LT-201 White Paper - Protective Gloves Rev. 1

Radiation Risks to the Handsof Staff and Physicians thatPerform Fluoroscopic ProceduresThe Benefits of Lead Free,Radiation-Attenuating Protective Gloves Minimizing Risk. Every Procedure. Every Time.™

Table of ContentsPART A. 1The Health Risks & Injuries Caused By X-Ray Radiation To Human Skin And The MedicalProfessional’s HandsPART B.Summarized Article Excerpts About The Need To Protect A Physicians Hands With RadiationProtective Gloves 21) Interventional Radiologists: Occupational Radiation Doses and Risks 2 Radiology, Niklason LT, Marx MV, Chan HP.;187: 729-733. 19932) Does the Endovascular Repair of Aortoiliac Aneurysms Pose A Radiation Safety Hazard To Vascular Surgeons? Journal of Vascular Surgery; Lipsitz, EC, Veith FJ. Ohki T, et al.32 (4): 2000 23) CT Fluoroscopy-Guided Abdominal Interventions: Techniques, Results & Radiation 2 Exposure Radiology, Silverman SG, Tuncali K, Adams DF, et al.212, 19994) Technical Note: An Assessment of X-Ray Protective Gloves 2 The British Journal of Radiology, Vol. 68, No. 812, August 19955) Radiation-Attenuating Surgical Gloves: Effects of Scatter and Secondary Electron 2 Production Radiology, Wagner LK, Mulhern OR, 200: 45-48, 19966) ACC EXPERT CONSENSUS DOCUMENT: Radiation Safety in the Practice of Cardiology Limacher et al., JACC Vol. 31, No. 4, 1998: 892-913 3PART C. 4Benefits from the New Lead Free Radiation Protection Gloves

www.epimed.comPART A: The health risks & injuries caused by X-Ray Radiation tohuman skin and the medical professional’s handsAre You at Risk? even after exposure to radiation has ceased. It can lead to hyperkeratotic plaques and painful keratoses on the sides of theThe increase in use of high dose and long fluoroscopically fingers and fingertips. Around the edges of the ulcers causedguided interventional procedures in the last twenty years has put by radiodermatitis pseudoepitheliomatous hyperplasia mayphysicians at a greater risk, as far as chronic exposure of the occur. The skin develops telangiectases and areas of epidermalhands to radiation is concerned. Radiodermatitis appears after a atrophy and dermal fibrosis. Progressive chronic radiodermatitisthreshold dose of radiation is obtained (see images 1 & 2 below). frequently gives rise to a painful burning sensation.Radiation exposure is cumulative and the effects are permanent. With malignant chronic radiodermatitis, neoplastic (Image 1 & 2) transformation develops in the ulcers or the keratoses. The commonest histological types are Bowen’s disease (squamousThe first signs of chronic occupational radiodermatitis may cell carcinoma in situ), squamous cell carcinoma and basal cellappear after some years of cumulative exposure. The usual carcinoma. These tend to appear at a much later stage, oftenparts affected are the hands, especially the left hand, due to the as much as twenty or thirty years after exposure to radiation.position it takes when carrying out operations. The fingers most From a clinical point of view malignant chronic radiodermatitis iscommonly affected are the dorsum and medial side of the index, apparent as areas of ulceration with poor wound healing.middle and ring fingers (see exhibit A below). Table #1 below highlights both the typical threshold doses and the skin injuries caused from over exposure to secondary radiation: Absorbed Dosage Threshold Adverse Skin Effects 3 Gy Temporary Epilation (Loss of Hair) 6 Gy Main Erythma (Skin Inflammation) 15-20 Gy Necrosis (Skin Decay) (Table #1) Dermatitis Radiodermatitis Ulcus Radiologica Bullosa Acuta Radiologicum (Exhibit A) Chronica AcutumProfessionalisChronic Radiodermatitishas Three Stages: Simple,Progressive and MalignantWith simple chronic radiodermatitis, the skin becomes dry,fine and hairless due to atrophy of the epidermis and is easilyvulnerable to minor trauma. It is also discolored with areas ofincreased pigmentation, hemorrhage areas and black spots.The epidermis presents areas of desquamation, fissuring (linearulcers) and micro-ulcers. The ridges of the epidermis which formthe fingerprints also disappear.Progressive chronic radiodermatitis shows in the appearanceof wart-like formations and ulcers, which continue to worsen 1

