1300 North 17 th Street Suite 1752 Arlington, Virginia 22209 Tel: 703.841.3200 Fax: 703.841.3392 www.medicalimaging.org April 17, 2013 Paul vanostenberg, DDS, MS Vice President Accreditation and Standards Joint Commission International 1515 West 22nd Street, Suite 1300W Oak Brook, IL 60523 USA SUBJECT: MITA Feedback on the 5 th Standards for Hospitals Edition of the Joint Commission International Accreditation Dear Dr. vanostenberg: The Medical Imaging & Technology Alliance (MITA) is grateful for the opportunity to provide feedback on the 5 th Edition of the Joint Commission International Accreditation Standards for Hospitals. In addition to MITA members, we have brought together companies representing the broad spectrum of the medical technology community from small implantable devices to large capital equipment. We share the commitment in your mission statement to continuously improve the safety and quality of care in the international community. MITA is the leading organization and collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers in the United States. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. These technologies include: medical X-ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, radiation therapy equipment, magnetic resonance imaging (MRI) and imaging information systems. MITA provides leadership for the medical imaging and radiation therapy industries on legislative and regulatory issues at the state, federal and international levels. It serves as an advocate for fair legislative and regulatory proposals that encourage innovation, investment in research and development, as well as the continued global competitiveness of the medical imaging and radiation therapy industries. MITA is also a leading standards-development organization for medical imaging and radiation therapy equipment. These standards are voluntary guidelines that establish commonly accepted methods of design, production, testing and communication for imaging and cancer treatment products. Sound technical standards of this kind improve safety and foster efficiencies in how care is delivered. As manufacturers have sought new market opportunities abroad, we know first-hand the value and importance that JCI brings to table to help improve healthcare outcomes. Many of our members have installed and support equipment in JCI accredited hospitals around the world. We fully understand 1
differences that exist between regions and countries, and work closely with international organizations such as the International Medical Device Regulators Forum (IMDRF) and others to promote harmonization of internationally accepted regulations and standards. As you know, many companies in the medical technology sector sell their equipment in a number of different countries, and divergence from internationally accepted policies and under-developed regulatory schemes negatively impact the ability of doctors to access and provide the highest quality of care to their patients, which unfortunately, increases the time and cost it takes medical technology to reach the patients that need them most. Your effort to develop common international standards for hospital accreditation, while also taking into account local needs and diverse cultures is deeply appreciated by industry as JCI promotes the rigorous standards of care that we demand of ourselves in the design and manufacture of life-saving medical technologies. Please find our comments to the newest edition of the standard below for JCI consideration in advance publication this fall. General Comments: 1. Replace medical equipment wherever mentioned with the term medical technology in order to be fully representative of the broad scope of products the standard is intended to cover. 2. Harmonize the JCI standard with international accepted IEC (International Electrotechnical Commission) and ISO (International Organization for Standardization) standards wherever possible as they conform to the highest levels of safety and performance, and are used by innovators in the design and manufacture of medical technology. 3. Create sections on standards that focus specifically on large capital equipment as well as for implantable medical devices and disposables at the end of their useful life. 4. Include provisions on hospital policies for the reuse of devices intended and labeled by their manufacturer for single use. Additionally, the reprocessing of medical devices intended and labeled by their manufacturer for reuse. 5. Work with industry to include measures to detect and prevent use of substandard, spurious, falselylabeled, fraudulent, or counterfeit medical devices. 6. Add a Code of Ethics section as a requirement for JCI accreditation. For example, MITA has its own Code of Ethics memorializing industry best practices. 7. Discuss further with industry the addition of minimum standards for quality management systems in the equipment that JCI accredited hospitals use, for example the use of ISO 13485. 8. Work closely with industry to add a new section to address device inventory management, traceability, and tracking. 2
