perioperative Systems DesignWarren S. Sandberg, MD, PhD*, Timothy J. Ganous, MPA†, and Charles Steiner, ME‡

Perioperative care may be considered as a system amenableto industrial design approaches. The current care model is dis-jointed, prone to breakdown by failure of one component, andhostile to personnel. Moving a patient as a person and dataset through the flow of perioperative care is not only possible,but it is essential for efficiency and safety. Perioperative sys-tems design integrates the research agenda in technology,safety, informatics, and even telemedicine by putting all thepieces that constitute patient care into a cogent, flexible, andwell-managed model.

the process to a tyranny of “standard operatingprocedure.”

The best perioperative systems highlight the po-tential for the application of basic principles of man-agement and industrial design, coupled with emerg-ing technologies, to smooth the flow of patientsthrough future ORs. However, it has not yet beenpossible to assemble all of the available pieces inone project, and many pieces are missing altogeth-er. Instead, today’s pre-, intra-, and postoperativeenvironments are characterized by

1. An array of ergonomic deficiencies; 2. Inefficient, ineffective, and redundant

processes; 3. Fragmented communications and team inte-

gration;4. Inflexible “systems” of operation, 5. Staffing shortages (nurses and technicians); 6. Varying levels of competency among peri-

operative personnel.

These factors contribute to an environment in whichsafety issues, frustration, and inefficiency must con-stantly be combated.

Current deficiencies are brought into sharpestfocus when the intraoperative portion of periopera-tive systems design is considered. In today’s ORs,teams are fragmented, while communications areby voice, landline telephone, and grease board. Ateam member who leaves the line-of-sight effec-tively leaves the team.

Significant energy is diverted from patient caresimply to make the ORs and their equipment func-tion. Supply and equipment deficiencies cause wast-ed time. Information systems are used to a limited

degree. The personalities and work habits of individual sur-geons are a strong factor in the OR’s function. The com-plexity of work is unrelentingly high. The workload is high-ly variable and has intense peaks. Unplanned events occurfrequently and in clusters, causing unpredictable responsesand high stress levels. This stress affects patient care andcontributes to a high employee turnover rate and burnout.

Example of the Current State ofPerioperative Systems

The most technologically advanced ORs in usetoday allow us to glimpse the potential of the fullyrealized ORF, while highlighting some of the previ-ously described problems. A specific example maybe illustrative here. Recently, the Center forIntegration of Medicine and Innovative Technology(CIMIT) developed a working ORF in concert withthe Telemedicine and Advanced TechnologyResearch Center (TATRC) and several industrialpartners at the Massachusetts General Hospital.

The objective of the CIMIT ORF project was tobring the most advanced intra- and perioperativetechnology approved for use with patients together ina single OR, with a commitment to keep the installa-tion at the forefront of available devices. Included inthe project were major physical plant changes toallow drastic modifications in workflow aimed at im-proving OR throughput. Extensive personnel re-sources were made available, and the CIMIT ORFquickly exceeded expectations with respect to patientthroughput. The average time between the departureof one patient from the OR and the subsequent pa-tient being ready for surgery was almost immediate-ly cut by 60% relative to comparable conventional

Sandberg, Ganous, and Steiner58

Home Check-in

Hospital Bed

Procedure Suite

PACU

ICU / ER

PreopHolding

Procedure Suite

OR

ICU

PACU

Hospital Bed

Post PACU

Figure 1. Graphic showing the perioperative movement of patients (PACU, postanesthesia care unit).

ORs doing similar cases (a mix of major intra-ab-dominal and routine laparoscopic procedures).

Three important qualitative observations arisefrom the early experience in the CIMIT ORF: First,improvements in one aspect of a perioperative sys-tem design highlight fragilities elsewhere in the pe-rioperative system; second, the current state of tech-nology is woefully unready for integration; andthird, communication with team members “over thehorizon” is still virtually impossible.

The dramatic enhancement in OR throughputhas had the effect of adding a catalyst to the rate-limiting step in a multistep reaction: a new rate-lim-iting step appears elsewhere. For example, the or-ganization and policies of the MassachusettsGeneral Hospital preoperative clinic allow healthypatients to bypass a personal interview with theanesthesiologist. In such cases, the responsibility fordiscussing anesthesia plans and procedures and ob-taining consent falls to the ORF team. This adds tothe intraoperative team’s workload and increasesthe likelihood of a day-of-surgery cancellation be-cause of unaddressed anesthetic concerns.

Similarly, the inability to consistently ensurethat presurgical documentation (consent, history,etc.) is in the patient’s record prior to arrival in the

suite interrupts the surgeon’s work. Limitations ofthe postoperative phase of the perioperative systemhave also appeared. For example, high occupancyin the hospital has caused all of the postanesthesiacare unit (PACU) beds to fill early in the day, whichin turn, strands a patient in the ORF and brings theoperation of the entire suite to a halt.

Integration of technology has been one of themajor goals and persistent challenges in theCIMIT ORF. On the surgical side, integration ofadvanced surgical devices has depended upon co-operation between traditional competitors in in-dustry. Enough progress has been made to appre-ciate the tremendous as-yet unrealized advan-tages full integration between devices wouldyield. Other systems are farther away from inte-gration. For example, the anesthesiologist inter-acts with as many as four separate displays, eachattached to its own computer: one for the hospi-tal’s patient information and order entry system,one for physiologic monitors, one for automatedanesthesia record keeping, and one for drug andsupply management.

Communication in the CIMIT ORF is still mosteffectively carried out face-to-face (Figure 2). Thisleads to extensive round-tripping by team membersthroughout the suite for planning and informationgathering. Analog walkie-talkies and cellularphones have been rejected as being insufficientlysecure for patient confidentiality and too awkwardto use. When team members leave the suite, com-munication degenerates to beeper pages and mes-sages on the main OR public address system. Land-line telephones are used for all requests for supplies,technical support, and custodial service betweencases, as well as communication with OR adminis-trators and other physicians.

