- Email: [email protected]
Clinical Issues—November 2015
CONTINUING EDUCATION
Clinical Issues
1.4
www.aorn.org/CE
BYRON L. BURLINGAME, MS, BSN, RN, CNOR; DENISE MAXWELL-DOWNING, MS, BSN, RN, CNOR Continuing Education Contact Hours
Approvals
indicates that continuing education (CE) contact hours are available for this activity. Earn the CE contact hours by reading this article, reviewing the purpose/goal and objectives, and completing the online Learner Evaluation at http:// www.aorn.org/CE. Each applicant who successfully completes this program can immediately print a certificate of completion.
This program meets criteria for CNOR and CRNFA recertification, as well as other CE requirements.
Event: #15546 Session: #0001 Fee: Members $11.20, Nonmembers $22.40 The contact hours for this article expire November 30, 2018. Pricing is subject to change.
Purpose/Goal To provide the learner with knowledge of AORN’s guidelines related to unique device identifiers and wearing a dosimeter.
Objectives 1. Discuss practices that could jeopardize safety in the perioperative area. 2. Discuss common areas of concern that relate to perioperative best practices. 3. Describe implementation of evidence-based practice in relation to perioperative nursing care.
AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019. Check with your state board of nursing for acceptance of this activity for relicensure.
Conflict-of-Interest Disclosures Byron L. Burlingame, MS, BSN, RN, CNOR, and Denise Maxwell-Downing, MS, BSN, RN, CNOR, have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article. The behavioral objectives for this program were created by Helen Starbuck Pashley, MA, BSN, CNOR, clinical editor, with consultation from Susan Bakewell, MS, RN-BC, director, Perioperative Education. Ms Starbuck Pashley and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article.
Sponsorship or Commercial Support No sponsorship or commercial support was received for this article.
Disclaimer Accreditation AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
AORN recognizes these activities as CE for RNs. This recognition does not imply that AORN or the American Nurses Credentialing Center approves or endorses products mentioned in the activity.
http://dx.doi.org/10.1016/j.aorn.2015.08.007 ª AORN, Inc, 2015
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CLINICAL ISSUES
1.4
www.aorn.org/CE
THIS MONTH Unique device identifier Key words: unique device identifier, UDI, FDA UDI. Wearing a dosimeter Key words: dosimeter, radiation monitoring device.
Unique device identifier QUESTION: At our facility, we have been discussing a new regulation that requires a unique device identifier (UDI) for medical devices (eg, implants). Can you clarify what a UDI is?
ANSWER: In September 2013, the US Food and Drug Administration (FDA) established the unique device identification (UDI) system rule. The rule outlines the requirements for device labelers to use for device packaging and labeling and includes standard date formatting and data submission requirements. This rule applies to all medical devices in distribution and use in the United States unless an exception or alternative applies (eg, existing inventories
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of finished devices labeled before the applicable compliance date; class I devices that the FDA has exempted from good manufacturing practices, such as urinals or x-ray film holders).1-3 The UDI is a unique alphanumeric or numeric code consisting of a device identifier (DI) and production information (PI) (Figure 1). The DI is a mandatory, fixed portion of the UDI that identifies the labeler and the specific version or model of the device. The PI portion is optional and may contain any or all of the following information: lot or batch within which a device was manufactured, serial number of the device, expiration date of the device,
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Section 616 amended section 522 of the US Federal Food, Drug, and Cosmetic Act (FDCA) and authorized the FDA to order postmarket surveillance for certain class II and class III medical devices. The amendment required manufacturers to commence surveillance within 15 months of an FDA postmarket surveillance order.7 Figure 1. Example of a three-dimensional linear bar code showing the product identification numbers and device identification numbers. Illustration from http:// www.fda.gov/downloads/medicaldevices/deviceregulation andguidance/guidancedocuments/ucm409401.pdf. date the device was manufactured, and identification code required for a human cell, tissue, or cellular or tissue-based product.2 The precursor to the UDI rule (ie, 21 CFR Part 807), which was written in 2004, required domestic and foreign manufacturers and initial distributors or importers of medical devices to register with the FDA. The regulation also required that devices be labeled with manufacturer details and that descriptive and informational literature accompany the device (eg, manufacturer instructional inserts). Also in 2004, the FDA established the medical device reporting (MDR) program (ie, 21 CFR Part 803). This regulation requires reporting to the FDA any device malfunctions that cause or contribute to a death or serious injury. The MDR program is a mechanism for the FDA and manufacturers to identify and monitor significant adverse events involving medical devices.4 The next step in the development of the UDI rule occurred in 2007, with the establishment of the FDA Safety and Innovation Act (FDASIA),5 which established a means for the FDA to address public health challenges and preserve the approval standards processes. The act also allowed an accelerated approval process for breakthrough therapies that were not previously allowed before the establishment of the act.1 In 2012, Congress amended the FDASIA regulation and changed user fees for prescription medications and medical devices. The amended act also added new sections related to medical devices: Section 518A required the FDA to establish a program to improve the device recall system. The section applied to recalls initiated by the FDA and removals or corrections initiated by a device manufacturer or importer.6 Section 614 required the FDA to issue a proposed rule regarding a UDI system by December 31, 2012.7
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The FDA’s position toward regulating health information technology (HIT) or software has been complex and, in many cases, unclear. In 2012, the FDA took the position that certain types of HIT can meet the definition of a medical device. The types of HIT that the FDA is now regulating include software on mobile platforms that perform blood pressure and ultrasound reads, remote display or notification of real-time alarms from bedside monitors, robotic surgical planning and control, and electrocardiography analytical software.8 The FDA does not regulate electronic health records. In September 2013, the FDA supplied a list of medical devices that it classified as implantable, life-saving, and life-sustaining in section 614 of the FDASIA,5 amending section 519(f) of the FDCA.9 The medical devices listed include
anesthesia machines and their disposable components, vascular clips, vascular graft prostheses greater than 6 mm, ureteral stents, and joint prostheses.9,10
A complete listing of devices by class can be accessed at http:// www.fda.gov/medicaldevices/deviceregulationandguidance/guidance documents/ucm081251.htm.
