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Manufacturer Responsibility (vs. User/Customer) for Preventive Maintenance/Repair

E

Embryo

#1
I represent an organization that develop, manufacture and service medical devices that require regular preventive maintenance to perform as intended. We have an internal service department that perform preventive maintenance and repair as required by the plan defined in the service manual for the device.

We are expanding sales to areas of the world where we have no representation and work together with distributors. The distributors have service technicians of their own that we, through extensive training, ensure can perform preventive maintenance and repair devices in the area of responsibility for the respective distributor. Should these distributors be considered as an organization to which we have outsourced a process (potentially affecting product quality) and therefore need to be on the approved suppliers list?

We review service reports from our distributor for potential complaints as we do for the service reports we generate internally.

We are now in the situation where a number of customers do not wish to pay (the annual fee) for the preventive maintenance program that we offer them (and in some countries, through our distributors); they think it is too expensive. It is our understanding that we are required to provide the customer with a service manual so that they, in theory, can perform preventive maintenance themselves (with the original spare parts that we can’t refuse to sell to them).

The question is what obligations we as a medical device manufacturer have in the situation above with customers not willing to pay for preventive maintenance. We don’t expect to receive any documentation (service reports etc.) from customers that are not covered by a service contract. In reality, it is their property and they may use it as they wish (or at least it is our opinion that we can't be responsible). In the user manual we state that preventive maintenance and repair has to be performed by certified service technicians. Are we expected to do more?

Can we be criticized (e.g. during an audit/inspection by our Notified Body or the FDA) for not having a system in place to review for example the service reports (that we are not sure even exist since we do not perform preventive maintenance)?

Your input is much appreciated!
 

Ronen E

Problem Solver
Staff member
Moderator
#2
Should these distributors be considered as an organization to which we have outsourced a process (potentially affecting product quality) and therefore need to be on the approved suppliers list?
Yes.

To the rest of your questions - if you clearly stated that the device requires service by qualified technicians (and explained what that means / how to get it right), and made every reasonable effort to make the users aware of that, yet they choose to ignore it - this would become "Abnormal Use", which is - in my understanding - the user's responsibility, from a medical devices regulatory perspective. Your job is to clarify the intended use, and support those who want to comply, in a reasonable way.

I'm not a legal practitioner and not sure what the answer is from a liability perspective. This would also naturally depend on laws of the country where the device in question is being used. You need to ask the lawyers about that.

Cheers,
Ronen.
 
E

Embryo

#3
Many thanks for the input; another question on the same topic:

How should the requirement to review service reports be interpreted?

I guess it is obvious that you should review your "own" service reports, i.e service reports from technicians within your own organisation. But what about service reports from other organisations servicing your products when they are installed at the customer site? During a warranty period we as a manufacturer are obliged to perform preventive maintenance on our products (and can outsource this to a certified distributor working in accordance with our procedures), but after the warranty period the customer typically has to pay for preventive maintenance. What if we have an agreement with a distributor (after the warranty period) stating that they may perform preventive mainenance, provided they source spare parts from us and only allow (from us) certificed technicians to perform preventive maintenance? Are we required to review these service reports? We have no contractual agreement with the user (the maintenance agreement is between the distributor and the user) and have no immediate insight into when and if at all preventive maintenance is performed.

I assume that there must be a clear answer to this since I can't imagine that we are the first organisation facing this situation and that other organisations have received clear feedback from the FDA and alike.

As always, your input is much appreciated!
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Many thanks for the input; another question on the same topic:

How should the requirement to review service reports be interpreted?

I guess it is obvious that you should review your "own" service reports, i.e service reports from technicians within your own organisation. But what about service reports from other organisations servicing your products when they are installed at the customer site? During a warranty period we as a manufacturer are obliged to perform preventive maintenance on our products (and can outsource this to a certified distributor working in accordance with our procedures), but after the warranty period the customer typically has to pay for preventive maintenance. What if we have an agreement with a distributor (after the warranty period) stating that they may perform preventive mainenance, provided they source spare parts from us and only allow (from us) certificed technicians to perform preventive maintenance? Are we required to review these service reports? We have no contractual agreement with the user (the maintenance agreement is between the distributor and the user) and have no immediate insight into when and if at all preventive maintenance is performed.

I assume that there must be a clear answer to this since I can't imagine that we are the first organisation facing this situation and that other organisations have received clear feedback from the FDA and alike.

As always, your input is much appreciated!
Hi,

I'm assuming you are referring to 21 CFR 820.200 (b):

Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with 820.100.
As far as I understand there is no explicit requirement regarding the (proactive) collection of service reports not generated by the device manufacturer or on their behalf.

Cheers,
Ronen.
 
M

maaquilino

#5
Many thanks for the input; another question on the same topic:

How should the requirement to review service reports be interpreted?

I guess it is obvious that you should review your "own" service reports, i.e service reports from technicians within your own organisation. But what about service reports from other organisations servicing your products when they are installed at the customer site? During a warranty period we as a manufacturer are obliged to perform preventive maintenance on our products (and can outsource this to a certified distributor working in accordance with our procedures), but after the warranty period the customer typically has to pay for preventive maintenance. What if we have an agreement with a distributor (after the warranty period) stating that they may perform preventive mainenance, provided they source spare parts from us and only allow (from us) certificed technicians to perform preventive maintenance? Are we required to review these service reports? We have no contractual agreement with the user (the maintenance agreement is between the distributor and the user) and have no immediate insight into when and if at all preventive maintenance is performed.

