GE Healthcare = Integrated IT Solutions, Warning Letter

From: Subject: GE Healthcare Integrated IT Solutions, Warning Letter Date: Wed, 20 Aug 2008 10:28:36 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C902AF.80DCB4D0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C902AF.80DCB4D0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6881c.htm GE Healthcare = Integrated IT Solutions, Warning Letter

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Department of Health and Human Services	Public Health Service Food and Drug = Administration
	Chicago District 550 West Jackson Blvd., 15th Floor = Chicago,=20 Illinois 60661 Telephone: = 312-353-5863

August 12, 2008

WARNING LETTER=20
CHI-4-08

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Vishal K. Wanchoo
President and CEO
GE Healthcare = Integrated IT=20 Solutions
540 W. Northwest Highway
Barrington, Illinois = 60010-3051

Dear Mr. Wanchoo:

During an inspection of your firm located in Barrington, Illinois, = from April=20 15 - May 13, 2008, an investigator from the Food and Drug Administration = (FDA)=20 determined that your firm manufactures and distributes Centricity = Imaging and=20 other Picture Archiving and Communication System (PACS) products. Under = Section=20 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. = 321(h)],=20 these products are defined as medical devices because they are intended = for use=20 in the diagnosis of disease or other conditions or in the cure, = mitigation,=20 treatment, or prevention of disease, or are intended to affect the = structure or=20 function of the body.

This inspection revealed that these devices are adulterated within = the=20 meaning of Section 501(h) of the Act [21 U.S.C. 351(h)], in that the = methods=20 used in, or the facilities or controls used for, their manufacture, = packing,=20 storage, or installation are not in conformity with the current Good=20 Manufacturing Practice (cGMP) requirements of the Quality System (QS) = regulation=20 found at Title 21, Code of Federal Regulations (CFR), = Part 820.=20 We received your response dated June 2, 2008, concerning our = investigator's=20 observations noted on the FDA-483, List of Inspection Observations, = which was=20 issued to your firm on May 13, 2008. We address this response below, in = relation=20 to each of the noted violations, where appropriate. These violations = include,=20 but are not limited to, the following:

1. Failure to establish and maintain adequate procedures for = analyzing=20 processes, work operations, concessions, quality audit reports, = quality=20 records, service records, complaints, returned product, and other = sources of=20 quality data to identify existing and potential causes of = nonconforming=20 product, or other quality problems, as required by 21 CFR = 820.100(a)(1).

For example:

a. Your CAPA procedures do not identify all CAPA data sources or = define=20 the requirements for analyzing and evaluating those data sources. = Examples=20 of data sources not included are: Complaint Handling Access Database = (CHAD)=20 complaints, Service data, and System Performance Reports (SPRs). =

b. Your CAPA procedures do not address obtaining and reviewing=20 information from other GE Healthcare sites that share the same = product=20 components (such as shared software code). In October 2007, GE = Medical=20 Systems in France submitted a correction and removal report for = safety=20 issues identified in their Advantage Workstation (AW) product. The=20 evaluation of the same safety issues identified in the GE Healthcare = IITS AW=20 Suite version 2.0.1 product (which builds on the AW software code) = did not=20 include the consideration that the site in France initially reported = these=20 issues.

We have reviewed your response and have concluded that your = response is=20 inadequate. Your response states that you will conduct a retrospective = review=20 of all available functional area trend analysis from all relevant = quality data=20 sources over the past two years (June 2006 to May 2008) to identify = potential=20 issues requiring escalation to CAPA. The review was to be completed by = July=20 31, 2008. Please submit the retrospective review for our review.

2. Failure to establish and maintain adequate procedures for the=20 identification, documentation, validation or where appropriate = verification,=20 review and approval of design changes before their implementation, as = required=20 by 21 CFR 820.30(i).

For example:

a. The AW Suite 2.0 System Requirements Specification has not = been=20 updated to reflect the Volume Viewer Advanced Vessel Analysis = requirement to=20 display a message when PET slices are missing from a loaded dataset. = This=20 issue was identified in Software Problem Report 64263 and a design = change=20 was implemented in AW Suite 2.0.1, released in October 2007. The = issue was=20 originally identified at GE Medical in France in a product with a = shared=20 code base (Advantage Workstation -AW). The Software Requirements=20 Specification for the AW product was updated in September 2007; = however,=20 this design change was not identified or implemented for the AW = Suite=20 2.0.

b. Release notes for Centricity PACS version 3.0.4 and = 2.1.5.5=20 include incorrect references to complaints that were fixed. For = example, the=20 issue of incorrect patient jackets intermittently opening is listed = in the=20 section of identified problems that are not fixed (complaint = 13092353). The=20 project plan and verification for this issue shows that the fix is = included=20 in 3.0.4 and 2.1.5.5.