www.epimed.comPART B: Summarized Article Excerpts About The Need To Protect APhysicians Hands With Radiation Protective Gloves1Interventional Radiologists: physicians at risk for injury, it also, if reported, becomes one Occupational Radiation Doses of the biggest limiting factors on the number of fluoroscopicallyand Risks guided interventional procedures physicians can safely do within a given time period. Radiology, Niklason LT, Marx MV, Chan HP.;187: 729-733. 1993 It is no surprise then, that radiation exposure to hands is frequently the most significant factor in terms of overall radiation Chronic irradiation of the hands is a principal radiation safety risk for physicians performing these increasingly common concern of all physicians involved in the broad spectrum of interventional procedures high dose fluoroscopically guided interventional procedures developed during the past 20 years. 4Technical Note: An Assessment of X-Ray2Does the Endovascular Repair Protective Gloves of Aortoiliac Aneurysms PoseA Radiation Safety Hazard To The British Journal of Radiology, Vol. 68, No.Vascular Surgeons? 812, August 1995 Journal of Vascular Surgery; Lipsitz, EC, Veith Abstract FJ. Ohki T, et al.32 (4): 2000 “An assessment of X-ray protective gloves is reported which demonstrates that a significant degree of protection from X-ray A surprising finding of the study is that the hands are the part of exposure can be offered by these gloves. The need for such the body for which interventional radiologists are least likely to protection, together with the method of assessment is discussed. use protective garments. It is recommended that X-ray protective gloves are considered It should be remembered that radiation exposure is cumulative when undertaking image intensifier work.” over one’s lifetime and that the effects are permanent”, says Evan C. Lipsitz, MD, Assistant Professor of Surgery, Montefiore Medical 5Radiation-Attenuating Surgical Center, Division of Vascular Surgery. He adds, “reducing fluoroscopy Gloves: Effects of Scatter and time, increasing distance from the source and using adequate Secondary Electron Production protection with monitoring are the most basic ways of reducing exposure and can significantly reduce exposure in all settings.” Radiology, Wagner LK, Mulhern OR, 200: 45- 48, 19963CT Fluoroscopy-Guided Abdominal Interventions: Radiation-attenuating flexible gloves are available as aTechniques, Results & Radiation substitute for standard exam gloves in situations in whichExposure medical personnel are likely to be exposed to radiation during fluoroscopic procedures. Also, radiation protective gloves may Radiology, Silverman SG, Tuncali K, Adams DF, be used with surgical gloves during surgery. The gloves are et al.212, 1999 made from materials that contain elements with atomic numbers large enough to attenuate x-rays. Accumulated radiation exposure to hands not only places Radiologists should refrain from placing hands in the direct beam, and if possible, work on the exit-beam side of the 2

www.epimed.compatient. Leading medical experts believe that reducing radiationexposure to the physician’s hands will also reduce exposure tothe patient, as well as the total body exposure of the operator.6ACC EXPERT CONSENSUS DOCUMENT: Radiation Safetyin the Practice of CardiologyLimacher et al., JACC Vol. 31, No. 4, 1998:892-913Cardiologists’ hands receive the highest X-ray exposure duringcatherization and electrophysiologic procedures because thehands are closest to the X-ray beam. Yet, hand exposures arefrequently not monitored. Long-term “low” level radiation (i.e. inthe order received in cardiology procedures) can pose a serioushealth risk. Summary: Lead & Lead Free Radiation Protection Gloves reduce the amount of scattered and secondary radiation exposure to the hand from primary X-ray beams during diagnostic procedures, angiography, cardiovascular, orthopaedic and urologic interventions, pain management, fluoroscopic procedures and where a C-arm is used. 3

