J Shoulder Elbow Surg (2014) 23, 1417-1418
www.elsevier.com/locate/ymse
EDITORIAL
Primum non nocere: risk assessment for new surgical procedures Tressa D. Amirthanayagam, MA (Cantab), FRCS (Orth)a,b,*, Roger J.H. Emery, MS, FRCS(Ed)a a b
Faculty of Medicine, Department of Surgery & Cancer, Imperial College London, St Mary’s Hospital, London, UK Mechanical Engineering Department, Imperial College London, London, UK
Medical devices such as total joint replacements are considered high risk and as such are described as class III medical devices. In North America, these devices require approval from the Food and Drug Administration’s Center for Devices and Radiological Health, and in Europe, CE Marking certification is needed for them to be sold. These measures attest to the verification by the manufacturer that the product meets safety, health, or environmental requirements. To achieve this, the manufacturer must produce a technical file. This has a number of components, most notably a technical requirements specification, risk analysis, and system rationale. The technical requirements specification defines a set of requirements that the product or system must meet or exceed. The risk analysis provides evidence that all risks that could cause potential harm to the patient have been identified and demonstrates what measures have been taken to mitigate these risks. The system rationale or design rationale provides documentation of the reasons behind decisions involved in designing a system or product. In addition to providing evidence for consumers by means of the CE mark or Food and Drug Administration approval that the device is considered safe for use, the technical file protects the manufacturer and distributors by serving as a defense with regard to liability claims. Although great emphasis is placed on optimizing the safety and efficacy of new implants, the importance of
IRB: Approval not required (Editorial). *Reprint requests: Tressa D. Amirthanayagam, MA (Cantab), FRCS (Orth), Clinical Research Fellow, Faculty of Medicine, Department of Surgery & Cancer, Imperial College London, St Mary’s Hospital, London, UK. E-mail address: [email protected] (T.D. Amirthanayagam).
surgical technique is often overlooked. Franta et al4 clearly demonstrate that the major causes of patient dissatisfaction after shoulder arthroplasty, namely, suboptimal implant position and alignment, instability, subscapularis failure, and infection, are predominantly associated with surgical technique. The medical devices industry is closely controlled, but no such regulations exist for novel surgical procedures and techniques, which could leave both the patient and surgeon vulnerable. An example is the Boytchev procedure for anterior shoulder stabilization, first described in 1951; it became popular in the 1980s with initially promising short-term follow-up.1,5 Although the idea of simply rerouting tendons behind the subscapularis to provide anterior stability may have seemed logical, it was associated with a 44% failure rate, an unacceptable level of complications including reoperation (19%) and musculocutaneous nerve injury (20%), and poor patient satisfaction.2 Would a formal risk assessment and review have helped to mitigate these risks? Currently there is a trend for taking well-established open procedures and performing them arthroscopically. This involves a steep learning curve for the surgeon, with increased potential risk to the patient. Is there a role, before widespread use of the new procedure, for formal assessment of any increased potential risk relative to the potential for improved clinical benefit to the patient? In this issue of the Journal of Shoulder and Elbow Surgery, Delaney et al3 report a 4% rate of nerve palsy requiring surgical intervention after the open Latarjet procedure. With the addition of intraoperative neuromonitoring, there were no further cases requiring reoperation, although a fifth of the cases still had clinically detectable nerve palsy. Given the high
1058-2746/$ - see front matter Ó 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. http://dx.doi.org/10.1016/j.jse.2014.06.056
1418 risk of neurologic injury with this as an open procedure, should we be performing intraoperative neuromonitoring when first performing the arthroscopic Latarjet procedure to assess and take steps to mitigate this risk? On balance, would the theoretical benefits of arthroscopic surgery justify the increased risks of a technically demanding new procedure? One may also question what is driving this trend for arthroscopic techniques. There is scant evidence that these procedures provide significant improvements to patient outcome over their well-established open counterparts. The companies that make arthroscopic devices have much to gain from an increased repertoire of arthroscopic procedures, as do the surgical pioneers who develop them. In addition, the advocates and early adopters of novel procedures are often more technically skilled and less risk averse than the general population of orthopedic surgeons. One must evaluate the safety of these procedures in less experienced hands should their use become widespread. If we are to adopt a formal risk assessment process and produce a technical file for novel surgical procedures in the same way as for medical devices, who would be responsible for regulating this? An independent regulatory body may not have sufficient knowledge of the practicalities of a specific surgical procedure to be able to assess the risks and whether they have been mitigated to acceptable levels. For surgery, would a peer review process be more appropriate? If so, would it be the role for journals such as this to take on that responsibility? There are concerns that additional review and regulation may stifle progress, and we would be adding to the bureaucracy to which our profession is already burdened. In addition, the risk assessment process may give a false sense of security; there are many problems that may be unforeseen,
T.D. Amirthanayagam, R.J.H. Emery and as with medical devices, clear reporting of adverse outcomes even once the technique is in regular use is essential. However, as physicians, it seems prudent for us to take all measures possible to minimize harm to our patients. Innovative surgery has remained unregulated as it resides in the realm between research and medical treatment. Perhaps it is time for us as a profession to address this.