We suspect that similar sorts of system vulner-abilities have come to light during the developmentof other technologically advanced OR initiatives,and we cited the previous specific example to pointout the potential difficulties of integrating changesin a particular facet of perioperative design within alarger system. Hence, perioperative systems mustbe considered globally when changes are made toone facet; in particular, upstream and downstreamissues must be addressed in an effective periopera-tive systems design.

Perioperative Timelines

The CIMIT ORF experience illustrates that the peri-operative process is actually a series of interconnected

Setting a Research Agenda for Perioperative Systems Design 59

Figure 2. The design of today’s operating room resultsin fragmented communication.


events and in actual practice, many steps in theprocess are completely dependent on the successfulcompletion of the preceding steps. This sequentialstructure makes it useful to conceive of the periop-erative process as a set of two nested timelines(Figures 3 and 4). The overall perioperative time-line begins with the decision to perform a proce-dure and ends with the patient’s departure from thepostprocedure recovery area. Nested within this

overall timeline is the intraoperative period, whichbegins when the patient arrives in the OR area.

In the representative set of perioperative time-lines shown in Figures 3 and 4, milestone eventsare indicated below the timeline in rough chrono-logical order with no attempt to represent the ac-tual elapsed time between events. Events and con-ditions shown above the timeline denote points atwhich the perioperative process can be derailed. It

Patient Late to Hospital

Cancellation: Patient III

Test Reporting Delay

Testing Resource Scarce

Late / Missed Appointments

Insurance Problem

No OR time available

Impared Communication

Decision for Surgery

Presurgical Education

Consent: Surgery

Speciality Referral

Schedule Case in OR

Request Surgical Equipment

Set up Preop Evalutaion

More Diagnostic testing

Adjuvant Therapy

Preop Eval / Exam / Education: Nursing

Preop Eval / Exam / Education: Anesthesia

Consent: Anesthesia Logistical instructions to Patient

More Diagnostic testing

Gather Information

Confirmatory phone call

Patient to Hospital

Identify Patient

Match Patient to procedure

Into Hospital Attire

Nursing Preop Assessment / Exam

Premedication

Transport to OR area

Day of surg testing & procedures

Preoperative Instructions Not Followed

Missing Results / Documents

Staffing Limitations

Day of Surgery Procedure Delay

Uncooperative Patient

Impaired Communication

OR Running Late

Emergency Demand for OR Transfer to ICU No Transportation

Hospital Full

Bed Not Ready

Post-op Testing Delay

Staffing LimitationsUnanticipated Event

Uncontrolled Pain

Prolonged Recovery

Prolonged Report

Transport to Recovery area

Transfer Care to PACU team

Post-op Labs / Tests

Find / Act on Test Results

Recover from Anesthesia

Pain Management

Discharge from Recovery area

Post Recovery Lounge

Floor Bed

Home

Preoperative Period Intraoperative Period Postop Period

Figure 4. Timeline for intraoperative period.

Procedure Mis-booked

Laterality Mis-booked

Surgical Equip Not Avail

Anes Equip Not Available

Pt Care Equipment Failure

Missing Anes Equipment

Monitor Failure

Anes Machine Failure

Absent Personnel

Missing information

Need Further Preop Workup

Difficult Vascular Access

Difficult Regional Anesthesia

Complicated induction

Difficult Ancillary Proc Anes

Critical Anes Event

Missing Surgical Equipment

Broken Equipment Obtain Replacement

Unanticipated Surgical Event

Surgical Procedure Changes

Dispo Change

Difficult Anc Surg Proc

Prolonged Emergency

Peri-emergence Event

Staffing Limitations

ICU Transport

Set up Anesthesia Machine

Set up Monitors

Prepare vascular access

Obtain Instruments

Open / Set up Instruments

Prepare Pt. Care Devices

Patient Arrives in OR Area

Identity / Procedure / Laterality

Anesthesia Re-eval / Exam

Transfer to OR Bed

Vascular Access

Apply Monitors Patient into OR

Create Anesthetic Record

Ancillary Anesthetic Procedures

Create Nursing Record

Get Surgeon to OR

Induce Anesthesia

Urinary Catheter

Position Patient

Surgical Exam

Prep & Drape

Electrocautery On Final Setup

Operate

Path Consult

Imaging

Closure

Apply Dressings

Ancillary Surgical Procedures

Create Surgical Record

Write Orders

Emergence from Anesthesia

Transfer to Stretcher

Reconnect Monitors Transport

Review Images

Intraoperative PeriodPreop Period Postop Period

Figure 3. Timeline for perioperative period.

is readily apparent that the perioperative process isextremely vulnerable to perturbations, particularlyduring the critical intraoperative portion, when de-lays in a single case propagate downstream and rip-ple across the OR as well.

The overall timeline shows that perioperativeprocesses (and perioperative systems design) ex-tend far beyond the OR, both in space and time. Infact, perioperative processes and their vulnerabili-ties are so distributed that the design of improve-ments will truly require a multidisciplinary andholistic approach. Any planned change in perioper-ative systems must be considered in the context ofthe entire system, and the timelines are a usefulconstruct for this purpose. Furthermore, any pro-posed research and development effort in periop-erative systems design should be evaluated interms of its likely and potential favorable impacton the perioperative timelines.

