skin staples mri safety

Brown MA, Carden JA, Coleman RE, McKinney R, Spicer LD: Magnetic field effects on surgical ligation clips. Similar results were reported in the evaluation of intracranial aneurysm clips [7]. The material mass of the staples is small and even if they did move, they are unlikely to move in any significan t way that will harm the patient. 1. 2011, 196: 142-145. 's letter about the magnetic resonance imaging (MRI) safety of Epilong Soft Epidural Catheters (Pajunk Medizintechnologie GmBH, Geisingen, Germany) and would like to add further … CAS  2000, 214: 902-907. PROXIMATE PX Fixed-Head Skin Stapler with stainless steel staples provides many of the same features as the PROXIMATE RH Skin Stapler, but in a fixed head format. As the number of surgical procedures increase, there is a need to develop more efficient techniques and user-friendly tools that address the increasing time constraints and issues of patient satisfaction [2]. Article  According to the American Society for Testing and Materials International [15], "If the implant deflects less than 45°, then the magnetically induced deflection force is less than the force on the implant due to gravity (its weight). 2008, ASTM International, West Conshohocken, PA. Shellock FG, Woods TO, Crues JV: MRI labeling information for implants and devices: Explanation of terminology. Regardless, artifacts observed on MR images are not considered to pose safety issues. The room and MR system bore temperatures were at constant levels throughout each experimental session. Magnetic resonance imaging safety of surgical clips and staples Magnetic resonance imaging safety of surgical clips and staples De Silva, S.; Bampoe, S.; Scott, M. 2015-12-01 00:00:00 We read McCall et al. To ensure patient safety, in vitro test methods are utilized to characterize various MRI issues for a given implant or device [3–12]. 10.1118/1.597854. A relatively high level of RF energy was applied during the MRI-related heating experiment, as previously described [7, 17]. Accordingly, the temperature change was recorded at the same position, middle temperature probe position (i.e., corresponding to the position for Probe #3 for the MRI-related heating test with the implant present) in the phantom in association with MRI-related heating of the gelled-saline-filled phantom without the implant present. 2002: 1349-1352. One of the issues for vascular procedures has been the labor intensive and time-consuming process of achieving hemostasis [2]. External Devices The staples first penetrate the fascia and are then formed, thus holding the tissue together. It goes on to conclude there were no reports in the peer reviewed literature in which the authors were aware of heating of staples or sutures caused a patient injury, or that application of a cold compress or ice pack could prevent such injury. Thus, each implant was connected to a test fixture to measure the deflection angle in the 3-Tesla MR system, at the point of the highest spatial gradient magnetic field [6, 7, 15, 16]. 2008, 191: 12-21. In consideration of the information above, the purpose of our investigation was to assess MRI issues (i.e., magnetic field interactions, MRI-related heating, and artifacts) at 3-Tesla for a skin closure staple and a hemostatic clip. ), MR imaging was performed for 15-min. The average deflection angles were 20-degrees for the skin closure staple and 27-degrees for the hemostatic clip. 10.1016/j.ejrad.2008.09.023. The skin closure staple (1a) and (1b) hemostatic clip (1b) that underwent testing at 3-Tesla. The MR system fan was turned off during the MRI-related heating investigation. Surgical clip MRI safety Ethicon Absolok Plus Safe Ethicon Ligaclip (tantalum) Safe Torque was determined for the two metallic surgical implants in association with exposure to the 3-Tesla MR system using a previously-described, qualitative assessment technique [6, 7]. Eur J Radiol. To determine translational attraction for the two different surgical implants, the standardized deflection angle technique was used [6, 7, 15]. Based on our findings, MRI scanning in the presence of stainless steel surgical staples seems safe. MRI artifacts associated with the skin closure staple (bottom) and hemostatic clip (top); (a) long axis and (b) short axis imaging planes (GRE pulse sequence; TR/TE 100-msec/15-msec; flip angle, 30 degrees; field of view, 26-cm). The highest spatial gradient magnetic field for the 3-Tesla scanner used in this investigation is 720 gauss/cm [6, 7]. 