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Medical device regulations and patient safety
Chapter 53
Medical device regulations and patient safety Michael Cheng, M.E., Ph.D., P.Eng., H.C.O.M.a, Brian Moher, Hons. B.A., LL.B.b, Ed Napke, M.D., D.P.H.c, Leo Lehtiniemi, M.A., Ph.D. Candidate (Sociology)d, Jonathan Erskine, Ph.D.e, Tidimogo Gaamangwe, Ph.D.f a
Biomedical Engineer, Patient Safety/Education Advocate, Ottawa, ON, Canada, bHealth Law & Medical Devices, Toronto, ON, Canada, cWorld Health Organization Drug Adverse Event Expert, Queen Elizaberth Jubilee Medal, Ottawa, ON, Canada, dMethodology Consultant, Ottawa, ON, Canada, eEuropean Health Property Network, Durham University, Durham, United Kingdom, fClinical Engineering Program, Winnipeg Regional Health Authority, Winnipeg, MB, Canada
Introduction This chapter is the product of a multidisciplinary collaboration that brought together various perspectives from uniquely different professions. The aim was to synthesize a uniform set of principles for enhancing patient safety. The authors include: (a) a physician recognized globally for his pioneering work on adverse effects of pharmaceutical drugs; (b) a lawyer with expertise in health law and medical device regulation; (c) a sociologist who evaluated the impacts of health and social policies and programs; (d) the executive director of the European Health Property Network with an administrative perspective; and (e) clinical engineers who have global leadership experience in patient safety systems. It is the authors’ hope that this multidisciplinary approach to this chapter will be informative not just to those who are clinical engineers, but also of value to all other stakeholders along the patient safety spectrum. The foundation for this chapter is the healthcare principle of "first do no harm." The uniform set of principles examined in this chapter are focused at preventing harm on a systemic level. The medical device regulatory principles contained in this chapter are from the WHO publication, "Medical device regulations: global overview and guiding principles" (World Health Organization, 2003). One critical problem in the regulation of medical devices is the failure to distinguish between product safety and patient safety. The distinction goes beyond terminology. It forms the basis for two essential patient-safety processes that might otherwise be ignored. The failure to make this distinction leads to obscuring the objectives associated with each step along the lifespan of a medical device. Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00054-7 Copyright © 2020 Elsevier Inc. All rights reserved.
At the initial stages of a medical device’s marketing and utilization lifespan, the focus is on such considerations as regulatory criteria applicable to medical devices (product safety). However, toward the middle and end stages, the proper focus of attention must be on the user, including various user-specific considerations. Failure to properly identify these various stages and their associated requirements compromise the integrity of the overarching processes and jeopardize the ultimate goal: patient safety and optimal performance (see Chapter 49 “a systems management framework for medical device safety and optimal outcomes”). The majority of medical device regulations in countries manufacturing medical devices converge toward the guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF) (GHTF, 2012a,b; WHO, 2003, 2017). The stated purpose of medical device regulations is to ensure the safety and performance of medical devices. However, many healthcare professionals and users of medical devices may not know the narrow scope and limitations of medical device regulations. Often they have unrealistic expectations about the regulators’ ability to protect public health (The World Bank, 2007). Hence, it is essential that the role of clinical engineering in the interest of patient safety is emphasized to all levels of health care (Cheng, 2010; Easty, 2018). Organization risk management processes are the responsibility of the user. The term “user,” in this context, means all those who use medical devices, directly or indirectly and includes government healthcare providers, independent healthcare facilities, physicians, surgeons, device operators, and the lay person-users in the case of home-use devices. 353
354 SECTION | 5 Safety
FIG. 1 From medical device regulations to patient safety: three essential steps.
In healthcare facilities, the user is predominantly responsible for two essential steps to ensure patient safety in using medical devices: (a) contextual product safety assessment; (b) and safe use and management. These two essential steps are actually the principal duties of clinical engineering (CE) professionals due to their education, training, and expertise. Therefore, this article will focus on noting that the purpose of medical device regulations (as a first step) is to ensure product safety; and there are two additional steps required to ensure patient safety, both of which are contextual and operational in nature (as opposed to regulatory). The three essential steps to ensure patient safety with medical devices established in this chapter are further developed into a comprehensive three stage systems management framework described in Chapter 49.