We have reviewed your response and have concluded that your = response is=20 inadequate. Your response states that you will conduct a retrospective = review=20 of all releases in the past two (2) years (June 2006 to May 2008) for = PACS and=20 Perinatal software products to ensure that documents required by the = design=20 change plan were released and that customer Release Notes accurately = reflect=20 the changes implemented in the release(s). You state the review will = be=20 completed by August 31, 2008. Please submit the retrospective review = for our=20 review.

3. Failure to establish and maintain adequate procedures for = finished=20 device acceptance to ensure that each production run, lot, or batch of = finished devices meets acceptance criteria, as required by 21 CFR = 820.80(d).=20

For example, manufacturing procedures do not include a requirement = for=20 conducting and documenting acceptance activities for CD/DVD burns and=20 eDistribution downloads to ensure that the software matches the = engineering=20 master files.

We have reviewed your response and have concluded that your = response is=20 inadequate. Your response states that you will conduct a retrospective = review=20 of manufacturing acceptance activities to verify production and = electronic=20 distribution (eDistribution) mechanisms of all current production = versions,=20 maintenance releases, service packs, and software patches against, the = master=20 media serviced through Barrington manufacturing. The review was to be=20 completed by July 31, 2008. Please submit the retrospective review for = our=20 review.

4. Failure to establish and maintain adequate procedures for the=20 information that must be documented in a record of the investigation, = as=20 required by 21 CFR 820.198(e).

For example:

a. The following complaints are incomplete and do not include an=20 investigation plan, investigation results, investigation updates or = the=20 identification or implementation of corrections or corrective = actions:

i. Compliant 1314915 was opened on November 16, 2007, because a = customer on [redacted] stated that CT exam = reports were=20 being assigned to incorrect exams. On 1/9/08, the complaint = evaluation=20 risk assessment resulted in an R2 rating (Product Safety issue) = and a work=20 a round was created for the customer. The CAPA Review Board = reviewed the=20 issue March 7, 2008, and decided a CAPA was not necessary. An=20 investigation to identify root cause was not conducted until = information=20 about the complaint investigation was requested during this = inspection.=20 Information provided on 5/1/08 revealed that a fix for this issue = was made=20 in April 2005. Mandatory Safety Field Modification Instruction = (FMI) 85122=20 was created on 5/12/08 for this issue.

ii. The investigation into two downloads of the CA1000 Spa12 = code=20 reported as different (complaint 13154048) was assigned on Dec. = 16, 2007,=20 and due April 30, 2008. The investigation decision rationale = states there=20 is a possible media release issue. The complaint investigation = does not=20 include an investigation plan, investigation results, = investigation=20 updates or the identification or implementation of corrections or=20 corrective actions. An investigation into this issue was not = initiated=20 until information related to this complaint was requested during = this=20 inspection.

b. Your investigation procedures do not include the Support = Central Case=20 system through which technicians and engineers document on-going=20 investigations of service records and complaints.

Your response appears to be adequate. Your response states that you = have=20 revised the IITS Investigation Work Instruction (DOC0350062). The = complaint=20 handling unit personnel were trained to ensure that complaints are not = closed=20 until there is a completed investigation or, if applicable, = a4ocumented=20 rationale for why an investigation is not required. You also revised = the IITS=20 Complaint Handling Work Instruction (DOC0350060). A final review has = been=20 established to assure all complaints have been properly investigated = and=20 documented. Training on the new procedures was conducted and training = records=20 were provided. We will verify the adequacy of this correction at our = next=20 inspection.

5. Failure to maintain adequate procedures for receiving, = reviewing, and=20 evaluating complaints by a formally designated unit, as required by 21 = CFR=20 820.198(a).