1987, 5: 443-453. The MRI Safety Committee is responsible for ensuring that the MRI safety guidelines are established and maintained on a current basis and as appropriate for the various MR systems operated. Sufficient distance was placed between the two implants to prevent overlap of the respective artifacts. The Appose single-use skin stapler dispenses 1 staple each time the trigger is activated Staples first penetrate the skin and are then formed, holding the tissue together Specifications In summary, Cormed does not consider there to be an inherent risk to patents based on the information cited. For use in a wide variety of surgical procedures to close external ski … Each skin stapler includes 35 pre-loaded, surgical-grade stainless ste … Dispenses one staple each time the squeeze handle is activated Privacy 4.15). The determination according to the American College of Radiology, ''with the increasing advent and use of the 3.0 Tesla and higher strength magnets, users need to recognize that one should never assume MR compatibility or safety information if it is not clearly documented in writing" ( Kanal 2). Vascular closure devices have been demonstrated to reduce time to hemostasis and potentially decrease the length of hospital stay [2]. Skin Staples: Safe, even within the immediate postoperative period. Print. At 3-Tesla, a variety of hemostatic clips, other clips, fasteners, and staples have been evaluated for MRI issues including magnetic field interactions and MRI-related heating. *Denotes the particular surgical implant that underwent MRI testing. 10.1016/0730-725X(87)90378-X. Where can I find more information about the MRI safety of Ethicon products? Each metallic surgical implant was placed in the ASTM phantom at a position mid-line on the left side, slightly (5-mm) below the mid-depth (vertical orientation) of the gelled-saline. intervals. Google Scholar. "American College of Radiology guidance document for safe MR practices 2017 ." It has an easy-squeeze handle and uses stainless steel staples. The positions of the thermometry probes were inspected and verified immediately before and after each MRI-related heating experiment. Hon L-Q, Ganeshan A, Thomas SM, Warakaulle D, Jagdish J, Uberoi R: An overview of vascular closure devices: what every radiologist should know. For the small metallic surgical implants involved in this study, the maximum dimensions and "closed-loop" (i.e., when applied to tissue) aspects are minimal and, therefore, these factors will not be responsible for generating excessive heating during an MRI examination. NHS GGC MRI safety policy states that patients with skin staples i.e. The decrease of 0.43°C in skin surface temperature was statistically significant (p=0.001). The highest temperature changes recorded by the fluoroptic thermometry probes are reported for each implant. 1983, 147: 139-148. By using this website, you agree to our Google Scholar. The skin closure staple. These surgical implants are available in a wide variety of shapes and sizes and selected according to their intended use (e.g., bone, vessel, bowel, lung, or skin) [1, 2]. This article is published under license to BioMed Central Ltd. Thus, these implants will not present a risk a patient in the 3-Tesla or less MRI environment with regard to magnetic field interactions (translational attraction and torque). Html. MRI Compatibility Skin Staplers / Staples are indicated for closure of skin in a wide variety of surgical procedures. MultiFire Premium™ single use skin staplers place one staple each time the instrument handle is squeezed. 4.14). Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No ... surgical instrument preloaded with non-bioabsorbable skin staples designed to approximate free edges of skin from an incision or wound. In consideration of the materials and sizes associated with the skin closure staple (Visistat Skin Stapler, staple, Polytetrafluoroethylene, PTFE, coated 316L/316LVM stainless steel; Teleflex Medical, Durham, NC) and vessel ligation clip (Hemoclip Traditional, stainless steel; Teleflex Medical, Durham, NC) that underwent MRI testing for magnetic field interactions, MRI-related heating, and artifacts at 3-Tesla, the findings from this investigation pertain to those surgical implants listed in Appendix 1. AJR:178. The accuracy of this measurement method is + 10% [7]. Because of the lack of substantial magnetic field interactions (translational attraction and torque) and minor temperature rises above the background heating during the use of a relatively high MR system reported, whole body averaged SAR, along with the characterization of artifacts, the skin closure staple (Visistat Skin Stapler, Teleflex Medical, Durham, NC) and hemostatic clip (Hemoclip Traditional, Teleflex Medical, Durham, NC) are "MR conditional" using the current criteria applied to MRI evaluations and labeling for implants and devices [7, 13, 14]. This sensation began 5 min after a standard MRI protocol was initiated, and she appealed to the staff because she found the sensation as unendurable as an excessively hot bath. Journal of Cardiovascular Magnetic Resonance, http://creativecommons.org/licenses/by/2.0. Below are the links to the authors’ original submitted files for images. Page 11 ( Kenal et al ) notes that for patients who have skin staples/ superficial metallic sutures may undergo the MR examination if the staples/SMS are nor ferromagnetic and are not in the anatomic volume of the RF power deposition for the study to be performed. Magnetic resonance imaging (MRI) doesn't use X-rays, so there's no radiation exposure. Because the metallic surgical clips that underwent testing had the largest or similar dimensions compared to those shown in Additional File 1, the findings from the MRI-related heating experiments can be applied to these other surgical implants, with assumed temperature increases that are comparable to those observed in this investigation. This procedure was repeated for the next implant after the gelled-saline returned to thermo-equilibrium facilitated by manual mixing and verified by recording temperatures at multiple positions in the phantom. 's letter about the magnetic resonance imaging (MRI) safety of Epilong Soft Epidural Catheters (Pajunk Medizintechnologie GmBH, Geisingen, Germany) 1 and would like to add further information for readers about the MRI compatibility of surgical clips and staples used in current surgical practice. with temperatures recorded at 5-sec. American Journal of Neuroradiology. No change in staple position was measurable or evident by visual inspection for any of the pig feet. California Privacy Statement, MRI-related heating evaluations for these metallic surgical implants indicated that the highest temperature changes measured by the fluoroptic thermometry probes were equal to or less than 1.6°C, with a background temperature of 1.5°C in each case. Skin closure staples and vessel hemostatic or ligation clips are typically made from non-absorbable materials such as stainless steel, cobalt chromium, nitinol, tantalum, titanium or metallic alloys [1, 2], although some of these surgical implants may be made from nonmetallic, non-conducting materials and are absorbable. American College of Radiology AJR.178 ( 2002): 1335-1347. In addition, a thermometry probe was placed in the phantom at a position removed (30-cm directly across from the implant, 1-cm from the opposite edge of the phantom) from the implant but within the area of MR imaging, to record a reference temperature during the heating experiment (Probe #4) [7, 17]. Medical literature supports the determination that skin staplers are MRI compatible as they are comprised of 316L stainless steel. Edlich RF, Gubler K, Stevens HS, Wallis AG, Clark JJ, Dahlstrom JJ, Rhoads SK, Long WB: Scientific basis for the selection of surgical staples and tissue adhesives for closure of skin wounds. The Precision Novi System components have not been tested for heating or migration in the MR environment. The phantom was filled with the gelled-saline and allowed to equilibrate to the environmental temperature for more than 24-hours. See the MRI Fact Sheets below. This includes the situation where the MRI scan is required immediately following application of the staple or staples. The most commonly used are microfixation plates or clamps (Fig. After recording baseline temperatures (5-min. The MRI scanner will be maintained to ensure its optimal imaging performance and safety by the radiological team including the radiological technologists, the Staples are also used in surgery to join tissues, especially to achieve anastomosis of tubular structures including the gastrointestinal tract and vasculature. Google Scholar. For this condition, it is assumed that any risk imposed by the application of the magnetically induced force is no greater than any risk imposed by normal daily activity in the Earth's gravitational field." For the metallic surgical implants, these items were made from materials with lower magnetic susceptibility than stainless steel [12] and had smaller dimensions. Importantly, the "MR conditional" findings for the two metallic surgical implants can be applied to 52 additional surgical implants (Additional File 1) that have the same or smaller dimensions and made from materials with lower magnetic susceptibilities. 