Opinion
EDITORIAL
INNOVATION IN SAFETY: SAFETY IN INNOVATION
Innovation in Safety, and Safety in Innovation Dan Eisenberg, MD; Sherry M. Wren, MD
Modern surgery’s heritage has been based on the introduction of innovative approaches to the way surgery was practiced, all in an attempt to improve patient outcomes. Innovations ranged widely from purely technical advances to simple changes in practice norms that resulted in safer surgery. These innovations in surgical safety had a profound impact on patient mortality and would transform the manner in which surgery, and medicine, would hence be approached. In 1867, for example, Joseph Lister introduced the use of a preoperative antibacterial preparation, at a time when surgical site and deep soft-tissue infections were common and often the cause of postoperative patient morbidity and mortality.1 In the United States, William Stewart Halsted insisted on universal operative hand scrubbing as a patient safety maneuver to decrease postoperative infections.2 These innovations were simple and are common sense by today’s standards, yet they effectively transformed the practice of surgery; they made it safer and allowed for the complexity of procedures to increase. The public’s perception of the surgeon changed as well, evolving from the experimental anatomist and radical thinker exemplified by John Hunter in the 18th century to the effective healer and possessor of special skill of modern times.3
Safety Safety as a field has greatly advanced in all professions and within surgery remains of central importance. Safety in modern parlance now represents a hallmark of outcome and process measures, often used to assess the quality of health care practitioners, hospitals, and health care systems. As surgery has become more complex, so have the innovative approaches to surgical safety. The approach to safety has broadened considerably in recent decades, with an emphasis on system practices and clinical outcomes data collection. The Department of Veterans Affairs developed a surgical quality program that became a standard in every Veterans Affairs hospital in 1995. The program not only tracked outcomes but also implemented a multi-tiered review of outliers. The National Surgical Quality Improvement Program (NSQIP) riskadjusted outcomes assessment tool is now recognized as the gold standard in quality measurement and tool for improvement. This resulted in recognition of NSQIP and Veterans Affairs surgery as a leader in safety and quality. The NSQIP program was then trialed and implemented in a number of academic teaching hospitals with similar results of improved postoperative morbidity and surgical site infection rates.4 Following this success, the American College of Surgeons received a patient safety grant from the Agency for jamasurgery.com
Healthcare Research and Quality and adopted similar methods to establish the American College of Surgeons–NSQIP,5 with the emphasis being on the system of surgical practice and outcomes rather than the individual surgeon. The focus on systems issues, instead of individual mistakes, was also championed by the Committee on Quality of Health Care in America of the Institute of Medicine. While examining in-hospital medical errors with a proclaimed mission to build a safer health system, the committee concluded that errors are caused by faulty systems rather than faulty health care practitioners and that mistakes can be prevented by designing health systems that are safer.6 Millions of dollars were committed through the Agency for Healthcare Research and Quality to address the question of how to improve patient safety. Resulting innovative approaches included the creation of a safety culture within the health care delivery system, largely by encouraging a team approach to patient care.7 Implementing the team approach to global surgical care, the World Health Organization developed guidelines for safe surgery in 2008, which included a simple and standardized safety checklist that incorporated all members of the health care team present in the operating room. In a short time, it was possible to show that this novel idea, which changed operating room practices, enhanced patient safety. The checklist concept has subsequently proven that a team approach to patient safety that demands communication between team members at sign in, before incision, and after completion of surgery results in decreased morbidity and mortality.8 In this process, each member of the team has a defined role, which concurrently also serves to focus attention to the individual health care provider. In so doing, personal accountability and the contribution of individual errors within the system are tracked and highlighted. The true innovative approach, perhaps, is the emphasis on the team approach for patient care and enhanced communication between team members. The resultant change in culture within health care organizations allows small and inexpensive changes to have a significant impact. For example, a standardized physician order set, along with nursing, physician, and patient education, has been shown to significantly reduce the incidence of postoperative pneumonia and unplanned intubation.9 Smaller, simple, less inexpensive, systematic innovative changes can lead to significant changes in outcomes. On the other hand, massive system changes should be undertaken with some caution. It is not always clear whether a broad system innovation requiring significant time, personnel, and fiJAMA Surgery January 2014 Volume 149, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Karolinska Institutet University Library User on 05/22/2015
7
Opinion Editorial