www.epimed.comPART C: Benefits from the New Lead Free Radiation Protection GlovesWe know that Cardiologists’ hands receive the highest X-ray Improved Safety & Performanceexposure during catheterization and electrophysiologic from Lead-Free Radiationprocedures because the hands are closest to the X-ray beam. Attenuating GlovesYet, hand exposures are frequently not monitored. Long-term“low” level radiation (i.e., of the order received in cardiology Recent advances in glove technology have encouragedprocedures) can pose a serious health risk. physicians to embrace radiation-attenuating gloves. For example, the new disposable thin film lead free gloves made ofBecause of the increased research and concern about radiation bismuth oxide have superb protection characteristics, providingrisks, Germany has enacted new regulations in 2002 that require 59% attenuation (see table #2 below).all healthcare professionals to wear gloves intended to reduceexposure to scattered and secondary radiation. Table #2: Attenuation Level¹The ALARA (As Low As Reasonably Achievable) concept in Beam Energy Level Skin Dose Reductionnow widely implemented in healthcare working environmentsworldwide. Specifically, the ALARA approach assumes that 60 kVp 59%occupational exposure to ionizing radiation is hazardous andmandates that measures, including the use of all types of 80kVp 49%personal protective shields such as lead free radiation protectiongloves (RPS’s) are one of the most effective ways to achieve 100kVp 42%this requirement. ¹Test methodology for attenuation measurementsDo All Radiation Attenuating according to EN 61331-1 at nominal thickness of 0.3mm.Gloves Provide the Same Level of Lead equivalence value: 0.03-0.04mm Pb.Protection? Although radiation protection is critical metric, it is only ½ of theAccording to the published literature, the answer is no. Radiation story. The clinical performance and the quality of the radiationprotective gloves currently on the market are made with different protective glove are also important for physicians and nurseshielding technology treatments that exhibit higher or lower assistants dealing with the challenges of live surgery & everlevels of safety in terms of protecting the hand from harmful more complex procedures.radiation. X-ray protective gloves made with lead represent olderoutdated technology that has been available for many years As a result, user-friendly features are designed into the Barriernow. Operators should use caution if they are currently using Technologies LEAD-FREE Radiaxion® gloves. The benefit is thatleaded gloves because they may be absorbing higher levels of these revolutionary sterile lead-free & powder free latex glovesdangerous radiation from lead gloves that do not protect to the feature enhanced dexterity with superior tactile sensitivity,degree presumed by the user. strength (reduced tearing), and comfort compared to traditional leaded gloves (see graphic to the left).For example, The (AAC) American Academy of CardiologyConsensus Document, Radiation Safety in the Practice of Another advantage is that these lead free disposable gloves areCardiology, states that Physicians performing fluoroscopy and “green” because they do not harm the environment like leadedcine angiography should take precautions to protect their hands disposable gloves do. This saves money for hospitals and clinics[but] leaded latex gloves provide only limited shielding capability, since it eliminates expensive lead disposal procedures.attenuating only 20% to 30% of the X-ray beam. In fact, innovative Barrier Technologies® LEAD-FREE gloves exhibit a significantly higher attenuating performance, blocking a greater percent of scatter x-ray compared with leaded gloves (see chart #1 on next page). 4

www.epimed.com Chart #1 In summary, medical directors and physicians now have newAttenuation Level Comparison of Radiation Protection state-of-the-art personal protective solution that will makeGloves: Barrier Technologies LEAD-FREE vs. Leading their operatory environment more secure against radiation. Specifically, these lead-free gloves can reduce the significant Leaded Brand cumulative risk associated with a lifetime of radiation exposure to the hand. However, the real value of the Barrier Technologies® LEAD-FREE radiation protective gloves is the improved peace of mind for all stakeholders, especially for medical personnel and for their families. Microroughened Superior tactile surface on sensitivity the palm and fingers, provides excellent instrument gripLeaded 60 kVp 80 kVp 100 kVp Hypertensile Powder free,Lead-Free 45% 35% 26% strength anatomic shape 59% 49% 42% minimizes tearing when Beaded cuff,Over time, the higher attenuation rate lowers both, the cumulative donning ensures easyradiation dose absorbed by the physician’s hand, and the risk of donning andskin cancer. helps prevent roll backChart #2 below highlights the benefit of lead-free gloves overleaded gloves by focusing on the increase in radiation shielding/attenuation by percentage. In this direct comparison, the leadedgloves are used as a baseline. The bars represent the relativeincrease in radiation protection from lead-free at three differentenergy beam levels, making evident the superior protection oflead-free gloves. Chart #2Comparative Increase In Hand Radiation Protection (Lead- Free Vs. Traditional Lead Radiation Glove) 5

13958 Diplomat Dr. phone: 800.866.3342 or 518.725.0209 email: [email protected] Dallas, TX 75234 fax: 518.725.0207 web: www.epimed.com LT-201 Rev. 1