Desired State for thePerioperative Systems

Today’s ORs deploy an impressive array of stand-alone technologies. Current trends point to ever-greater technological capability in diagnostic andtherapeutic tools. We anticipate continued minia-turization of tools and equipment, more maturevoice recognition and other communication tech-nologies, and continued advances in robotics andimaging that will lead to more and more noninva-sive procedures. We have moved from the networkdecade of the 90s to the age of sensors today, andin another leap, will move to the coming biotech-nology decade as well as seeing the routine devel-opment and manufacture of nanoscale materials.These developments will allow the realization of theperioperative system design of the future.

Preoperative Period

From a patient’s perspective, the ideal perioperativesystem allows them to move from home to proce-dure and back to home seamlessly, comfortably,and safely. From a surgeon’s perspective, such a de-sign allows them to transition smoothly betweenprocedures and other clinical activities with mini-mal frustration while ensuring the safety and com-fort of their patients. For the remaining stakehold-ers in perioperative systems, the ideal design pro-vides a rewarding work experience by minimizing

frustration and wasted effort, absorbing the effectsof peaks in workload and unexpected events, whileensuring the comfort and safety of patients andhealthcare providers alike.

The perioperative system design of the futurewill put the patient at the center of the process.Starting from the decision for surgery in the sur-geon’s office, expert software will assist with med-ical decision making. Referring to comprehensivedatabases of the patient’s medical history, as wellas aggregate and surgeon-specific outcomes expe-rience for the contemplated procedure in case-matched controls, decision support software will beable to suggest optimal presurgical testing, diag-nostic studies, and interventions to minimize peri-operative risk. Interfaced with the patient’s calen-dar and testing facility schedules, these programswill suggest and schedule dates for indicated tests.

Scheduling a case will create a secure Websitefor the procedure to coordinate appointments, dis-seminate results to appropriate stakeholders, andkeep the patient apprised of their progress along theperioperative timeline. The patient will be able toreview educational material tailored for their spe-cific procedure within the context of their intercur-rent medical conditions. Again, guided by expertsoftware, specific reminders, perioperative instruc-tions, and information (eg, directions and drivetime to the hospital under current traffic conditions)will be sent to the patient.

Practitioner-specific case lists linked to the in-dividual patient and procedure sites will be avail-able to anesthesia, surgical, and allied personnelsufficiently in advance of the contemplated proce-dure to allow final interventions to be easily madeprior to the day of surgery.

Prior to the day’s cases, automated supply man-agement will dispense supplies for each case basedon a moving window of the surgeon’s past use ofitems for the booked procedure. A second rank ofless commonly used supplies, and the items neededfor the surgeon’s most common “changes” to thebooked procedure, will be identified by looking fur-ther back for infrequently used items. These will bereadied in the background for rapid provision.

Expert workflow process software will use pas-sive sensor technology, such as radio frequencyidentification (RFID) tags in conjunction with sen-sors in key portals (eg, doorways), to track andmonitor the progress of critical supplies, devices,and actors. When an incipient bottleneck is devel-oping, appropriate personnel will be alerted in timeto avert the problem before its effects are felt in theOR. This technology, coupled with time-and-motion


data from more fine-grained sensors throughout theOR, will be used to detect the key events in eachOR and infer the progress and projected end timesin each room. These data will be used to balancethe workload across the ORs by moving cases, whenappropriate. Again, this system will rely on expertworkflow process software to monitor the workflowand suggest interventions.

On the day of surgery, patients will participateactively in their own check-in process by using theirWebsite to confirm the site and nature of thesurgery. The patient will don a beacon device thatidentifies them and tracks their location within thehospital. It will also link authorized practitioners tothe patient’s medical record and to the hospital’s in-formation management and order entry system.Perioperative patients will also wear physiologicmonitors that communicate through the beacon tothe hospital information system. Physiologic moni-toring will be continuous.

The anesthesia and surgical teams, and appro-priate OR personnel, will be authorized to accessthe patient’s electronic medical record and enter or-ders by RFID when in proximity to the patient andby more conventional means when working re-motely. The interface will be a wireless hand-helddevice carried by the practitioner. Location andprocess-specific records, such as the perioperativenursing record (used to track personnel and equip-ment) and the anesthesia record (an information-dense accounting of a period of intense interven-tions) will be created and maintained automati-cally when advanced sensors detect key events andwill be seamlessly integrated with the patient’s hos-pital medical record. Hence, the user interface forthese documents will be completely transparent tothe practitioner.

Intraoperative Period

Real-time access to comprehensive medicalknowledge databases will play a key role in guid-ing intraoperative management. For example, asystem proposed by Gage will be operant: At thebeginning of anesthesia, the anesthesia worksta-tion will access worldwide aggregate anesthesiarecord databases and practitioner-specific data-bases.1 As the anesthetic progresses, the case athand and matched historical controls will be com-pared. Decision support software will use thesecomparisons to suggest optimal management.Moving beyond database connectivity, the anes-thesia workstation will run physiologic models tai-

lored to the patient’s procedure and comorbidities.Divergence between model and patient behaviorwill intelligently activate alarms. Appropriate dif-ferential diagnoses of patient and equipment prob-lems will be generated and displayed along withcontext-specific decision support information.

OR equipment, including surgical, anesthesiaand ancillary patient support devices (ie, beds,warmers), will be fully integrated within and acrosscategories. Equipment will be fully compatible atthe software level, such that single controllers withuser interfaces tailored for use by surgeons, anes-thesiologists, and nurses can operate all of the rele-vant equipment. Conversely, this equipment will befully modular at the hardware level. This allows theOR to be optimally configured to the case at hand,but capabilities can be rapidly enhanced to copewith unexpected complications, and individual de-vices can be hot-swapped in the event of failure. Allof the equipment in the OR will identify itself andreport on its condition to the perioperative record,thus creating another database that can be used forutilization and quality assurance purposes.