Labeling Requirements A device labeler is defined as a manufacturer, reprocessor, specification developer, repackager, or relabeler who creates and places a label on a medical device.6 Under the FDA rule, device labelers are required to supply UDI data on a label or, in certain circumstances, directly on the medical device itself. The UDI must be in a human- and machine-readable format. The human-readable or plain text formatting may contain up to 29 characters (eg, 123abcd456ves1987630kevq5xb89). The machine-readable format uses automatic identification and data capture (AIDC) technology that can be in a threedimensional linear or two-dimensional data matrix barcode or radio-frequency identification device (RFID) format.11 Labelers must place the UDI mark directly on a device if the device is intended for more than one use and intended to be reprocessed before each use (eg, drill bits, instruments). This requirement does not apply if
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any type of direct marking would interfere with the safety and effectiveness of the device, it is not technologically feasible to directly mark the device, the device is cleared or approved as a single-use device, or the device already has a permanent UDI directly marked on it.1
Standardized Date Format
Clinical Issues
(GUDID). The FDA established the GUDID so clinicians and consumers are able to search and download information entered on each medical device in distribution and use in the United States. The GUDID contains a standard set of attributes for each medical device submitted by the device labelers. Only the DI portion of the UDI is available in the GUDID database; the PI and personal health information of the patient using the device are not available in the database.1,2
The FDA rule requires medical device packaging to contain a manufacture date or an expiration date for the device. The date must be presented in a standard format consistent with international standards and practice (ie, yyyy-mm-dd). An example of a fictitious medical device label that contains the UDI number, product name, expiration date, reference (catalog) number, and lot numbers is displayed in Figure 2.1,6
The time frame for implementing the UDI system is spread over seven years (Table 1).2 The final date when a UDI must be placed on a device is based on the classification of the device.12 When fully implemented, labels on many of the medical devices used in perioperative services (eg, instruments, implants, life-sustaining devices) will include a UDI.
Data Submission
UDI Benefits
Device labelers must submit information on each device to the FDA’s Global Unique Device Identification Database
When fully adopted and implemented, the UDI rule will offer a wide variety of benefits to clinicians, consumers,
Figure 2. Example of a hypothetical unique device identifier (UDI) label. Illustration from http://www.fda.gov/ downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm409401.pdf.
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Table 1. Unique Device Identification (UDI) Implementation Requirements Implementation date and pertinent section of law
1
Devices that must bear a UDI
September 24, 2014 x801.18 x801.20 x801.50(b) x830.300 x801.55
The labels and packages of class III medical devices, devices licensed under the Public Health Service Act (PHS Act), and class III stand-alone
September 24, 2015 x801.18 x801.20 x801.50(b) x801.45 x830.300
The labels and packages of implantable, life-supporting, and life-sustaining devices and stand-alone software that are life-supporting or life-sustaining devices A device that is life supporting or life sustaining is required to be labeled with a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use
September 24, 2016 x801.18 x801.20 x801.45 x801.50
Class III devices are required to be labeled with a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use The labels and packages of class II medical devices and class II stand-alone software
September 24, 2018 x801.18 x801.20 x801.45 x801.50(b) x830.300
Class II devices are required to be labeled with a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III
September 24, 2020 x801.45
Class I devices, and devices that have not been classified into class I, class II, or class III are required to be labeled with a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use
1. Compliance Dates for UDI Requirements. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/UniqueDeviceIdentification/CompliancedatesforUDIRequirements/default.htm. Accessed July 16, 2015.