nancial investment does indeed achieve its stated goal in promoting surgical safety. The Surgical Care Improvement Project was established with a major goal of preventing surgical site infections. Multiple Surgical Care Improvement Project measures were imposed and widely implemented at significant cost. Moreover, individual health care practitioners and health care institutions were publicly evaluated based on their compliance with these measures. This was done, however, without evidence to support the clinical efficacy of these measures. In fact, since its inception in 2006, studies have failed to show an association between the implementation of the Surgical Care Improvement Project and a lower probability of infection.10 Similarly, the concept of the surgical center of excellence (COE) grew out of concerns for patient safety. Centers of excellence now exist for multiple surgical specialties and nonsurgical disciplines. Promoting the team approach within an organization, the bariatric and metabolic surgery COE, for example, requires a minimum case volume, a specific infrastructure, dedicated multidisciplinary personnel, and systematic data collection. In 2006, COE designation was required by the Centers for Medicare and Medicaid Services in an effort to promote safety, and institutions met criteria for COE designation at enormous expense, despite the fact that there was no conclusive evidence to suggest that it does actually promote safety.11 The lack of significant improvement in patient outcomes with the implementation of the COE requirements has been both a surprise and disappointment to many. In fact, as of September 2013, the Centers for Medicare and Medicaid Services no longer require that covered bariatric surgery procedures be performed in certified facilities. Broad systemwide changes that include changes in infrastructure and personnel are expensive. In an era of health care cost containment, there should be an emphasis on evidencebased implementation of costly systemic innovative changes, even though they often seem intuitively beneficial. Although encouraging a standardized approach to patient care, the utility of these practices needs to be evaluated to ensure an improvement in patient outcome, not more documentation for its own sake.
Innovation It is vital within surgery to allow for rapid implementation of technological and technical innovation to surgical practice. New devices and techniques are introduced into the operating room daily, and their use has been historically left to the decision and discretion of the surgeon. Despite close regulation of new devices and assessment of their safety by the US Food and Drug Administration, surgeons are still afforded significant leeway to decide what is safe and effective in the operating room. In fact, it is generally understood that new and creative approaches have always been the driving force behind change and progress in surgery. Minimally invasive surgery, transplantation, and cardiac surgery, for example, would not have developed without the creativity and daring of surgeons implementing innovations in the operating room. However, important questions were formally raised within the surgical community within the last few decades with re8
spect to new innovations, including the fundamental question of how patient safety is guaranteed throughout the process of innovation. To tackle this important issue, the surgical community has recognized that innovation lies within a spectrum ranging from a minor variation of accepted surgical practice to human research.12 While the former is unlikely to change the safety profile of an operation and the latter already undergoes formal oversight of human research, there has been little to guide the surgeon in introducing surgical innovations safely. As Strasberg and Ludbrook13 pointed out, laparoscopic cholecystectomy was viewed on the one hand as more than a minor variation compared with open cholecystectomy, while on the other hand not human subject investigational research requiring institutional review board approval. Thus, this innovation that changed the practice of general surgery was widely accepted in the United States with little oversight or regulation, despite being initially associated with increased patient morbidity. The call, therefore, is not for hindering innovative practices but for a systematic, regulated implementation of them. Biffl et al12 proposed that surgical innovation committees be established on a local level to ensure appropriate oversight and disclosure of surgical innovations. Indeed, such committees can serve not only to standardize the process of introducing innovation to ensure a quality standard of patient safety but also to protect the surgeon from potential litigation. The demand for increased regulation and scrutiny of surgeon practices will undoubtedly continue to grow as the rate of innovation continues to grow. With the Internet widely available, patients are increasingly well informed about new trends; at the same time, the climate of questioning (or even doubting) physicians’ integrity becomes more entrenched in medical and surgical practice. With increasing political pressure14 and changes in public perception,15 the need for surgeons to be aboveboard and open to scrutiny and review has never been greater. Despite this, it is important to avoid introducing cumbersome regulation that will accomplish little more than stifling the innovative spirit that has underscored the evolution of surgery. Some innovators would argue that this is the current climate within the United States, leading to new innovations often being trialed overseas because of regulatory issues. But, modern surgical innovation cannot progress without assurances of patient safety. This will require regulatory mechanisms to be in place, and it is to the benefit of the patient and the surgeon that these mechanisms arise from surgical organizations and not other bureaucratic regulatory bodies. Surgeons, within the health care systems in which they practice, should lead the charge to establish clear, standardized guidelines for safe practices in an ever-changing field. The national surgical leadership should continue to take the initiative to ensure that safety in innovation is made certain by surgeons who are organized and joined in a common purpose of providing excellent, responsible care. Similarly, easy-to-implement and inexpensive innovations in safety are likely to prove meaningful and effective in ensuring that surgery continues to be modern, effective, and safe.