Typical regulatory requirements for medical devicesa Medical device regulations ensure that the manufacturer satisfies the regulatory requirements in designing, producing, packaging, and labeling its products. Labeling includes a description of the device, the intended use, and the instructions for use. The manufacturer is also required to preserve (maintain) the quality of the device in the delivery process to the customer as well as to conduct post-market surveillance, adverse event reporting, corrective action, and
p reventive action. It makes good sense for manufacturers to be responsible for the safety and performance of products they produce. Like drug regulations, medical device regulations directed at ensuring product safety are fundamental to protecting public health. Typically, drugs have a much greater safety margin after regulatory clearance. In contrast, medical device patient outcomes largely depend on the environment, human factors, knowledge, and skills of the user. Following regulatory clearance as Step 1, two additional essential steps must be taken by the user in order to ensure patient safety as illustrated in Fig. 1.
Three essential steps to ensure patient safety Steps 1–3 are discussed in greater detail below. At Step 1, the focus of the assessment by the regulator is on the general safety of the product. At Step 2, the safety analysis is directed at the context and circumstances in which the device would be used. At Step 3, the focus shifts to the operation and management of a device. Step 1: Product Safety Assessment: The user must ensure that the marketed product has been cleared or certified by the regulatory authority of the relevant country. This is to ensure general product safety in compliance with the regulatory requirements of a medical device regulator. Step 2: Use Context Safety Assessment:
a. Some countries’ medical device regulations may also govern users, for example, the US Safe Medical Device Act requires user facilities to report adverse events with medical devices.
It is important to note that Step 1 does not cover the unique environmental and human factors that will a ffect a
Medical device regulations and patient safety Chapter | 53 355
particular user. Therefore, the user must proceed to consider the specifications of the marketed device and examine the range of environmental and human factors and conditions under which the device was designed to be used. Following this assessment, the user must then decide whether the marketed product is still safe given the user’s environment and human factor conditions (US FDA, n.d.; Easty, 2018). Step 3: Safe Use and Management:
●
●
●
●
It is critical for all stakeholders to recognize that medical device regulations typically govern only the manufacturer. They function by requiring manufacturers to carry out the following, amongst other things (see typical regulatory requirements described above): to provide instructions for safe use; to preserve (maintain) the quality of the device in the delivery process to the customer; and to conduct postmarket surveillance, adverse event reporting, corrective action, and preventive action. After delivery, however, the device is possessed by the user and it is the user who must take up the responsibility to follow safe use instructions, maintain device quality, and monitor device performance. In healthcare facilities, these steps are the principal duties of CE. The following aspects of medical device maintenance, use, and operation should be addressed by a healthcare facility’s medical device processes: ●
●
Safe Use: each medical device is unique, and as such, there should be a policy in the healthcare facilities that each user must be trained before using any medical device.
●
Quality Preservation: maintaining a medical device’s quality and integrity. Medical Device Storage: location records within a healthcare facility. Adverse Event Vigilance: performance surveillance and adverse event reporting. Medical Device Problem Investigation: programs for investigating possible problems. Procedures for Notification: the dissemination of device alerts to stakeholders. Disposal/Replacement: safe and appropriate disposal of unwanted devices.
Recommendations Healthcare providers are responsible for the safety of patients in their facilities. This article has demonstrated that the CE services are essential in translating product safety regulations to patient safety, particularly in the preservation of medical device quality and post-market surveillance (Cheng, 2004; Newland and Moher, 2007) as well as in technology assessment. However, in many parts of the world, CE are still seeking recognition of their crucial work. We recommend that the message of this article be put into a simple but impactful message (such as Fig. 1) to promote the recognition of CE. A possible example is as follows: in addition, please refer to a comprehensive management framework described in Chapter 49.
Three essential steps to ensure patient safety
Step 1
Step 2
Step 3
Product safety in general
Product safety in use context
Safe use and management
Meets medical device regulatory requirements
After regulatory clearance of general product safety, users still need to assess product safety in use context, e.g., local environmental and human factors ..... etc (described in texts above)
Users must preserve (maintain) the quality of ALL medical device delivered by suppliers. Users must be competently trained before using a medical device Users must be have in-house programs to monitor medical device performance, to report and investigate adverse events, and to rapidly disseminate medical device alerts to those who may be affected
Crucial user responsibility Three essential steps to ensure patient safety with medical devices.
