Radiation Protection Systems to Mitigate Occupational Health Risks

Radiation Protection Systems to Mitigate Occupational Health Risks James A. Goldstein M. D. Director of Research and Education Department of Cardiology William Beaumont Hospital

I, James A Goldstein M. D. , have a relevant conflict of interest to disclose: Owner of equity in ECLS, Inc, developing Radiation Protection System

Occupational Health Hazards in the Interventional Laboratory Time for a Safer Environment Klein et al: On behalf of the Multi-Specialty Occupational Health Group Cath and CV Intervent 2009; 73: 432/J Vasc Intervent Radiol 2009; 20: 147 “Interventional physicians and their professional societies should strive toward the ultimate zero radiation exposure work environment, that would eliminate the need for personal protective apparel and prevent its orthopedic and ergonomic consequences“

Evolution of Cardiac Catheterization Laboratory 1970 Interventional Era

Causes of Occupational Injuries X-Ray Imaging Radiation Protection Orthopedic Injury Radiation Exposure Radiation Injury

Risk for Radiation-Induced Cataract for Staff in Interventional Cardiology: Is There Reason for Concern? Ciraj-Bjelac, et al. Cath Cardiovasc Intv 2010; 76: 826 -34 Table III. Number of Interentional Cardiologists with Posterior Lens Changes Graded by Severity of Lens Changes with Associated Cumulative Doses to the Lens of the Eye Dose (Gy) Score No. % 0 in both eyes 27 48 1. 6 0. 5 in one eye 8 14 18 3 0. 5 in both eyes >1 in one eye (0. 5 or more in the other eye) Mean Media n Min Max 0. 94 0. 02 7. 4 2. 4 1. 8 0. 04 8. 4 32 7. 4 1. 3 0. 02 43. 0 5 3. 0 2. 8 0. 24 4. 5 Lens changes found in either or both eyes in 34/67 (51%)

Occupational Radiation Exposure: Brain Tumors • Left side of Brain 85% 12% 16% 17% • Mean latency period=23. 5 years Roguin A. AJC 2013; 111: 1368 -72 55%

Work-Related Musculoskeletal Pain by Job Survey: N=1, 543 N=1, 042 Exposed vs 501 Unexposed Not just MD’s Nurses and Techs Suffer too! Age>50, Working>15 yrs = >50% Sx! Orme N, et al. JACC 2015; 65: 8206 Back Pain>50% Age Related Yrs Working

Rate Of Health Problems By Years Of Work Survey: N=466 Exposed vs 280 Unexposed Ortho Illness Skin Lesions Cataracts Andreassi et al. Circ Cardiovasc Interv. 2016; 9:

Cath Lab Orthopedic Epidemic ACC Survey Nagelhout Cardio. Surve 2016; 40 Ortho Issues in 48% Caused/Worsened by Work in 70% Retire or cut Back in 50%

We are Like Football Players with Leather Helmets and No Face Masks

Reducing Radiation Exposure Conventional (No impact on ortho injury) Novel (↓ ortho injury) Training & awareness Remove operator (Robotic) Operator Issues Distance from source ↓ “Time-on” ↓ Oblique, angulated views Keep hands out of field! Unique radiation shielding Zero. Gravity Radiation Apparel Trinity Shielding System Shielding or coverage Head cover Rad-pad (30 -70% reduction) ↓ Frame rate

We Need a Paradigm Shift in Cath Lab Occupational Health Zero Radiation Exposure Eliminate Cancer/Cataract Risk No Lead Aprons Eliminate Orthopedic Burdens

RADPAD • Reduced exposure 30 -70%, depends on site measured • Still need to wear leaded aprons, doesn’t protect brain

Novel Systems for Improved Occupational Health in the Catheterization Laboratory • Robotic Systems Getting the Operator Out of Harms Way • Radiation Shielding Systems Getting the Lead off Our Backs

TM Trinity Radiation Protection System Ceiling Mounted Shield Radiation Patient Drape Vascular Access Aperture • Complete Radiation Shielding • Eliminates Orthopedic Burden of Lead

Trinity Radiation Protection System Single Ceiling Element Ceiling-suspended upper lead barrier w Drop Down lower Shield Tandem Motion with Table Vertical, longitudinal, lateral movement w x-ray table movement Vascular Access Aperture Radial and Femoral Access Radiation Patient Drape Interlocks with Upper Shield Aperture

Elimination of Radiation Exposure to Operators Fattal et al: Cath and Cardiovasc Intervent 2013

State of Michigan: Lead Not Needed The State of Michigan Radiation Safety Section Bureau of Health Systems reviewed these testing results and provided a certification letter stating: “The Trinity Radiation Protection Shield meets the intent of rule 348(1) which requires lead aprons equivalent to 0. 5 mm lead as long as the physician or other personnel remain in the area protected by the device ”

Trinity Evolution Next Version: “Apple-Like” • Lower Footprint • Lighter • More Facile

Physicians Deserve & Should Demand a Safe Work Environment! Institutions Should Embrace the Need for Operator/Health Care Team Protection OSHA May Eventually Mandate it