For example, complaint handling procedure titled=20 [redacted] was not followed with regard to obtaining = more=20 information or further evaluating perinatal product service records = with=20 complaint status of 'Unknown'. The Perinatal Service Record Complaint = Status=20 in the 2007 quarter 4 management review shows 570 records identified = as=20 Unknown (3,377 records were identified as non-complaints and 632 = records were=20 identified as complaints).

Your response appears to be adequate. Your response states that = you have=20 revised the IITS Complaint Handling Access Database (CHAD), = DOC0417335, to=20 provide guidance for re-evaluation on a periodic basis of the CHAD = database=20 event records that contain insufficient information needed to make a = complaint determination to ensure timely and effective follow-up. = You have=20 also revised your IITS Siebel Service Record Complaint Review = procedure,=20 DOC0350068, to provide guidance for re-evaluation on a periodic = basis of the=20 Siebel database event records that contain insufficient information = needed=20 to make a complaint determination to ensure that effective follow-up = is=20 implemented to make a complaint determination. Product specific = service=20 system work instructions were modified to enhance timeliness and=20 completeness of service records. Work Instructions and CASE Workflow = and CPN=20 Service Management were modified to further facilitate complaint = evaluation,=20 MDR determination and the potential safety impact of service data. = Training=20 was conducted for these specific procedural modifications and = training=20 records were provided. We will verify the adequacy of this = correction at our=20 next inspection.

The inspection also revealed that your Centricity Imaging devices = are=20 misbranded under Section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)], = in that=20 your firm failed or refused to furnish material or information = respecting the=20 device that is required by or under section 519 of the Act [21 U.S.C. = 360i]=20 and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation, and = 21 CFR=20 Part 806 - Reports of Corrections and Removals regulation. Significant = deviations include, but are not limited to, the following:

6. A MDR report was not submitted within 30, days of receiving or = otherwise=20 becoming aware of information that reasonably suggest that marketed = device has=20 malfunctioned and would be likely to cause or contribute to a death or = serious=20 injury if the malfunction were to recur, as required by 21 CFR = 803.50(a)(2).=20

For example, complaint 13116009 was not submitted as a MDR. In = accordance=20 with comment 12 of the preamble to the MDR regulation, "A malfunction = is=20 reportable if any one of the following is true. . .(5) the = manufacturer takes=20 or would be required to take an action under section 518 or 519(f)=20 [redesignated 519(g) by 110 P.L. 85, Sec. 226 (Sept. 27, 2007)] of the = Act as=20 a result of the malfunction of the device or other similar devices." = 60 Fed.=20 Reg. 63578, 63585 (Dec. 11, 1995). Your July 20 and August 2, 2007, = correction=20 correspondences regarding the software malfunctions for the Centricity = Perinatal Systems have been classified as a Class II recall, = Z-2037-2008, and=20 is considered a section 519(g) action.

7. Failure to adequately maintain a MDR event file as part of your=20 complaint file, as required by 21 CFR 803.18(e). For example, your MDR = event=20 file for complaint 13116009 did not document an explanation of why you = did not=20 submit a MDR report as well as the results of your evaluation of this = event.=20

8. Failure to conduct an investigation and evaluate the cause of = each=20 event, as required by 21 CFR 803.50(b)(3). For example, complaint = 13092353 did=20 not include documentation of an investigation into a patient = misdiagnosis=20 which occurred after an incorrect patient jacket opened on the = Centricity PACS=20 workstation and did not determine if it represents a MDR reportable = event.=20

9. Failure to develop, maintain, and implement adequate written MDR = procedures, as required by 21 CFR 803.17. For example, the initial = decision=20 not to report a MDR for several complaints conflicts with your firm's=20 complaint evaluation risk assessment which lists a severity rating of = 2=20 "Defect has caused or has potential to cause serious injury" and a = final=20 rating of R2, "This complaint has been evaluated as a Product Safety = issue. .=20 ." You did not implement your procedure for determining when an event = meets=20 the criteria for MDR reporting.

We have reviewed your response and have concluded that your = response is=20 inadequate. You will be conducting a retrospective review of all = complaint=20 records for the past 2 years (June 2006 to May 2008) associated with = PACS and=20 Perinatal to re-evaluate MDR reportability for adverse events or = reportable=20 malfunctions. The review will be completed by August 31, 2008. Please = submit=20 the retrospective review for our review.