industry personnel, the FDA, and health care organizations. Some of the benefits identified by the FDA include allowing more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly; reducing medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device; enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices;
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providing a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls; providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies; and leading to the development of a medical device identification system that is recognized around the world.13 The UDI regulations primarily affect device labelers but also will affect perioperative clinicians by changing the data required for documentation on an implantable medical device and may change how device information is captured for documentation in the patient’s medical record. Starting September 23, 2015, perioperative RNs are required to document the UDI data on all class II implantable, lifesupporting, and life-sustaining devices. In September 2016,
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Clinical Issues
class II and class III medical devices will require UDI documentation. Currently, the documentation process for implantable medical devices includes capturing in an electronic health record or in a paper-based record the implantable medical device descriptor; its reference or catalog number; the size, if not captured in the catalog number; the lot number; the expiration date; and the quantity used of the implantable medical device.14 This information is captured in an electronic documentation system, on an implant log sheet, or on a manufacturer’s inventory control sheet that is manually or electronically transcribed into the patient’s medical record. The lot number and expiration date are captured only when available on the device packaging label (eg, individually sterile packaged devices, total joint implants). The new documentation requirements include the UDI number in addition to data that are currently required for identification of implantable medical devices.14 Clinicians can document the UDI by using a scanning device or by manual entry of the UDI number from the medical device, the medical device packaging label, or an inventory control sheet that contains the UDI. A scanning device that interfaces with a health care organization’s electronic documentation system and materials management system may decrease human error from manual entry of the number and support accurate UDI data capture for patient safety (eg, recalls) and research. To facilitate these changes in documentation, health care organizations will need to acquire the new technology, educate personnel, and develop or revise policies and procedures related to implantable medical device capture to ensure they address UDI. For the most current information regarding the UDI, nurses should visit the FDA web site.15
Byron L. Burlingame, MS, BSN, RN, CNOR, is a perioperative nursing specialist in the Nursing Department at AORN, Inc, Denver, CO.
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Denise MaxwellDowning, MS, BSN, RN, CNOR, is an informatics nurse specialist for AORN Syntegrity, Denver, CO.
References 1. Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff. US Food and Drug Administration. Center for Devices and Radiological Health, Center for Biologics and Evaluation Research. http://www.fda.gov/downloads/medicaldevices/deviceregulationand guidance/guidancedocuments/ucm409401.pdf. Accessed July 16, 2015. 2. UDI Basics. US Food and Drug Administration. http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/UniqueDevice Identification/UDIBasics/default.htm. Accessed July 16, 2015. 3. List of class I devices, by product code, that FDA has by regulation exempted from the GMP requirements of x21 CFR. Part 820, Quality System Regulation, FDA, April 2012. US Food and Drug Administration. http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/UniqueDeviceIdentification/UCM382 498.pdf. Accessed July 16, 2015. 4. Overview of Device Regulation. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/default.htm. Accessed July 16, 2015. 5. Food and Drug Administration Safety and Innovation Act (FDASIA) Overview. US Food and Drug Administration. http://www.fda.gov/ downloads/ForHealthProfessionals/UCM330622.pdf. Accessed July 16, 2015. 6. US FDA Unique Device Identification (UDI) Rule Frequently Asked Questions (FAQs). GS1 Healthcare US. http://www.gs1us.org/Desktop Modules/Bring2mind/DMX/Download.aspx?Command¼Core_Down load&EntryId¼865&PortalId¼0&TabId¼785. Accessed June 22, 2015. 7. Food and Drug Administration Safety and Innovation Act, 21 USC 301 (2012). http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/ pdf/PLAW-112publ144.pdf. Accessed July 16, 2015. 8. FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk- Based Framework. The Office of the National Coordinator for Health Information Technology.
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BurlingamedMaxwell-Downing US Food and Drug Administration. http://www.fda.gov/downloa ds/AboutFDA/CentersOffices/OfficeofMedicalProductsandToba cco/CDRH/CDRHReports/UCM391521.pdf. Accessed July 16, 2015. 9. List of Medical Devices, by Product Code, that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices for purposes of Section 614 of FDASIA amending Section 519(f) of the FDC Act. US Food and Drug Administration. http://www.fda.gov/downloads/ MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdenti fication/UCM382463.pdf. Accessed July 22, 2015. 10. Preamendments Class III Strategy. Office of Device Evaluation. US Food and Drug Administration. http://www.fda.gov/medical devices/deviceregulationandguidance/guidancedocuments/ucm081 251.htm. Accessed July 16, 2015. 11. How Can GS1 Standards Help Your Company Meet FDA UDI Requirements? GS1 Healthcare US. http://www.gs1us.org/
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12.
13.
14. 15.
industries/healthcare/gs1-healthcare-us/fda-udi. Accessed July 16, 2015. Compliance Dates for UDI Requirements. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/Device RegulationandGuidance/UniqueDeviceIdentification/Compliance datesforUDIRequirements/default.htm. Accessed July 15, 2015. Benefits of a UDI system. US Food and Drug Administration. http:// www.fda.gov/medicaldevices/deviceregulationandguidance/unique deviceidentification/benefitsofaudisystem/default.htm. Accessed July 16, 2015. Guideline for information management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015:491-512. UDI Resources. US Food and Drug Administration. http://www.fda .gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDevice Identification/ChangesbetweenUDIProposedandFinalRules/default .htm. Accessed July 31, 2015.
Wearing a dosimeter QUESTION: We have had an increase in the number and types of procedures that use radiation in my facility, and I am concerned about my exposure levels. My manager says that regulations do not require RN circulators to wear dosimeters. What can you tell me about wearing a dosimeter?