The ideal user interface will display critical in-formation saliently, while allowing easy access tocomprehensive data. Recording and equipment con-trol functions will reside in the same device.Requirements for manual data entry will be mini-mized by (1) automatic recording from therapeuticdevices (ventilator, infusion pump settings), (2) theuse of advanced sensors to detect and record keyevents (intubation, incision), or (3) voice recogni-tion technology to record spoken announcements(eg, drug, route, dose). The user interfaces for sur-gical, anesthesia, and nursing workstations will re-side on devices that are fully mobile (ie, hand car-ried and wirelessly connected).

Voice communications in the OR will be handsfree, wireless, and secure, and will use voice com-mands to configure the circle of participants to theneeds of the moment. This technology will alloweasy and instant communication with other person-nel throughout the OR. A team member who leavesthe OR will remain in the communication loop.Enhanced video capacity will facilitate “telesurgery”consultations.

Intraoperative supply chain management willbe as intuitive to use as today’s supply cabinetsand chest-of-drawer workstations, but with deeperreserves, broader inventory, and software en-hancements. For the user, obtaining an itemshould be as simple as removing it from its stor-age location. In the background, the system vali-dates the user’s authorization to access the item,


establishes the patient’s identity and associates thepatient with the item (allergy check or alert), doc-uments use, registers the charge, and links to cen-tral supply to ensure replenishment as well asidentify and ready likely follow-on items.

Postoperative Period

Recovery personnel will have access to all informa-tion relevant to their patient’s intraoperative courseand preoperative issues prior to the patient’s arrivalin the postanesthesia care unit (PACU). All patientswill travel fully monitored from the operating roomto the PACU, and the PACU record will simply bean extension of the anesthetic record.

Flexible spaces will be rapidly reconfigured tomeet the recovery space needs. What sets the PACUof today’s OR apart from any other unit in the hos-pital includes a cadre of highly skilled nursing per-sonnel and physicians, piped oxygen and vacuum,physiologic monitors, and specific supplies. Due totheir high cost, the availability of monitors is fre-quently the largest infrastructure impediment toadding PACU capacity.

In the PACU of the future, patients will arrivewearing their monitors. Equipment miniaturizationwill have developed to the point that a source ofelectricity and access to a wireless local area net-work (LAN) is all that will be needed to support amobile “PACU workstation,” including oxygen, vac-uum, a display for the monitors, and supplies. Thismobility of infrastructure will make it possible toreshape flexible spaces into traditional PACU bays,ambulatory recovery space, overnight critical carebeds, or ambulatory PACU spaces, based on the pro-jected needs from the day’s workload.

Smart scheduling software will predict periodsof peak demand for PACU services and schedulepersonnel appropriately.

Summary

The ORF will be characterized by intuitive commu-nications and sensor technologies that reduce oreliminate medical errors; provide complete 24-hoursituational awareness to clinicians, support staff,and management; and support the creation andnurturing of highly trained and cohesive teams.These environments will be scalable.

In the future, the patient’s surgical environ-ment will be the primary focus, and the healthcare

facility will use technology to improve both the ef-ficiency and effectiveness of the delivery process.This includes the flow of people, information, andmaterials, and the integration of human systemsinto these technologies.

Recommended Research Roadmap

The Perioperative Systems Design Workgroupagreed that safe and efficient perioperative systemsare critical to both military and civilian contexts.However, today’s complex perioperative processes,sometimes perceived as chaotic, unwieldy, and frus-trating, have grown up without direction in re-sponse to developments in surgical practice andtechnology. Consequently, inefficient perioperativesystems have dampened the benefits of new surgicaltechniques and high technology.

Research and development is now needed inseveral areas that defy easy sorting into specific pro-jects; accordingly, we present two schemas for or-ganizing this research effort. The first is basedloosely on categories of effort within perioperativesystems design, and might at first glance lend itselfto the evaluation of technological innovation in pe-rioperative systems. The second research schema in-vites researchers to consider their work in terms ofthe overall goals of perioperative systems design.This second, goal-oriented schema is meant to pro-vide an encompassing framework for the criticalevaluation of research within the global context ofan entire perioperative system.

Category Research Roadmap

Our Perioperative Systems Design Workgroup iden-tified eight major categories for research: safety, in-tegration, connectivity, information, equipment,outcomes, facility design, and personnel. Some ofthese categories also drew the attention of the otherfour workgroups, in some cases forming the bulk oftheir efforts. They are re-treated here for the sake ofcompleteness and to stress the idea that periopera-tive systems design encompasses the complete careof the patient, from admission to discharge. The re-search categories identified by the other work-groups that are most relevant to the multidiscipli-nary focus of our workgroup are highlighted belowin the first six items:


Safety

The Patient Safety Workgroup viewed safe care as aprecondition and first priority in surgical settings, andwe took this to include all patient settings considered inperioperative systems design. The Patient SafetyWorkgroup pointed out that ensuring safety was con-sistent with patient-centered care and achieving opti-mal outcomes. The group also recognized that most er-rors result from poorly designed systems and clinicalprocesses, and are not the fault of individual clinicians.The Telemedicine Workgroup advocated the use ofteleconsultation to broaden the resources brought tobear on intraoperative processes as well as the use ofhigh-resolution recording of complete intraoperativedata for later analysis of critical events.

Integration

Both the OR Informatics and Advanced DevicesWorkgroups focused on equipment data stream andinformation integration as areas for development.Both workgroups commented on the impressive ca-pabilities of stand-alone equipment and lamentedtheir lack of integration with each other. TheAdvanced Devices Workgroup focused on the in-creasing number and types of sensors that cliniciansmonitor and control. Pointing out the limitations ofhuman ability to capture, process, and integrate rawdata streams, a call was made for research into datacapture and use, optimized for both real-time analy-sis and after-the-fact interpretation. The InformaticsWorkgroup called attention to the fragmentation ofmedical information from clinical resources such aslabs, medical records, and databases.