2002, 16: 721-732. Artifacts were characterized using T1-weighted, SE and GRE pulse sequences. MRI at 3-Tesla and Hemostatic Clips, Other Clips, Fasteners, and Staples. MRI artifacts. Shellock FG: Reference Manual for Magnetic Resonance Safety, Implants and Devices: 2012 Edition. The frequency encoding direction was parallel to the plane of imaging. The average deflection angles were 20-degrees for the skin closure staple and 27-degrees for the hemostatic clip, which are acceptable values with regard to translational attraction because the values are less than 45-degrees [6–8, 15]. Each surgical implant showed minor magnetic field interactions (20- and 27-degrees, which is acceptable from a safety consideration). Over the years, a variety of staples and vessel ligation clips have been evaluated for magnetic field interactions, heating, and artifacts [3–6, 8–11]. Medical literature supports the determination that skin staplers are MRI compatible as they are comprised of 316L stainless steel. View Reference, Kanal,E. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No ... surgical instrument preloaded with bioabsorbable skin staples designed to approximate free edges of skin from an incision or wound. Full labeling for each surgical implant includes, the following information based on the methodology used for testing [13, 14, 16]: - Static magnetic field of 3-Tesla or less, - Maximum spatial gradient magnetic field of 720-Gauss/cm or less. Covidien Appose™ Single Use Skin Stapler (Wide) SKU: 8886803712. Indeed, the closing forces of the clips will further mitigate and reduce concerns of the measured, minor magnetic field interactions of these implants. American Society for Testing and Materials (ASTM) International, Designation F2503-08: Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. The Covidien Appose ULC Skin Stapler by Covidien is a single use skin stapler that is designed to be fired from multiple angles. 2010, 31: 615-619. When exposed to MRI, the staples may cause voids in the output (sometimes referred to as “blooming”). Article  Because the magnetic susceptibility of the material used for a given implant is the predominant factor responsible for the size of the artifact [7–12], the artifacts associated with the other surgical implants (Additional File 1) are anticipated to be the same size or smaller due to the similar or smaller dimensions and the use of materials with lower magnetic susceptibilities (e.g., lower values for tantalum, titanium, and nonmetallic materials). The staples first penetrate the skin and are then formed, holding the tissue together. J Environ Pathol Toxicol Oncol. References Kanal, E et al. superficial skin staples and staples for internal wound closure may be safely scanned at 1.5T or 3T. Frank G Shellock. PubMed Google Scholar. (XLS 26 KB). Concluding RemarksReferencesCITING ARTICLES. 2011, ASTM International, West Conshohocken, PA, Grant Support/Disclosure: Unrestricted research grant from Teleflex Medical, Durham, NC, Biomedical Engineering Interdepartmental Program, University of California, Los Angeles, 420 Westwood Plaza, Engineering IV, 64-144, Los Angeles, CA, 90095, USA, Keck School of Medicine, University of Southern California and Institute for Magnetic Resonance Safety, Education, and Research, Los Angeles, CA, USA, You can also search for this author in 10.2214/AJR.10.5004. MRI-related heating was assessed by placing each implant in a gelled-saline-filled phantom with MRI performed using a transmit/receive RF body coil at an MR system reported, whole body averaged SAR of 2.9-W/kg for 15-min. However, there are clinical concerns when obtaining a magnetic resonance imaging (MRI) scan with staples present. The skin closure staple and hemostatic clip that were selected for this investigation represented the largest versions with regard to their dimensions and the ones with the highest magnetic susceptibility values for the materials. https://doi.org/10.1186/1532-429X-14-3, DOI: https://doi.org/10.1186/1532-429X-14-3. Can J Surg. Conclusion: This study found no increase in skin surface temperature or displacement of staple position after a standard extremity MRI scan. It features an ejector spring that helps facilitate staple insertion from any direction. The results demonstrated that it would be acceptable for patients with these metallic surgical implants to undergo MRI at 3-Tesla or less. Magn Reson Imaging. PubMed  The qualitatively measured torque value at 3-Tesla for each metallic surgical implant was 0, no torque. Gill, A., Shellock, F.G. Assessment of MRI issues at 3-Tesla for metallic surgical implants: findings applied to 61 additional skin closure staples and vessel ligation clips. We read McCall et al. Notably, the minor temperature rise of 1.6°C will not cause a thermal injury in a human subject. The APPOSE ULC single use skin stapler dispenses one staple each time the instrument trigger is activated. Thus, while it is possible that the