A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

In my work, I’ve found that medical device companies often struggle with postmarket data collection and usage. Some companies collect too much data and then do nothing with it. More “poundage” is not better. Other companies wait for eye-openers like complaints, medical device reports, non-conforming products and negative process results, scrap reports and returns. They anticipate these bits and pieces of bad news to bubble to the top of their quality overflow scenarios. It’s not a pretty sight, thinking that a Management Review will miraculously “put out the fires using risk to make decisions about postmarket incidences.”

Simply put, postmarket surveillance is an assemblage of processes and activities used to proactively monitor, record and react to the performance of a medical device after it has been introduced into and shipped to the marketplace. Proactively is an important and operative word in this process. Just waiting for complaint data to arrive at your company is not good enough. Frankly, it’s never been the best way to measure performance because it’s so after-the-fact—so backward-looking.

Also, we should straighten out one point before we progress to the meat of this article. The principle differences between vigilance and postmarket surveillance are important to understand. Vigilance is the reporting of adverse incidents by manufacturers to the regulatory authorities and their subsequent sharing of key incident data between each other. Postmarket surveillance is the process by which information on overall device performance (good and bad outcomes) is captured, analyzed and then acted upon. This article is an overview and an update of the process involved with postmarket surveillance, of which vigilance can (and should) be a part. Nevertheless, it is a struggle to gain widespread appreciation that these two activities are not in fact one and the same. It’s like the words and concepts explaining verification versus validation. Some individuals just don’t get it.


Snippets of Background Information

Postmarket surveillance is not a new concept, as postmarket surveillance of medical devices was initiated in the U.S. with the enactment of the Food and Drug Administration Modernization Act of 1970 under Section 522 for class II and class III devices. (By the way, Class I devices are also part of the surveillance picture.) In 1989, the Therapeutic Goods Act provided the legislative basis for uniform national controls over goods used in the prevention, diagnosis, curing or alleviation of a disease, ailment, defect or injury in Australia. In June 1993 vigilance requirement for medical devices for member states and manufacturers was published as Council Directive 90/385/EEC and 93/42/ EEC, followed by incorporation of amendments of revision 5 of MEDDEV guidance 2.12–1 in 2007 by the European Union.

Concerning rudimentary regulatory tools, FDA basically uses the processes involved with medical device tracking, medical device reporting, complaints, recalls, unique device identification and seizures, whereas the EU has adverse event reporting, field safety notices, investigations, enforcement, postmarket clinical follow-up and the review of company records (during audits) as their means to their end.

These activities are designed to generate information regarding use of the device to pragmatically identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes. The need for surveillance “stands up” immediately upon commercialization of the device in the field. Be cognizant of the fact that this process starts in design and development.


Using the Risk Tools

Making sure that your company has adequate input into the risk management process during product development and manufacturing will assist your Quality Review Board (QRB) in characterizing possible product safety issues. The risk profile of the device advances from these efforts, and can be used to effectively develop the postmarket surveillance strategy for each device type. It is important to note that the requirements for postmarket surveillance should be directly aligned with the risks associated with the device based on its intended and indications for use. Using the words “in proportion to” or “in alignment with” is appropriate from a procedural standpoint.

In developing a robust surveillance process, your company should consider whether or not the product or technology is new to the manufacturer and/or the marketplace. Legacy products have a successful past in the market, whereas new devices, new technological adaptations and revised indications for use should be a focus of more intense surveillance activities. Remember, it’s all about risk. How many times have you heard that over the past seven years? When your company has a long history of development and marketing of similar device types, you are likely to have a clear understanding of the patient population and the reasonably foreseeable risks associated with this legacy product. Available data regarding state-of-the-art market experience for similar products and technology may be adequate for low-risk devices with a long history of clinical success.

Whether it’s for FDA or EU compliance, postmarket surveillance should be a systematic process having to do with data collection and lessons learned and a proactive exercise concerned with collecting and analyzing information on a regular basis. If your company consistently collects the same types of relevant information, you might be able to see trends. The degree, level of depth, methods and use of this information are subjective and should be defined succinctly in your company’s Risk Management Plan. Some companies have a great process in place and they collect a lot of data but, in fact, they don’t do anything with the information. Risk management is a tool that helps define this gathering process, but disseminating the information into action plans is another story. Your company needs to be somewhere between superfluous and relevant. You should plan this activity from a strategic standpoint and tactically embrace the information at every QRB meeting and every Management Review session.

As I said, the old-fashioned approach of looking at just complaint data is an after-the-fact story and those trends, being very important to the big picture, don’t necessarily include these sources of valuable information:


                            Clinical evaluation reports   |   Literature reviews   |   Focus panels   |   In-house quality data
 
                            Post-launch production changes   |   Competitive claims   |   Labelling presented on websites
 
                                  Service reports   |   Adverse events, per se   |   Regulatory filings/actions/guidance


Interestingly enough, these same data elements can be used effectively in your company’s risk management process. The challenge is how to get all of this wonderful information cross-functionally in a useable format that can be analyzed and then used to prevent future issues. I’ll outline a framework below, but first, let’s see how postmarket surveillance is defined in the U.S. and EU.

Next: The Lifecycle Approach



The Lifecycle Approach is a Worldwide Initiative

Lifecycle postmarket surveillance is an approach to market surveillance that involves use of data and information from all stages of the lifecycle of a medical device to direct and support the conduct of surveillance activities and investigations. The outcome and findings from these postmarket investigations are used to update, develop and reinforce new premarket requirements.