(3)
(4)
ANSWER: The new AORN “Guideline for radiation safety” recommends that “Radiation monitors be worn by personnel as required by regulatory agencies.”1(e22) The requirements of the applicable regulatory agencies should be included in your facility’s radiation safety program. The regulations authored by the local, state, or federal regulatory bodies are the most stringent of the various regulations and must be followed. The federal regulations from the Nuclear Regulatory Commission are provided here as an example; however, local or state regulations may be more stringent, and practitioners must follow the regulations that are the most stringent. Federal regulations do not state whether a person in a specific position is required to wear a monitor; rather, the regulations state that monitors must be worn by people who meet the following criteria: (1)
(2)
Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in x 20.1201(a), Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15
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rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv); Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv); and Individuals entering a high or very high radiation area.2(p359-360)
If a question arises about how to meet these criteria, an employee should contact the facility’s radiation safety committee or the facility’s radiation safety officer or facility equivalent to discuss how the determination was made regarding who does or does not need to wear a dosimeter. To determine how much radiation staff members in a specific position are likely to receive (criteria 1), the facility radiation safety committee or administrators should determine who must wear a dosimeter based on a trial period during which everyone participating in a select group of procedures wears a dosimeter. If the results of the dosimeter readings reveal a level less than the regulatory requirements, facility policies can state that the RN circulator does not need to wear a dosimeter or that only individuals who are close to the radiation field need to wear one. For example, the RN circulator would not need to wear a dosimeter, but the scrub person and the first assistant would. The determinations made previously at your facility may need to be reviewed by the radiation safety committee if there has been an increase in the frequency of radiation use. If a facility’s radiation safety program or local, state, or federal regulations require perioperative team members to
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Clinical Issues
wear dosimeters, they should be worn in the same location each time they are worn (eg, on the collar of the apron or scrub attire). Regulations also may require an individual (eg, a pregnant woman) to wear two dosimeters, which may assist with calculating a more accurate occupational dose. If so, the individual should wear one dosimeter on the outside of the lead apron and one on the inside.1 Regulations require that dosimeter readings be provided annually to the perioperative team members wearing the dosimeters1,3; however, dosimeter readings may be provided more often. Team members should remove dosimeters at the end of the workday and before leaving the facility. After removal, dosimeters should be stored at the facility in a location that receives no radiation exposure. Wearing dosimeters outside of the facility or storing them in a location where radiation is present (eg, an OR, an interventional radiology suite) may result in readings that are artificially high.1
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Byron L. Burlingame, MS, BSN, RN, CNOR, is a perioperative nursing specialist in the Nursing Department at AORN, Inc, Denver, CO.
References 1. Guideline for radiation safety. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015:e1-e34. 2. 10 CFR 20.1502 Conditions requiring individual monitoring of external and internal occupational dose. 2013. US Government Publishing Office. http://www.gpo.gov/fdsys/pkg/CFR-2013-title10 -vol1/pdf/CFR-2013-title10-vol1-part20.pdf. Accessed July 16, 2015. 3. x29 CFR 1910.1096. Toxic and hazardous substances: Ionizing radiation. Occupational Safety and Health Administration. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_ table¼STANDARDS&p_id¼10098. Accessed July 16, 2015.
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LEARNER EVALUATION
Continuing Education: Clinical Issues 1.4
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T
his evaluation is used to determine the extent to which this continuing education program met your learning needs. The evaluation is printed here for your convenience. To receive continuing education credit, you must complete the online Learner Evaluation at http://www.aorn.org/CE. Rate the items as described below.
PURPOSE/GOAL
6.
Will you be able to use the information from this article in your work setting? 1. Yes 2. No
7.
Will you change your practice as a result of reading this article? (If yes, answer question #7A. If no, answer question #7B.)
7A.
How will you change your practice? (Select all that apply) 1. I will provide education to my team regarding why change is needed. 2. I will work with management to change/implement a policy and procedure. 3. I will plan an informational meeting with physicians to seek their input and acceptance of the need for change. 4. I will implement change and evaluate the effect of the change at regular intervals until the change is incorporated as best practice. 5. Other: __________________________________
7B.
If you will not change your practice as a result of reading this article, why? (Select all that apply) 1. The content of the article is not relevant to my practice. 2. I do not have enough time to teach others about the purpose of the needed change. 3. I do not have management support to make a change. 4. Other: __________________________________
8.
Our accrediting body requires that we verify the time you needed to complete the 1.4 continuing education contact hour (84-minute) program: _______________
To provide the learner with knowledge of AORN’s guidelines related to unique device identifiers and wearing a dosimeter.
OBJECTIVES To what extent were the following objectives of this continuing education program achieved? 1. Discuss practices that could jeopardize safety in the perioperative area. Low 1. 2. 3. 4. 5. High 2.
3.
Discuss common areas of concern that relate to perioperative best practices. Low 1. 2. 3. 4. 5. High Describe implementation of evidence-based practice in relation to perioperative nursing care. Low 1. 2. 3. 4. 5. High
CONTENT 4.
5.
