Introduction. Human Factors Engineering and Safety in Radiation Oncology
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1 Human Factors Engineering and Safety in Radiation Oncology Introduction Jim Schewe Philips Radiation Oncology Systems North Central Chapter, AAPM Fall
2 Overview Human Factors in Software: General Issues Practical Examples Applicability to Safety in Radiation Oncology Regulatory Context RT Safety: Recent History ROSSI: Radiation Oncology Safety Stakeholders Initiative Guidelines for Error & Warning Messages 2
3 Disclosures I work for Philips I m not an expert in: human factors regulatory affairs software engineering clinical I m a physicist > 3
4 So, what s the problem? People are buggy Human interaction with technology adds a layer of complexity 4
5 What is usability, anyway? I don t know much about human factors, but I know what I don t like 5
6 Examples are easy to find User satisfaction is important 6
7 Relationship to safety Information Overload Lots of information Clinicians use it to make decisions edia/photodb/web/ F ML jpg 7
8 Relationship to safety If it s in the computer, it must be right an R/V system or computer control system will certainly help decrease the number and severity of random treatment delivery errors. However, the use of automated or semi automated systems make the entire treatment planning and delivery process much more susceptible to systematic errors. 8 (emphasis mine)
9 Safety: Regulatory Context 9
10 ISO 14971: Risk Management Human factors are in scope For the particular medical device being considered, the manufacturer shall document the intended use and reasonably foreseeable misuse. Section 4 So is feedback The requirements of this International Standard are applicable to all stages of the life cycle of a medical device. Section 1 (emphases mine) 10
11 Risk controls should take human factors into account From ISO The manufacturer shall use one or more of the following risk control options in the priority order listed: a) inherent safety by design; b) protective measures in the medical device itself or in the manufacturing process; c) information for safety. Hierarchy of Effectiveness 11 hierarchy of effectiveness process/
12 Other Standards and Human Factors IAEA
13 RT Safety: A Little History 13 13
14 Patient 1: Scott Jerome Parks St Vincent s Hospital, NYC, 2005 Oropharynx IMRT Plan changed after 4 fractions correctly treated Plan completed correctly TPS process manually stopped during save Plan is corrupted DQA done after 3 fractions with new plan 3 fractions treated with open fields ~13 Gy/fx, ~650% overdose Patient Died in 2007 Patient 2: Alexandra Jn Charles SUNY Downstate, Brooklyn, 2005 Breast Tangents with wedges Therapist 1: omits wedge Therapist 2: misses error Therapists 1 n: miss error on daily treatment Missing wedge indicated on R&V Physicist misses error on weekly checks 27 fractions treated w/o wedges ~350% overdose Patient Died in
15 Setup Beam Isocenter Pinnacle example and a human factors type solution In another case, an unnamed medical facility told federal officials in 2008 that Philips Healthcare made treatment planning software with an obscure, automatic default setting, causing a patient with tonsil cancer to be mistakenly irradiated 31 times in the optic nerve. There shall be no default isocenter assigned to the setup beams. There shall be no default machine assigned to the setup beams. 15
16 (Some) Safety Responses & New Efforts Regulatory, Government, Clinical, Industrial 2010: AAPM: Miami Safety Summit 2010: Vendor Readiness Initiative 2010: FDA meeting w/ vendors and users Reevaluate 510(k) process : ASTRO White Papers 2012: Safety Is No Accident 2012: ASTRO Meeting with FDA Commissioner 2013: IHE RO QA w/ Plan Veto 2014: RO ILS: Incident Learning System 2014: Updated Accreditation Process etc. And ROSSI (2010) 16 Schewe & Negrut: NCCAAPM Fall 2015
17 ROSSI Radiation Oncology Safety Stakeholders Initiative Industry/Clinical Collaboration to work on RTP safety issues Grass Roots Ad hoc Informal Meets every AAPM & ASTRO First was ASTRO Working Groups meet ad hoc 17
18 ROSSI People Members are: Physicists Physicians Therapists Dosimetrists Administrators Vendors Regulators They come from: Academic Centers Free standing Clinics AAPM ASTRO Vendors AAMD ASRT MITA & AdvaMed SROA FDA 18
19 ROSSI Organization Working Groups Organized by Topic Clinical & Industry Co Chairs Deliverable = White Paper(s) Error Messages Quality Assurance Training Usability *Risk Management 19
20 Error Messages Working Group White Papers 20
21 Terminology 21
22 Frequency The most basic way to reduce the number of error messages is to prevent errors from occurring in the first place. When error messages are necessary, follow these guidelines: Display in a consistent way & place Single message when possible Consider using error logs When needed for trouble shooting, but not for user in real time Use icons to: Show system state Allow user to click for more info 22
23 Usability Six Guidelines Details in next presentation 23
24 Conclusions ROSSI: plays a unique, complementary role to other safety efforts attempts to avoid bureaucratic hurdles inherent elsewhere is grass roots & informal is interdisciplinary Everyone is welcome! (hopefully) will help improve products and practice Other potential impacts: Outreach & visibility to safety issues and solutions Driving more formal recommendations & standards 24
25 Conclusions (II) Human Factors, Usability, and Safety in RT Technology: drives changes in practice and vice versa can help prevent errors, but also introduce new ones involves interactions with humans Usability is an important aspect of safety Human Factors Engineering is new to a lot of us There s plenty to learn 25
26 26
27 And Now 27
28 Information Overload How do I get to London? 28
29 PC Load Letter Yes, it was really a thing Paper Cassette (The tray) Load (refill) it With Letter size paper 29
30 ROSSI Organization Leadership Co Chairs Dick Fraass (Cedars Sinai) * Alf Siochi (West Virginia) Rajinder Dhada (Elekta) * (Stephen Vastagh: MITA) * * = Initial ROSSI Organizers Working Groups have Clinical & Industry Co Chairs 30
31 Responses and Initiatives Many and varied Regulatory & Government Clinicians Industry 31
32 ROSSI History Lead Up June 2010 FDA Meeting Vendor/User issues identified July 2010 (AAPM) Industry presentation to TPC August 2010 Fraass solicits topics November 2010 (ASTRO) First meeting First Meeting Organizers: Dick Fraass (Cedars Sinai) Stephen Vastagh (MITA) Invitees: Physicists, Physicians, RTTs, dosimetrists, vendors... Initial goals: ID a few problems Talk about them Find consensus on solutions Publish 32
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