Disclaimer The authors, their immediate families, and any research foundation with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article. Roger Emery is a former Deputy International Editor of the Journal of Shoulder and Elbow Surgery.
References 1. Conforty B. The results of the Boytchev procedure for treatment of recurrent dislocation of the shoulder. Int Orthop 1980;4:127-32. 2. Dalsgaard HL, Gøthgen CB, Hoogmartens MJ. The Boytchev procedure for recurrent anterior dislocation of the shoulder. A controversial technique. Acta Orthop Belg 2000;66:248-50. 3. Delaney RA, Freehill MT, Janfaza DR, Vlassakov KV, Higgins LD, Warner JJ. 2014 Neer Award Paper. Neuromonitoring the Latarjet procedure. J Shoulder Elbow Surg 2014;23:1473-80. http://dx.doi.org/ 10.1016/j.jse.2014.04.003 4. Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg 2007;16:555-62. http://dx.doi.org/10.1016/j.jse. 2006.11.004 5. Ha’Eri GB. Boytchev procedure for the treatment of anterior shoulder instability. Clin Orthop Relat Res 1986;206:196-201.
www.elsevier.com/locate/ymse
EDITORIAL
Primum non nocere: risk assessment for new surgical procedures Tressa D. Amirthanayagam, MA (Cantab), FRCS (Orth)a,b,*, Roger J.H. Emery, MS, FRCS(Ed)a a b
Faculty of Medicine, Department of Surgery & Cancer, Imperial College London, St Mary’s Hospital, London, UK Mechanical Engineering Department, Imperial College London, London, UK
Medical devices such as total joint replacements are considered high risk and as such are described as class III medical devices. In North America, these devices require approval from the Food and Drug Administration’s Center for Devices and Radiological Health, and in Europe, CE Marking certification is needed for them to be sold. These measures attest to the verification by the manufacturer that the product meets safety, health, or environmental requirements. To achieve this, the manufacturer must produce a technical file. This has a number of components, most notably a technical requirements specification, risk analysis, and system rationale. The technical requirements specification defines a set of requirements that the product or system must meet or exceed. The risk analysis provides evidence that all risks that could cause potential harm to the patient have been identified and demonstrates what measures have been taken to mitigate these risks. The system rationale or design rationale provides documentation of the reasons behind decisions involved in designing a system or product. In addition to providing evidence for consumers by means of the CE mark or Food and Drug Administration approval that the device is considered safe for use, the technical file protects the manufacturer and distributors by serving as a defense with regard to liability claims. Although great emphasis is placed on optimizing the safety and efficacy of new implants, the importance of
IRB: Approval not required (Editorial). *Reprint requests: Tressa D. Amirthanayagam, MA (Cantab), FRCS (Orth), Clinical Research Fellow, Faculty of Medicine, Department of Surgery & Cancer, Imperial College London, St Mary’s Hospital, London, UK. E-mail address: [email protected] (T.D. Amirthanayagam).
