Sometimes, medical device companies do not handle a complaint correctly. Sometimes they do not follow an adequate design control process or misrepresent their device. Sometimes their packing is missing a compliant IFU.
And then there are times when all of these things are happening at once. Where a medical device company is simply not operating as a medical device company, and from outside appearances you are wondering if the company even knows it is a medical device company.
That is what we will be covering in this week’s Warning Letter of the Week (WLOTW), where we will be reviewing an FDA Warning Letter given to Sea-Long Medical Systems (full Warning Letter).
Sea-Long Medical Systems is a manufacturer of “Treatment Hood(s) .. intended to: provide the use any place that a clinician would normally use a mask for medical purposes of supplying gas/oxygen/air.” During an FDA inspection, the FDA found inadequate procedures in almost every relevant area they inspected.
Let’s dive into the Warning Letter to understand the scope of the issue and try to understand where things went wrong.
Table of Contents
Overview of Warning Letter for Sea-Long Medical Systems
I want to start by being generous to Sea-Long Medical Systems, and saying that I do not believe there was any negative intent or malice from their side. Based on the info provided on their website, it looks like the company was purchased recently by a family that had positive experiences with the products.
My guess is that the new owners most likely have an operations or manufacturing background, but were new to the medical device industry, and did not fully understand their regulatory burden. Based on their view of the product and resources put into their website, I doubt that they would intentionally avoid maintaining a QMS. (Please note that all of this is an assumption and should be considered an opinion).
Now, let’s look through the warning letter to see what I mean when I say they avoided maintaining a QMS.
There are three different sections of FDA violations. The first is the GMP violations related to FDA 21 Part CFR 820, followed by design and misbranding violations, and finally packaging-related violations.
Here are each of the different GMP-related sections that were listed in the Warning Letter:
- Failure to establish and maintain procedures for evaluating complaints by a formally designated unit
- Failure to perform process validation
- Failure to establish design change procedures
- Failure to establish corrective action procedures
- Failure to maintain non-conforming product procedures
- Failure to establish procedures for finished device acceptance
- Failure to document incoming inspections
- Failure to maintain Device Master Records (DMRs)
- Failure to maintain Device History Records (DHRs) for each lot
- Failure to perform internal audits
- Failure to perform Management Review
Phew. That’s a lot. You can go take a drink of water or take a walk around the block if you need.
By their own admission they did not have a functioning QMS in place (per the FDA), “During the inspection, your management stated that your firm has not established any quality system procedures“. It sounds like the FDA could have kept going with their findings, but findings on 11 different areas probably got the point across.
Now, let’s move on to the misbranding and intended use findings.
Per the FDA Warning Letter, Sea-Long Medical Systems did have 510(k) clearance for their product, but with a limited intended use. However, the FDA provided multiple news articles and information from Sea-Long Medical’s website demonstrating that they were advertising their products outside of their approved intended use.
Based on the news articles, a lot of the new intended uses were related to the Covid-19 pandemic, which the FDA takes very seriously. One of the news articles also references how the devices were modified to aid with the pandemic (it’s rough to have NBC advertise your design control violations).
None of the new intended uses were approved by the FDA through a new 510(k) or premarket approval. Therefore, the devices are considered misbranded for these uses, and in violation of FDA regulations.
The last violations were related to the packaging of the devices manufactured by Sea-Long Medical Systems. Specifically, there were no proper plain-text or machine-readable UDIs on the devices. There was also no information provided for to FDA’s Global Unique Device Identification Database.
Deep Dive into Findings
Now that we have an overview of the Warning Letter, we can look more in-depth into some of the findings to help understand the mistakes made by Sea-Long Medical Systems and avoid those mistakes in the future.
Since there are so many different violations in this Warning Letter, I will not be covering every single finding included, and will instead be highlighting FDA statements that I find interesting or especially useful.
Complaints
The FDA included five different examples of complaints. Sea-Long Medical Systems determined that the devices in the complaint records failed to meet specifications and several of them involved devices being used during treatment. However, “all five (5) complaint records did not contain a “Corrective Action/Preventive Action form” and “Root Cause Analysis form” as required by your complaint handling procedure. Also, there was no rationale why no investigation was necessary and the name of the person(s) responsible for the decision not to investigate in any of the records.“
There were also no serial numbers for devices that were involved with the complaints, and the information for the complaints was not properly documented in a complaint log.
If you would like to learn more about creating a compliant complaint handling procedure, check out ISO 13485 Complaint Handling: The Definitive Guide.
Validation
The two processes that were missing validation were welding and the cleaning of Treatments Hoods used for multiple patients. Welding is one process that will always require validation, so it is an important area of focus for a medical device company. The cleaning of a device (especially for a reusable device used on faces, during Covid) is also something that will certainly require validation.
Corrective Actions
The piece of this finding that interested me was that a “Masterlist of Operating Procedures” directed employees to use “the old CAPA procedure … from the firm’s previous quality management system“. However, while reviewing the old procedure, the FDA found that it directs employees “to an electronic file; however, the file path was corrupt, and the file was unable to open or unretrievable.“
This is a reminder to ensure that you do not have any broken links in your document control system. While certain documents can get lost in the shuffle, if a company is using a manual document control system it can be easy to break links and remove access to documents. A broken link in this situation is the same as no evidence.
Non-Conforming Products and Inspection
These two findings are related, as they both reference an “Inspection Specification Sheet“. The Inspection Sheet was not included or referenced in the nonconforming material procedure. Furthermore, Sea-Long Medical Systems did not maintain any records of the completed inspection sheet.
During the FDA inspection, Sea-Long Medical Systems created a “Treatment Hood Inspection Process“, however, the procedure did not properly state how to complete and retain the Inspection Sheet.
In regards to receiving inspection, the company failed to inspect at least 12 orders of “latex neck seals” from their supplier.
Device History Records, Internal Audits, and Management Review
I’m including all of these findings together because they are related to failing to follow procedures and not maintaining records. The last documented DHR was from 2018, the last internal audit was conducted in 2016, and the last documented management review meeting was in 2018.
Intended Uses
The last finding I will be covering is related to the finding(s) for improper intended uses. Medical device companies should know that they cannot advertise their products for uses that are not included in their 510(k) or PMA.
However, some companies do not understand how news articles and similar posted material can affect the company. Many of these news articles were likely written in conjunction with Sea-Long Medical Systems, or on behalf of the company (many new articles you see on these types of websites are advertisements, or are pushed by the company), which makes the information even worse.
Medical device companies should get ahead of these types of news articles, and make sure they clearly specify how their devices can be used.
Wrapping Up
That was this week’s WLOTW article covering the FDA Warning Letter given to Sea-Long Medical Systems. The WLOTW articles are intended to provide coverage of FDA findings to help companies and quality assurance/regulatory professionals learn from the mistakes of other companies.
While it is highly likely that if you are reading this article your company has an established QMS or is in the process of implementing a QMS, it is still interesting to understand the FDA’s viewpoint of companies that do not have a proper QMS. There are also lots of companies operating that do not fully understand their role as medical device manufacturers, and they should take this as a lesson on why it is important to build a well-running QMS. Avoiding these areas can be a huge risk, that can put the company squarely in the path of the FDA.
As always, if you have any questions or thoughts on this Warning Letter, feel free to leave them in the comments below.