356 SECTION | 5 Safety
References Cheng, M., 2004. Postmarket surveillance and vigilance on medical devices. In: Clinical Engineering Handbook. Dyro, pp. 647–648. see: http://www.unimasr.net/ums/upload/files/2011/May/UniMasr.com_1 4ab3dd34c5b89a8eedfe9a1f60900d8.pdf. Cheng, M., 2010. Shared Responsibility in Medical Device Safety and Performance, Regulatory Feature Article, Regulatory Affairs MedtechJournal, pp. 10–11. UK, September/October. Now part of Scrip Regulatory Affairs, see www.scripregulatoryaffairs.com. Easty, A., 2018. Applying human factors methods in a clinical engineering setting to reduce medical device risks. Global Clin. Eng. J. 1 (1). https://globalce.org/index.php/GlobalCE/issue/view/4. GHTF, 2012a. Essential Principles of Safety and Performance of Medical Devices. Global Harmonization Task Force. GHTF/SG1/N68:2012, http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtfsg1-n68-2012-safety-performancemedical-devices-121102.pdf. GHTF, 2012b. Principles of Conformity Assessment for Medical Devices. Global Harmonization Task Force. GHTF/SG1/N78:2012, http://www.
imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n78-2012-conformity-assessment-medicaldevices-121102.pdf. Newland, J., Moher, B., 2007. The Regulation of Medical Devices: Seven Simple Insights for Enhancing Patient Safety. Canadian Institute, p. 21. The World Bank, 2007. An Overview of Medical Device Policy and Regulation HNP Brief #8, the World Bank. http://siteresources. worldbank.org/HEALTHNUTRITIONANDPOPULATION/ Resources/281627-1109774792596/HNPBrief8.pdf. US FDA, n.d. Human Factors Considerations, US FDA website https:// www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HumanFactors/ucm124829.htm WHO, 2003. Medical Device Regulations: Global Overview and Guiding Principles. http://www.who.int/medical_devices/publications/ med_reg_global_overview/en/. WHO, 2017. WHO Global Model Regulatory Framework for Medical Devices Including In Vitro Diagnostic Medical Devices. http://www. who.int/medical_devices/publications/global_model_regulatory_ framework_meddev/en/.
Medical device regulations and patient safety Michael Cheng, M.E., Ph.D., P.Eng., H.C.O.M.a, Brian Moher, Hons. B.A., LL.B.b, Ed Napke, M.D., D.P.H.c, Leo Lehtiniemi, M.A., Ph.D. Candidate (Sociology)d, Jonathan Erskine, Ph.D.e, Tidimogo Gaamangwe, Ph.D.f a
Biomedical Engineer, Patient Safety/Education Advocate, Ottawa, ON, Canada, bHealth Law & Medical Devices, Toronto, ON, Canada, cWorld Health Organization Drug Adverse Event Expert, Queen Elizaberth Jubilee Medal, Ottawa, ON, Canada, dMethodology Consultant, Ottawa, ON, Canada, eEuropean Health Property Network, Durham University, Durham, United Kingdom, fClinical Engineering Program, Winnipeg Regional Health Authority, Winnipeg, MB, Canada
Introduction This chapter is the product of a multidisciplinary collaboration that brought together various perspectives from uniquely different professions. The aim was to synthesize a uniform set of principles for enhancing patient safety. The authors include: (a) a physician recognized globally for his pioneering work on adverse effects of pharmaceutical drugs; (b) a lawyer with expertise in health law and medical device regulation; (c) a sociologist who evaluated the impacts of health and social policies and programs; (d) the executive director of the European Health Property Network with an administrative perspective; and (e) clinical engineers who have global leadership experience in patient safety systems. It is the authors’ hope that this multidisciplinary approach to this chapter will be informative not just to those who are clinical engineers, but also of value to all other stakeholders along the patient safety spectrum. The foundation for this chapter is the healthcare principle of "first do no harm." The uniform set of principles examined in this chapter are focused at preventing harm on a systemic level. The medical device regulatory principles contained in this chapter are from the WHO publication, "Medical device regulations: global overview and guiding principles" (World Health Organization, 2003). One critical problem in the regulation of medical devices is the failure to distinguish between product safety and patient safety. The distinction goes beyond terminology. It forms the basis for two essential patient-safety processes that might otherwise be ignored. The failure to make this distinction leads to obscuring the objectives associated with each step along the lifespan of a medical device. Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00054-7 Copyright © 2020 Elsevier Inc. All rights reserved.
