Servicing is a functional requirement, mandated by the Quality System Regulation (QSR), and often overlooked by device manufacturers. Granted, 21 CFR, Part 820.200 is often associated with capital equipment; however, manufacturers of disposable medical devices still must consider the requirement.

As with all aspects of the QSR, a written procedure is required, delineating a device manufacturer’s steps for compliance with the requirement. If servicing is not relevant for the device manufacturer, written rationale as to why servicing is not a requirement should still be generated.

As many of you already know, Dr. D is always preaching to the choir in regards to compliance. The doctor, being a precentor (look-it up) of compliance to regulations for the medical device industry, strongly believes in the need for well-written procedures and written rationales to support ongoing compliance to the QSR and other mandated regulatory requirements, required to participate in the device industry. Written procedures supporting compliance with the mandated industry regulations should be considered the price of admission.

Warning letter violations
Dr. D spent a significant amount of time searching FDA’s warning-letter database in search of enforcement actions depicting compliance issues due to servicing. I was able to locate two violators of the QSR, with each being duly rewarded with a warning letter. Each violator had one common problem: failure to establish and maintain procedures. Device manufacturers need to remember that it is an ineluctable (look-it up if you must) fact that you will receive Form 483s and potentially warning letters for not establishing procedures. As Dr. D has often stated, compliance to DG Rule # 6 is not an option; “All procedures, work instructions, drawings, specifications, etc. must be written, well-documented, and controlled within a defined document control system.”

The second warning-letter recipient clearly endeared their organization with the agency, as evidenced by two of their ten observations, noted in the warning letter, rooted in servicing issues. Not only did this device manufacturer fail to establish procedures for servicing, the servicing reports being collected from the field were not being appropriately analyzed employing statistical techniques. Although the doctor has not leaped onto his soapbox too much in regards to the importance of analyzing collected data, what is the point of data collection if the results are not analyzed, trended, and if necessary, do not drive change?

Warning letter One (June 2010): Observation 5 of 6 – Failure to establish Servicing procedures as required by 21 CFR 820.00(a). Specially, your service manual does not address issues related to software failures.

Warning Letter Two (May 2009): Observation 7 of 10 – Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets specified requirements, as required by 21 CFR 820.200(a). Specifically, your firm does not have any procedures for servicing.

Observation 8 of 10 – Failure to analyze service reports with appropriate statistical methodology, as required by 21 CFR 820.200(b). Specifically, your firm does, not have any procedures for analyzing service reports. In addition, the service reports were not analyzed following appropriate statistical methods.

Quality System Regulation – 21 CFR, Part 820
QSR – Subpart N – Servicing
Section 820.200 Servicing

(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.

(b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with 820.100.

(c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of 820.198.

(d) Service reports shall be documented and shall include:

1. The name of the device serviced;
2. Any device identification(s) and control number(s) used;
3. The date of service;
4. The individual(s) servicing the device;
5. The service performed; and
6. The test and inspection data. 

Servicing
Not wanting to state the obvious but obliged to do so, section 820.200 is divided into four subsections (a through d). In the eyes of FDA, there is sufficient granularity delineated within the servicing section for device manufacturers to develop a procedure, or if necessary, a set of procedures, incorporating servicing into their quality model. Remember, depending on the nature of the device being distributed into the US markets, a full-blown procedure may not be required; however, device manufacturers are compelled to at least develop a procedure and written rationale as to why the servicing requirement is not relevant to their business model. Dr. D strongly believes that there are no such animals as minimum-level of compliance or maximum-level of compliance. There is only compliance, period!

Establish and maintain instructions and procedures
The first section of the servicing requirement defines the necessity for device manufacturers to establish servicing, with the caveat that states, “Where servicing is a specific requirement.” As Dr. D stated in the previous section establishing procedures is a salient requirement. Even though the agency has given device manufacturers the proverbial “get-out-of-jail free card” a written procedure, albeit brief, is strongly recommended for device manufacturers that claim servicing is not specific requirement. One of Dr. D’s favorite mantras is and will continue to be; “documented evidence of compliance is a device manufacturer’s best defense during an FDA inspection.”

