Inspections, Compliance, Enforcement, and Criminal Investigations
Hill-Rom, Inc. 15-Jan-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
January 15, 2008
President and CEO
1069 State Route 46E
Batesville, Indiana 47006-9167
Dear Mr. Soderberg:
During an inspection of your firm located in Batesville, Indiana on May 29, 2007 through June 21, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures VersaCare Beds models P3200 and P3201. 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.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received two responses from [redacted] and [redacted] dated July 2, 2007, and October 2, 2007, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example: your firm determined that a modification of design of the latching mechanism was required as a corrective action to fix an unacceptable latch failure rate in the field (CAPA00825). According to your firm's associated Field Action
Assessment/Health Hazard Evaluation #2005-028, the total quantity of affected VersaCare Hospital Beds in distribution is [redacted] However of the [redacted] beds in global distribution, only [redacted] beds had been corrected as of July 25, 2007 (Recall Z-0240-2008).
According to your firm's Field Action Assessment/Health Hazard Evaluation #2005-028, there were no plans to notify consignees of the potential health hazard (Section F, Step 3) and no plans to perform a field correction of all affected units (Section G, Step 2) even though a design change of the latching mechanism was performed to mitigate what you admit is "an unacceptable failure rate in the field" (CAPA00825).
Upon determining that a design change was in order to mitigate a potential health hazard, all [redacted] affected units should have been corrected, not only those beds that field sales and marketing management decided should be corrected. Your firm's reasoning for not performing a field correction of all affected units is stated in Field Action Assessment/Health Hazard Evaluation #2005-028, "Non-latching of the VersaCare side rail is a customer satisfaction issue" (Section A, Step 7). This summary and conclusion is inadequate to address a potential risk to health.
The Office of Compliance has reviewed your response, dated July 2, 2007, which was intended to address Observation 2 of the FDA 483 given to your firm at the conclusion of the June 21, 2007 FDA inspection, Your response to this observation was determined to be inadequate because your firm did not fully implement CAPA00825 as required by 21 CFR 820.100(a). Your firm redesigned the malfunctioning latching mechanism; however your firm did not implement this design change into all affected devices.
The Office of Compliance has also reviewed your response, dated October 2, 2007, which was intended to update your. July 2, 2007, response to Observation 2 of the FDA 483 given to your firm At the conclusion of the June 21, 2007 FDA inspection. Your response included a proposed device correction plan for the Hill-Rom VersaCare beds manufactured prior to January 26, 2006. This proposed device correction plan appears to be adequate in addressing corrections to all [redacted] affected devices in distribution globally.
2. Failure to establish and maintain adequate procedures for reviewing and evaluating complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications as required by 21 CFR 820.198(c).
For example: your firm marked complaints out of [redacted] complaints received for the VersaCare, TotalCare and Affinity hospital beds within a two year period as
"AdminFixNotKnown", failing to fully review, evaluate and investigate these complaints. Two examples of your finn not reviewing, evaluating and investigating complaints, are complaints [redacted] and [redacted] Your firm received an oral report of a malfunctioning bed, your firm then provided some initial guidance in fixing the malfunction but failed to evaluate or investigate the malfunction. Your firm attempted to call the complainant two times, on the same day, and after no response, closed the complaint.
We have reviewed your response and have concluded that it is inadequate because, even though your firm stated that "we will begin immediately to include trending complaints that fall within the 'AdminFixNotKnown' category" (Page 9, paragraph 7, sentence 4) there was no evidence provided that this trending is in fact occurring as well as no evidence provided of revised procedures.
Our inspection also revealed that your VersaCare Beds models P3200 and P3201 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 MR) regulation. Significant deviations include, but are not limited to, the following:
Failure to report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur as required by 21 CFR 803.50(a)(2):
For example: your firm received a report on March 9, 2007, (Hill-Rom Complaint No. 0000485937) of a patient falling out of the VersaCare Bed on February 21, 2007; due to a siderail moving downward resulting in a serious injury. Your firm failed to report to the FDA within 30 days of receipt of complaints of malfunctions of the Hill-Rom VersaCare Bed that could have resulted in similar injuries received after March 9, 2007. There are at least 140 of these malfunctions which should have been reported in accordance with 21 CFR 803.50(a)(2).
We have reviewed your response and have concluded that it is inadequate because your firm has a responsibility to report malfunctions to FDA within 30 days of receipt of complaints of malfunctions as outlined in 21 CFR 803.50(a) and there has been no evidence presented that would mitigate this responsibility. In your response letter, your firm states that "no latching" and "false latching" are two separate issues and the 140 malfunctions which were not reported were "no latching" malfunction reports. Based on our review of the record, the same device design feature resulted in both the total and partial failures to latch. You determined that the same repair would fix both total and partial failures to latch. Therefore, these types of malfunctions are inseparable and should have been reported as MDRs.
Our inspection also revealed that your VersaCare Beds models P3200 and P3201 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 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:
Failure to submit a written report to FDA of any correction or removal of a device to reduce a risk to health posed by the device as required by 21 CFR 806.10(a)(1).
For example: your firm failed to report [redacted] corrective actions of the Hill-Rom VersaCare Bed to FDA. These corrections reduced the risk to health posed by the VersaCare Bed. After further evaluation, the Office of Compliance within the Food and Drug Administration's Center for Devices and Radiological Health has classified your correction as a Class II recall indicating a situation in which use of, or exposure to the violative product, the Hill-Rom VersaCare Bed, may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
We have reviewed your response and have concluded that it is inadequate because your firm received approximately [redacted] latch malfunction complaints since manufacture of this device began in 2004 and your firm performed these [redacted] corrections that reduced the risk of the device. If a patient were to fall from the VersaCare Beds models P3200 and P3201, this incident may cause temporary or medically reversible adverse health consequences indicative of a Class II recall as defined in 21 CFR 7.3(m)(2)
Failure to submit any report required by 21 CFR 806.10(a) within 10-working days of initiating such correction or removal, as required by 21 CFR 806.10(b).
For example: Your firm initiated a recall on September 6, 2007 of the Hill-Rom [redacted] due to the bed brakes having the potential to not hold or lock properly. Your firm failed to report a recall of the Hi1l-Rom [redacted] Model P3700 within 10 days. FDA's Detroit District Office was not made aware of this recall by your firm until November 8, 2007.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations. are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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(s), or similar violation(s), 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 reply should be directed to Paige E. Wilson, Compliance Officer at the-above address.
Finally, you should know that this letter is not, intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Joann M. Givens
Detroit District Office