Docstoc

Facilitating Medical Innovation and Technology The Role of FDA

Document Sample
Facilitating Medical Innovation and Technology The Role of FDA Powered By Docstoc
					In attempting to arrive at the truth, I have applied
everywhere for information, but in scarcely an
instance have I been able to obtain hospital records fit
for any purposes of comparison.

If they could be obtained, …they would show
how…money was being spent, what amount of good
was really being done with it..; and… these improved
statistics would tell us more of the relative value of
particular operations and modes of treatment .. and
the truth thus ascertained would enable us to save life
and suffering, and to improve the treatment and
management of the sick…

Florence Nightingale
Notes on hospitals (1859, revised 1863)

                                                           1
Update on CDRH Informatics/UDI Work




                                   Terrie Reed
                          Senior Policy Analyst
 FDA Center for Devices and Radiological Health
                                        3/12/10
How do you define Health Informatics?

  • Methods used to optimize the
    acquisition, storage, retrieval, and
    analysis of health information.
    Tools include not only computers
    but also clinical guidelines,
    formal medical terminologies, and
    information and communication
    systems.


                                           3
 How do you define Health Informatics?

• For CDRH
  – Standard Vocabularies
  – Standard Methods of Data Exchange
  – Alignment of Database Information
• GOAL of Health Informatics
  – Facilitate sharing of data across TPLC
    and with other Stakeholders

                                             4
        CDRH Informatics Work
Examples of Standard Vocabularies
• Event Problem Codes – Fully Live 4/2/2010
• Evaluation Codes – Under Development
• Global Medical Device Nomenclature (GMDN)
• Product Dictionary – Unique Device Identifier
  (UDI)




                                                  5
      CDRH Informatics Work (cont’d)
Examples of Standard Methods of Data Exchange
• Health Level Seven (HL7)
  – Regulated Product Submission (RPS) – STED
  – Individual Case Safety Report (ICSR) - eMDR
  – Structure Product Labeling (SPL) Product
    Information + Content of the Label
Examples of Aligning Databases –
• Product Codes =>UDI


                                                  6
                         The Need for UDI
•   US Has No Good System To Track Medical Implants
•   AP Enterprise: United States Has No Reliable System To Track
•   Defective Medical Implants
•   (AP) New York October 5, 2009. Three years ago, the maker of a
    surgical clip called the Hem-o-lok issued an urgent recall notice
    warning doctors to stop using the fasteners on living kidney donors. It
    said the clips could dislodge. in their bodies, with "serious, even life-
    threatening consequences.“ Not everyone got the message. Last
    October, a surgeon in Brooklyn used one of the clips to tie off Michael
    King's renal artery when he donated a kidney to his ailing wife.
    Twelve hours later, the clip popped off. King bled to death internally in
    the hospital as his wife lay helplessly nearby. He was 29.

http://www.cbsnews.com/stories/2009/10/05/ap/health/main5364655.shtml



                                                                                7
            Device Information Lifecycle
                            GPOs                                          Rentals
                                                       Clinical
 Manufacturer                                        Substitution
                                                                            Sold
                                   Distributor
             Device X
  Reuse       Lot Y                  Direct               Hospital       Physician
            Exp Date Z                                                   preference
                                     Recall
 Reorder                                                                 Off-master
                                                                          purchase
            Clinical Use                                   Unit
                                    Sales Rep                            Hoarding
Reimbursement
                                           AE Reporting
                    EHR                                                Postmarket
   Registries                            Population Databases          Surveillance

                         Comparative                         FDA’s Sentinel System
                         Effectiveness
                                                                                      8
                                                                                          8
        Current Device Identification
• Non-standard device identification systems;
• Standards used in different ways
• Not necessarily unique or unambiguous
• Manufacturers’ own number/catalogue number
• Distributors’ – apply different, proprietary number; lot
  or serial number not captured
• Hospital – yet different identification number/code
   –Information on use not usually captured
   –Control numbers rarely captured




                                                             9
         UDI Can Improve… Visibility
• Medical device recalls
• Adverse event reporting and postmarket surveillance
• Tracking and tracing, supply chain security; and anti-
  counterfeiting/diversion (location systems)
• Comparative effectiveness (e.g., registries)
• Disaster/terror preparation and shortages/substitutions
• Reduce medical errors
• Documenting medical device use in patient’s EHR/PHR, hospital
  information systems, claims data
• Sentinel Initiative - strengthening FDA’s ability to query data
  systems for relevant device information




                                                                    10
          Medical Device Identification
Develop a system to identify medical devices, which is:
• Consistent
• Unambiguous (differentiates among all dimensions)
• Standardized
• Unique at all levels of packaging
• Harmonized internationally

And facilitates the:
• Storage,
• Exchange, and
• Integration of data and systems




                                                          11
              Future Information Lifecycle
   Re/order                                                    Reimbursement
                              Hospital
                                                               Expiration date?

               Distributor                  Clinical Use         Effectiveness

                                UDI                                 Recalled?
                              Device X
          Manufacturer                             EHR
                              Model Y
                                                                      Safe?

               Recall                       AE reporting
                                                                Registries
                             Surveillance
                                                           Population databases
Counterfeit

                                                                                  12
           FDA Amendments Act of 2007

September 27, 2007, the FDAAA signed into law:
The Secretary shall promulgate regulations establishing
 a unique device identification system for medical
 devices requiring the label of devices to bear a unique
 identifier, unless the Secretary requires an alternative
 placement or provides an exception for a particular
 device or type of device. The unique identifier shall
 adequately identify the device through distribution and
 use, and may include information on the lot or serial
 number.