Not wanting to state the obvious but obliged to do so, section 820.200 is divided into four subsections (a through d). In the eyes of FDA, there is sufficient granularity delineated within the servicing section for device manufacturers to develop a procedure, or if necessary, a set of procedures, incorporating servicing into their quality model. Remember, depending on the nature of the device being distributed into the US markets, a full-blown procedure may not be required; however, device manufacturers are compelled to at least develop a procedure and written rationale as to why the servicing requirement is not relevant to their business model. Dr. D strongly believes that there are no such animals as minimum-level of compliance or maximum-level of compliance. There is only compliance, period!The first section of the servicing requirement defines the necessity for device manufacturers to establish servicing, with the caveat that states, “Where servicing is a specific requirement.” As Dr. D stated in the previous section establishing procedures is a salient requirement. Even though the agency has given device manufacturers the proverbial “get-out-of-jail free card” a written procedure, albeit brief, is strongly recommended for device manufacturers that claim servicing is not specific requirement. One of Dr. D’s favorite mantras is and will continue to be; “documented evidence of compliance is a device manufacturer’s best defense during an FDA inspection.”

Analyze service reports
The second salient requirement of the servicing regulation is the actual analysis of the service reports employing recognized statistical methodologies. The bottom-line requirement for service reports is extremely elementary. The reports contain data; and data screams to be analyzed. Besides, who wants to sit across from your friendly FDA investigator and attempt to explain that your organization collected data just for the sake of having data? What would be the point? Exactly, there would be no point, so just be prepared to ask, where do I sign the Form 483.

Event reporting
The third salient requirement of the servicing regulation is that, if during the review of a service report it has been determined an adverse event has occurred (serious patient injury or death) the servicing record needs to be captured and recorded as a complaint that is reportable. Complaints shall be managed in accordance with 820.198. If you need a refresher on complaint management requirements, Dr. D would like to suggest rereading the previous three editions of DG, which delineated the requirements of an effective complaint-management system. Additionally, servicing records logged as complaints, and where the adverse events are deemed reportable, the events shall be reported to the agency in accordance with 21 CFR, Part 803. The form employed for reporting adverse events, Form 3500(a) can be downloaded from FDA’s website. Furthermore, electronic reporting is now the preferred methodology of the agency.

Service reports
Similar to other record requirements associated with the QSR, there are specific deliverables associated with service reports. The QSR mandates that at least six (6) pieces of information be collected and retained as part of ongoing compliance with the servicing requirements. These salient pieces of information are:

1. The actual name of the device that was serviced (preferably the registered legal name);
2. Device identification and control number (e.g., unit serial number);
3. The date the service was actually performed (self explanatory – the doctor hopes);
4. The name of the individual performing the service (recommend capturing the name of the individual’s organization if it is different from the manufacturer);
5. The nature of the service performed (self explanatory); and
6. The actual inspection and/or test reports associated with the service (evidence that the service occurred and the piece of equipment is functioning within specification).

Although not specifically delineated within the regulation, Dr. D recommends capturing additional information such as: (a) location of the unit being serviced; (b) reason behind the service call; (c) point of contact; (d) list of components replaced; (e) revision of software loaded; (f) operating hours, if captured by a meter on the piece of equipment being serviced; and (g) if the servicing was being performed during a full or blue moon (just kidding about the moon). These additional pieces of information, specifically information that modifies the as-built or as-shipped configuration should find its way back to the Device History Record (DHR). Additionally, if servicing is being performed to incorporate specific design changes, these should be captured in the Design History File (DHF). Furthermore, make sure these changes have been validated, and received the appropriate level of regulatory review and approval, including FDA, if deemed appropriate.

Takeaways
One of the reason the QSR has a servicing requirement, other than the obvious patient and user safety and efficacy, is to protect end users from the infamous red-light guarantee, a.k.a., as long as you see the red-tail lights of the shipping truck, the equipment is guaranteed to function. All kidding aside, it really is a mission critical assignment to provide adequate servicing for equipment deployed in healthcare facilities, while ensuring all of the relevant servicing activities are recorded, tracked trended, analyzed, etc.

Additionally, keeping track of changes to configuration becomes a daunting task if record keeping is poor. Dr. D has first hand experience in executing recalls (there is that dirty six-letter word again), because inadequate servicing records placed into question the actual configuration of equipment released into distribution. The root of the recall was nestled in record accuracy and ineffective management of service records. That said, unlike tossing a hand grenade, or the cliché “close but no cigars” record accuracy counts.

In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG, when I begin providing guidance for Subpart – O (Statistical Techniques), specifically 820.250 – cheers from Dr. D. and best wishes for continued professional success.

References:

1. Code of Federal Regulation. (2010, April). Title 21 Part 803: Medical device reporting. Washington, D.C.: U. S. Government Printing Office.
2. Code of Federal Regulation. (2010, April). Title 21 Part 820: Quality system regulation.     Washington, D.C.: U. S. Government Printing Office.
3. Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ. 
4. FDA – U.S. Food and Drug Administration Website. (2010). Warning letters. Retrieved November 12, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/