To what extent did this article increase your knowledge of the subject matter? Low 1. 2. 3. 4. 5. High To what extent were your individual objectives met? Low 1. 2. 3. 4. 5. High
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Clinical Issues
1.4
www.aorn.org/CE
BYRON L. BURLINGAME, MS, BSN, RN, CNOR; DENISE MAXWELL-DOWNING, MS, BSN, RN, CNOR Continuing Education Contact Hours
Approvals
indicates that continuing education (CE) contact hours are available for this activity. Earn the CE contact hours by reading this article, reviewing the purpose/goal and objectives, and completing the online Learner Evaluation at http:// www.aorn.org/CE. Each applicant who successfully completes this program can immediately print a certificate of completion.
This program meets criteria for CNOR and CRNFA recertification, as well as other CE requirements.
Event: #15546 Session: #0001 Fee: Members $11.20, Nonmembers $22.40 The contact hours for this article expire November 30, 2018. Pricing is subject to change.
Purpose/Goal To provide the learner with knowledge of AORN’s guidelines related to unique device identifiers and wearing a dosimeter.
Objectives 1. Discuss practices that could jeopardize safety in the perioperative area. 2. Discuss common areas of concern that relate to perioperative best practices. 3. Describe implementation of evidence-based practice in relation to perioperative nursing care.
AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019. Check with your state board of nursing for acceptance of this activity for relicensure.
Conflict-of-Interest Disclosures Byron L. Burlingame, MS, BSN, RN, CNOR, and Denise Maxwell-Downing, MS, BSN, RN, CNOR, have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article. The behavioral objectives for this program were created by Helen Starbuck Pashley, MA, BSN, CNOR, clinical editor, with consultation from Susan Bakewell, MS, RN-BC, director, Perioperative Education. Ms Starbuck Pashley and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article.
Sponsorship or Commercial Support No sponsorship or commercial support was received for this article.
Disclaimer Accreditation AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
AORN recognizes these activities as CE for RNs. This recognition does not imply that AORN or the American Nurses Credentialing Center approves or endorses products mentioned in the activity.
http://dx.doi.org/10.1016/j.aorn.2015.08.007 ª AORN, Inc, 2015
536 j AORN Journal
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CLINICAL ISSUES
1.4
www.aorn.org/CE
THIS MONTH Unique device identifier Key words: unique device identifier, UDI, FDA UDI. Wearing a dosimeter Key words: dosimeter, radiation monitoring device.
Unique device identifier QUESTION: At our facility, we have been discussing a new regulation that requires a unique device identifier (UDI) for medical devices (eg, implants). Can you clarify what a UDI is?
ANSWER: In September 2013, the US Food and Drug Administration (FDA) established the unique device identification (UDI) system rule. The rule outlines the requirements for device labelers to use for device packaging and labeling and includes standard date formatting and data submission requirements. This rule applies to all medical devices in distribution and use in the United States unless an exception or alternative applies (eg, existing inventories
www.aornjournal.org
of finished devices labeled before the applicable compliance date; class I devices that the FDA has exempted from good manufacturing practices, such as urinals or x-ray film holders).1-3 The UDI is a unique alphanumeric or numeric code consisting of a device identifier (DI) and production information (PI) (Figure 1). The DI is a mandatory, fixed portion of the UDI that identifies the labeler and the specific version or model of the device. The PI portion is optional and may contain any or all of the following information: lot or batch within which a device was manufactured, serial number of the device, expiration date of the device,
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Section 616 amended section 522 of the US Federal Food, Drug, and Cosmetic Act (FDCA) and authorized the FDA to order postmarket surveillance for certain class II and class III medical devices. The amendment required manufacturers to commence surveillance within 15 months of an FDA postmarket surveillance order.7 Figure 1. Example of a three-dimensional linear bar code showing the product identification numbers and device identification numbers. Illustration from http:// www.fda.gov/downloads/medicaldevices/deviceregulation andguidance/guidancedocuments/ucm409401.pdf. date the device was manufactured, and identification code required for a human cell, tissue, or cellular or tissue-based product.2 The precursor to the UDI rule (ie, 21 CFR Part 807), which was written in 2004, required domestic and foreign manufacturers and initial distributors or importers of medical devices to register with the FDA. The regulation also required that devices be labeled with manufacturer details and that descriptive and informational literature accompany the device (eg, manufacturer instructional inserts). Also in 2004, the FDA established the medical device reporting (MDR) program (ie, 21 CFR Part 803). This regulation requires reporting to the FDA any device malfunctions that cause or contribute to a death or serious injury. The MDR program is a mechanism for the FDA and manufacturers to identify and monitor significant adverse events involving medical devices.4 The next step in the development of the UDI rule occurred in 2007, with the establishment of the FDA Safety and Innovation Act (FDASIA),5 which established a means for the FDA to address public health challenges and preserve the approval standards processes. The act also allowed an accelerated approval process for breakthrough therapies that were not previously allowed before the establishment of the act.1 In 2012, Congress amended the FDASIA regulation and changed user fees for prescription medications and medical devices. The amended act also added new sections related to medical devices: Section 518A required the FDA to establish a program to improve the device recall system. The section applied to recalls initiated by the FDA and removals or corrections initiated by a device manufacturer or importer.6 Section 614 required the FDA to issue a proposed rule regarding a UDI system by December 31, 2012.7
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The FDA’s position toward regulating health information technology (HIT) or software has been complex and, in many cases, unclear. In 2012, the FDA took the position that certain types of HIT can meet the definition of a medical device. The types of HIT that the FDA is now regulating include software on mobile platforms that perform blood pressure and ultrasound reads, remote display or notification of real-time alarms from bedside monitors, robotic surgical planning and control, and electrocardiography analytical software.8 The FDA does not regulate electronic health records. In September 2013, the FDA supplied a list of medical devices that it classified as implantable, life-saving, and life-sustaining in section 614 of the FDASIA,5 amending section 519(f) of the FDCA.9 The medical devices listed include
anesthesia machines and their disposable components, vascular clips, vascular graft prostheses greater than 6 mm, ureteral stents, and joint prostheses.9,10
A complete listing of devices by class can be accessed at http:// www.fda.gov/medicaldevices/deviceregulationandguidance/guidance documents/ucm081251.htm.
