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On July 10 a proposed rule by the U.S. Department of Health and Human Services (HHS) was published; it was titled Unique Device Identification (UDI) System. The following is a synopsis:

A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the Food and Drug Administration (FDA) identify product problems more quickly, better target recalls and improve patient safety. The FDA has worked closely with the industry, the clinical community and patient and consumer groups, and has conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.

In 2007 Congress passed legislation on a proposal by the FDA to have medical devices distributed in the U.S. carry a UDI—a unique device identifier. The FDA UDI regulation will establish a single device identification system that is consistent, unambiguous, standardized and globally harmonized. All manufacturers of medical devices will be required to comply with the new UDI methodology.

The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA also is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.

UDI will benefit the interoperability of sharing medical device information between clinical information systems. Accountable care organizations (ACOs), healthcare reform legislation and the Health Information Technology for Economic and Clinical Health (HITECH) Act all point to the requirement for information to be shared effectively among providers. The idea is that this system potentially will improve the quality of information in adverse event reports regarding medical devices.

When UDI rules are published, healthcare providers will be challenged to incorporate device identification into information systems and operational processes throughout their organizations.

A UDI is a unique numeric or alphanumeric code that acts as a key to indicate certain basic identifying information about a device (such as the name of the manufacturer or the type of device), and it may represent certain other information about the device (such as its expiration date or batch/lot number). This information will be consolidated in a publicly available UDI database, and no identifying patient information will be stored in this device information center.

Anticipated benefits:

  1. Reduces medical errors.
    1. Provides a standard method to document the device in the:
    2. EHRs;
    3. Clinical information systems;
    4. Claims data sources; and
    5. Registries.
    6. Provides a standard identifier allowing more effective management of recalls by:
      1. Healthcare facilities;
      2. Manufacturers; and
      3. Distributors.
      4. Creates a post-market surveillance system for premarket approval or clearance of new devices and new uses of current marketed devices.
      5. Enables healthcare workers to identify a device precisely using information and characteristics of the device.
      6. Enables a higher level of  analyzing and reporting adverse events.
        1. Problem devices can be identified quickly and
        2. Corrected more quickly.
        3. Develops a medical device identification system recognized worldwide.
        4. Provides a foundation for a global, secure distribution chain to address counterfeiting and diversion, as well as for medical emergencies.

When do UDI requirements start?

Class III medical devices must have UDIs within one year of a final rule being published; Class II devices must have UDIs within three years, and Class I devices must have UDIs within five years. The final rule is expected to be released by spring 2013.



ICD-10-PCS and Devices

ICD-10-PCS should contain information that correlates a specific device value used in the original root operation in which the device was placed (bypass, dilation, insertion, occlusion, replacement, and so on) with its more general device value used in other root operations. In root operations such as Removal and Revision, the device values are often the aggregate, general device of an entire family of specific device values.

Device values fall into four basic groups:

  1. Graphs and prostheses;
  2. Implants;
  3. Simple or mechanical appliances; and
  4. Electronic appliances.

ICD-10-PCS recognizes four general types of devices, including:

  • Biological or synthetic material that takes the place of all or a portion of a body part, such as a skin graft or a joint prosthesis;
  • Biological or synthetic material that assists or prevents a physiological function, such as an intrauterine device;
  • Therapeutic material that is not absorbed by, eliminated by, or incorporated into a body part, such as a radioactive implant; and
  • Mechanical or electronic appliances used to assist, monitor, take the place of, or prevent a physiological function, such as a cardiac pacemaker or orthopedic pins.

For ICD-10-PCS coding purposes, only devices that remain in place after a procedure has been completed are included. In addition, materials incidental to a procedure, such as clips, ligatures and sutures, are not considered devices.

Procedures That Always Involve Devices

Root Operation




Putting in a nonbiological appliance that monitors, assists, performs or prevents a physiological function but does not physically take the place of a body part.



Putting in or on a biological or synthetic material that physically takes the place and/or function of all or a portion of a body part.



Taking out or off a device from a body part.



Taking out or off a device from a body part and putting back an identical or similar device, in or on the same body part, without cutting or puncturing the skin or a mucous membrane.



Correcting, to the extent possible, a portion of a malfunctioning device or the position of a displaced device.



Putting in or on biological or synthetic material that physically reinforces and/or augments the function of a portion of a body part.





General guidelines


A device is coded only if a device remains after the procedure is completed. If no device remains, the device value “No Device” is coded.


Materials such as sutures, ligatures, radiological markers and temporary post-operative wound drains are considered integral to the performance of a procedure and are not coded as devices.


Procedures performed on a device only and not on a body part are specified in the root operations Change, Irrigation, Removal and Revision, and are coded to the procedure performed.

Example: Irrigation of percutaneous nephrostomy tube is coded to the root operation Irrigation of indwelling device in the Administration section.

Drainage device


A separate procedure to put in a drainage device is coded to the root operation Drainage with the device value Drainage Device.

New ICD-10-PCS Draft Device Key Added to ICD-10-PCS Core Content

One of the additions to ICD-10-PCS in the 2012 draft was the inclusion of a device key.

The device key is a table that identifies specific devices, including many brand names for those devices in the first column, and then provides ICD-10-PCS classification for each device.

The device table contains more than 300 new entries in the PCS index and in standalone ICD-10-PCS reference tables.

There are two table listings, one listed by device name (brand name or common name) and one listed by PCS device value, for ease of use as a printed document.

Device Key (Example)

3f (Aortic) Bioprosthesis valve


Use: zooplastic tissue in heart and great vessels


AbioCor® Total Replacement Heart


Use: synthetic substitute


Acellular Hydrated Dermis


Use: nonautologous tissue substitute


Device Aggregation Table

ICD-10-PCS Device Classification Maintenance Standards Developed and Applied to FY2012 update

Based on industry feedback and internal review, two new maintenance standards were developed to preserve the usability and maintainability of PCS.

1. Device information is contained only in the device character.

2. ICD-10-PCS contains a PCS-to-PCS Device Aggregation Table between root operations, using both general and specific devices, and root operations like Removal and Revision, that only use general devices.

This additional reference table provides a mechanism for directing coders and secondary data users from more specific device values used in the original root operations to root operations in the system where the selection of device values is less specific. Each specific device is assigned to its aggregate general device in the Device Aggregation Table, as shown in the example below.

Device Aggregation Table (Example)

Specific Device

for Operation

in Body System

General Device

Autologous Arterial Tissue

All applicable

Heart and great vessels, lower arteries, lower veins, upper arteries, upper veins

7 Autologous tissue substitute

Autologous Venous Tissue

All applicable

Heart and great vessels, lower arteries, lower veins, upper, arteries, upper veins

7 Autologous tissue substitute

Cardiac Lead, Defibrillator




Heart and great vessels


M Cardiac lead

About the author

Anita Archer has extensive management experience in the healthcare industry, with an emphasis on revenue cycle management and systems implementation and support. She is a certified professional coder and an AHIMA-approved ICD-10-CM/PCS trainer, and has been responsible for revenue cycle improvements in physician practices, hospitals and ancillary services. She has extensive system implementation experience and is a superb project manager and team leader. Anita is currently the director of regulatory compliance at Hayes Management Consulting.

Contact the author


To comment on this article please go to editor@icd10monitor.com


Unique Device Identification Update – FDA and GHTF


Federal Register / Vol. 77, No. 132 / Tuesday, July 10, 2012 / Proposed Rules



ICD-10 Procedure Coding System (ICD-10-PCS) 2012 Tables and Index




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