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TITLE 25HEALTH SERVICES
PART 7TEXAS MEDICAL DISCLOSURE PANEL
CHAPTER 601INFORMED CONSENT
RULE §601.2Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A

(a) Anesthesia.

  (1) Epidural.

    (A) Nerve damage.

    (B) Persistent back pain.

    (C) Headache.

    (D) Bleeding/epidural hematoma.

    (E) Infection.

    (F) Medical necessity to convert to general anesthesia.

    (G) Brain damage.

    (H) Chronic pain.

  (2) General.

    (A) Permanent organ damage.

    (B) Memory dysfunction/memory loss.

    (C) Injury to vocal cords, teeth, lips, eyes.

    (D) Awareness during the procedure.

    (E) Brain damage.

  (3) Spinal.

    (A) Nerve damage.

    (B) Persistent back pain.

    (C) Bleeding/epidural hematoma.

    (D) Infection.

    (E) Medical necessity to convert to general anesthesia.

    (F) Brain damage.

    (G) Headache.

    (H) Chronic pain.

  (4) Regional block.

    (A) Nerve damage.

    (B) Persistent pain.

    (C) Bleeding/hematoma.

    (D) Infection.

    (E) Medical necessity to convert to general anesthesia.

    (F) Brain damage.

  (5) Deep sedation.

    (A) Memory dysfunction/memory loss.

    (B) Medical necessity to convert to general anesthesia.

    (C) Permanent organ damage.

    (D) Brain damage.

  (6) Moderate sedation.

    (A) Memory dysfunction/memory loss.

    (B) Medical necessity to convert to general anesthesia.

    (C) Permanent organ damage.

    (D) Brain damage.

  (7) Prenatal/Early Childhood Anesthesia. Potential long-term negative effects on memory, behavior, and learning with prolonged or repeated exposure to general anesthesia/moderate sedation/deep sedation during pregnancy and in early childhood.

(b) Cardiovascular system.

  (1) Cardiac.

    (A) Coronary artery bypass.

      (i) Acute myocardial infarction (heart attack).

      (ii) Hemorrhage (severe bleeding).

      (iii) Kidney failure.

      (iv) Stroke.

      (v) Sudden death.

      (vi) Infection of chest wall/chest cavity.

    (B) Heart valve replacement by open surgery, structural heart surgery.

      (i) Acute myocardial infarction (heart attack).

      (ii) Hemorrhage (severe bleeding).

      (iii) Kidney failure.

      (iv) Stroke.

      (v) Sudden death.

      (vi) Infection of chest wall/chest cavity.

      (vii) Valve related delayed onset infection.

      (viii) Malfunction of new valve.

      (ix) Persistence of problem for which surgery was performed, including need for repeat surgery.

    (C) Heart transplant.

      (i) Infection.

      (ii) Rejection.

      (iii) Death.

    (D) Coronary angiography (Injection of contrast material into arteries of the heart), coronary angioplasty (opening narrowing in heart vessel), and coronary stent insertion (placement of permanent tube into heart blood vessel to open it).

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.

      (ii) Arrhythmia (abnormal heart rhythm), possibly life threatening.

      (iii) Hemorrhage (severe bleeding).

      (iv) Myocardial infarction (heart attack).

      (v) Worsening of the condition for which the procedure is being done.

      (vi) Sudden death.

      (vii) Stroke.

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

    (E) Percutaneous (through the skin) or minimally invasive heart valve insertion/replacement.

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.

      (ii) Arrhythmia (abnormal heart rhythm), possibly life threatening.

      (iii) Hemorrhage (severe bleeding).

      (iv) Myocardial infarction (heart attack).

      (v) Worsening of the condition for which the procedure is being done.

      (vi) Sudden death.

      (vii) Stroke.

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Malfunction of new valve.

      (xi) Need for permanent pacemaker implantation.

    (F) Left atrial appendage closure (closing of small pouch on left side of heart) - percutaneous (through the skin) or minimally invasive.

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.

      (ii) Arrhythmia (abnormal heart rhythm), possibly life threatening.

      (iii) Hemorrhage (severe bleeding).

      (iv) Myocardial infarction (heart attack).

      (v) Worsening of the condition for which the procedure is being done.

      (vi) Sudden death.

      (vii) Stroke.

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Device embolization (device moves from intended location).

      (xi) Pericardial effusion (development of fluid in the sack around the heart) and cardiac tamponade (fluid around heart causing too much pressure for heart to pump properly).

