What, No Installation Records?
Violation of §820.170 (Installation) is one of the seldom-cited violations of the quality system regulation, in Dr. D’s humble opinion, of course. The doctor believes it is just common sense to think that all activities associated with the installation of medical equipment should probably be documented. In fact, the old doc thinks that corporate legal strongly believes that installation activities should be documented just in case Mr. Murphy decides to make a grand appearance when recently installed medical equipment is powered on for the first time. Can you say blue smoke generator? Seriously, our dear friends from FDA expect installation activities to be properly documented; and when medical equipment malfunctions, adverse events are quickly reported in accordance with Part 803 requirements (Medical Device Reporting). Dr. D cannot fathom the uncomfortable position a Chief Jailable Officer (CJO) is placed, when sitting across from an investigator from the FDA, while attempting to explain why installation records associated with their establishment’s equipment are not being properly completed and retained. Such lapses in compliance are just begging for a form 483 observation, which happened to be the case for the device establishment referenced in this week’s guidance. No CJO wants to be forced into providing a jumble of non-sequiturs (look-it-up) when tasked with having to defend a lapse in compliance. Enjoy!
Warning Letter – September 20, 2017
As Dr. D has mentioned on multiple occasions, there really is no magic associated with the agency’s decision-making process when it comes to the issuance of a warning letter. Several form 483 observations, coupled with less than adequate responses, observations made against medical device reporting, and device recalls (Dr. D’s nasty 6-letter word), and the offending establishment will find itself on the fast-track toward receiving that prized agency warning letter. The offending establishment mentioned in this week’s guidance had all of the key ingredients: (a) 9 observations, (b) 8 not adequate responses, (c) one observation citing issues with the medical device reporting process and (d) one observation citing issues with the correction and removal process. On a positive note, these issues can be corrected and the offending establishment moved back into the good graces of FDA. However, it will take some old-fashioned elbow grease to make it happen.
Warning Letter Excerpt
Observation Six (6) “Failure to adequately establish and maintain procedures for installation and inspection instructions, and where appropriate, test procedures as required by 21 CFR 820.170(a). For example, your firm did not follow its own procedure, P65, “Installation and qualification of devices”, (multiple version reviewed) which states that service personnel (distributors) should fill out and return completed installation and qualification reports after installation of an automatic analyzer (i.e. Redacted Product Name, etc.). Since 2011, out of the (b)(4)(Redacted Product Name) installed in the United States by your firm’s sister site, only (b)(4) installation and qualification reports were returned. Your firm’s System Support Manager confirmed that installation/qualification reports for these units installed in the United States market were not always returned.
Your firm’s response dated April 19, 2017, is not adequate. Your firm provided a draft Remediation Plan (Gantt chart) outlining task and stated that you will provide detailed responses by Observation, with supporting documentation, approximately on a monthly basis. However, to date, no response or documentation has been submitted. Your firm’s response(s) should include a description and evidence of implementation of corrections and corrective actions, which must consider systemic problems, to address this observation.
21 CFR, Part 820.170 – Installation
“(a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device.”
“(b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer’s instructions and procedures and shall document the inspection and any test results to demonstrate proper installation.”
Compliance for Dummies
It is imperative that all installation activities performed in the United States and places outside of the United States (other regulatory environments) be properly documented. Yes, device establishments routinely retain service organizations to perform these activities. However, it is incumbent upon the device establishment that owns the regulatory responsibility to ensure adequate installation instructions are created and the service organizations performing installation activities are appropriately trained and qualified. Can you say written installation instructions?
Simply stated, the FDA expects to see device establishments adhere to the following bulleted points, as they apply to the installation of medical device equipment.
- Written installation procedures are required for all installation activities. This applies to the device establishment and their service company, should a service company be retained.
- Written preventive maintenance (PM) instructions are required, should routine PMs be required to keep the installed equipment operational.
- A written user’s manual is required (instructions for use) to ensure all users understand the operational parameters of the installed equipment.
- A written procedure that includes reporting requirements is required, should a serious adverse event occur during the employment of installed medical equipment.
- A written procedure that includes the addressing of corrections and removals of installed medical equipment is required, should a field action become necessary. Please ensure that the procedure includes advisory notices.
- Finally, all records associated with the installed medical equipment need to be retained. Most device establishments retain the installation, PM (servicing records) in the equipment’s device history record (DHR). However, as long as it is retained and retrievable upon request, our dear friends from the agency will remain happy.
Takeaways
For this week’s guidance, the doctor will leave the readers with just one takeaway. Installed medical equipment is still a medical device and as such, all aspects of the QSR will apply. Regardless of whether the installation and servicing activities are performed by the manufacturer or their servicing supplier, everything shall be documented in writing. Why? Because if an event or activity is not documented in writing, it never happened in the eyes of FDA. In closing, thank you again for joining Dr. D, and the doctor hopes you found value (and some humor) in the guidance provided. Until the next installment of DG, cheers from Dr. D. and best wishes for continued professional success.
References
- Code of Federal Regulation. (April 2017). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (September 2017). ELITech Group B.V. 9/20/17. Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed December 11, 2017.Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm581033.htm
Related Articles
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
-
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
-
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