Connectivity

The Advanced Devices Workgroup stressed the im-portance of device interconnectivity. Current de-vices neither communicate with each other nor withcommon interfaces. All devices in the future shouldbe able to be seamlessly plugged into a network forcontrol, data capture, and safety. A DICOM-likestandard needs to be created for all equipment thatis used in future operating rooms; furthermore, thisstandard needs to provide interoperability in bothcivilian and military environments.

Although the Advanced Devices Workgroup fo-cused primarily on surgical equipment, its positionon connectivity logically applies to all devices usedin perioperative systems, especially since some de-

vices, such as procedure surfaces, fall within thecontrol of multiple OR stakeholders. Connectivitywas also a focus of the Medical Informatics andTelemedicine Workgroups, again, primarily for in-traoperative devices.

Information

The Telemedicine Workgroup commented on thetremendous amount of information that passesthrough the typical operating room without beingcaptured or recorded, and called for the develop-ment of technology to capture, broadcast, andrecord surgical procedures. The Advanced DevicesWorkgroup called for developing technologies andmethods to extract relevant information from volu-minous data both for intraoperative guidance andpostoperative analysis. The Informatics Workgroupemphasized the need for “smart” software to assistwith decision making for complex data sets and thedevelopment of standards for information manage-ment to make complete medical information fullyaccessible.

Equipment

Both the Advanced Devices and InformaticsWorkgroups touched on the need to improve the ORworker’s user interface. The Advanced DevicesWorkgroup couched this discussion in terms of man-aging data streams and integrated device control forsurgeons. The Informatics Workgroup extended thisnotion, calling for research to design and test the op-timal user interface (UI) for surgeons, anesthesiolo-gists, and nurses to input and access clinical data. Theoptimal UI will support multimode access, where clin-icians are able to use mobile devices (such as the PDAor tablet computers), Internet browser access toIntranets, and adequate remote access through se-cured Internet connections.

The Perioperative Systems Design Workgroupembraces the need to rethink and reconfigure theuser interfaces for all OR workers, with an empha-sis on integrated data capture, real-time analysis,access to patient records and medical knowledge,coupled with device control.

Outcomes

A recurring theme from the other workgroups wasthe need to demonstrate return on investment from


potentially expensive ORF research initiatives. Forexample, from the Advanced Devices Workgroupcomes this mandate: In order to fully capture thepurported benefits of the components of the ORF, aswell as the efficiencies of systems integration, it isnecessary to model, predict, and then measure theeffect of different patient flow schemes, differentstaffing models, and room functionality in the pres-ence or absence of its various components. Only byperforming such a detailed analysis can one justifythe potential added expenses of such a sophisticat-ed OR environment and identify areas of waste thatshould be modified or eliminated from the design.

The Patient Safety Workgroup chose to focuson outcomes measurement from a quality assuranceperspective. They advocated using the sophisticateddata collection capability of a realized ORF to iden-tify the true incidence and prevalence of adverseevents, to determine the cost of adverse events andto demonstrate the cost-effectiveness of initiativesto ensure safety.

Two additional general issues pertaining to theORF and identified by the Perioperative SystemsDesign Workgroup are facility design and personnel.

Facility Design

The pace of technological innovation will only continueto accelerate. Thus it is likely that disruptive techno-logical breakthroughs will occur more than once duringthe lifetime of the buildings erected to house the ORF.Thus, hospital facilities of the future must be designedto support and nurture technological innovation. Inconflict with this notion, today’s hospitals grow by ac-cretion and renovation, rather than creation fromscratch. Research in perioperative systems designshould include a consideration of how spaces can bemade more accommodating to new technology, andhow new technologies can be used to extend the capa-bilities of existing space.

Personnel

The ORF will accelerate the onslaught of new tech-nologies and their associated cognitive load on thepeople who work there. Without proper attentionto the care of individuals (caregivers and, to a less-er extent, patients) using the workspace, future ORsmay exceed the capacities of their designers. Thisissue encompasses but goes beyond ensuring thesafety and comfort of personnel. New technologies

may require completely reconfiguring the OR work-force, redefining work roles and redistributingtasks. Ironically, in future ORs, it may be surgeonswhose capacity for work is exceeded, as improvedperioperative systems quicken the tempo of patientflow through the perioperative timeline.

Goal Oriented Research Roadmap

Perioperative systems design cuts across all aspectsof the care of the surgical patient. It intersects allof the issues addressed by the Safety, Informatics,Telemedicine and Advanced Devices Workgroups.Research critical to improving perioperative systemsdesign may not lend itself to organization under thecategory schema described above. For example, re-search into advanced devices to automatically se-lect and deliver supplies to the OR in a timely fash-ion will touch on safety, equipment, connectivity,information, integration, and facility design in thecategory schema, but it might more easily be de-scribed as an effort to improve readiness in the OR.To address this we have developed a second re-search schema by defining four broad concepts per-taining to the fundamental goals of perioperativesystems design research. These goals encompass the“why” of perioperative systems design research, andany proposed effort must be critically evaluatedwith respect to how it impacts them:

Readiness

Pertains to the ability of the perioperative process tobe fault-tolerant as well as self-correcting, and togracefully accommodate unanticipated events.

Workflow

Addresses the optimal design and deployment ofresources and processes associated with the pre-,intra-, and postoperative timelines.

