2008 ASHP Summer Meeting Seattle, Washington Educational Session Abstracts

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1 2008 ASHP Summer Meeting Seattle, Washington Educational Session Abstracts 110 Robotic IV automation: human intelligence combined with robotic accuracy Culligan, M.W. Saint Francis Hospital and Medical Center, 114 Woodland Street, Hartford, CT USA. Power, L. A. Power Enterprises, 507 Crestmont Drive, San Francisco, California USA. Abstract: This session will define robotics and demonstrate how this science has been applied to the compounding of sterile preparations. The general characteristics of compounding robots will be discussed, including accuracy, consistency and ease of maintaining a controlled environment. Detailed overviews of the existing sterile compounding robots will be presented. Learning Objectives: 1. Describe the components of robots used to compound sterile preparations. 2. Describe the systems for attaining sterility and accuracy in the robotic compounding process. 3. Compare the sterile compounding robots. Self-Assessment Questions: 1. Select the components that robots use to compound sterile preparations: a. Syringes and needles as in manual compounding b. IV sets to transfer fluids from one container to another c. Evacuated bottles or empty sterile bags d. Sophisticated mechanics and software e. Dispensing pins 2. Which of the following does NOT contribute to the sterility and accuracy in the robotic compounding process? a. A contained ISO 5 or better compounding environment b. Human operator reads labels before placing drugs into robot c. Limited human access to the immediate compounding area

2 2008 ASHP Summer Meeting Seattle, Washington Educational Session Abstracts d. Drugs and diluents are verified using redundant electronic methods e. All identification and compounding steps are documented electronically 3. The three sterile compounding robots can do all of the following except: a. Compound sterile and accurate preparations b. Prepare syringes as final dose containers c. Deliver final dose to the patient d. Label preparations with documentation codes e. Maintain electronic records of all compounding steps Answers: 1. d; 2. b; 3. c

3 Robotic IV Automation: Human Intelligence Combined with Robotic Accuracy ASHP SUMMER MEETING JUNE 2008 Seattle, Washington Michael Culligan, R.Ph. Saint Francis Hospital & Med Center Hartford, CT Luci A. Power, M.S. Power Enterprises San Francisco, CA

4 Which robot would best compound IV sterile preparations? A. R2-D2 B. C-3PO C. Bender D. Mr. Data Answer: None of the Above!

5 Robots are not just for science fiction anymore! Anthropomorphic Robot ASIMO a humanoid robot manufactured by Honda "Advanced Step in Innovative MObility Designed to interact with humans

Articulated Robot Powered, rotary joints Extensive range of motion At least 3 axes of movement Can be rotational, vertical &/or horizontal What is a robot?

6 Articulated Robot Powered, rotary joints Extensive range of motion At least 3 axes of movement Can be rotational, vertical &/or horizontal What is a robot? Robotics Institute of America A re-programmable multi-functional manipulator designed to move materials, parts, tools, or specialized devices through variable programmed motions for the performance of a variety of tasks

7 What is a robot? International standard ISO 8373 Automatically controlled, reprogrammable, multipurpose, manipulator programmable in three or more axes, which may be either fixed in place or mobile for use in industrial automation applications ROBOTIC IV AUTOMATION Compounding robots are IV preparation devices that automate the compounding of sterile preparations by using robotics, software, and hardware

8 OVERVIEW OF ROBOTICS There are currently 3 robots capable of compounding sterile preparations: CytoCare IntelliFill RIVA Current Robotic Automation

9 OVERVIEW OF ROBOTICS What are these devices? FDA approved Class II Exempt (Pharmacy Compounding) Medical Devices? Primary Engineering Control (PEC) per USP 797 Isolators? Something else? OVERVIEW OF ROBOTICS Compounding robots as IV preparation devices consist of hardware, including the robotics and other sophisticated mechanics; and software that controls the mechanics Robots are much more complicated than automated compounding devices (ACD)

10 OVERVIEW OF ROBOTICS Sterile compounding robots operate within closed units with HEPA generated unidirectional air of ISO Class 5 or better The closed unit isolates the critical aseptic processing areas from surrounding area during compounding OVERVIEW OF ROBOTICS Human access to the compounding area is limited to cleaning and set up Only emergency access to the compounding area is possible during the compounding process the robot must be disabled via an emergency system

