©ECRI XIV. Skin “Burns” from Medical Devices TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, USA Tel: , ext Web Sites:

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4 Investigative Approach for Medical Device “Burns” “ OPALSS ” CRITERIA –Onset –Progression –Appearance –Location –Shape –Size

©ECRI Etiologies: SUSPECTED DEVICE “BURNS” Electrical Thermal Chemical Mechanical Radiation Pharmacologic Physiologic/Medical

©ECRI Electrical –RF (surgical diathermy) –DC (e.g., battery voltage) –AC (mains) Thermal –Direct Contact (warmed or warming devices, flashed devices) –Irradiant Etiologies: SUSPECTED DEVICE “BURNS”

©ECRI Chemical –Prepping Agents –Ethylene Oxide (EtO) –Electrode Gels Mechanical –Prolonged Pressure > 2 to 3 hours –Tourniquets –Electrode Adhesive Etiologies: SUSPECTED DEVICE “BURNS”

©ECRI Etiologies: SUSPECTED DEVICE “BURNS” Radiation –Diagnostic –Therapeutic

©ECRI Etiologies: SUSPECTED DEVICE “BURNS” Pharmacologic Adverse Reactions –Warfarin (Coumadin) Therapy –Infiltrations –Barbiturate Injections High dose Injection in subcutaneous or fat layer –Penicillin G in an artery (should be intramuscular)

©ECRI Etiologies: SUSPECTED DEVICE “BURNS” Physiologic/Medical –Allergic Reactions –Aplasia Cutis (Neonates) –Pernio (Chilblain) –DIC (Disseminated Intravascular coagulopathy) –Ecthyma Gangrenosum –Epidermolysis Bullosa –Guttate Morphea

©ECRI Etiologies: SUSPECTED DEVICE “BURNS” Physiologic/Medical (cont.) –Lichen Sclerosis et Atrophicus –Livedo Reticularis (plus Idiopathica) –Lupus Erythematosus –Pupura Fulminans –Necrotizing Fasciitus (“Flesh Eating Bacteria”) –Toxic Epidermal Necrosis

©ECRI Etiologies: SUSPECTED DEVICE “BURNS” Physiologic/Medical (cont.) –Ischemic Lesions from: Peripheral Vascular Disease Venous Stasis Diabetes Mellitus Cryoglobulinemia Arterial Emboli of Plaque (Blue-toe Syndrome) Anterior Compartment Syndrome Ref: Okun MR, Edelstein LM, Fisher BK. Gross and Microscopic Pathology of the Skin. Canton, MA, USA: Dermatopathology Foundation Press, 1988.

©ECRI Investigative Approach for Medical Device “Burns” “ OPALSS ” CRITERIA –Onset –Progression –Appearance –Location –Shape –Size

©ECRI Investigative Approach for Medical Device “Burns” “OPALSS” Criteria: –ONSET When was it discovered? Get precise time and date. When did surgery occur? Where was discovery made?

©ECRI Investigative Approach for Medical Device “Burns” “OPALSS” Criteria: –PROGRESSION Did lesion get larger, deeper? Did blister(s) form? When? Did an eschar form?

©ECRI Investigative Approach for Medical Device “Burns” “OPALSS” Criteria: –APPEARANCE What did the lesion look like? Colour Texture Note central and surrounding areas

©ECRI Investigative Approach for Medical Device “Burns” “OPALSS” Criteria: –LOCATION Where was lesion on the body? Record: –Relationship to electrodes –High pressure areas of contact –Definable current paths (surgical diathermy)

©ECRI Investigative Approach for Medical Device “Burns” “OPALSS” Criteria: –SHAPE Corresponding geometry Patterns of devices or electrodes

©ECRI Investigative Approach for Medical Device “Burns” “OPALSS” Criteria: –SIZE Dimensions Area (cm2) Note ALL affected tissue area and include in area calculations

©ECRI Case Examples: Suspected medical device “Burns” during surgery (35mm slides) Electrical Thermal Chemical Mechanical Pharmacologic Physiologic/Medical

©ECRI Case Examples: Skin “burns” from devices See: Health Devices (12)

©ECRI QUESTIONS? XIV. Skin “Burns” from Medical Devices