JAMA Surgery January 2014 Volume 149, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Karolinska Institutet University Library User on 05/22/2015
jamasurgery.com
Editorial Opinion
ARTICLE INFORMATION Author Affiliations: Department of Surgery, Stanford University School of Medicine, Palo Alto, California (Eisenberg, Wren); Palo Alto Veterans Affairs Health Care System, Palo Alto, California (Eisenberg, Wren). Corresponding Author: Sherry M. Wren, MD, Palo Alto Veterans Affairs Health Care System, G112, 3801 Miranda Ave, Palo Alto, CA 94304 (swren @stanford.edu).
Improvement Program in the private sector: the Patient Safety in Surgery Study. Ann Surg. 2008;248(2):329-336. 5. Birkmeyer JD, Shahian DM, Dimick JB, et al. Blueprint for a new American College of Surgeons: National Surgical Quality Improvement Program. J Am Coll Surg. 2008;207(5):777-782. 6. Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press; 1999.
Published Online: December 18, 2013. doi:10.1001/jamasurg.2013.5112.
7. Clancy CM. Ten years after To Err is Human. Am J Med Qual. 2009;24(6):525-528.
Conflict of Interest Disclosures: None reported.
8. Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360(5): 491-499.
REFERENCES 1. Lister J. On a new method of treating compound fracture, abscess, etc. Lancet. 1867;89:387-389. 2. Schwulst SJ, Mazuski JE. Surgical prophylaxis and other complication avoidance care bundles. Surg Clin North Am. 2012;92(2):285-305, ix. 3. Moore W. The Knife Man. New York, NY: Broadway Books; 2005:170. 4. Khuri SF, Henderson WG, Daley J, et al; Principal Investigators of the Patient Safety in Surgery Study. Successful implementation of the Department of Veterans Affairs' National Surgical Quality
jamasurgery.com
9. Cassidy MR, Rosenkranz P, McCabe K, Rosen JE, McAneny D. I COUGH: reducing postoperative pulmonary complications with a multidisciplinary patient care program. JAMA Surg. 2013;148(8):740-745. 10. Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010;303(24):2479-2485.
11. Dimick JB, Nicholas LH, Ryan AM, Thumma JR, Birkmeyer JD. Bariatric surgery complications before vs after implementation of a national policy restricting coverage to centers of excellence. JAMA. 2013;309(8):792-799. 12. Biffl WL, Spain DA, Reitsma AM, et al; Society of University Surgeons Surgical Innovations Project Team. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg. 2008;206(3):1204-1209. 13. Strasberg SM, Ludbrook PA. Who oversees innovative practice? is there a structure that meets the monitoring needs of new techniques? J Am Coll Surg. 2003;196(6):938-948. 14. Dr Obama’s tonsillectomy: do Americans want a federal board deciding if their kids need surgery? Wall Street Journal. July 26, 2009. http://online.wsj.com /news/articles/SB10001424052970204886304 574308472181248330. Accessed November 21, 2013. 15. Eisler P, Hansen B. Doctors perform thousands of unnecessary surgeries. USA Today. June 18, 2013. http://www.usatoday.com/story/news/nation/2013 /06/18/unnecessary-surgery-usa-today -investigation/2435009/. Accessed November 21, 2013.