11 OVERVIEW OF ROBOTICS Human support is needed by the robot to: Provide drugs, solutions and supplies for compounding Remove completed preparations Remove waste containers Maintain printer and labels Clean the ISO 5 environment Trouble shoot robot operations OVERVIEW OF ROBOTICS How much human time is required? Initially: at least one operator 1 on 1 with the robot Each robot is different Staff time will also depend on task batch versus individual dose Cleaning time for daily activity: minutes

12 Overview of Cleaning Not Easy Time Consuming Critical Step Occasionally clean with something other than Alcohol Do not cut corners Overview of Cleaning More stringent cleaning for robot compounding hazardous drugs Documentation of effective cleaning: Surface sampling for disinfection Fluorescence or surface sampling for marker hazardous drugs

13 OVERVIEW OF ROBOTICS Robotic systems utilize multiple and redundant safety checks for accuracy of all stages of compounding from initial components to final preparation OVERVIEW OF ROBOTICS Robots MUST verify all drug, solution and supply selections Selection is verified by software controls barcode verification 360 degree digital pictures verification of weight and height

14 OVERVIEW OF ROBOTICS Compounding robots interface with pharmacy systems to retrieve patient specific doses to be compounded From this information, compounding workflow is established: stats, timed doses, doses needed by drug, etc. Software tracks what s in the queue OVERVIEW OF ROBOTICS Robots may operate in batch mode to produce multiple doses of like drug: e.g. heparin flushes; or doses to be frozen for later use e.g. cefazolin 1 gram

15 OVERVIEW OF ROBOTICS Compounding robots must document all identification and compounding steps by electronic &/or photographic methods Labeling must include a barcode or other unique identifier as well as standard, readable labels per pharmacy requirements CytoCare Cabinet

16 Overview of CytoCare ISO 5 compounding area Contained air handling system designed for hazardous drugs No human access to compounding area during compounding process Flexible selection of syringes, IV bags, elastomeric infusers and bottles

17 Overview of CytoCare Identification of drug, diluent and final containers by bar-code reader and optical imaging Calculation of dose volumes Performs serial dilutions Adjustment of diluents as needed CytoCare Robot Arm

18 Overview of CytoCare Weight checks of volumes dispensed Interfaces to pharmacy system via HL7 Automated data collection and reporting RIVA

19 Overview of RIVA ISO 5 compounding area ISO 5 vestibules for loading inventory into the storage carousels Contained air handling system designed for standard sterile compounding but may be used for hazardous drugs No human access to compounding area during compounding process

RIVA with ISO 5 vestibule Overview of RIVA cont d Utilizes multiple sizes of syringes and IV bags for compounding and dispensing Identification

20 RIVA with ISO 5 vestibule Overview of RIVA cont d Utilizes multiple sizes of syringes and IV bags for compounding and dispensing Identification of drug, diluent and final containers by bar-code reader and optical imaging Additional identification of drug vials by height and expected weight

pharmacy system via the label data to process the orders Automated

21 Overview of RIVA cont d Performs serial dilutions Adjustment of diluents as needed Weight checks of volumes dispensed Interfaces to pharmacy system via the label data to process the orders Automated data collection and reporting RIVA Robotic Arm with IV Bag Syringe Manipulator

22 Overview of IntelliFill Overview of Intellifill IntelliFill IV automates the preparation of small-volume IV medications in 12 ml syringes for doses as small as 0.5mls to as large as 11.5mls. Can hold up to ~40 different medications in drug cabinet First Introduced in 2002

23 Overview of Intellifill Fills syringes capped and sterilized Reservoir Mode up to pph Vial Mode up to pph Reconstitutes for manual and its own use Multi-dose draw Serial Dilution Final weight check Overview of Intellifill Bar code scan of all containers Two-step formulary management with separate permissions Pictures of vials Bar code scan of labels

Overview of Intellifill Email Notification Automated Tasks and logging (i.e. cleaning, pre

24 Overview of Intellifill Notification Automated Tasks and logging (i.e. cleaning, pre filters, etc) Produces customized labels through interface Minimal consumable waste Labels

