Hello everyone and welcome back to another week of MedTech Compliance Chronicles! We are slowly but surely winding down on the QMS requirements, a massive accomplishment on the path to bringing a new medical device to market. This week we will be covering a few final production requirements that are not on their own enough for a whole post but also cannot be ignored. Today’s post will cover general process requirements, storage handling and distribution and installation and servicing. Essentially, what’s left at this point before you can go ahead and start producing your product is working out the general requirements for all processes (not just the ones that needed validation that we discussed in last week’s post), as well as requirements around the preservation of the product, and its safety and efficacy throughout the supply chain.
General Process Requirements
While we have covered many process requirements in the posts about the process approach and process validation, there are some general requirements from the US FDA for all processes within the QMS. For the most part, these general requirements encompass having a documented procedure for how to perform each process and verifying the output of processes. The former being a pretty simple concept, you need to have a controlled (meaning it has gone through the whole document control process) procedure, often called a work instruction or work aid in this application, that details to the person performing the process the steps that need to be taken in order to produce acceptable results. While there are no strict requirements on how these instructional procedures should be made, every effort should be made to ensure that they are as simple and easy to understand as possible. Ideally, a person knowledgeable in the trade should be able to pick up the document and perform the process and produce an acceptable result with little to no comments or questions to the person who wrote the procedure. Some tips for making sure your procedures are clear and consistently understood are to use simplified technical English (if the language of the procedures is English) and to include no more than one action in each step. For example, if an assembly process requires that a part is first fitted to another part via a snap-fit application and then permanently fixed via a screw, these should be two separate steps in the procedure.
The other general requirement for all processes in the QMS is that their outputs be verified. This might have been implied in the process validation requirements but the FDA also clearly states that manufacturer’s must ensure that requirements for in-process product are met. If a process is not validated, the outputs of that process must be verified to meet their requirements. The in-process (not finished goods) verification activities are your routine inspection/testing that is done throughout production. You must retain some type of evidence that all of the identified inspection/testing was completed and that only product that was found acceptable was forwarded to the next process. There are a couple additional requirements around final release or release of a finished device for distribution. These involve verifying that all of the activities identified in the Device Master Record (DMR) have been completed and performing a complete documentation review for the associated device/lot or batch of devices. The device’s labeling shall also be inspected here to verify the accuracy of its information.
Storage, Handling and Distribution
Storage, handling and distribution requirements can vary quite significantly from product to product. For this reason, the actual regulations limit their verbiage to simply require that the manufacturer “ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur” during storage, handling or distribution and that only devices which have passed all acceptance activities are approved for distribution. Because these requirements are vague and usually on the organization producing the device to determine, I will use the remainder of this section to go over some examples of these types of requirements that an organization might need to consider.
Temperature sensitive devices, such as biological implants or chemical compounds might specify upper and/or lower limits on the storage temperature they can be subjected to and an organization might provide evidence that their storage conditions meet such requirements by keeping data loggers that constantly maintain temperature data for the storage locations. Sensitive electronic devices, such as pacemakers or PCB components might require electrostatic discharge (ESD) safe packaging and specific handling instructions to only be removed from their packaging in an ESD safe environment. Large or heavy devices, such as MRI machines or hospital beds could include instructions to use special equipment or a minimum number of people to move them. Similarly, smaller or lightweight devices might require a more robust packaging design to protect them during shipment.
Regardless of what your device is, you must identify its requirements around storage, handling and distribution. You must then take action to ensure these requirements are met and design appropriate packaging for these conditions. Finally, you must keep evidence that these conditions are consistently met in the facility.
Installation and Servicing
It is up to the organization to determine if their device requires installation or servicing. These requirements are not applicable to many medical devices. Installation refers to the process of setting up and configuring medical devices at their location of use. This could include assembling complex machinery, connecting system components, calibrating devices to ensure they meet specific medical standards, and/or integrating them into existing healthcare infrastructure. Servicing involves the maintenance, repair and general upkeep of medical devices to ensure they function correctly throughout their lifecycle. This includes routine checks, updates and repairs of the device, and may often involve software updates, hardware replacements, troubleshooting, and technical support.
If your device requires installation and/or servicing you must establish and maintain procedures for how to perform these activities as well as acceptance criteria for verifying that they have been performed properly. Many organizations, particularly smaller organizations or foreign organizations, do not perform installation or servicing of their devices themselves. When this route is chosen, you typically have three options; have the customer perform the installation, enter an agreement with another organization to be a supplier of installation and servicing services or allow any qualified third party to perform the installation (i.e., your requirements would be something like “any electrician certified with local ordinances can install the device”). In these situations however, you must ensure that you provide all of the necessary instructions for how to perform the pertinent activities to the party performing them. Another important requirement regarding servicing specifically is that all service requests must be analyzed to determine if the request or event surrounding the request constitutes a complaint or adverse event. You must also maintain detailed records of all installation and servicing activities which are performed by your organization or a supplier, including the results of acceptance inspection/tests performed to verify the device’s adequacy for use post installation/servicing.
Conclusion
With this post, combined with the previous few posts, you should now have an understanding of the product realization process for medical devices. You should now know what the general requirements for all processes in your QMS are. You should know that you must not just consider making the device but also consider how to deliver it in working condition. Finally, you should consider if your device is one that will require installation and servicing activities and, if it is, define and record these activities just as you do with your other QMS processes.
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