10. Failure to submit a written report to FDA of any correction or = removal=20 of a device initiated by such manufacturer or importer to remedy a = violation=20 of the act caused by the device which may present a risk to health, as = required by 21 CFR 806.10(a)(2). For example, your correction to apply = a=20 software patch for the Centricity Perinatal Monitoring System problem = of=20 non-identifiable patient information being added to an incorrect file = was not=20 reported to FDA. A letter describing this issue was sent to customers = on July=20 20, 2007, and patches are available beginning in August 2007.

11. Failure to submit a written report (within 10 days) to FDA of = any=20 correction or removal of a device initiated by a manufacturer, as = required by=20 21 CFR 806.10(b).

For example:

a. Correction and Removal report 3004526608-4/17/08-002-C for AW = Suite=20 version 2.0.1 was reported to FDA on April 21, 2008, although AW = Suite 2.0.1=20 was approved for release in October 2007. A notification to = customers=20 regarding the safety issues corrected in AW Suite version 2.0.1 was = not=20 issued at the time of release. The safety issues included Advanced = Vessel=20 Analysis (AVA) incorrect tracking and measurement and AVA measure = not=20 updated after editing the centerline.

b. Correction and Removal report 3004526608-05/06/08-003-C was = reported=20 to FDA on May 6, 2008, for a patient safety issue involving = incorrect study=20 date and time information being displayed in the Centricity PACS = software.=20 The Field Modification Instruction (FMI) Development and Deployment = Plan for=20 this issue was approved as a Mandatory Safety FMI in December 2007.=20

12. Failure to keep a record of justification for not reporting the = correction or removal action to FDA, as required by 21 CFR 806.20. For = example, your correction to apply a software patch for the Centricity=20 Perinatal Monitoring System problem of non-identifiable patient = information=20 being added to an incorrect file was not reported to FDA. There was no = justification in the record for why this correction was not reported = to FDA.=20

We have reviewed your response and have concluded that your = response is=20 inadequate. Your response states that you will conduct a retrospective = review=20 of product releases (e.g., patches, maintenance releases, service = packs, new=20 product introduction) distributed to the field for PACS and Perinatal = products=20 over the past 2 years (June 2006 to May 2008) to determine if there = are=20 additional field actions that should have been reported to FDA as = Corrections=20 and Removals and were not. The review will be completed by August 31, = 2008.=20 Please submit the retrospective review for our review. =

You should take prompt action to correct these deviations and to = establish=20 procedures to prevent their recurrence. Failure to promptly correct = these=20 deviations may result in FDA initiating regulatory action without = further=20 notice, including but not limited to, seizure, injunction, and/or civil = money=20 penalties. Also, federal agencies are advised of the issuance of all = Warning=20 Letters about devices so that they may take this information into = account when=20 considering the award of contracts. Additionally, premarket approval=20 applications for Class III devices to which the Quality System = Regulation=20 deviations are reasonably related will not be approved until the = violations have=20 been corrected. Requests for Certificates to Foreign Governments will = not be=20 granted until the violations related to the subject devices have been = corrected.=20

Please notify this office, in writing, within 15 working days of = receipt of=20 this letter of the specific steps you have taken to correct the = violations,=20 including:

=95 An explanation of your plan to prevent these violations from = recurring.=20
=95 Any documentation of the corrective actions you have taken. =
=95 An=20 explanation of each step being taken to identify and make corrections = to any=20 underlying systems problems necessary to assure that similar = violations will=20 not recur.
=95 A timetable for implementation of corrective = actions. If they=20 will not be completed within 15 working days, state the reason for the = delay=20 and the timetable for completing the corrective actions. =

Finally, you should know that this letter is not intended to be an=20 all-inclusive list of the violations at your facility. It is your = responsibility=20 to ensure compliance with applicable laws and regulations administered = by FDA.=20 The specific violations noted in this letter and in the Inspectional=20 Observations, Form FDA-483, issued at the closeout of the inspection may = be=20 symptomatic of serious problems in your firm's manufacturing and quality = assurance systems. You should investigate and determine the causes of = the=20 violations, and take prompt actions to correct the violations and to = bring your=20 products into compliance:

Please address your written response to Lorelei Jarrell, Compliance = Officer,=20 Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, = IL=20 60661. If you have any questions about the content of this letter, = please=20 contact Ms. Jarrell at 312-596-4216.

Sincerely,

/S/

Scott J. Maclntire
District Director

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FDA/Freedom=20 of Information

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