Retrospective Analysis of FDA Medical Device Market Clearances/Approvals and Recalls
I. Retrospective Analysis
The device, “Organ Care System (OCS) Lung System”, approved by the FDA in late March of 2018, was manufactured by medical device company TransMedics, Inc. This medical device company was founded in order to better address the issue of storage/general lack of organs for transplantation and seems to have recently focused their efforts on heart, liver, and lung systems. The OCS Lung System is meant to act as a working body for the lung while it is waiting for transplantation. As the current standard for ex-vivo lungs awaiting transplantation is cold, static storage, there is a certain level of time-dependent damage done to the organ, as it is not in use (Southard). To combat that, this device works to keep the organs working as though they were inside the body by “using” them by “warming, pumping, ventilating, and managing gas content of the perfusate” as well as actively monitoring the condition of the transplant (Center for Devices and Radiological Health, OCS).
General controls information that the company (TransMedics, Inc., located in Andover, Massachusetts) provided the FDA for their device, “Organ Care System (OCS) Lung System” would be in relation to their promise to adhere to good clinical laboratory practices in 21 CFR part 58. Should the company fail to adhere to these GMP’s, it may be grounds for withdrawal of their approval. Furthermore, they are required to report to the FDA no later than 30 calendar days after the day they receive or otherwise become aware of information, from any source, that reasonably suggests one of their marketed devices caused or contributed to a death or a serious injury, or that it malfunctioned and could contribute to a death or a serious injury in the future. The company also provided information on the labeling of their product in their PMA application as a 236 page booklet. This would aim to prevent adulteration and misbranding. In addition, there are listings of contraindications, which are specific situations in which their device should not be used, as well as warnings and precautions, which further their attempts to remove adulteration and misbranding (Center for Devices and Radiological Health, OCS).
Medical Device Submission Route
The OCS Lung System was classified as a Class III medical device, as even though human life is not technically dependent on it at the time of use, were the machine to fail, there would be a very real possibility of losing an organ ready for transplant, which could likely lead to patient death. As a result of this classification and the lack of predicate devices, the medical device regulatory pathway taken was the Premarket-Approval Pathway (PMA). As the most stringent type of device marketing required by the FDA, TransMedics, Inc. conducted numerous non-clinical and clinical trials in order to assure that their device (OCS Lung System) was safe and effective for its intended use. There is also a post-approval study (INSPIRE) listed on their PMA approval notification, where they are watching 349 patients post-transplantation (that used their device) and studying mortality rates (Center for Devices and Radiological Health, OCS).
FDA Clearance or Approval Response Letter
Immediately after the device is declared FDA approved, the FDA quickly points out that TransMedics’ approval is still contingent on their adherence to a few more conditions, including restriction of sale and distribution to prescription, establishment of an expiration date, requirement of periodic reports as follow-up, a post-approval study, and to finalize their labeling. Initially, the FDA labels the OCS Lung System as a restricted device, and may only be manufactured, distributed, and marketed, with the intent of the final user being a specifically trained and experienced practitioner, and this must be specified in the labelling of their device. Next, the approval is contingent on the company submitting period reports at intervals of one year from the date of approval of the original PMA, including the number of devices sold and distributed during the reporting period, including those distributed to distributors (this information will eventually be used as a denominator in calculating the frequency and prevalence of adverse events). Finally, additional reports are required, now centering around the post-approval study that must now be conducted, once every six months for the first two years, and then annually thereafter. Failure to adhere to these conditions could be grounds for withdrawal of approval (Center for Devices and Radiological Health, OCS).
Reflection and Insights Gained & Perspectives Formed
Before this course, I had little to no knowledge of the inner workings of the FDA but heard constant complaints about the pharmaceutical/general medical industry and their outrageous prices. While I still feel I don’t know enough about how this relates to the political aspect of things, I definitely have a greater understanding and appreciation of why it is such a lengthy and expensive process to get FDA approval, namely for Class III devices and drugs.