surgical technique is often overlooked. Franta et al4 clearly demonstrate that the major causes of patient dissatisfaction after shoulder arthroplasty, namely, suboptimal implant position and alignment, instability, subscapularis failure, and infection, are predominantly associated with surgical technique. The medical devices industry is closely controlled, but no such regulations exist for novel surgical procedures and techniques, which could leave both the patient and surgeon vulnerable. An example is the Boytchev procedure for anterior shoulder stabilization, first described in 1951; it became popular in the 1980s with initially promising short-term follow-up.1,5 Although the idea of simply rerouting tendons behind the subscapularis to provide anterior stability may have seemed logical, it was associated with a 44% failure rate, an unacceptable level of complications including reoperation (19%) and musculocutaneous nerve injury (20%), and poor patient satisfaction.2 Would a formal risk assessment and review have helped to mitigate these risks? Currently there is a trend for taking well-established open procedures and performing them arthroscopically. This involves a steep learning curve for the surgeon, with increased potential risk to the patient. Is there a role, before widespread use of the new procedure, for formal assessment of any increased potential risk relative to the potential for improved clinical benefit to the patient? In this issue of the Journal of Shoulder and Elbow Surgery, Delaney et al3 report a 4% rate of nerve palsy requiring surgical intervention after the open Latarjet procedure. With the addition of intraoperative neuromonitoring, there were no further cases requiring reoperation, although a fifth of the cases still had clinically detectable nerve palsy. Given the high
1058-2746/$ - see front matter Ó 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. http://dx.doi.org/10.1016/j.jse.2014.06.056
1418 risk of neurologic injury with this as an open procedure, should we be performing intraoperative neuromonitoring when first performing the arthroscopic Latarjet procedure to assess and take steps to mitigate this risk? On balance, would the theoretical benefits of arthroscopic surgery justify the increased risks of a technically demanding new procedure? One may also question what is driving this trend for arthroscopic techniques. There is scant evidence that these procedures provide significant improvements to patient outcome over their well-established open counterparts. The companies that make arthroscopic devices have much to gain from an increased repertoire of arthroscopic procedures, as do the surgical pioneers who develop them. In addition, the advocates and early adopters of novel procedures are often more technically skilled and less risk averse than the general population of orthopedic surgeons. One must evaluate the safety of these procedures in less experienced hands should their use become widespread. If we are to adopt a formal risk assessment process and produce a technical file for novel surgical procedures in the same way as for medical devices, who would be responsible for regulating this? An independent regulatory body may not have sufficient knowledge of the practicalities of a specific surgical procedure to be able to assess the risks and whether they have been mitigated to acceptable levels. For surgery, would a peer review process be more appropriate? If so, would it be the role for journals such as this to take on that responsibility? There are concerns that additional review and regulation may stifle progress, and we would be adding to the bureaucracy to which our profession is already burdened. In addition, the risk assessment process may give a false sense of security; there are many problems that may be unforeseen,
T.D. Amirthanayagam, R.J.H. Emery and as with medical devices, clear reporting of adverse outcomes even once the technique is in regular use is essential. However, as physicians, it seems prudent for us to take all measures possible to minimize harm to our patients. Innovative surgery has remained unregulated as it resides in the realm between research and medical treatment. Perhaps it is time for us as a profession to address this.
Disclaimer The authors, their immediate families, and any research foundation with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article. Roger Emery is a former Deputy International Editor of the Journal of Shoulder and Elbow Surgery.
References 1. Conforty B. The results of the Boytchev procedure for treatment of recurrent dislocation of the shoulder. Int Orthop 1980;4:127-32. 2. Dalsgaard HL, Gøthgen CB, Hoogmartens MJ. The Boytchev procedure for recurrent anterior dislocation of the shoulder. A controversial technique. Acta Orthop Belg 2000;66:248-50. 3. Delaney RA, Freehill MT, Janfaza DR, Vlassakov KV, Higgins LD, Warner JJ. 2014 Neer Award Paper. Neuromonitoring the Latarjet procedure. J Shoulder Elbow Surg 2014;23:1473-80. http://dx.doi.org/ 10.1016/j.jse.2014.04.003 4. Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg 2007;16:555-62. http://dx.doi.org/10.1016/j.jse. 2006.11.004 5. Ha’Eri GB. Boytchev procedure for the treatment of anterior shoulder instability. Clin Orthop Relat Res 1986;206:196-201.