25 IntelliFill i.v. Automation Deck Cannot operate with doors open ISO Class 5 enclosure Hands-free, unattended operation Outputs to: Conveyor normal doses Reject drawer rejects First Dose/Quarantine drawer for immediate processing

26 IntelliFill i.v. Interface Print Stream Pass-through printing of items device does not prepare Easy down-time recovery Ability to customize labels easily Examples Medication Mixed Utilizing Automation at St. Francis Heparin Flushes (2 strengths) Cefazolin Cefepime Ceftriaxone Cefuroxime Famotidine Magnesium Buffered Lidocaine Adenosine Ampicillin Methylprednisolone Phenylephrine Ephedrine Vecuronium Caffeine Gentamicin Vancomycin Furosemide Cefotaxime Metoclopramide

27 Why do we need IV automation? Select the best reason to implement robotic compounding at YOUR site: A. Improved accuracy B. Less opportunity for contamination C. Improved productivity D. Reduce worker exposure to hazards E. Improved documentation of compounding activities F. Reduced labor force G. Other

28 Select the best reason to NOT use robotic compounding at YOUR site: A. Expense of purchase B. Space requirements C. Expense of clean room & robot D. Concern for actual operation will it really do what they say it will do? E. No back up plan what happens if??? F. Other When will you be looking into robotic compounding? A. Never B. In next 6 months C. In next 12 months D. Greater than 12 months less than 3 years E. Greater than 3 years

29 Why do we need IV automation? Robotic IV automation removes the largest source of contamination from the compounding environment: the human operator Robots provide consistent operational support Improved accuracy and documentation Goals of Automation Increase patient safety Facilitates bed side bar code medication administration Increase sterile compounding efficiency/services Overall cost reduction Meet JCAHO Standard 4.20 Only the Pharmacy compounds or admixes sterile products Reduce nursing workload related to admixing Optimize productivity of pharmacist

30 Why automate IV Admixtures? Productivity the most labor-intensive part of pharmacy practice Severity medication errors in this space have a higher frequency of sequelae Better documentation and process control Why automate IV Admixtures? Contamination The most significant source of contamination in IV admixtures is human touch. Accuracy Support BPOC Initiatives

31 The Perfect Robot? Automates the entire IV room Fast No human involvement 100% Accuracy Affordable The Perfect Robot? Minimal Impact on other disciplines Small size Reports Affordable Consumables Flexible Labels

32 The Perfect Robot? Self cleaning Multiple types of bar-codes Free upgrades Easy to operate Able to place anywhere Challenges to Automation Low-tech objects Vials only controlled dimension is the internal diameter of its neck Needles don t have to be straight, don t have to be sharp Syringes low accuracy, but we treat them as if they were accurate Bags

33 Challenges to Automation Few standards with poor compliance automation has to be very tolerant Industry standards for vial fill are wide Cross-contamination The computer is a literal idiot! Common sense is often neither common nor sensible The computer has to be told details users ignore Dead space in the syringe Acceptable variances What happens when 15 things go wrong?

The low tech vial Doesn t have to be round Doesn t have to be flat Dimensions aren t consistent Only controlled dimension is neck internal diameter Vial

34 The low tech vial Doesn t have to be round Doesn t have to be flat Dimensions aren t consistent Only controlled dimension is neck internal diameter Vial Fill Accuracy ± 15% - 10 gm vial might have 8.5 gm in it, might have 11.5 gm in it. FDA definition of adultery is delivers less than 90% of labeled potency

10 ml might have 9.6 ml in it; might have 10.4 ml in it, or anywhere in between.

35 The low tech needle Doesn t have to be straight Doesn t have to have consistent length Wide variance in luer specification Syringe Accuracy ISO ml syringe pulled to 10 ml might have 9.6 ml in it; might have 10.4 ml in it, or anywhere in between. Dead space up to 0.1 ml Weight measurement is generally more accurate that visual measurement

36 ROBOTIC IV AUTOMATION Training Both hands-on and/or web-based Yearly assessment Constant assessment with QA procedures ROBOTIC IV AUTOMATION Other Thoughts Peace of mind Fewer worries in a busy, stressful sterile mixing area Automation doesn t get distracted or stressed Enhancement of Exposure to Pharmacy practice Safety, Safety, Safety

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