I assume that there must be a clear answer to this since I can't imagine that we are the first organisation facing this situation and that other organisations have received clear feedback from the FDA and alike.

As always, your input is much appreciated!
Also, as a manufacturer, you are responsible for your device compliance, and your distributor (whom the FDA also considers a ‘manufacturer’) must also follow comply with regulations – if the distributor doesn’t, you as the device manufacturer are still responsible for ensuring compliance. One example is traceability; you must have it in case you need to recall your device, so the distributor must have it – or you need to beef up your own processes to ensure it - so you know who they sold it to.

If you have a contract with a distributor, where they have to source parts from you and only allow your certified technicians to perform PM, then I think it would benefit you to review service reports from this distributor. It seems to me that doing this would help you to know what problems your devices may be having, which if you didn’t review these reports, you wouldn’t know about.

If a customer chooses to not buy your service package, there’s not a lot you can do about it…and according to the info from CFR 820’s preamble, you’re not responsible for them if they don’t buy it. So if you don’t have a contract with your distributor to use your parts and technicians, then you don’t have to review any service parts form customers who don’t purchase your service contract, or the distributors service contract.

The FDA has stated they are going to have a separate Rule for persons who perform servicing and refurbishing functions outside the control of the original manufacturer, though I haven’t been able to find that Rule. I posted the pertinent comments below so you didn’t have to look them up, along with a link to CFR 820 with the preamble, and a link to FDA proposed documents. Hope this helps!

Site to lookup proposed docs/changes to docs
http://www.regulations.gov/#!home

CFR 820 with preamble – I did searches using the words: maintenance, service, and distributor
http://www.fda.gov/MedicalDevices/D...ments/QualitySystemsRegulations/ucm230127.htm

Several comments in response to the proposed definition of ‘‘manufacturer’’ stated that refurbishers and servicers should be added to the definition of a ‘‘manufacturer.’’ Other comments recommended adding the term ‘‘remanufacturer.’’ Other comments requested deletion of contract sterilizers, installers, specification developers, repackagers, relabelers, and initial distributors from the definition.
One comment stated that the phrase ‘‘processes a finished device’’ should be explained in the definition of manufacturer. FDA’s Compliance Policy Guide (CPG) 7124.28 contains the agency’s policy regarding the provisions of the act and regulations with which persons who recondition or rebuild used devices are expected to comply. This CPG is in the process of being revised in light of FDA’s experience in this area. FDA is not including the terms ‘‘servicer’’ or ‘‘refurbisher,’’ as they relate to entities outside the control of the original equipment manufacturer, in this final regulation, even though it believes that persons who perform such functions meet the definition of manufacturer. Because of a number of competitive and other issues, including sharply divided views by members of the GMP Advisory Committee at the September 1995 meeting, FDA has elected to address application of the CGMP requirements to persons who perform servicing and refurbishing functions outside the control of the original manufacturer in a separate rulemaking later this year, with another opportunity for public comment. FDA agrees that the term ‘‘remanufacturing’’ should be added to the definition of ‘‘manufacturer’’ and has separately defined the term. A remanufacturer is defined as ‘‘any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.’’ However, FDA disagrees that contract sterilizers, installers, specification developers, repackagers, relabelers, and initial distributors should be deleted from the definition, primarily because all such persons may have a significant effect on the safety and effectiveness of a device and on the public health. All persons who perform these functions meet the definition of manufacturer, and therefore should be inspected to ensure that they are complying with the applicable provisions. For example, a specification developer initiates the design requirements for a device that is manufactured by a second party for subsequent commercial distribution. Such a developer is subject to design controls. Further, those that perform the functions of contract sterilization, installation, relabeling, remanufacturing, and repacking have routinely been considered to be manufacturers under the original CGMP definition, and the agency has treated them as such by inspecting them to ensure that they comply with the appropriate portions of the original CGMP. By explicitly including them in the definition of ‘‘manufacturer’’ the agency has simply codified its longstanding policy and interpretation of the original regulation. The phrase ‘‘processes a finished device’’ applies to a finished device after distribution. Again, this phrase has been part of the CGMP regulation definition of ‘‘manufacturer’’ for 18 years.

40. A few comments stated that including the term ‘‘maintenance’’ in the proposed definition of ‘‘servicing’’ implies that preventative maintenance would be subject to the regulation. Other comments said that it may not be desirable to return old devices or devices that have received field modifications to the original specifications. Therefore, the comments suggested deleting the last part of the definition that states that ‘‘servicing’’ is returning a device to its specifications. FDA has deleted the definition of ‘‘servicing’’ and has not added a definition of ‘‘servicer’’ because this will be covered in the separate rulemaking discussed above. FDA notes, however, that servicing performed by manufacturers and remanufacturers is subject to the requirements in ? 820.200 Servicing. These requirements are a codification of longstanding interpretations of the original CGMP,

N. Servicing (Subpart N) 199. Numerous comments were received on the servicing requirements that were proposed. Many of these comments dealt with competitive issues between manufacturers that perform or contract out their own servicing and third party service organizations. The comments received, as well as the recommendations from the GMP Advisory Committee, were split on many issues. Therefore in this regulation, FDA has chosen to codify only longstanding requirements for servicing performed by original manufacturers and remanufacturers. The requirements in ? 820.200 are similar to those in ISO 9001:1994, with some supplemental requirements for clarification on monitoring service reports, on the relationship of service reports and complaints, and on the type of information FDA believes is essential in any service report. As described above in the definition section of this preamble, a separate rulemaking will specify and clarify the requirements for third party service organizations.

? 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 or 804 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.
 
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