Labeling Requirements A device labeler is defined as a manufacturer, reprocessor, specification developer, repackager, or relabeler who creates and places a label on a medical device.6 Under the FDA rule, device labelers are required to supply UDI data on a label or, in certain circumstances, directly on the medical device itself. The UDI must be in a human- and machine-readable format. The human-readable or plain text formatting may contain up to 29 characters (eg, 123abcd456ves1987630kevq5xb89). The machine-readable format uses automatic identification and data capture (AIDC) technology that can be in a threedimensional linear or two-dimensional data matrix barcode or radio-frequency identification device (RFID) format.11 Labelers must place the UDI mark directly on a device if the device is intended for more than one use and intended to be reprocessed before each use (eg, drill bits, instruments). This requirement does not apply if
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any type of direct marking would interfere with the safety and effectiveness of the device, it is not technologically feasible to directly mark the device, the device is cleared or approved as a single-use device, or the device already has a permanent UDI directly marked on it.1
Standardized Date Format
Clinical Issues
(GUDID). The FDA established the GUDID so clinicians and consumers are able to search and download information entered on each medical device in distribution and use in the United States. The GUDID contains a standard set of attributes for each medical device submitted by the device labelers. Only the DI portion of the UDI is available in the GUDID database; the PI and personal health information of the patient using the device are not available in the database.1,2
The FDA rule requires medical device packaging to contain a manufacture date or an expiration date for the device. The date must be presented in a standard format consistent with international standards and practice (ie, yyyy-mm-dd). An example of a fictitious medical device label that contains the UDI number, product name, expiration date, reference (catalog) number, and lot numbers is displayed in Figure 2.1,6
The time frame for implementing the UDI system is spread over seven years (Table 1).2 The final date when a UDI must be placed on a device is based on the classification of the device.12 When fully implemented, labels on many of the medical devices used in perioperative services (eg, instruments, implants, life-sustaining devices) will include a UDI.
Data Submission
UDI Benefits
Device labelers must submit information on each device to the FDA’s Global Unique Device Identification Database
When fully adopted and implemented, the UDI rule will offer a wide variety of benefits to clinicians, consumers,
Figure 2. Example of a hypothetical unique device identifier (UDI) label. Illustration from http://www.fda.gov/ downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm409401.pdf.
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BurlingamedMaxwell-Downing
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Table 1. Unique Device Identification (UDI) Implementation Requirements Implementation date and pertinent section of law
1
Devices that must bear a UDI
September 24, 2014 x801.18 x801.20 x801.50(b) x830.300 x801.55
The labels and packages of class III medical devices, devices licensed under the Public Health Service Act (PHS Act), and class III stand-alone
September 24, 2015 x801.18 x801.20 x801.50(b) x801.45 x830.300
The labels and packages of implantable, life-supporting, and life-sustaining devices and stand-alone software that are life-supporting or life-sustaining devices A device that is life supporting or life sustaining is required to be labeled with a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use
September 24, 2016 x801.18 x801.20 x801.45 x801.50
Class III devices are required to be labeled with a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use The labels and packages of class II medical devices and class II stand-alone software
September 24, 2018 x801.18 x801.20 x801.45 x801.50(b) x830.300
Class II devices are required to be labeled with a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III
September 24, 2020 x801.45
Class I devices, and devices that have not been classified into class I, class II, or class III are required to be labeled with a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use
1. Compliance Dates for UDI Requirements. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/UniqueDeviceIdentification/CompliancedatesforUDIRequirements/default.htm. Accessed July 16, 2015.