At the initial stages of a medical device’s marketing and utilization lifespan, the focus is on such considerations as regulatory criteria applicable to medical devices (product safety). However, toward the middle and end stages, the proper focus of attention must be on the user, including various user-specific considerations. Failure to properly identify these various stages and their associated requirements compromise the integrity of the overarching processes and jeopardize the ultimate goal: patient safety and optimal performance (see Chapter 49 “a systems management framework for medical device safety and optimal outcomes”). The majority of medical device regulations in countries manufacturing medical devices converge toward the guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF) (GHTF, 2012a,b; WHO, 2003, 2017). The stated purpose of medical device regulations is to ensure the safety and performance of medical devices. However, many healthcare professionals and users of medical devices may not know the narrow scope and limitations of medical device regulations. Often they have unrealistic expectations about the regulators’ ability to protect public health (The World Bank, 2007). Hence, it is essential that the role of clinical engineering in the interest of patient safety is emphasized to all levels of health care (Cheng, 2010; Easty, 2018). Organization risk management processes are the responsibility of the user. The term “user,” in this context, means all those who use medical devices, directly or indirectly and includes government healthcare providers, independent healthcare facilities, physicians, surgeons, device operators, and the lay person-users in the case of home-use devices. 353
354 SECTION | 5 Safety
FIG. 1 From medical device regulations to patient safety: three essential steps.
In healthcare facilities, the user is predominantly responsible for two essential steps to ensure patient safety in using medical devices: (a) contextual product safety assessment; (b) and safe use and management. These two essential steps are actually the principal duties of clinical engineering (CE) professionals due to their education, training, and expertise. Therefore, this article will focus on noting that the purpose of medical device regulations (as a first step) is to ensure product safety; and there are two additional steps required to ensure patient safety, both of which are contextual and operational in nature (as opposed to regulatory). The three essential steps to ensure patient safety with medical devices established in this chapter are further developed into a comprehensive three stage systems management framework described in Chapter 49.
Typical regulatory requirements for medical devicesa Medical device regulations ensure that the manufacturer satisfies the regulatory requirements in designing, producing, packaging, and labeling its products. Labeling includes a description of the device, the intended use, and the instructions for use. The manufacturer is also required to preserve (maintain) the quality of the device in the delivery process to the customer as well as to conduct post-market surveillance, adverse event reporting, corrective action, and
p reventive action. It makes good sense for manufacturers to be responsible for the safety and performance of products they produce. Like drug regulations, medical device regulations directed at ensuring product safety are fundamental to protecting public health. Typically, drugs have a much greater safety margin after regulatory clearance. In contrast, medical device patient outcomes largely depend on the environment, human factors, knowledge, and skills of the user. Following regulatory clearance as Step 1, two additional essential steps must be taken by the user in order to ensure patient safety as illustrated in Fig. 1.
Three essential steps to ensure patient safety Steps 1–3 are discussed in greater detail below. At Step 1, the focus of the assessment by the regulator is on the general safety of the product. At Step 2, the safety analysis is directed at the context and circumstances in which the device would be used. At Step 3, the focus shifts to the operation and management of a device. Step 1: Product Safety Assessment: The user must ensure that the marketed product has been cleared or certified by the regulatory authority of the relevant country. This is to ensure general product safety in compliance with the regulatory requirements of a medical device regulator. Step 2: Use Context Safety Assessment:
a. Some countries’ medical device regulations may also govern users, for example, the US Safe Medical Device Act requires user facilities to report adverse events with medical devices.
It is important to note that Step 1 does not cover the unique environmental and human factors that will a ffect a
Medical device regulations and patient safety Chapter | 53 355
particular user. Therefore, the user must proceed to consider the specifications of the marketed device and examine the range of environmental and human factors and conditions under which the device was designed to be used. Following this assessment, the user must then decide whether the marketed product is still safe given the user’s environment and human factor conditions (US FDA, n.d.; Easty, 2018). Step 3: Safe Use and Management:
●
●
●
●
It is critical for all stakeholders to recognize that medical device regulations typically govern only the manufacturer. They function by requiring manufacturers to carry out the following, amongst other things (see typical regulatory requirements described above): to provide instructions for safe use; to preserve (maintain) the quality of the device in the delivery process to the customer; and to conduct postmarket surveillance, adverse event reporting, corrective action, and preventive action. After delivery, however, the device is possessed by the user and it is the user who must take up the responsibility to follow safe use instructions, maintain device quality, and monitor device performance. In healthcare facilities, these steps are the principal duties of CE. The following aspects of medical device maintenance, use, and operation should be addressed by a healthcare facility’s medical device processes: ●
●
Safe Use: each medical device is unique, and as such, there should be a policy in the healthcare facilities that each user must be trained before using any medical device.
