Heartsine Technologies Inc 2/3/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19105
Delivered Via United Parcel Service
February 3, 2014
Mr. Declan O’Mahoney, CEO
HeartSine Technologies, Ltd.
203 Airport Road West
Belfast, BT3 9ED
Northern Ireland, United Kingdom
Dear Mr. O’Mahoney:
During an inspection of your firm located in Newtown, Pennsylvania, from August 13, 2013 to August 22, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class III Automatic External Defibrillators (AED) devices, such as the PAD 300P. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the 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.
Our inspection revealed that your Automated External Defibrillator (AED) devices 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 device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803-Medical Device Reporting (MDR) regulation. We have received your responses from (b)(4), dated (b)(4) concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. 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 report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(2). The following examples demonstrate reportable events that were not submitted as MDRs within the required time frame. These examples are not all-inclusive and there may be additional reportable events that your firm failed to report.
For example: Complaints (b)(4) describe a malfunction of the HeartSine Samaritan 300P and Pad Pak that is directly related to an open recall. As such, the complaints meet the criteria for reportability.
We reviewed your firm’s response, dated (b)(4), and conclude that it appears to be adequate.Your firm cited the root cause for late reporting of MDRs as related to (b)(4). Your firm opened a (b)(4) to address corrections, which include (b)(4) cited in the FDA 483 (Observation 5); as well as other corrective actions.
2. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.
For example: After reviewing your firm’s MDR procedure (b)(4), the following issues were noted:
i. Procedure (b)(4) does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a. The procedure omits the definitions for the terms “caused or contributed” and “serious injury”, and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
ii. Procedure (b)(4) does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. The procedure does not include the correct address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
iii. Procedure (b)(4) does not describe how it will address documentation and record-keeping requirements, including:
a. Documentation of adverse event related information maintained as MDR event files.
b. Information that was evaluated to determine if an event was reportable.
c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
Your firm’s procedure includes references to (b)(4). Annual certifications are no longer required and we recommend that all references to an (b)(4) be removed from your firm’s MDR procedure (see: Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting; Annual Certification; Final rule).
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at: ReportabilityReviewTeam@fda.hhs.gov.
Our inspection also revealed that your firm’s Automated External Defibrillator (AED) devices 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 device that is required by or under section 519(e) of the Act, 21 U.S.C. 360e and 21 C.F.R. Part 821 – Medical Device Tracking Requirements. These violations include, but are not limited to, the following:
a. Failure to keep current records containing information, such as name, address, and telephone number of the distributor, patient, or prescribing physician along with the lot number, batch number, or the serial number of the device, on each tracked device released for distribution, as required by 21 C.F.R. 821.25(b). For example, sampling of the records entered in the tracking system database from (b)(4) distributors for your firm’s defibrillator products and accessories revealed serial numbers and lot numbers had been entered under the heading of (b)(4) from various years including (b)(4). Also, your firm’s tracking procedure, (b)(4), document no.(b)(4), only requires distributors to (b)(4) and provide the information upon (b)(4) rather than upon receipt of the device.
b. Failure to conduct tracking system audits at intervals not greater than once every six months for the first three years of distribution and at least once a year thereafter based on a statistically relevant sampling of tracking records, as required by 21 C.F.R. 821.25(c)(3). For example, the documents provided during the inspection indicate that the last audit was performed in (b)(4). No audit information was available for 2013.
Also, the tracking procedure does not define how your firm will:
· assure statistical relevance of its audit process, though its referenced SOP acknowledges the need to do so.
· validate the ongoing accuracy of the data collected and maintained for each tracked device, recipient patient, prescribing physician, physician following the patient, explanting physician, and distributor.
· will test its notification processes to assure that communications about its tracked devices will reach all appropriate recipients.
We have reviewed your firm’s responses, dated (b)(4) and determined that they do not adequately address the requirements of 21 C.F.R. Part 821 – Medical Device Tracking Requirements, as described above.
We have reviewed your firm’s responses to the FDA-483, dated (b)(4), and determined that they appear sufficient to address the Quality System (QS) deficiencies identified on the FDA-483; however we remind you that it is your firm’s responsibility to adhere to its procedures, as well as applicable federal regulations. We also recognize your firm’s voluntary recall (b)(4) associated with the Samaritan 300/300P PAD devices. Your firm’s voluntary corrections will be further evaluated during the next inspection at your facility.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your written response should be sent to Richard C. Cherry, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Mr. Cherry at (215) 717-3075 or e-mail at Richard.Cherry@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Anne E. Johnson
Acting District Director