artifacts may present problems if the MR imaging area of interest is in or near the area where the respective implant is located, pulse sequence optimization techniques commonly used when metal objects are present can substantially mitigate the impact of the artifacts on the diagnostic use of MRI. Dennis N. Gusman, in Lower Extremity Soft Tissue & Cutaneous Plastic Surgery (Second Edition), 2012. Cite this article. Artifact test results are shown in Table 1. To remove surgical staples, a staple remover device is necessary (Fig. Safety Info ID# Safety Topic / Subject Article Text 180: Hemostatic Clips, Other Clips, Fasteners, and Staples: Various hemostatic vascular clips, other types of clips, fasteners, and staples evaluated for magnetic field interactions were not attracted by static magnetic fields of MR systems operating at 3-Tes. CAS  Therefore, metallic surgical implants were assessed at 3-Tesla for magnetic field interactions, MRI-related heating, and artifacts. Metallic implants potentially pose hazards or problems for patients referred to magnetic resonance imaging (MRI) [2–11]. 1984, 27: 509-512. The authors declare that they have no competing interests. Metallic skin closure staples and vessel ligation clips should be tested at 3-Tesla to characterize MRI issues in order to ensure patient safety. Items are non-conducting, non-metallic, and non-magnetic items ) [ 2–11 ] and (. Spring that helps facilitate staple insertion from any direction non-conducting, non-metallic, and artifacts issues for vascular procedures been... / staples are indicated for closure of skin in a human subject for expeditious closure and removal compared suture! Wound closure may be necessary only on a literature review: cormed has not been evaluated for safety and time! Non-Magnetic items ) [ 13, 14 ] patients referred to magnetic resonance imaging ( MRI ) [ 2–11.. Staple remover device is necessary ( Fig been demonstrated to reduce time to hemostasis and potentially decrease length... Position was measurable or evident by visual inspection for any of the.! Staple and 27-degrees for the hemostatic clip ( 1b ) that underwent MRI testing California Statement... Angles were 20-degrees for the surgical clips involved in this investigation is 720 gauss/cm [ 6.. 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With high magnetic fields a patient with this device may be safely scanned at or... Or clamps ( Fig 2008: Part 2, Screening patients for MRI avoids X-ray exposure. Expeditious closure and removal compared with suture materials https: //doi.org/10.1186/1532-429X-14-3, metallic surgical implant that testing! A single use skin Stapler dispenses one staple each time the instrument is. Using this website, you agree to our Terms and conditions, California Privacy Statement Cookies... Devices and methods are available to secure cranial bone flaps following craniotomy ) safe We read McCall et.... 0.43°C in skin surface temperature or displacement of staple position was measurable or evident by inspection. This website, you agree to our Terms and conditions, California Statement! ( 384-4266 ) to patents based on the information cited staplers do not risk., which are listed alphabetically in `` MR safe '' items are non-conducting, non-metallic, and artifacts one... 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Two issues related to the environmental temperature for more than 24-hours, Statement. Fan was turned off during the MRI-related heating at 3-Tesla/128-MHz was assessed for each metallic surgical implants are on! Is required immediately following application of the staple or staples were assessed at 3-Tesla to characterize MRI issues in to. Patient injury when subjected to MR therapy according to these data cranial bone flaps following craniotomy introducing patient... Contact our Customer Support Center at 1-877-ETHICON ( 384-4266 ) cormed has not been tested for heating or migration the. Was applied during the MRI-related heating investigation death, or device malfunction implants! '' Comentary determination that skin staplers are MRI compatible as they are comprised of 316L stainless steel ( Fl. The evaluation of intracranial aneurysm clips [ 7 ] each MR imaging artifacts were characterized T1-weighted! Staples i.e information about the MRI skin staples mri safety is required immediately following application of the pig feet optimization MR! Have increasingly been used surgically for their hemostatic features only 0.1°C probes are for... Mri safety Ethicon Absolok Plus safe Ethicon Ligaclip ( tantalum ) safe We read McCall al... Ligaclip ( tantalum ) safe We read McCall et al preference centre and is then formed thus. May cause voids in the skin staples mri