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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Munroe Regional Medical Centre 1/11/10


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  10903 New Hampshire Avenue
Silver Spring, MD 20993

JAN 11 2010


Steve A. Purves
President and CEO
Munroe Regional Medical Center, Inc.
1500 SW 1st Avenue
Ocala, Florida 34474

Dear Mr. Purves:

During an inspection of your firm located in Ocala, Florida on September 14, 15 and 21, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility and is subject to the statutory reporting requirements of the Medical Device Reporting (MDR) regulation, found at Title 21, Code of Federal Regulations (CFR), Part 803.

The EsophyX® devices used at your facility to perform surgical procedures are medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h). The products are devices because they are intended for the use in diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

The inspection revealed that your facility is not in conformance with the MDR regulations found at 21 CFR 803 and the EsophyX® devices used by your facility are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR 803. We received a response from Paul Clark, FACHE, Senior Vice President and Chief Operating Officer; Ben Poole, Director of Risk Management; and Judi Proctor, Director of Materials Management, dated October 7, 2009, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to Mr. Clark. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to develop, maintain, and implement adequate written MDR procedures as requir3d by 21 CFR 803.17.

For example: An incident report (b)(4) filed July 29, 2009 was generated and confirmed an adverse event involving a patient who suffered a torn esophagus during a procedure. Following the event, Munroe transferred the patient by ambulance to another user facility. The employee(s) responsible for submitting the MDR event to the manufacturer subsequently determined that the event was not serious and not reportable, though the decision-making process and final justification was not documented.

We have reviewed your response and have concluded that it is inadequate. The Munroe global policy fails to adequately define a process that would enable your facility to comply with the reporting requirements of 21 CFR 803; including timely and effective communication of events subject to MDR; a standardized review process to determine when an event meets the criteria for reporting; timely transmission of reports; and recordkeeping.  More specifically, there are no internal systems in your revised policy entitled, (b)(4) effective date October 05, 2009, and/or your policy entitled, (b)(4) effective date September 25, 2009, that provide for:

• Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1);
• A standardized review process or procedure for determining when an event meets the criteria for reporting under the MDR regulations, as required by 21 CFR 803.17(a)(2); and
• Timely transmission of complete medical device reports to manufacturers or to FDA, or to both if necessary, as required by 21 CFR 803.17(a)(3).

In addition, there are no documentation and recordkeeping requirements in your procedures listed above, for:

• Information that was evaluated to determine if an event is reportable, as required by 21 CFR 803.17(b)(1).

2. Failure to maintain complete MDR event files that contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making processes used to determine if an device-related event was or was not reportable, as required by 21 CFR 803.18(b)(1)(i).

For example, Incident report (b)(4) dated July 29, 2009, involving a patient suffering a tom esophagus during a surgical procedure using the EsophyX® device at your facility, was not complete. The incident report contains sufficient evidence to reasonably suggest that your facility had become aware of a reportable serious injury event. However, the incident report does not document your deliberations and decision making processes used to determine if the device-related serious injury was or was not reportable, as required by 21 CFR 803.18(b)(1)(i).

We have reviewed your response and have concluded that it is inadequate because your response does not provide specific detail on how your facility has addressed this issue.

3. Failure to submit an MDR adverse event report on a FDA Form 3500A (MEDWATCH form) or an approved electronic equivalent, as approved under 21 CFR 803.14, as required by 21 CFR 803.11.

For example, your facility failed to submit an MDR adverse event report on an FDA Form 3500A (MEDWATCH form) or an approved electronic equivalent to the manufacturer of the EsophyX® device for the event involving a patient suffering a torn esophagus during a surgical procedure using the device.

We have reviewed your response and have concluded that it is inadequate. Your revised (b)(4) policy, dated October 5, 2009, submitted with your response, references only a form for device functions and defects, and fails to account for the complete patient and device information that would be required for submission of a complete FDA Form 3500A. Furthermore, your new and revised documents fail to adequately demonstrate knowledge and understanding of your MDR obligations. Your policy fails to define how to identify an MDR reportable event; fails to define how to appropriately compile a reportable event; fails to provide instruction on collection of data sufficient to complete, when appropriate, an FDA Form 3500A or an authorized electronic equivalent; and fails to clarify when and to whom to send a completed FDA Form 3500A. It also fails to clarify when a report should go only to the manufacturer or go only to FDA or go to both the FDA and to the manufacturer.

It should be noted that on September 23, 2009, two days after completion of the facility inspection, an MDR Policy Specialist from our Office of Surveillance and Biometrics (OSB),
received a phone message from Ms. Dawn Watkins/Munroe Medical Center, seeking MDR reporting guidance. Despite multiple attempts to reach Ms. Watkins (i.e., multiple returned calls, voicemail messages and a call-back phone number), our MDR Policy Specialist never received a call back from Munroe. It remains unclear if the facility understands its reporting obligations. We remain available to provide any support desired.

In addition, we are concerned that you chose to withhold the subject device (the EsophyX®), which was involved in a device-related, serious injury or malfunction, from the manufacturer. The manufacturer was thus prevented from conducting an investigation into the root-cause of the serious adverse event involving their device, as they are required to do in accordance with 21 CFR 820.198(c) and 21 CFR 820.198(d).

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation, or similar violation, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Mr. Paul Tilton, Branch Chief, Obstetric/Gynecology, Gastroenterology & Urology Devices Branch, Division of Enforcement A, Office of Compliance, CDRH, Building 66 - Room 3540, 10903 New Hampshire Avenue, Silver Spring, MD 20993. If you have any questions about the general content of this letter please contact Mr. Tilton at 301-796-5770. Questions specific to the MDR regulation and reporting requirements, may be directed to Ms. Sharon Kapsch, MDR Policy Branch Chief, Division of Post Market Surveillance, Office of Surveillance and Biometrics, at 301-796-6104.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.


Sincerely yours,

Timothy A. Ulatowski
Office of Compliance
Center for Devices and
Radiological Health