JAMA Surgery January 2014 Volume 149, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Karolinska Institutet University Library User on 05/22/2015
9
EDITORIAL
INNOVATION IN SAFETY: SAFETY IN INNOVATION
Innovation in Safety, and Safety in Innovation Dan Eisenberg, MD; Sherry M. Wren, MD
Modern surgery’s heritage has been based on the introduction of innovative approaches to the way surgery was practiced, all in an attempt to improve patient outcomes. Innovations ranged widely from purely technical advances to simple changes in practice norms that resulted in safer surgery. These innovations in surgical safety had a profound impact on patient mortality and would transform the manner in which surgery, and medicine, would hence be approached. In 1867, for example, Joseph Lister introduced the use of a preoperative antibacterial preparation, at a time when surgical site and deep soft-tissue infections were common and often the cause of postoperative patient morbidity and mortality.1 In the United States, William Stewart Halsted insisted on universal operative hand scrubbing as a patient safety maneuver to decrease postoperative infections.2 These innovations were simple and are common sense by today’s standards, yet they effectively transformed the practice of surgery; they made it safer and allowed for the complexity of procedures to increase. The public’s perception of the surgeon changed as well, evolving from the experimental anatomist and radical thinker exemplified by John Hunter in the 18th century to the effective healer and possessor of special skill of modern times.3
Safety Safety as a field has greatly advanced in all professions and within surgery remains of central importance. Safety in modern parlance now represents a hallmark of outcome and process measures, often used to assess the quality of health care practitioners, hospitals, and health care systems. As surgery has become more complex, so have the innovative approaches to surgical safety. The approach to safety has broadened considerably in recent decades, with an emphasis on system practices and clinical outcomes data collection. The Department of Veterans Affairs developed a surgical quality program that became a standard in every Veterans Affairs hospital in 1995. The program not only tracked outcomes but also implemented a multi-tiered review of outliers. The National Surgical Quality Improvement Program (NSQIP) riskadjusted outcomes assessment tool is now recognized as the gold standard in quality measurement and tool for improvement. This resulted in recognition of NSQIP and Veterans Affairs surgery as a leader in safety and quality. The NSQIP program was then trialed and implemented in a number of academic teaching hospitals with similar results of improved postoperative morbidity and surgical site infection rates.4 Following this success, the American College of Surgeons received a patient safety grant from the Agency for jamasurgery.com
Healthcare Research and Quality and adopted similar methods to establish the American College of Surgeons–NSQIP,5 with the emphasis being on the system of surgical practice and outcomes rather than the individual surgeon. The focus on systems issues, instead of individual mistakes, was also championed by the Committee on Quality of Health Care in America of the Institute of Medicine. While examining in-hospital medical errors with a proclaimed mission to build a safer health system, the committee concluded that errors are caused by faulty systems rather than faulty health care practitioners and that mistakes can be prevented by designing health systems that are safer.6 Millions of dollars were committed through the Agency for Healthcare Research and Quality to address the question of how to improve patient safety. Resulting innovative approaches included the creation of a safety culture within the health care delivery system, largely by encouraging a team approach to patient care.7 Implementing the team approach to global surgical care, the World Health Organization developed guidelines for safe surgery in 2008, which included a simple and standardized safety checklist that incorporated all members of the health care team present in the operating room. In a short time, it was possible to show that this novel idea, which changed operating room practices, enhanced patient safety. The checklist concept has subsequently proven that a team approach to patient safety that demands communication between team members at sign in, before incision, and after completion of surgery results in decreased morbidity and mortality.8 In this process, each member of the team has a defined role, which concurrently also serves to focus attention to the individual health care provider. In so doing, personal accountability and the contribution of individual errors within the system are tracked and highlighted. The true innovative approach, perhaps, is the emphasis on the team approach for patient care and enhanced communication between team members. The resultant change in culture within health care organizations allows small and inexpensive changes to have a significant impact. For example, a standardized physician order set, along with nursing, physician, and patient education, has been shown to significantly reduce the incidence of postoperative pneumonia and unplanned intubation.9 Smaller, simple, less inexpensive, systematic innovative changes can lead to significant changes in outcomes. On the other hand, massive system changes should be undertaken with some caution. It is not always clear whether a broad system innovation requiring significant time, personnel, and fiJAMA Surgery January 2014 Volume 149, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Karolinska Institutet University Library User on 05/22/2015
7
Opinion Editorial