industry personnel, the FDA, and health care organizations. Some of the benefits identified by the FDA include allowing more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly; reducing medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device; enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices;
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providing a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls; providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies; and leading to the development of a medical device identification system that is recognized around the world.13 The UDI regulations primarily affect device labelers but also will affect perioperative clinicians by changing the data required for documentation on an implantable medical device and may change how device information is captured for documentation in the patient’s medical record. Starting September 23, 2015, perioperative RNs are required to document the UDI data on all class II implantable, lifesupporting, and life-sustaining devices. In September 2016,
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Clinical Issues
class II and class III medical devices will require UDI documentation. Currently, the documentation process for implantable medical devices includes capturing in an electronic health record or in a paper-based record the implantable medical device descriptor; its reference or catalog number; the size, if not captured in the catalog number; the lot number; the expiration date; and the quantity used of the implantable medical device.14 This information is captured in an electronic documentation system, on an implant log sheet, or on a manufacturer’s inventory control sheet that is manually or electronically transcribed into the patient’s medical record. The lot number and expiration date are captured only when available on the device packaging label (eg, individually sterile packaged devices, total joint implants). The new documentation requirements include the UDI number in addition to data that are currently required for identification of implantable medical devices.14 Clinicians can document the UDI by using a scanning device or by manual entry of the UDI number from the medical device, the medical device packaging label, or an inventory control sheet that contains the UDI. A scanning device that interfaces with a health care organization’s electronic documentation system and materials management system may decrease human error from manual entry of the number and support accurate UDI data capture for patient safety (eg, recalls) and research. To facilitate these changes in documentation, health care organizations will need to acquire the new technology, educate personnel, and develop or revise policies and procedures related to implantable medical device capture to ensure they address UDI. For the most current information regarding the UDI, nurses should visit the FDA web site.15
Byron L. Burlingame, MS, BSN, RN, CNOR, is a perioperative nursing specialist in the Nursing Department at AORN, Inc, Denver, CO.
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Denise MaxwellDowning, MS, BSN, RN, CNOR, is an informatics nurse specialist for AORN Syntegrity, Denver, CO.
References 1. Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff. US Food and Drug Administration. Center for Devices and Radiological Health, Center for Biologics and Evaluation Research. http://www.fda.gov/downloads/medicaldevices/deviceregulationand guidance/guidancedocuments/ucm409401.pdf. Accessed July 16, 2015. 2. UDI Basics. US Food and Drug Administration. http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/UniqueDevice Identification/UDIBasics/default.htm. Accessed July 16, 2015. 3. List of class I devices, by product code, that FDA has by regulation exempted from the GMP requirements of x21 CFR. Part 820, Quality System Regulation, FDA, April 2012. US Food and Drug Administration. http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/UniqueDeviceIdentification/UCM382 498.pdf. Accessed July 16, 2015. 4. Overview of Device Regulation. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/default.htm. Accessed July 16, 2015. 5. Food and Drug Administration Safety and Innovation Act (FDASIA) Overview. US Food and Drug Administration. http://www.fda.gov/ downloads/ForHealthProfessionals/UCM330622.pdf. Accessed July 16, 2015. 6. US FDA Unique Device Identification (UDI) Rule Frequently Asked Questions (FAQs). GS1 Healthcare US. http://www.gs1us.org/Desktop Modules/Bring2mind/DMX/Download.aspx?Command¼Core_Down load&EntryId¼865&PortalId¼0&TabId¼785. Accessed June 22, 2015. 7. Food and Drug Administration Safety and Innovation Act, 21 USC 301 (2012). http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/ pdf/PLAW-112publ144.pdf. Accessed July 16, 2015. 8. FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk- Based Framework. The Office of the National Coordinator for Health Information Technology.
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BurlingamedMaxwell-Downing US Food and Drug Administration. http://www.fda.gov/downloa ds/AboutFDA/CentersOffices/OfficeofMedicalProductsandToba cco/CDRH/CDRHReports/UCM391521.pdf. Accessed July 16, 2015. 9. List of Medical Devices, by Product Code, that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices for purposes of Section 614 of FDASIA amending Section 519(f) of the FDC Act. US Food and Drug Administration. http://www.fda.gov/downloads/ MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdenti fication/UCM382463.pdf. Accessed July 22, 2015. 10. Preamendments Class III Strategy. Office of Device Evaluation. US Food and Drug Administration. http://www.fda.gov/medical devices/deviceregulationandguidance/guidancedocuments/ucm081 251.htm. Accessed July 16, 2015. 11. How Can GS1 Standards Help Your Company Meet FDA UDI Requirements? GS1 Healthcare US. http://www.gs1us.org/
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12.
13.
14. 15.
industries/healthcare/gs1-healthcare-us/fda-udi. Accessed July 16, 2015. Compliance Dates for UDI Requirements. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/Device RegulationandGuidance/UniqueDeviceIdentification/Compliance datesforUDIRequirements/default.htm. Accessed July 15, 2015. Benefits of a UDI system. US Food and Drug Administration. http:// www.fda.gov/medicaldevices/deviceregulationandguidance/unique deviceidentification/benefitsofaudisystem/default.htm. Accessed July 16, 2015. Guideline for information management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015:491-512. UDI Resources. US Food and Drug Administration. http://www.fda .gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDevice Identification/ChangesbetweenUDIProposedandFinalRules/default .htm. Accessed July 31, 2015.
Wearing a dosimeter QUESTION: We have had an increase in the number and types of procedures that use radiation in my facility, and I am concerned about my exposure levels. My manager says that regulations do not require RN circulators to wear dosimeters. What can you tell me about wearing a dosimeter?
