This module discusses many of the contents of the device master record (DMR), and among those contents were the procedures on post-market surveillance. Post market surveillance is becoming an increasingly scrutinized and important component of device development as the FDA begins to require it for more and more products.
What are some ways in which post-market surveillance can be carried out on a medical device product?
Spiral Medical Development
www.spiralmeddev.com
Hi All,
Post Market Surveillance is simply the process of monitoring a device after it is part of the market. It includes many aspects of a medical device, like device failure. There are even requirements for some Class II and III medical devices to have required post market surveillance.
The main way that post-market surveillance can be carried out on a medical device is through the monitoring of device failure. At the previous company I worked with, any device that failed was sent back to the failure analysis lab. This allowed us to identify if the failure was a manufacturing error, user error, or if there was a problem with the device as a whole. This allowed for the monitoring of the device and ensuring that any device failures were not due to the safety or manufacturing of a device.
-Andrew Nashed
It is interesting to learn that Section 522 of the Federal Food, Drug and Cosmetic Act gives the FDA the authority to require a manufacturer to conduct post-market surveillance of a class II or class III device when the device meets the following criteria:
(1)its failure would be reasonably likely to have serious adverse health consequences;
(2)it is expected to have significant use in pediatric populations;
(3)it is intended to be implanted in the body for more than one year; or
(4)it is intended to be a life-sustaining or life-supporting device used outside a device user facility.
There are many ways in which the FDA uses and request a post market surveillance. Some of the current medical device post-market surveillance system used are:
1. Medical Device Reporting (MDR) - In which the CDRH requires a mandatory MDR from device manufacturers, user facilities and importers. Therefore, manufacturers, user facilities and importers must report under the MDR
regulations whenever they become aware of an event that reasonably suggests that a device may have caused or contributed to a death or serious injury. In addition, malfunctions must be reported too and failure to comply with the MDR could render the device “misbranded,” and may result more severe penalties such as injunction, seizure or civil money penalties. In addition, health professionals and consumers could also voluntarily report to the FDA adverse events relating to the use of marketed medical devices.
2) Medical Product Safety Network (MedSun) — MedSun is an enhanced
surveillance network comprised of approximately 280 hospitals nationwide
that work interactively with the FDA to better understand and report on medical device use and adverse outcomes in the real world clinical environment.
This link gives more current FDA medical device post-market surveillance strategies. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM301924.pdf
nice information you have found neb2 i have post two more that i think it crucial to know all the surveillance strategies.
4. Postmarket Surveillance Studies — The FDA may order a manufacturer of certain Class II or Class III devices to conduct postmarket surveillance studies (often referred to as “522 studies”).3 Study approaches vary widely and may include non-clinical device testing, analysis of existing clinical databases, observational studies, and, rarely, randomized controlled trials. Status updates for ongoing postmarket surveillance studies covering approximately a dozen device types may be found on our website at http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMA/pss.cfm.
5. FDA Discretionary Studies — In addition to medical device adverse event reports, post-approval and postmarket surveillance studies, the FDA also conducts its own research to monitor device performance, investigate adverse event signals and characterize device-associated benefits and risks to patient sub-populations. A variety of privacy-protected data sources are used including national registries, Medicare and Medicaid administrative and claims data, data from integrated health systems, electronic health records, and published scientific literature.
From my experience, the most post-market surveillance we would receive is from the end user, or the patient. People will often call the company’s main hotline if they have any major complaints. Additionally, doctors, responsible for administering the device, also were quick to provide feedback on any faulty designs. In some cases, patient surveys can be administered as well as holding focus groups to gain consumer feedback on the product can be especially useful but are the initiative of the company, and would ultimately cost money to gain information on.
Concerning the production of the device, in process controls and checks should be taken throughout the production to ensure the quality, safety, and efficacy of the product. Depending on the product, in some cases, failures are permitted as per the FDA guideline but the number of failures depends on the batch size and if the following sample pulled for testing from the batch does pass the next time. The monitoring of these failed samples is crucial for post-market surveillance as well because if the product is failing coming off of the production line, it is going to fail when it reaches the end user.
Hey
I think in pharma as mj34 said it is usually from the patient and Doctors. They provide us with feedback on how the drug is working and any adverse effects. Also on the company end even when a drug is on the market we still do release testing on each release lot so having a strong QA team and process is critical. If reagents are changed bridging is done and maybe an animal study before it goes into production.