    (G) Patent foramen ovale/atrial septal defect/ventricular septal defect closure by percutaneous (through the skin) or minimally invasive procedure (closing of abnormal hole between the chambers of the heart).

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.

      (ii) Arrhythmia (abnormal heart rhythm), possibly life threatening.

      (iii) Hemorrhage (severe bleeding).

      (iv) Myocardial infarction (heart attack).

      (v) Worsening of the condition for which the procedure is being done.

      (vi) Sudden death.

      (vii) Stroke.

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Atrial fibrillation (irregular heart rhythm).

      (xi) Pulmonary embolus (development of blood clot that travels to blood vessels in lungs).

      (xii) Device embolization (device moves from where it is placed).

      (xiii) Cardiac perforation (creation of hole in wall of heart).

    (H) Electrophysiology studies (exams of heart rhythm), arrhythmia ablation (procedure to control or stop abnormal heart rhythms).

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.

      (ii) Arrhythmia (abnormal heart rhythm), possibly life threatening.

      (iii) Hemorrhage (severe bleeding).

      (iv) Myocardial infarction (heart attack).

      (v) Worsening of the condition for which the procedure is being done.

      (vi) Sudden death.

      (vii) Stroke.

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Rupture of myocardium/cardiac perforation (hole in wall of heart).

      (xi) Cause or worsening of arrhythmia (damage to heart electrical system causing abnormal heart rhythm), possibly requiring permanent pacemaker implantation, possibly life threatening.

      (xii) Pulmonary vein stenosis (narrowing of blood vessel going from lung to t).

    (I) Pacemaker insertion, AICD insertion (implanted device to shock the heart out of an abnormal rhythm).

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.

      (ii) Arrhythmia (abnormal heart rhythm), possibly life threatening.

      (iii) Hemorrhage (severe bleeding).

      (iv) Myocardial infarction (heart attack).

      (v) Worsening of the condition for which the procedure is being done.

      (vi) Sudden death.

      (vii) Stroke.

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during the procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Rupture of myocardium/cardiac perforation (hole in wall of heart).

      (xi) Cause or worsening of arrhythmia (damage to heart electrical system causing abnormal heart rhythm), possibly requiring permanent pacemaker implantation, possibly life threatening.

      (xii) Device related delayed onset infection (infection related to the device that happens at some time after surgery).

    (J) Electrical cardioversion (shocking the heart out of an abnormal rhythm).

      (i) Heart arrhythmias (abnormal heart rhythm), possibly life threatening.

      (ii) Skin burns on chest.

    (K) Stress testing.

      (i) Acute myocardial infarction (heart attack).

      (ii) Heart arrhythmias (abnormal heart rhythm), possibly life threatening.

    (L) Transesophageal echocardiography (ultrasound exam of the heart from inside the throat).

      (i) Sore throat.

      (ii) Vocal cord damage.

      (iii) Esophageal perforation (hole or tear in tube from mouth to stomach.

    (M) Circulatory assist devices (devices to help heart pump blood).

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.

      (ii) Arrhythmia (abnormal heart rhythm), possibly life threatening.

      (iii) Hemorrhage (severe bleeding).

      (iv) Myocardial infarction (heart attack).

      (v) Worsening of the condition for which the procedure is being done.

      (vi) Sudden death.

      (vii) Stroke.

      (viii) Contrast nephropathy or other kidney injury (kidney damage due to the contrast agent used during the procedure or procedure itself).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Hemorrhage (severe bleeding) possibly leading to sudden death.

      (xi) Hemolysis (blood cells get broken apart).

      (xii) Right heart failure (poor functioning of the side of heart not assisted by device).

      (xiii) Acquired von Willebrand syndrome (platelets do not work).

      (xiv) Arrhythmia (irregular or abnormal heart rhythm).

      (xv) Cardiac or vascular injury or perforation (hole in heart or blood vessel).

      (xvi) Limb ischemia (lack of blood flow or oxygen to limb that device placed through).

      (xvii) Device migration or malfunction.

      (xviii) Exposure of device/wound break down with need for surgery to cover/reimplant.

    (N) Extracorporeal Membrane Oxygenation (ECMO).

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention including emergency open heart surgery.

      (ii) Arrhythmia (abnormal heart rhythm), possibly life threatening.

      (iii) Hemorrhage (severe bleeding).

      (iv) Myocardial infarction (heart attack).

      (v) Worsening of the condition for which the procedure is being done.

      (vi) Sudden death.

Cont'd...

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