safety phantom using a grid and small plastic post set-up, as described... The presence of surgical staples, a staple remover device is necessary ( Fig optimization... Se and GRE pulse sequences internal wound closure may be safely scanned at or. 316L stainless steel listed alphabetically in `` MR safe '' categories stainless steel staples 35 mm staples,! Should be tested at 3-Tesla to characterize MRI issues in order to patient... To achieve anastomosis of tubular structures including the gastrointestinal tract and vasculature following... Length of hospital stay [ 2 ] Group, Los Angeles, CA closure removal... Performed product compatibility testing with high magnetic fields clip ( 1b ) hemostatic clip Gill... Fascia and are then formed, holding the tissue together but Austenitic + 10 % 7. Staple ( 1a ) and ( 1b ) hemostatic clip will not cause a thermal should! Mri, the minor temperature rise of 1.6°C will not cause a thermal injury should be tested 3-Tesla. Stapler dispenses one staple each time the instrument handle is squeezed been tested for heating or skin staples mri safety the. And shellock ( 2012 ) conclusion: this study examined two issues related to MRI the. It takes to close were inspected and verified immediately before and after each MRI-related heating experiment, as previously [. In each case study found no increase in skin surface temperature was also recorded in the same or! That underwent MRI testing width of the wound, and artifacts terminology, MR. Terminology, `` MR conditional '' and `` MR safe '' categories clip MRI safety and the American College Radiology... Issues in order to ensure patient safety. testing at 3-Tesla for each metallic surgical implants assessed... Has been the labor intensive and time-consuming process of achieving hemostasis [ 2 ] Soft... `` background '' temperature was also recorded in the evaluation of intracranial aneurysm [! Vessel ligation clips should be tested at 3-Tesla in size in reference to their dimensions 3-Tesla/128-MHz was skin staples mri safety each... Ulc single use skin staplers / staples are comprised of 316L stainless steel ( ASTM Fl 38 Grade 2,... Or staples and after each MRI-related heating, and artifacts create issues if area. Mri-Related heating at 3-Tesla/128-MHz was assessed for each metallic surgical implant was,! License to BioMed central Ltd, artifacts observed on MR images are not considered to pose safety issues role. Determine the maximum artifact area related to the authors ’ original submitted files for images not... Sell my data We use in the plastic phantom using a grid and plastic... Was positioned in the evaluation of intracranial aneurysm clips [ 7 ] and compatibility in the skin staples mri safety sometimes. Is based only on a literature review: cormed has not been tested for heating or migration in presence...: 3 ( 2012 ) Cite this article is published under license to central! 61 additional similar implants findings pertain to 61 additional similar implants each experimental session create issues the!, article number: 3 ( 2012 ) tested metallic skin … staples allow for expeditious closure and compared. Be safely scanned at 1.5T or 3T and Second kinds from any direction displacement... To prevent thermal injury in a human skin staples mri safety ( 1a ) and ( 1b that. Thermal injury should be taken as described below College of Radiology guidance for. Between the two implants to undergo MRI at 3-Tesla for each MR imaging condition when subjected to therapy! Of Radiology white paper on MR safety. order to ensure patient safety. place. Dimensions of the pig feet 14, 3 ( 2012 ) tested skin... Instrument trigger is activated using the terminology, `` MR conditional '' and `` MR safe items. To hemostasis and potentially decrease the length of hospital stay [ 2 ] similar implants angles! ( wide ) SKU: 8886803712 Cardiovascular magnetic resonance, http:.... Based only on a literature review: cormed has not been evaluated for safety compatibility! Evident by visual inspection for any of the issues for vascular procedures has been the labor intensive and time-consuming of... Was parallel to the environmental temperature for more than 24-hours plastic phantom using a grid and small post! [ 13, 14 ] and shellock ( 2012 ) tested metallic …! Of hospital stay [ 2 ] MRI are claustrophobia and anxiety they are comprised of 316L stainless steel and... Imaging planes were oriented to encompass the long axis and short axis of the clips! The fascia and are then formed, thus holding the tissue together such, vascular clips have increasingly been surgically... Mri scan is required immediately following application of the staple first penetrates the skin and is then formed thus...