User Expectations

Addresses the needs of those who use the surgicalenvironment, including patients, the surgical team,and other aligned clinicians. Expectations mayrange from the emotional (eg, reducing frustration,increasing satisfaction) to the physical (eg, reducing


fatigue and stress). In addition, expectations mayemanate from awareness of technological progressin other industrial and cultural settings (eg, use ofwireless bar-coding in retail, robotics and machine-assisted tasking in manufacturing, and customerservice models enhanced through connectivity withthe internet).

Training

Addresses the enhanced competency of the peri-operative team—individually and collectively—before, during, and after the surgical process, andthe development of a learning environment insurgery.

Summary

The issues involved in designing and deploying op-timal perioperative systems are multidisciplinary,and will draw input from the following fields: in-dustrial engineering and systems engineering forproduction system designs, workflow design, sys-tems analysis, and quality assurance; human factorsand ergonomics for workplace layout, safety, andtraining; computer science and human-computer in-teraction for user-centered information systems andeasy-to-use computer systems; and managementscience for staffing, retention, and organizationalbehavioral analysis.

Given the breadth of the topic, it is easy for re-search to occur in apparent isolation, based primar-ily in one of the disciplines listed previously. Hence,a central goal of the Perioperative Systems DesignWorkgroup is to create a basis for a cohesive andmutually supportive academic and industrial engi-neering community focused on the surgical envi-ronment. To facilitate this goal, the workgroupcreated two schemas for research and solution de-velopment, one based on broad categories, theother based on goals of the perioperative process.The Perioperative Systems Workgroup advocatesthat any research pertaining to the ORF be con-sidered in light its impact on the perioperativetimelines and in terms of the goal orinted schema.For example, a new technology based in one ofthe eight categories may be developed to addressspecific user expectations; however, if this tech-nology requires skilled operators, unique supplies,or any other scarce resource, it is likely to have anegative impact on overall readiness. This may be

mitigated if sufficient attention is paid to work-flow issues during development and deploymentof new technology. New technologies should al-ways be developed with an eye to training, if onlyto maximize their ease of introduction and realizetheir full potential. We believe that these schemaswill facilitate research programming and fundingto target operational goals relevant to most stake-holders in the surgical environment.

Recommended Research Agenda

In the previous section, we laid out eight majortopic areas for ORF research and established aframework for considering which perioperative sys-tems design goals specific research projects mightaddress. To accomplish the creation of the desiredstate of technology in future perioperative systems,a concerted research effort in several more specificareas must be undertaken. These are laid out below.In some cases, the divisions between the topicsseem almost artificial, because the topics are soclosely related and draw so heavily upon eachother.

A major workflow goal throughout the researcheffort must be directed at reducing the number ofuser interfaces that healthcare personnel must ad-dress, and equally important, making these inter-faces more transparent. Here, we define “transpar-ent” as a combination of being intuitive to use andrequiring minimal interruption in the user’s prima-ry activity, patient care.

Facilities

The rate of change in medical technology willonly increase. Robust demonstration of a newtechnology’s effectiveness through outcomes pro-jects will increase the urgency of its widespreaddeployment. This will lead to increased pressureon hospital facilities to provide a reconfigurableinfrastructure. Future hospital design shouldfocus on providing spaces designed for maximumflexibility and anticipating the need to reconfig-ure the space. For example, interior partitionwalls should be devoid of wiring or plumbing,with impervious surfaces pre-applied, and engi-neered so that, like furniture, they can be addedto a large, finished space. Reconfigurable parti-tions can be achieved by inclusion of services inceilings and accessed by pendants (electricity


and gases), while wireless connectivity andportable, battery-powered user interface deviceswill obviate the need for LAN connections ortelephone connections in many walls. This re-search effort can be expected to pay large divi-dends for the life of a successful building interms of workflow and user expectations.Developing and testing the basic concepts for aflexible hospital space should be a short-term un-dertaking.

Communications

Communications can be (somewhat artificially) di-vided into person-to-person voice and person-to-group nonverbal blocks. Both will retain their utili-ty in the perioperative system design of the future,and both require significant research and engineer-ing effort to realize their full potential.

Voice communication will continue to be amainstay for conveying instructions and data, andfor synchronizing the information state and plansamong team members. What will be different aboutthe ORF is that people will communicate withequipment and the medical record in much thesame way as they communicate with each other: byvoice. All of this functionality must be deliveredwithout restricting the mobility of personnel. Hencethe need for the continued development of er-gonomically perfect, wearable, hands-free, wirelessvoice communications devices.

Other forms of communication that are current-ly in use must gain new functionality to fulfill theirmissions in the ORF. For example, the ubiquitous“dry-erase” white board is likely to persist, if only be-cause it is so effective for broadcast communicationand providing visual organizing cues. Research inareas of nonvoice communication must focus on cap-turing the data that people put on such “big-picture”devices so that it can be used by decision analysisprograms. Basically, people must be able to commu-nicate with software and databases via the whiteboard. Similarly, the software and databases must beable to use the same device to communicate withpeople without destroying its functionality.

In a related area, paper documents have a rep-resentational value of the big picture. Current soft-ware designed for the electronic recording of datathat is traditionally represented graphically on papermust be engineered so that this graphic informationis returned to the display of data.

As the cost of sophisticated equipment falls and

technology continues to develop, we anticipate thatsignificant steps toward the desired state in com-munications can be achieved in 3 to 5 years, withmajor benefits to the intraoperative timeline interms of workflow, readiness, user expectations,and training.

Patient Monitors

Today’s conventional physiologic monitors requireminiaturization and the application of short-rangewireless technology to make them full-time wear-able and free of leads. “Put them on once, alwayson” wireless monitors for patients should be a short-term research focus. Once in the perioperative en-vironment, vital signs should always be monitored,and they should be monitored without tangled, con-taminated leads that must be removed and reap-plied with each change of location. Creating thismonitor architecture allows the patient to be moni-tored wherever there is a display, since the moni-toring hardware and software will be on the patient,rather than the wall. We expect that this level oftechnology could be achieved in 3 to 5 years, withmodest improvements in perioperative workflowbut a dramatic impact on perioperative readiness(the ability to anticipate and react to physiologicperturbations foreshadowing catastrophic events).