●
Quality Preservation: maintaining a medical device’s quality and integrity. Medical Device Storage: location records within a healthcare facility. Adverse Event Vigilance: performance surveillance and adverse event reporting. Medical Device Problem Investigation: programs for investigating possible problems. Procedures for Notification: the dissemination of device alerts to stakeholders. Disposal/Replacement: safe and appropriate disposal of unwanted devices.
Recommendations Healthcare providers are responsible for the safety of patients in their facilities. This article has demonstrated that the CE services are essential in translating product safety regulations to patient safety, particularly in the preservation of medical device quality and post-market surveillance (Cheng, 2004; Newland and Moher, 2007) as well as in technology assessment. However, in many parts of the world, CE are still seeking recognition of their crucial work. We recommend that the message of this article be put into a simple but impactful message (such as Fig. 1) to promote the recognition of CE. A possible example is as follows: in addition, please refer to a comprehensive management framework described in Chapter 49.
Three essential steps to ensure patient safety
Step 1
Step 2
Step 3
Product safety in general
Product safety in use context
Safe use and management
Meets medical device regulatory requirements
After regulatory clearance of general product safety, users still need to assess product safety in use context, e.g., local environmental and human factors ..... etc (described in texts above)
Users must preserve (maintain) the quality of ALL medical device delivered by suppliers. Users must be competently trained before using a medical device Users must be have in-house programs to monitor medical device performance, to report and investigate adverse events, and to rapidly disseminate medical device alerts to those who may be affected
Crucial user responsibility Three essential steps to ensure patient safety with medical devices.
356 SECTION | 5 Safety
References Cheng, M., 2004. Postmarket surveillance and vigilance on medical devices. In: Clinical Engineering Handbook. Dyro, pp. 647–648. see: http://www.unimasr.net/ums/upload/files/2011/May/UniMasr.com_1 4ab3dd34c5b89a8eedfe9a1f60900d8.pdf. Cheng, M., 2010. Shared Responsibility in Medical Device Safety and Performance, Regulatory Feature Article, Regulatory Affairs MedtechJournal, pp. 10–11. UK, September/October. Now part of Scrip Regulatory Affairs, see www.scripregulatoryaffairs.com. Easty, A., 2018. Applying human factors methods in a clinical engineering setting to reduce medical device risks. Global Clin. Eng. J. 1 (1). https://globalce.org/index.php/GlobalCE/issue/view/4. GHTF, 2012a. Essential Principles of Safety and Performance of Medical Devices. Global Harmonization Task Force. GHTF/SG1/N68:2012, http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtfsg1-n68-2012-safety-performancemedical-devices-121102.pdf. GHTF, 2012b. Principles of Conformity Assessment for Medical Devices. Global Harmonization Task Force. GHTF/SG1/N78:2012, http://www.
imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n78-2012-conformity-assessment-medicaldevices-121102.pdf. Newland, J., Moher, B., 2007. The Regulation of Medical Devices: Seven Simple Insights for Enhancing Patient Safety. Canadian Institute, p. 21. The World Bank, 2007. An Overview of Medical Device Policy and Regulation HNP Brief #8, the World Bank. http://siteresources. worldbank.org/HEALTHNUTRITIONANDPOPULATION/ Resources/281627-1109774792596/HNPBrief8.pdf. US FDA, n.d. Human Factors Considerations, US FDA website https:// www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HumanFactors/ucm124829.htm WHO, 2003. Medical Device Regulations: Global Overview and Guiding Principles. http://www.who.int/medical_devices/publications/ med_reg_global_overview/en/. WHO, 2017. WHO Global Model Regulatory Framework for Medical Devices Including In Vitro Diagnostic Medical Devices. http://www. who.int/medical_devices/publications/global_model_regulatory_ framework_meddev/en/.