Hi All,
I believe all of you have identified so many ways that post market surveillance can be conducted. The main pitfall that I have seen manufacturers fall in most of the time is the understanding of the term post-market. Post-Market means after obtaining marketing authorizations from regulatory agencies, not when you actually market the product. So if the manufacturer obtained authorization to market the product, but have not yet introduced the product tot the market, the manufacturer is still required to conduct post-market surveillance. From my experience, I have seen post-market surveillance conducted in many ways including:
- Customer complaint or Product Quality Complaint data analysis and trending
- Product Related Adverse Event analysis and Trending (Sometimes referred to as Periodic Safety Update Report)
- Manufacturing Performance Monitoring - I have seen manufacturers conduct an annual analysis to determine Process deficiencies and any unexpected manufacturing issues.
- Annual satisfaction surveys sent to customers to obtain customer feedback
All these information are usually reviewed during the management review for each product or product family.
Per personal experience to track the medical devices while it is on market, the company I work at has a technical support team that answers any immediate questions or complaints a user may have. Hopefully most of the time the issue is not serious and is resolved by technical support but the complaint is still logged. However, if the issue is a bit more serious which requires the device to be shipped backed and examined by our engineers an ER or Event Report is created. This ER contains the issue the user is experiencing with the device where the Engineer then has to figure out the cause, and if there is an issue in another device thus doing a verification with n sample size. The device goes through a full quality check and inspection before being shipped back out into the market. Additionally, in house testing occurs called integration testing whenever a new software is released for the device.
I agree with the comments provided so far. The importance of post-market surveillance is to provide the necessary information on the product being used by patients and confirming that is maintaining the safety and efficacy of the product. Also, it is crucial to take into consideration the different requirements of the various regions such as US, EU, japan and China (figure on the link below, Table 1). By taking a look within each respective column with each region for their manufacturing quality-control systems, this assists in maintaining the oversight required to know if product is meeting expectations. In other words, making sure that within the four major MD markets the best post-market strategies are being utilized to support the public health goals within the different system features.
As everyone already answered the initial question in full detail. I would like to add why I believe it is important to have post market surveillance. Yes it gives companies feedback and how to better future products or if a defect is detected, then how to recover. But data collected during this surveillance is what matters and how that data is shared is critical. Sharing of such surveillance can be an issue with different competitors for money reason. So to point out that this can be looked at from a different point of view. The data and sharing of this data in a timely manner is critical for future medical devices or similar products or adding another extension or function to the current product on the market.
The FDA uses post-market surveillance to monitor the safety and effectiveness of medical devices once they are on the market. It is a regulatory requirement and a system that provides continuous feedback about the device on the market in order to maintain a high standard of product quality. Thus, the feedback and data that is collected is very important for the success of a company. Post-market surveillance can be carried out in several ways: monitoring of manufacturing performance (are there defects or issues with the manufacturing of the product?), monitoring of product failure, and data collection and analysis of customer complaints and feedback.
I have to agree with Jnm22 and mj34 but I want to add a little more about this that I think is important. We first need to understand that post-market-surveillance is to pretty much monitoring a device after is out in the market. Mostly how we going to monitor these devices is by the consumers, which would be our customer, they can be doctors, patients, etc. so a way to try to surveillance this devices it can be complicated. The way to do some PMS is by doing some proactive actions type for example, performing customer surveys, try to do some post CE mark clinical trials, including PMCF, manufacturer sponsored device tracking/implant registries, or expert user groups. Another way is to get some reactive actions, for examples, getting customer complains about the device, or getting maintenance/service reports, by social media.
Post Market Surveillance is obvious in instances of failure, as many have stated, FDA has guidelines on how to go about it. But I think even participation factor from marketing end, where one would monitor just feedback on lets say amazon, or online forums such as reddits. End users can give feedback on improvements for the next iteration of the product, for it would be suggestions that are better suited from real world applications, something the design team could've have never conceived of. One such product that comes to mind, is the toothpaste flip top end cap, a modification made by a teenager, his suggestion was welcomed by colgate-palmolive, and was implemented very quickly. Now I don't see why even modifications/suggestions for medical devices cannot be made from such feedback, maybe small visual markers on buttons, such as colored led lights for night usage.
From my experience the tracking of medical devices in the post market surveliance often comes consumer feedback itself, we have a team that dedicates themselves to addressing potential issues. The address concerns with the use of the device and often times, from my experience, its a user error, the instructions within labeling were misinterpreted and as a result they thought the device was broken. Bigger issues on the otherhand are handled with diligence with the help of post market surveliance
Chris
It seems like one of the simplest and most cost effective ways to conduct post-market surveillance would be to request feedback from the patients using the device. For example, if the device is a knee replacement, it would be in the best interest of the company to request the feedback of the doctor/surgeon applying the device for any issues that they may have run into as far as packaging, sterilization, and product integrity. Concerning the long term use of the knee replacement itself, it would be best to follow up and request feedback from the patient to see how satisfied they are with the product and what issues they have run into since having it.