Effective monitors of each of the major anes-thetic interventions: hypnosis, analgesia, andparalysis would be beneficial and merit further re-search. Two of these three monitors are availablein some form, while the third (analgesia) remainsa long-term goal. Having all three integrated andconsistently deployed could yield significant im-provements in perioperative workflow.

An advanced sensor to detect, identify, andquantitate drug administration would be beneficial,in that it would remove the need for human in-volvement in documentation. Such technology isprobably a longer-term goal (ie, 10 years).

Perioperative Medical Informatics

The ideal perioperative system in the ORF de-pends entirely on having complete informationabout the patient, disease, surgeon, procedure,anesthesiologist, etc, all available in the sameplace for use by people and expert software. Muchof the required information is already gathered andstored in today’s perioperative systems, but not al-ways electronically and never in a single database.


Hence, we endorse the research agenda set forth inthe White Paper on Medical Informatics. Relatedareas of research necessary to use the accumulateddata prospectively and effectively are:

Standards for Database Connectivity

Proprietary standards for databases have grown upfor a variety of reasons. Although it may suit thepurposes of the developers and owners of today’smedical databases to limit their connectivity, theORF will not be realized if such silos of informationare allowed to continue. Establishing the frameworkfor a single access point for all patient information,as well as the required data about practitioners, willrequire a basic science effort by academic re-searchers coordinating with the research work doneby industrial developers. The necessary standardsare not likely to grow out of a competitive market-place, so a regulatory contribution to this effort islikely to be required.

Finally, legislative work to protect the privacyof patients and practitioners in an era where com-plete data about both are known and readily acces-sible will be necessary. This aspect of the researcheffort should be accomplished in the short term.

Although standards for connectivity will havelittle direct impact on perioperative timelines, theyare a required step for enabling much more dra-matic improvements through ready access to infor-mation.

Expert Software

We anticipate that several areas in the periopera-tive systems design of the future will require deci-sion assistance provided by expert software. Suchsoftware has been described as having “knowledgeinside” and will be used in three overlapping sets ofcircumstances: (1) to optimize decision makingwhen the number of variables affecting the decisionexceeds human cognitive capacity (eg, scheduling),(2) to bring aggregate medical knowledge (histori-cal and prospective research) and patient-specificdata into the decision-making process, and (3) tomake lower level decisions autonomously in thebackground (eg, picking supplies for routine cases).Scheduling software, both for day of surgery andfor the entire perioperative period will removemuch of the apparent chaos found in today’s ORs,and will smooth out the effects of unanticipatedevents by quickly adjusting schedules to accommo-

date new circumstances. To do this, such softwarewill need access to complete data about all of theactors. Wide application of expert software dependson standards for information sharing and seamlessaccess to complete data. Once achieved, huge im-provements in perioperative readiness and work-flow are likely. However, this is likely to remain anintermediate-term goal (5 to 7 years) while the pre-requisite steps are accomplished.

Voice Recognition

Voice recognition for the purpose of controlling de-vices and software has the obvious advantages ofallowing the user’s hands to be doing somethingelse and of preventing contamination of the user in-terface. Voice recognition for the control of devices,query of databases, and use of software will be anear-universal feature of perioperative systems de-sign in the desired state of technology. Research inthe areas of informatics, information standards, andexpert software should all proceed with the as-sumption that the voice will be the mode of in-struction input. Initially, the direct impact of voice-recognition devices on perioperative timelines mayonly be a modest improvement, or may even becounterproductive; however, as voice recognitionestablishes itself as a part of intuitive, easy-to-useinterfaces, its impact on workflow will become morepositive.

Single User Interfaces Optimized forTarget Users

To create an environment where clinicians focus onthe care of the patient rather than on the control ofdevices, interaction with medical equipment mustbecome intuitive and transparent. Redundant ac-tions must be eliminated and all relevant informa-tion and control elements placed within easy reachof the user. The intraoperative user interfaces mightideally reside on a tablet computer-based device.Key features will be wireless connectivity and mo-bility within the OR, and the ability to tolerate high-level disinfection between cases. Perioperative per-sonnel will also need a smaller, PDA-like device forinteracting with patient medical records, the hospi-tal order entry system, and imaging displays for usein the preoperative and postoperative periods. Sucha device should be hand held and fit in a pocket.

The development and testing of optimal userinterfaces for each member of the perioperative



team should be a primary goal in perioperativesystems design. This research goal touches onthe previously mentioned informatics, standards,expert software, voice recognition, and commu-nications research topics, and echoes a primaryresearch goal of the Informatics Workgroup.Because the optimal user interface depends onachieving all of the information connectivity pre-viously described, and the plug-and-play devicearchitecture described next, it is probably far-thest from realization. However, research in thisarea will contribute significantly to meeting userexpectations and improving workflow.

Plug-and-Play, Modular OperatingRoom Equipment

The creation of a single-user interface implies takingover control of devices and receiving data from sen-sors remotely and independently from whateveruser interface was supplied with the device.Realization of an optimal, unitary information andcontrol interface requires the creation of technologyto allow software-level seamless integration of allOR equipment in such a way that another devicecan invoke all of its functionality. Because technol-ogy will continue to be acquired and deployedpiecemeal to avoid the cost of replacing usableequipment that is not obsolete, hardware modular-ity and interconnectivity should become engineer-ing and design objectives.

