US Food and Drug Administration Unique Device Identifier Rule: Perioperative Basics

Everyday Informatics March 2016

Claire Karas, BSN, RN, CRNFA

Perioperative and procedural nurses are frontline caregivers who are in frequent contact with medical products and devices. Implants, supplies, and other products are essential tools of perioperative patient care. The need for vigilant surveillance, evidence-based outcomes and patient safety initiatives have brought about a major change in the way perioperative nurses will interact with product data collection within the next two years. Recently released federal regulatory guidance related to increased vigilance will affect every patient and every nurse every day.

The Food and Drug Amendments Act of 2007 charged the Food and Drug Administration (FDA) with establishing a tracking and tracing system to support comprehensive identification of medical devices. In 2013, the FDA released the Unique Device Identification (UDI) rule, (Brookings Institute, 2015) which establishes landmark guidance for all medical device manufacturers doing business in or importing products to the United States. This regulatory action directs manufacturer’s compliance with a standardized labeling and marking schema that allow end users (eg, facilities, the FDA, third-party payers) to successfully track and trace medical products and devices. The intent of this action is that any device will be identifiable through its entire lifecycle of supply chain and patient use or implantation. This will encompass follow through up to and including explantation, removal, or the death of the patient. Additionally, the FDA was charged with establishing and maintaining a publically accessible, comprehensive reference file of devices and products known as the Global UDI Database (GUDID). This resource will be comprised of manufacturer-populated standardized descriptions. Implementation of UDI is a major industry undertaking on a timeline that has already begun, as shown in Table 1 (U.S Food & Drug Administration, September).

Accurate capture of product and device data will benefit supply chain providers, caregivers, physicians, facilities, registries, third-party payers, and public health employees, and will support evidence-based outcome methodologies. A demonstration project conducted at Mercy Hospital in Chesterfield, Missouri, (Joseph Drozda, Helmering, Moore, & Smith, 2013) (Tcheng, et al., 2014) substantiates the hypothesis that standardized identifiers will improve the effectiveness of supply chain management, reduce costs, and create a sustainable method for surveillance of medical devices.

THE COMING CHANGES

In 2012, the Global Harmonization Task Force defined medical devices as follows:

“Medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  • investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • supporting or sustaining life
  • control of conception,
  • disinfection of medical devices
  • providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. (Study Group 1 of the Global Harmonization Task Force, 2012)

The first change nurses will see is the change of date format from the US traditional MM/DD/YYYY to the ISO standard YYYY/MM/DD. This change has been required for Class III medical devices went into effect in September 2015 for implantable, life-supporting, and life- sustaining devices; this change will be required for other types of devices in subsequent years. In and of itself, this change will affect item masters, electronic medical records, implant logs, and device registration information forms.

THE EFFECTS OF UDI

Cost reductions from UDI will become evident as facilities engage all suppliers to provide compliant device data, but early reports indicate that substantial savings are commonplace (Galoozis, 2014). Computerized data systems for inventory, charge, and implant records should be reviewed for compliance with the data schema in particular. Hospitals, outpatient surgery centers, and office-based procedure areas that have implemented barcode reading or radio- frequency identifier technology as a feature of meaningful use are well positioned to have successful transitions to UDI requirements.

Validity of barcode scanning as a method of tracking and tracing technology is evident to anyone who currently shops in large grocery or retail outlets. Barcode scanning is a commonplace way to use a scanner when checking out food, clothing, and household purchases with or without assistance. Medication scanning systems used by hospital pharmacies clearly demonstrate improvements in cost, safety, and efficiencies (Millard, 2010). Most significantly, the scanning technology can quantify reductions in medication errors over time.

Facilities without barcode scanning technology will be challenged to provide efficient methods for reliable documentation of the human-readable portion of the codes. It is probable that some of these strings of numeric code will expand to 55 or more characters (Food and Drug Administration, 2014). Documentation and procedural techniques at the department level should be examined now in preparation for mandated tracking changes that manufacturers will introduce. It would be most helpful to make this discussion a collaborative effort with industry representatives, supply chain personnel, information technology personnel, and nursing team members being represented from inception to implementation to derive best practice outcomes. One common misconception is that barcodes or QR (ie, quick response) codes could be accessed using smartphones—rather, it is more likely that compliance with the Health Insurance Portability and Accountability Act and hospital policies will be at cross purposes with this workaround. Proceeding with caution is the best advice for those charged with developing procedural plans that support accurate documentation.

CONCLUSION

The UDI rule presents a unique opportunity for perioperative and procedural nurses to engage with materials management and supply chain leaders for effective and timely implementation that supports overall evidence-based outcomes and patient safety initiatives. Standardization of product names, item descriptions, and classifications is a basic requirement of this process. Perioperative nurses are uniquely qualified to provide technical support for these clinical applications and informatics expansions.


Claire Karas, BSN, RN, CRNFA, is a clinical analyst global catalog at Healthcare IQ, Palmetto, FL. Ms Karas has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.

References

Brookings Institute. (2015). Unique Device Identification (UDI) Implementation. Washington DC: http://www.brookings.edu/about/centers/health/projects/development‐and‐use‐of‐medical‐ devices/udi. Retrieved from http://www.brookings.edu/about/centers/health/projects/development‐and‐use‐of‐medical‐ devices/udi

Food and Drug Administration. (2014). Unique Device Identifier System: Frequently Asked Questions. Washington, D.C.: US Department of Health and Human Services .

Galoozis, C. (2014, July 23). Medtronic Minimally Invasive Therapies. Retrieved from Sharing Healthcare Solutions: http://sharinghealthcaresolutions.covidien.com/udi‐is‐here‐to‐stay‐‐‐how‐will‐it‐ impact‐providers‐

Joseph Drozda, J. M., Helmering, P., Moore, V., & Smith, T. (2013). Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence‐Based REgulatory Science and Public Health Surveillance: Final Report. Washington DC: Food & Drug Administration.

Millard, M. (2010, June 14). Bar Code Tech and eMAR Significantly Reduce Medication Errors. Healthcare IT News.

Study Group 1 of the Global Harmonization Task Force. (2012). Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device". Geneva, Switzerland: International Medical Device Regulators Forum/World Healht Organization. Retrieved from http://www.gs1.org/docs/healthcare/ghtf‐sg1‐n071‐2012‐definition‐of‐terms‐120516.pdf

Tcheng, J., Crowley, J., Madris, T., Reed, T., Dudas, J., Thompson MD, K., . . . Drozda, J. M. (2014, October). Unique Device Identifiers for Coronary Stent Postmarket Surviellance and ResearH: A Report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration. American Heart Journal, pp. 406‐413. Retrieved from http://www.ahjonline.com/article/S0002‐8703(14)00405‐0/pdf

U.S Food & Drug Administration. (September, 24 2013). Compliance Dates for UDI Requirements. Retrieved from Device Advice: Comprehensive REgulatory Assistance: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification

/CompliancedatesforUDIRequirements/default.htm

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