nancial investment does indeed achieve its stated goal in promoting surgical safety. The Surgical Care Improvement Project was established with a major goal of preventing surgical site infections. Multiple Surgical Care Improvement Project measures were imposed and widely implemented at significant cost. Moreover, individual health care practitioners and health care institutions were publicly evaluated based on their compliance with these measures. This was done, however, without evidence to support the clinical efficacy of these measures. In fact, since its inception in 2006, studies have failed to show an association between the implementation of the Surgical Care Improvement Project and a lower probability of infection.10 Similarly, the concept of the surgical center of excellence (COE) grew out of concerns for patient safety. Centers of excellence now exist for multiple surgical specialties and nonsurgical disciplines. Promoting the team approach within an organization, the bariatric and metabolic surgery COE, for example, requires a minimum case volume, a specific infrastructure, dedicated multidisciplinary personnel, and systematic data collection. In 2006, COE designation was required by the Centers for Medicare and Medicaid Services in an effort to promote safety, and institutions met criteria for COE designation at enormous expense, despite the fact that there was no conclusive evidence to suggest that it does actually promote safety.11 The lack of significant improvement in patient outcomes with the implementation of the COE requirements has been both a surprise and disappointment to many. In fact, as of September 2013, the Centers for Medicare and Medicaid Services no longer require that covered bariatric surgery procedures be performed in certified facilities. Broad systemwide changes that include changes in infrastructure and personnel are expensive. In an era of health care cost containment, there should be an emphasis on evidencebased implementation of costly systemic innovative changes, even though they often seem intuitively beneficial. Although encouraging a standardized approach to patient care, the utility of these practices needs to be evaluated to ensure an improvement in patient outcome, not more documentation for its own sake.
Innovation It is vital within surgery to allow for rapid implementation of technological and technical innovation to surgical practice. New devices and techniques are introduced into the operating room daily, and their use has been historically left to the decision and discretion of the surgeon. Despite close regulation of new devices and assessment of their safety by the US Food and Drug Administration, surgeons are still afforded significant leeway to decide what is safe and effective in the operating room. In fact, it is generally understood that new and creative approaches have always been the driving force behind change and progress in surgery. Minimally invasive surgery, transplantation, and cardiac surgery, for example, would not have developed without the creativity and daring of surgeons implementing innovations in the operating room. However, important questions were formally raised within the surgical community within the last few decades with re8
spect to new innovations, including the fundamental question of how patient safety is guaranteed throughout the process of innovation. To tackle this important issue, the surgical community has recognized that innovation lies within a spectrum ranging from a minor variation of accepted surgical practice to human research.12 While the former is unlikely to change the safety profile of an operation and the latter already undergoes formal oversight of human research, there has been little to guide the surgeon in introducing surgical innovations safely. As Strasberg and Ludbrook13 pointed out, laparoscopic cholecystectomy was viewed on the one hand as more than a minor variation compared with open cholecystectomy, while on the other hand not human subject investigational research requiring institutional review board approval. Thus, this innovation that changed the practice of general surgery was widely accepted in the United States with little oversight or regulation, despite being initially associated with increased patient morbidity. The call, therefore, is not for hindering innovative practices but for a systematic, regulated implementation of them. Biffl et al12 proposed that surgical innovation committees be established on a local level to ensure appropriate oversight and disclosure of surgical innovations. Indeed, such committees can serve not only to standardize the process of introducing innovation to ensure a quality standard of patient safety but also to protect the surgeon from potential litigation. The demand for increased regulation and scrutiny of surgeon practices will undoubtedly continue to grow as the rate of innovation continues to grow. With the Internet widely available, patients are increasingly well informed about new trends; at the same time, the climate of questioning (or even doubting) physicians’ integrity becomes more entrenched in medical and surgical practice. With increasing political pressure14 and changes in public perception,15 the need for surgeons to be aboveboard and open to scrutiny and review has never been greater. Despite this, it is important to avoid introducing cumbersome regulation that will accomplish little more than stifling the innovative spirit that has underscored the evolution of surgery. Some innovators would argue that this is the current climate within the United States, leading to new innovations often being trialed overseas because of regulatory issues. But, modern surgical innovation cannot progress without assurances of patient safety. This will require regulatory mechanisms to be in place, and it is to the benefit of the patient and the surgeon that these mechanisms arise from surgical organizations and not other bureaucratic regulatory bodies. Surgeons, within the health care systems in which they practice, should lead the charge to establish clear, standardized guidelines for safe practices in an ever-changing field. The national surgical leadership should continue to take the initiative to ensure that safety in innovation is made certain by surgeons who are organized and joined in a common purpose of providing excellent, responsible care. Similarly, easy-to-implement and inexpensive innovations in safety are likely to prove meaningful and effective in ensuring that surgery continues to be modern, effective, and safe.