The drive towards modularity will also be sup-ported by the need for flexibility in how equipmentis deployed from case to case. What we are describ-ing is the creation of a plug-and-play environmentfor OR equipment similar to the one that is justcoming to fruition for personal computing. This willrequire traditional competitors to collaborate, or atleast cooperate, and might best be sponsored by cre-ating a government–user–industry consortium todevelop the necessary standards to support theneeded interconnectivity.

Development of plug-and-play OR equipmentreiterates a major research goal of the AdvancedDevices Workgroup and extends it to encompassall of the equipment used in perioperative systems.Developing plug-and-play perioperative technolo-gy is a prerequisite to constructing optimal peri-operative user interfaces, and should be made anurgent short-term priority with an expected de-ployment time frame of 3 to 5 years for all ORequipment. Moreover, as it becomes available, plug-and-play modular equipment will yield significant

improvements in readiness, workflow, and user ex-pectations in its own right.

Perioperative Advanced Devices

Advanced devices for supply chain managementand process monitoring await research and engi-neering development. Perioperative supply chainmanagement is waiting for the application of ro-botics and expert software to completely automatethe picking and delivery of supplies for surgery,anesthesia, and ancillary patient care, both preop-eratively and intraoperatively. Research and engi-neering in this area should focus on creating securesupply delivery with a completely passive, trans-parent user interface.

Robotic picking, delivery, and dispensing ofdrugs and supplies, assisted by expert software fordecision assistance and autonomous decision mak-ing, should be a research focus. Machine-learningalgorithms could be applied here in conjunctionwith historical data mining to predict what supplieswill be needed and deliver them to the therapeuticlocation preemptively. As with all of the other peri-operative technology implemented in the perioper-ative systems design of the future, these elementsshould be developed as software-integrated hard-ware-modular plug-and-play devices.

These technologies will have major positive im-pacts on readiness and workflow. In many cases,the technological hurdles have been cleared in otherfields such as manufacturing, and what is needed isan effective transfer to perioperative systems. Thiscould be accomplished in a 3- to 5-year time frame.

Part of the optimal user interface for any pro-cedure-based practitioner is the interface device’sability to infer where in the process the system is atthe current time and to offer an intuitive, contextbased, focused set of next moves on the controlside, while automatically recording complete dataand displaying that which is most relevant. The usershould have minimal intrusions on their attentionto the patient from both the control and recordingsides of the user interface. To achieve this capabili-ty to infer system states and procedure progress, theperioperative user interface devices that are devel-oped will require inputs from advanced sensors. Forexample, such devices might include advanced op-tical sensors and image analysis software to infer, inconjunction with data from the gas analyzer, whenintubation has occurred during the induction ofanesthesia, or when the penultimate suture of agiven type has been removed from the scrub table,


prompting the delivery of another. These technolo-gies will have major impacts on readiness, work-flow, user expectations, and training; however,huge amounts of processing power and connectivi-ty will be required as well as development of thesensors themselves. Thus, they are more likely to bedeployed on the 7- to 10-year time scale.

Suggested Collaborators forPerioperative Systems Design Research

The application of new technologies to periopera-tive systems designs for the ORF must be driven bythe organizations that will use them in order to ac-commodate the unique features of the deployed lo-cations. Ideally, this will be a collaborative effortled by the users, rather than work done in isolation.

Industry will play a key role in the developmentof perioperative technologies. Equipment manufac-turers have the critical masses of engineering talentand production capacity to design, develop, andbuild new technologies. Clearly there is a role forORF implementation projects to push technologyand systems to the limits of their designs, pointingthe way for future development. These projectsshould also serve as test beds for potential newtechnologies and systems.

Umbrella organizations like CIMIT, TATRC, andthe Defense Adavanced Research Projects Agency(DARPA) will play key roles in (1) facilitating theinteraction between users and developers, (2) iden-tifying areas of mutual interest between tradition-ally isolated parties, and (3) bringing various stake-holders together. Finally, standards organizationswith broad representation from all parties will playa strong role in developing the needed software andhardware standards for interconnectivity.

Conclusions

We begin by restating an essential definition.Perioperative systems design describes a rationalapproach to managing the convergent flow of pa-tients from disparate physical and temporal start-

ing points, through the operating room, and thento such a place and time where future events per-taining to the patient have no further impact on ORoperations.

In contrast to the notion of perioperative sys-tems design, today’s complex perioperativeprocesses have grown up without direction in re-sponse to developments in surgical practice andtechnology. Consequently, the benefits of new sur-gical techniques and high technology have beendampened by inefficient perioperative systems.Perioperative processes are so distributed, andtheir vulnerabilities are so pervasive, that their re-construction will truly require multidisciplinaryand holistic approaches.

We have presented two schemas for organizingthe research effort in perioperative systems design.The first is based loosely on categories of effort:safety, integration, connectivity, information, equip-ment, outcomes, facility design, and personnel. Thesecond research schema is meant to invite re-searchers to consider their work in terms of theoverall goals of perioperative systems design: readi-ness, workflow, user expectations, and training. Ourgoal-oriented schema encourages critical evaluationof research within the global context of an entireperioperative system.

Referring back to the perioperative timelines, itis clear that perioperative processes are extremelyvulnerable to perturbations, particularly during thecritical intraoperative portion. Making the periop-erative system more robust and fault tolerant is akey goal. Any proposed research and developmenteffort in perioperative systems design should beevaluated in terms of its impact on the perioperativetimelines, ie, what is its likely contribution to im-provements in readiness and workflow, meetinguser expectations, and enhancing training in the ORof the Future.

Acknowledgement

This paper is presented courtesy of the Telemedicine andAdvanced Technology Research Center.

References1. Gage JS: Anesthesia Information Management Systems. ASA

Newsletter 66(6), 2002.

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