                                                            13
                  HR 3962 – Health Care Reform
SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY
(b) Electronic Exchange and Use in Certified Electronic Health Records of Unique Device Identifiers-
…
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA- The Secretary of Health and
     Human Services, acting through the head of the Office of the National Coordinator for Health Information
     Technology, shall adopt standards, implementation specifications, and certification criteria for the
    electronic exchange and use in certified electronic health
    records of a unique device identifier for each covered
    device referred to in paragraph (1), if such an identifier is
    required by section 519(f) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 360i(f)) for the device.

(c) Unique Device Identification System- The Secretary of
   Health and Human Services, acting through the
   Commissioner of Food and Drugs, shall issue proposed
   regulations to implement section 519(f) of the Federal
   Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not
   later than 6 months after the date of the enactment of this
   Act.
                                                                                                                14
    1st – Developing the Identifying Code
– Develop UDI code according to ISO 15459 [GS1,
  HIBCC]
– Created and maintained by the manufacturer
– Concatenating Device and Production Identifier
– Device Identifier (DI): [static] Manufacturer, make,
  model [i.e., each catalogue number]
– Production Identifier (PI): [dynamic] if currently
  serialized – serial number; if currently identified at
  the lot, the lot number, and expiration date
– Risk based approach – DI; DI + lot; DI + serial (or lot
  and serial)


                                                            15
       2nd – Applying code to Label
• Applied at all levels of packaging, down to the
  lowest level (the patient use level or unit of use)
• Human readable and/or encoded in a form of
  automatic identification technology
– Direct Part Marking (DPM) for some devices
– No specific technology would be identified
  (technology neutral)
– Identify a series of standards (linear barcode, 2-
  dimensional barcode, RFID)



                                                        16
        3rd – Developing UDI Database to Store
           Code and Other Attributes (GHTF)
•   Labeler Contact name, phone, email
•   Device Identifier Type/Code [GTIN, HIBCC]
•   Brand/Trade Name; Description
•   Device model number (or reference number)
•   Size; Unit of Measure/Packaging level/quantity
•   Control – Lot and/or Serial Number; Exp. Date
•   GMDN Classification code/term
•   Storage condition; Sterility;
•   Contains known, labeled allergen (e.g., latex)
•   URL for additional information – Web address

For more details - see GHTF Draft Discussion Paper:
http://ec.europa.eu/enterprise/newsroom/cf/document.cfm?ac
  tion=display&doc_id=5556&userservice_id=1
                                                             17
                            FDA’s UDI Database
                            The label of Medical Device 123 Size 45:
                              Device Identifier (Device XYZ123)
Manufacturer
                               Production Identifier (Lot #ABC)          Distribution
  (Acme)
                                Expiration date (MMDDYYYY)
                                        Sterile; Latex free

Minimum Data Set
                                                                            FDA
For each Device Identifier:
• Manufacturer and model
• GMDN Code                                       FDA Managed
• Other attributes

                                                      Business           FDA’s UDI
                GSI GDSN                 SPL
                                                       Rules              Database
Other options




                    or
                HIBCC UPN
                    or                                     Public User
                  Labeler                                   Interface
                                                                                        18
  4th - Adoption and Implementation
• Resolve technology issues – barcodes, RFID, DPM
– Develop appropriate UDI Database
– Facilitate distributor uptake and use
– Facilitate hospital uptake and use
– Facilitate use of UDI throughout device lifecycle
– Develop medical error reduction (e.g., latex)
– Drive integration – MMIS-Clinical
– Drive appropriate use of UDI in EMRs
– Determine appropriate role in reimbursement
– Address privacy concerns



                                                      19
                   UDI Database Pilot
Phase 1-3
Purpose:
Assess the feasibility of collecting, storing, and retrieving UDI data
  from initial creation (manufacturer) to point of use (hospital) .
Results:
• Data suppliers (manufacturers) had concerns about data definitions,
  obtaining the data from various sources and manipulating for UDI
  upload.
• Participants confused about the purpose/use of UDID.
• Users (hospitals) liked UDID – it provided data they regularly need -
  e.g. information related to recalls and identifying alternate
  products/manufacturers for recalls.




                                                                20
                                                                     20
                  UDI Database Pilot
Phase 4
Purpose:
Assess how UDI data will impact FDA device information use in
 current systems

Method:
• Vendors submit data via spreadsheets
• FDA analyze data for completeness and accuracy
• FDA analyze data for impact on current systems
• FDA use results to inform development of UDI Database

Results:
Pending


                                                                21
                                                                     21
        Limitations of UDI and UDID
• UDID contains only “static” information.
• Includes identifying information and other
  attributes about the device.
• UDID does NOT contain production
  information, such as lot or serial numbers.
• UDID is NOT track/trace or other similar
  purposes requiring the full UDI
• UDID provides link to Better Product
  Information- not a replacement for
  Recalls/Adverse Event Databases.

                                                22
                                                     22
Conclusion: UDI as Foundational Element

 UDI will facilitate integration of data across
  disparate systems in the supply chain:
 – more efficient and effective device recalls,
 – improved postmarket surveillance,
 – better adverse event reporting,
 – better device identification in registries,
 – ability to document specific device use in patient’s
   Electronic Health Records,
 – collection of device information in population-based data
   sets.
 BUT – only if UDI is captured, stored, integrated and exchanged
   by ALL stakeholders.




                                                                   23
Unique Device Identification
    www.fda.gov/MedicalDevices/
   DeviceRegulationandGuidance/
      UniqueDeviceIdentifiers

Email: cdrhudi@fda.hhs.gov



                                  24

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:5
posted:7/31/2011
language:English
pages:24