9. Include as a requirement of accreditation the ability of the hospital to cooperate with the supplier in the management of timely and comprehensive device recalls as well as field safety corrective actions. 10. Place emphasis on the appropriate management of medical devices. Manufacturers, inventors and developers of equipment have developed evidence based maintenance recommendations. As such, these recommendations should be followed without exception. We request that in addition to maintenance, JCI work collaboratively with manufacturers to develop accreditation standards that cover: a. Qualification, training and re-qualification of device users b. Procurement by hospitals and their criteria to select devices c. Compliance by users with device labeling and instructions for use 11. Create a section that tests hospital compliance with regulatory requirements, for example with national requirements for user reporting of adverse events. 12. Include requirements for hospital policies regarding access to medical device instructions for use via electronic media. As more manufacturers make their operating instructions available on-line, hospitals should ensure that users have the means to obtain this information in a timely and reliable manner. 13. Require policies on the control and regulatory compliance of any medical devices manufactured inhouse. 14. Add a provision that hospitals provide policies on the management of remote diagnosis and therapies mediated by medical devices, for example telemedicine. Specific Comments: 1. International Conference on Harmonization (ICH) of Medicines Regulation Guidance on Good Clinical Practices (GCP) for Medicines Clinical Investigations (pages 273 of 313) PROPOSAL: For clinical investigations of medical devices, it should also refer to and recognize the corresponding international standard ISO 14155:2011: Clinical investigation of medical devices for human subjects -- Good clinical practice. That document, along with Global Harmonization Task Force (GHTF) guidance, provides analogous GCP guidance for medical devices. 2. Facility Management and Safety (FMS) Chapter (general) PROPOSAL: JCI should consider how to adapt future versions of the JCI standard to address the capture, use and uploading of medical device unique device identification (UDI) information. Traceability and effective management of recalls of medical devices (and medicines) are already addressed in several places, however we recommend that they be reviewed and revised once the UDI requirements enter into force. 3
BACKGROUND: The United State Food and Drug Administration (FDA) is close to adopting a final rule to require UDI marking of medical devices. For several years, there has been active work in GHTF and IMDRF to develop internationally harmonized guidance on UDI. The claimed public health benefits and device tracking and traceability objectives of UDI cannot be achieved unless user facilities (hospitals, clinics, nursing homes and others) have reliable systems to capture UDI data at the point of device use and to upload that data to national or international databases. Today there is limited guidance and limited regulatory activity to promote user facility adoption of such systems (and their integration with existing internal inventory management systems). 3. Assessment of Patients (AOP) Chapter AOP.5.11 (page 80) AOP.5.11 The organization has access to experts in specialized diagnostic areas when necessary. PROPOSAL: The organization has access to experts in specialized diagnostic and therapeutic areas when necessary. 4. Assessment of Patients (AOP) Chapter AOP.6.6 (page 80) AOP.6.6 X-ray film and other supplies are regularly available. PROPOSAL: Make reference to computer facility/internet connection for digital storage and transmission of diagnostic information. 5. Assessment of Patients (AOP) Chapter Measureable Elements AOP.6.6 (page 98) Measurable Elements of AOP.6 1. Radiology and diagnostic imaging services meet applicable local and national standards, laws, and regulations. 2. Adequate, regular, and convenient radiology and diagnostic imaging services are available to meet patient needs. 3. Radiology and diagnostic imaging services are available for emergencies after normal hours of operation. PROPOSAL: 1. In addition, address the equipment itself 2. Work with industry to discuss further whether to include requirements on facility design elements 3. Address issues in this case with regard to having access to a second opinion 6. Care of Patients (COP) Chapter Intent of COP.2.2 (page 109) Patient care activities include orders (for example, for laboratory testing, administration of medications, nursing care, and nutrition therapy). Diagnostic, surgical, and other procedures are ordered by individuals qualified to do so. PROPOSAL: Please clarify how this measured and verified 4
7. Care of Patients (COP) Chapter Intent of COP.2.2 (page 109) Each organization decides which orders must be written rather than verbal; which diagnostic imaging and clinical laboratory test orders must provide a clinical indication /rationale; any exceptions in specialized settings, such as emergency departments and intensive care units; who is permitted to write orders; and where orders are to be located in the patient record. PROPOSAL: Add the following as a last bullet Post operation instructions provided to patient 8. Care of Patients (COP) Chapter Intent of COP.2.4 (page 110) Intent of COP.2.4 The care and treatment process is an ongoing cycle of assessments and reassessments, planning and delivering care, and assessing outcomes. Patients and their families are informed of the results of the assessment process, are informed of the planned care and treatment, and participate in care decisions. Thus, to complete the cycle of information with patients, they need to be informed of the outcome(s) of care and treatment. This includes being informed of any unanticipated outcomes of care. PROPOSAL: Patients and their families need to be properly instructed in the use of technology provided at point of care, and in the case of remote diagnosis/monitoring purposes of select implanted technologies. 9. Medical Management and Use (MMU) Chapter Measureable Elements of MMU.5.1 (page 137) 3. There is a process to contact the individual who prescribed or ordered the medication when questions arise. PROPOSAL: Add more specificity, for example that there is a system of notification in the case of a field action, medical device recall or update. 10. Governance, Leadership and Direction (GLD) Chapter Standard GLD.3.2.1 (page 188) Standard GLD.3.2.1 Equipment, supplies, and medications recommended by professional organizations or by alternative authoritative sources are used. PROPOSAL: This section could be improved by developing minimal standards to determine who can make these recommendations. 5