JAMA Surgery January 2014 Volume 149, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Karolinska Institutet University Library User on 05/22/2015
jamasurgery.com
Editorial Opinion
ARTICLE INFORMATION Author Affiliations: Department of Surgery, Stanford University School of Medicine, Palo Alto, California (Eisenberg, Wren); Palo Alto Veterans Affairs Health Care System, Palo Alto, California (Eisenberg, Wren). Corresponding Author: Sherry M. Wren, MD, Palo Alto Veterans Affairs Health Care System, G112, 3801 Miranda Ave, Palo Alto, CA 94304 (swren @stanford.edu).
Improvement Program in the private sector: the Patient Safety in Surgery Study. Ann Surg. 2008;248(2):329-336. 5. Birkmeyer JD, Shahian DM, Dimick JB, et al. Blueprint for a new American College of Surgeons: National Surgical Quality Improvement Program. J Am Coll Surg. 2008;207(5):777-782. 6. Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press; 1999.
Published Online: December 18, 2013. doi:10.1001/jamasurg.2013.5112.
7. Clancy CM. Ten years after To Err is Human. Am J Med Qual. 2009;24(6):525-528.
Conflict of Interest Disclosures: None reported.
8. Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360(5): 491-499.
REFERENCES 1. Lister J. On a new method of treating compound fracture, abscess, etc. Lancet. 1867;89:387-389. 2. Schwulst SJ, Mazuski JE. Surgical prophylaxis and other complication avoidance care bundles. Surg Clin North Am. 2012;92(2):285-305, ix. 3. Moore W. The Knife Man. New York, NY: Broadway Books; 2005:170. 4. Khuri SF, Henderson WG, Daley J, et al; Principal Investigators of the Patient Safety in Surgery Study. Successful implementation of the Department of Veterans Affairs' National Surgical Quality
jamasurgery.com
9. Cassidy MR, Rosenkranz P, McCabe K, Rosen JE, McAneny D. I COUGH: reducing postoperative pulmonary complications with a multidisciplinary patient care program. JAMA Surg. 2013;148(8):740-745. 10. Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010;303(24):2479-2485.
11. Dimick JB, Nicholas LH, Ryan AM, Thumma JR, Birkmeyer JD. Bariatric surgery complications before vs after implementation of a national policy restricting coverage to centers of excellence. JAMA. 2013;309(8):792-799. 12. Biffl WL, Spain DA, Reitsma AM, et al; Society of University Surgeons Surgical Innovations Project Team. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg. 2008;206(3):1204-1209. 13. Strasberg SM, Ludbrook PA. Who oversees innovative practice? is there a structure that meets the monitoring needs of new techniques? J Am Coll Surg. 2003;196(6):938-948. 14. Dr Obama’s tonsillectomy: do Americans want a federal board deciding if their kids need surgery? Wall Street Journal. July 26, 2009. http://online.wsj.com /news/articles/SB10001424052970204886304 574308472181248330. Accessed November 21, 2013. 15. Eisler P, Hansen B. Doctors perform thousands of unnecessary surgeries. USA Today. June 18, 2013. http://www.usatoday.com/story/news/nation/2013 /06/18/unnecessary-surgery-usa-today -investigation/2435009/. Accessed November 21, 2013.
JAMA Surgery January 2014 Volume 149, Number 1
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Karolinska Institutet University Library User on 05/22/2015
9
![[Confusion regarding device innovation endangering patient safety].](/assets/img/hold.png)