(3)
(4)
ANSWER: The new AORN “Guideline for radiation safety” recommends that “Radiation monitors be worn by personnel as required by regulatory agencies.”1(e22) The requirements of the applicable regulatory agencies should be included in your facility’s radiation safety program. The regulations authored by the local, state, or federal regulatory bodies are the most stringent of the various regulations and must be followed. The federal regulations from the Nuclear Regulatory Commission are provided here as an example; however, local or state regulations may be more stringent, and practitioners must follow the regulations that are the most stringent. Federal regulations do not state whether a person in a specific position is required to wear a monitor; rather, the regulations state that monitors must be worn by people who meet the following criteria: (1)
(2)
Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in x 20.1201(a), Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15
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rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv); Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv); and Individuals entering a high or very high radiation area.2(p359-360)
If a question arises about how to meet these criteria, an employee should contact the facility’s radiation safety committee or the facility’s radiation safety officer or facility equivalent to discuss how the determination was made regarding who does or does not need to wear a dosimeter. To determine how much radiation staff members in a specific position are likely to receive (criteria 1), the facility radiation safety committee or administrators should determine who must wear a dosimeter based on a trial period during which everyone participating in a select group of procedures wears a dosimeter. If the results of the dosimeter readings reveal a level less than the regulatory requirements, facility policies can state that the RN circulator does not need to wear a dosimeter or that only individuals who are close to the radiation field need to wear one. For example, the RN circulator would not need to wear a dosimeter, but the scrub person and the first assistant would. The determinations made previously at your facility may need to be reviewed by the radiation safety committee if there has been an increase in the frequency of radiation use. If a facility’s radiation safety program or local, state, or federal regulations require perioperative team members to
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Clinical Issues
wear dosimeters, they should be worn in the same location each time they are worn (eg, on the collar of the apron or scrub attire). Regulations also may require an individual (eg, a pregnant woman) to wear two dosimeters, which may assist with calculating a more accurate occupational dose. If so, the individual should wear one dosimeter on the outside of the lead apron and one on the inside.1 Regulations require that dosimeter readings be provided annually to the perioperative team members wearing the dosimeters1,3; however, dosimeter readings may be provided more often. Team members should remove dosimeters at the end of the workday and before leaving the facility. After removal, dosimeters should be stored at the facility in a location that receives no radiation exposure. Wearing dosimeters outside of the facility or storing them in a location where radiation is present (eg, an OR, an interventional radiology suite) may result in readings that are artificially high.1
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Byron L. Burlingame, MS, BSN, RN, CNOR, is a perioperative nursing specialist in the Nursing Department at AORN, Inc, Denver, CO.
References 1. Guideline for radiation safety. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015:e1-e34. 2. 10 CFR 20.1502 Conditions requiring individual monitoring of external and internal occupational dose. 2013. US Government Publishing Office. http://www.gpo.gov/fdsys/pkg/CFR-2013-title10 -vol1/pdf/CFR-2013-title10-vol1-part20.pdf. Accessed July 16, 2015. 3. x29 CFR 1910.1096. Toxic and hazardous substances: Ionizing radiation. Occupational Safety and Health Administration. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_ table¼STANDARDS&p_id¼10098. Accessed July 16, 2015.
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LEARNER EVALUATION
Continuing Education: Clinical Issues 1.4
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T
his evaluation is used to determine the extent to which this continuing education program met your learning needs. The evaluation is printed here for your convenience. To receive continuing education credit, you must complete the online Learner Evaluation at http://www.aorn.org/CE. Rate the items as described below.
PURPOSE/GOAL
6.
Will you be able to use the information from this article in your work setting? 1. Yes 2. No
7.
Will you change your practice as a result of reading this article? (If yes, answer question #7A. If no, answer question #7B.)
7A.
How will you change your practice? (Select all that apply) 1. I will provide education to my team regarding why change is needed. 2. I will work with management to change/implement a policy and procedure. 3. I will plan an informational meeting with physicians to seek their input and acceptance of the need for change. 4. I will implement change and evaluate the effect of the change at regular intervals until the change is incorporated as best practice. 5. Other: __________________________________
7B.
If you will not change your practice as a result of reading this article, why? (Select all that apply) 1. The content of the article is not relevant to my practice. 2. I do not have enough time to teach others about the purpose of the needed change. 3. I do not have management support to make a change. 4. Other: __________________________________
8.
Our accrediting body requires that we verify the time you needed to complete the 1.4 continuing education contact hour (84-minute) program: _______________
To provide the learner with knowledge of AORN’s guidelines related to unique device identifiers and wearing a dosimeter.
OBJECTIVES To what extent were the following objectives of this continuing education program achieved? 1. Discuss practices that could jeopardize safety in the perioperative area. Low 1. 2. 3. 4. 5. High 2.
3.
Discuss common areas of concern that relate to perioperative best practices. Low 1. 2. 3. 4. 5. High Describe implementation of evidence-based practice in relation to perioperative nursing care. Low 1. 2. 3. 4. 5. High
CONTENT 4.
5.
To what extent did this article increase your knowledge of the subject matter? Low 1. 2. 3. 4. 5. High To what extent were your individual objectives met? Low 1. 2. 3. 4. 5. High
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