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As an undergraduate biomedical engineer, I understand that though the FDA regulatory process feels distant and currently of little relevance to me, it will be a part of my life sooner (Senior Capstone), and for a longer duration, than I anticipate. As such, I found it interesting how familiar some parts of the FDA process felt to me. I had participated in Engineering Projects in Community Service (EPICS) for two semesters, and each semester required constant note-keeping of our anticipated users, prototype process, immense background research, risk analysis, etc., and much of it seemed very similar to certain parts of the application process. Similarly, over the summer I completed an REU at UT Austin, where the final week was spent on creating a technical report document, where I displayed my findings, my errors, the exact steps I took, and proper documentation of all of my code/lab work/built machines. At the time, it felt troublesome and time-consuming, but I see how important that recordkeeping and proper documentation can actually be when the time comes to prove the safety and effectiveness of your device.
II. Forensic Analysis
MiniMed insulin pumps, distributed by Medtronic from the dates of August 6, 1999 to July 24, 2018 are being recalled as a Class I recall due to an issue with the cybersecurity of its wireless connection (Center for Devices and Radiological Health, Minimed). Medtronic is the largest medical device company in the world, as a “$145 billion global entity that sells medical devices in 150 countries” (McFarlane). They focus their business into four main entities: cardiac and vascular, minimally invasive therapies, restorative therapies, and diabetes (McFarlane). Because of the size and international reach of Medtronic, it is clear that a recall stemming from a potentially deadly issue should be taken extremely seriously.
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Diabetes is an incredibly widespread and prevalent condition, affecting 30.3 million Americans (9.4 percent of the U.S. population) and an estimated 415 million people worldwide (1 in 11 of the world’s adult population) (CDC, Diabetes). Out of the two types of diabetes, type 1 diabetes is more common in children and is a result of the body being unable to make insulin, as the immune system of the diabetic actually attacks and destroys the cells in the pancreas that make insulin. Type 2 diabetes is generally developed later in life and is the more common type of diabetes. It works similarly to type 1, where the body simply does not make insulin or does not use it effectively (National Institute of Diabetes and Digestive and Kidney Diseases). In both cases, it is of utmost important to constantly monitor your blood glucose levels and to adjust insulin intake accordingly. Should a diabetic with high blood glucose fail to take their insulin in time (or at all), they could go into a state of hyperglycemia, and if left untreated could result in a number of serious conditions or death. Conversely, should a patient take too much insulin, the blood glucose concentration would decrease drastically and they could go into a state of hypoglycemia, which is just as serious of an issue.
In response to this serious disease, Medtronic created the MiniMed Insulin Pump technology, which is composed of three main parts: the insulin pump, the infusion set, and the reservoir. The reservoir is a small plastic cartridge that lies inside of the pump and stores insulin (Medtronic’s holds up to 300 units) and needs to be changed regularly. The infusion set is a thin tube that leads from the reservoir to wherever the insulin needs to be injected into your body. Again, this needs to be changed regularly. Lastly, the insulin pump itself is a small electronic device that is used to program the insulin and record tracking data. The pump provides insulin to the body in two distinct ways: the basal rate and the bolus rate. The basal rate is a light, continuous flow of insulin throughout the day. The bolus rate is additional insulin that is delivered on demand to match the food the diabetic eats throughout the day. The bolus rate is able to be controlled through an optional wireless remote, which is intended to be used by the diabetic exclusively (or their physician) (Medtronic).
Medical Device Recall
The MiniMed Insulin Pump’s wireless remote controller was recalled due to concerns of its cybersecurity. As specified above, the intent was to make sure only the diabetic could control their bolus rate and insulin delivery rate. However, Medtronic realized that there was a possibility that an external, unauthorized person would be able to instruct the pump to over- or under-deliver insulin to the patient as a result of the wireless connection (Center for Devices and Radiological Health, Minimed). Either of these incidents could easily result in hyperglycemia or hypoglycemia. Medtronic was able to identify the issue before it could be taken advantage of, so luckily there were no prior reports or incidents related to these potential risks.