11. Governance, Leadership and Direction (GLD) Chapter Intent of GLF.3.2.1 (page 188) Intent of GLD.3.2.1 Risks in clinical care processes are significantly reduced when appropriate and well-functioning equipment is used to provide the planned services. This is especially true for clinical areas, such as anesthesia, radiology and diagnostic imaging, diabetes, neurosurgery, cardiology, radiation oncology, and other high-risk services when provided. Adequate supplies and medications are also available and appropriate for planned use and emergent situations. Each organization understands the required or recommended equipment, supplies, and medications necessary to provide the planned services to its patient population. Recommendations on equipment, supplies, and medication can come from a government agency, national or international anesthesia professional organizations, or other authoritative sources. PROPOSAL: Include diabetes and neurosurgery as additional clinical areas. 12. Governance, Leadership and Direction (GLD) Chapter Measurable Elements of GLD.3.2.1 (page 188) Measurable Elements of GLD.3.2.1 1. The organization uses the recommendations of professional organizations and other authoritative sources to identify the equipment and supplies it will need to provide the planned services. (Also see MMU.2.2, ME 1) 2. The identified equipment, supplies, and medications are obtained. (Also see MMU.2.2, ME 2) 3. The identified equipment, supplies, and medications are used. (Also see ASC.3, intent statement, and PROPOSAL: Please clarify in point number one what are the minimum requirements for defining the quality of planned services. 13. Governance, Leadership and Direction (GLD) Chapter Standard GLD.3.5 (page 191) Standard GLD.3.5 Organization leaders ensure that there are uniform programs for the recruitment, retention, development, and continuing education of all staff. PROPOSAL: Please clarify what the frequency or standard is for these programs. 14. Governance, Leadership and Direction (GLD) Chapter Intent of GLD.5 (page 192) Intent of GLD.5 The clinical care, patient outcomes, and overall management of a health care organization are only as good as the clinical and managerial activities of each individual department or service. Good departmental or service performance requires clear leadership from a qualified individual. In larger departments or services, leadership may be separated. In such a case, the responsibilities of each role are defined in writing. (Also see ACC.6.1, ME 1; ACS.2, ME 2; AOP.5.9 related to the direction of 6
clinical laboratory services; AOP.6.7 related to the direction of radiology and diagnostic imaging services; MMU.1.1 related to the direction of the pharmacy or pharmaceutical services; and ACS.2 related to the direction of anesthesia services) PROPOSAL: Please also consider as related to implantable devices? 15. Facility Management and Safety (FMS) Chapter Standard FMS.8 (page 206) Standard FMS.8 The organization plans and implements a program for inspecting, testing, and maintaining medical equipment technology and documenting the results. PROPOSAL: For capital equipment, use of manufacturer standards is most appropriate to ensure device safety. For implants, minimum standards are also needed to ensure that a device is not expired or under recall and that the hospital has a sufficient level of supporting technologies. 16. Facility Management and Safety (FMS) Chapter Intent of FMS.8 and FMS.8.1 (page 206) Intent of FMS.8 and FMS.8.1 Qualified individuals provide these services. Equipment is inspected and tested when new and then on an ongoing basis, according to the equipment s age and use or based on manufacturer instructions. Inspections, testing results, and any maintenance are documented. This helps ensure the continuity of the maintenance process and helps when doing capital planning for replacements, upgrades, and other changes. (Also see AOP.6.5, intent statement) PROPOSAL: Define minimum training levels for radiographic equipment and education for implanting physicians within their specialty? 17. Facility Management and Safety (FMS) Chapter - Measurable Elements of FMS.8 (page 208) PROPOSAL: Please note that it is necessary have the firm whose device is being implanted to be permitted access into the operation theater to the support surgical team with the implant. 18. Facility Management and Safety (FMS) Chapter Standard FMS.8.2 (page 208) Standard FMS.8.2 The organization has a product/equipment recall system PROPOSAL: Please add that the organization be in regular contact with national/regional competent medical regulatory authorities. In addition to providing feedback on this edition of the standard, we welcome further collaboration with JCI in the design and development of future standards as well as to provide education and training for JCI surveyors. With medical technologies evolving at breathtaking speeds, industry involvement is critical to ensure that accreditation are kept relevant and up-to-date. We are happy to make industry experts available to help increase your familiarity and understanding with the products we manufacture, 7
because keeping the standard and surveyors current is the best way to ensure that patients are receiving the highest quality of care in the 90 countries that have JCI accredited hospitals. Again, thank you for this important opportunity to provide feedback on your standard. We greatly appreciate your consideration of our proposals, and look forward to following up in response to our questions and proposals. As a friendly reminder, please note that this submission does not constitute an official endorsement of the JCI standard by MITA or its member companies. If you have any questions or comments regarding this letter, please feel free to contact me at our convenience at by e-mail grodriguez@medicalimaging.org or by phone 703-841-3235. Sincerely, Gail Rodriguez MITA Executive Director 8