In wake of the recall, Medtronic began by notifying affected customers and first providing them with brief, general information in a patient letter; a summary of the issue in laymen’s terms, what factors had to be present in order to make their pump vulnerable, and steps to take in order to protect their security. Importantly, though it is listed as a recall, Medtronic specifies that user do not have to turn in their device and are encouraged to continue using their device, with exception only to turning off the “Easy Bolus” option, disabling the remote option on the pump, and taking extra care not to share the serial ID on their controller with anybody. Additionally, newer remote controller models that are not vulnerable to this risk are not compatible with the insulin pump and no financial compensation is being made to affected customers. In essence, Medtronic merely provided reassurance that this should not be a huge, life-threatening error as well as instructions on how to keep the device safe.
In Medtronic’s evaluation of possible failure modes using FMEA, it is easy to retrospectively say that attention should have been given to the safety of a wireless connection between the controller and the insulin pump, but distribution of these devices started in 1999, and FDA approval was received even earlier. At the time, cybersecurity was not as large of a concern as it is in presently, and implanted medical devices were only just being realized as a potential hazard for hackers (Devost). However, it is clear that the issue was at least known, regardless of how commonplace it was. Thus, it should have been on Medtronic’s radar for possible issues at the very least, especially considering that it is direct control of concentration of insulin, something that requires precision and accuracy in order to do no harm. In order to have prevented this “failure”, additional work should have been done to garner information from experts on wireless connectivity or cybersecurity in general and the security details surrounding it. It is up to Medtronic to cover all safety aspects of their device, which likely entail the obvious biological compatibility and safety as well as the chemical, electrical, materials, and digital security of their device.
With my introductory knowledge of biomedical engineering, I find a good portion of my answers by asking others, which is actually where I feel I have an advantage over more experienced biomedical engineers. Because I do not yet know the “limits” of bioengineering, nor do I feel confident enough to ensure a practical and safe design, I have gotten ample practice in asking for oversight from all fields. With this experience, my personal retrospective insight would be to ask more questions from everyone and within every field. In a more general sense, this in depth analysis of a recalled medical device showed me the importance of owning up to your mistakes and being extremely transparent throughout the entirety of the process, because people’s lives depend on it, which is always and inevitably more important than revenue or company image.
- 2019, EditorPosted on 15th January, and Editor. “Since 1996, the Number of People with Diabetes in the UK Has Risen from 1.4 Million to 3.5 Million. Diabetes Prevalence Is Estimated to Rise to 5 Million by 2025.” Diabetes, 6 Apr. 2019, https://www.diabetes.co.uk/diabetes-prevalence.html.
- Center for Devices and Radiological Health. “Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-remote-controllers-minimed-insulin-pumps-potential-cybersecurity-risks.
- Center for Devices and Radiological Health. “TransMedics OCS Lung System - P160013/S002.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/medical-devices/recently-approved-devices/transmedics-ocs-lung-system-p160013s002.
- Devost, Matt. “What Did Cybersecurity and Cyberwar Look like in 1999?” OODA Loop, 20 Jan. 2018, https://www.oodaloop.com/archive/2018/01/20/cybersecurity-cyberwar-look-like-1999/.
- McFarlane, Greg. “How Medtronic Makes Money.” Investopedia, Investopedia, 4 Dec. 2019, https://www.investopedia.com/articles/markets/021316/how-medtronic-makes-money-mdt.asp.
- Medtronic. “Diabetes Treatment - Insulin Pump Technology.” Medtronic, https://www.medtronic.com/ca-en/diabetes/home/what-is-diabetes/insulin-therapy/insulin-pump.html.
- “New CDC Report: More than 100 Million Americans Have Diabetes or Prediabetes.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 18 July 2017, https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html.
- Southard, James H. “Organ Preservation.” Annual Review of Medicine, vol. 46, Feb. 1995.
- “What Is Diabetes?” National Institute of Diabetes and Digestive and Kidney Diseases, U.S. Department of Health and Human Services, 1 Dec. 2016, https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes.
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