The FDA Approach: CDRH 2016-2017 Strategic Priorities Information generated through the Medical Device Postmarket Surveillance System should meet priority public health and healthcare needs related to medical device safety and effectiveness, including:

  • Providing better information to support patient, clinician, health system and payor decisions about medical devices  
  • Informing CDRH’s regulatory decision-making to ensure safety and accelerate product innovation (facilitate premarket approval/clearance and expansion of indications for existing devices) 
  • Mitigating potential harms by supporting rapid response to device safety problems
  • Gathering information about existing products to inform the development of new and innovative devices, and
  • Improving health outcomes through better decision-making based on information from real world experiences with medical devices

FDA may identify device issues that are appropriate for postmarket surveillance at any point during the life cycle of a device. Such issues may be identified through a variety of sources, including analysis of adverse event reports, a recall or corrective action, post-approval data, review of premarket data, reports from other governmental authorities or review of scientific literature.

Examples of situations that may raise postmarket questions and push FDA to order postmarket surveillance include:

  • To understand the nature, severity or frequency of suspected problems reported in adverse event reports or in the published literature
  • To obtain more information on device performance associated with real-world clinical practice
  • To address long term or infrequent safety and effectiveness issues for implantable and other devices, for which premarket testing provided more limited information
  • To understand rates of malfunction or failure of a device intended for long-term use or incidents of latent issues resulting from device use
  • To define the association between problems and devices when unexpected or unexplained serious adverse events occur after a device is marketed, if there is a change in the nature of serious adverse events (e.g., risk-based severity), or if there is an increase in the frequency of serious adverse events

Specifically, actions to be enabled by FDA include:

  • Establish a Unique Device Identification System and Promote Its Incorporation into Electronic Health Information
  • Promote the Development of National and International Device Registries for Selected Products
  • Modernize Adverse Event Reporting and Analysis
  • Develop and Use New Methods for Evidence Generation, Synthesis and Appraisal


The EU Approach: Postmarket surveillance based upon risk


Postmarket surveillance is an integral part of the European Medical Device Regulation (MDR), neatly aligned with the requirement to evaluate your medical device through the lifecycle of the product. The Medical Device Directive (MDD 93/42/EEC) referring to the need for postmarket surveillance is very obvious for all classes of medical devices. It indicates that for any device, proportionate to the risk class and appropriate for the type of device your company shall plan, establish, document, implement, maintain and update a postmarket surveillance system which shall be an integral part of the manufacturer’s quality management system. For each medical device, whether it is a high risk active implant or a low risk manual instrument, postmarketing data must be collected. However, the scope of this approach can vary and shall be proportionate to the risk class of the device.

Previously, a reactive approach for lower risk devices, e.g. in the form of vigilance registries, would be acceptable, as long as strong clinical evidence for safety and performance was expected based on premarket data. Currently, it is more likely that your Notified Body requires you to proactively collect data on the clinical safety and clinical performance of your device, regardless of its classification. After all, the user’s threshold for vigilance reporting may limit you to obtain sound evidence of “real-life” safety and performance data. The exact requirements for proactive data collection, e.g. on user experience, are not set and should be discussed between your company and your Notified Body. Yes, the scope and detail of this surveillance effort is negotiable to a certain degree. The aim of surveillance is to ensure that your company fulfils the obligations imposed by the approved and compliant quality management system.

Goals for the Postmarket Surveillance Process in Europe:

  • Public health is protected effectively
  • Medical devices placed on the market continuously conform to the requirements for safety and performance
  • Problems or changes in safety and performance of a medical device are detected and acted on in an effective and timely manner
  • Medical device market surveillance activities are effective to cover national responsibilities and provide valuable input into European system
  • Data gathered from market surveillance is used to drive better standards of safety and performance - inform other phases in the lifecycle

  • Challenges Concerning Postmarket Surveillance Process in Europe:

  • Different interpretations and approaches to the activities that constitute medical device market surveillance
  • Decentralized system for conformity assessment/certification and market surveillance – chain is only as strong as the weakest link
  • Lack of transparency and information on products available
  • Array and complexity of medical device technologies and ensuring effective regulation
  • Iterative nature of medical device product development
  • Learning curve associated with technology advances

    Next: Take these steps to start collecting the right data

    Procedural Framework and Notes 

    As previously mentioned, the challenge is collecting the right data that then can and will be used. These steps provide a starting point:

  • Data collection should be correlated between pre- and postmarket data
  • Set up a QRB to disseminate and make decisions about trends (this is imperative)
  • The QRB comprises a cross-functional group of process owners having responsibility to management and stakeholders
  • Decide on the types of postmarket data that are appropriate to your device types, and stay connected to realize trends
  • Ensure that there is a dynamic plan in place that addresses postmarket surveillance in terms of:
    • Sources of feedback
    • Who is responsible for collection and dissemination of data
    • Who is responsible for evaluation and reporting on this gathered data
    • How you will record and retain the records containing this data
    • How and with whom do you communicate the results of surveillance activities
    • Define the life-cycle scope that your company will use to corral the information
    • How does the linkage to corrective and preventive action work, and where does risk management fit in
    • Ensure that the plan contains both active and passive methods of data acquisition
    • Assure that solicited feedback from the field isn’t skewed by bias
    • Assure that unsolicited feedback is credible


In Conclusion


We live and work in a global marketplace. Like everything else, surveillance is not just a system utilized by the U.S. or individual European nations, and then everybody else. Such a system should have a broad patient reach, real-world accuracy with which results can be transferred to all humans, a scalable and reusable infrastructure, assured and continuous accrual of information for near real-time analysis and the use of structured data. Surveillance must therefore be harmonized to minimize inconsistencies to realize an effective impact. Postmarket surveillance plays a key role in enhancing the safety and quality of medical devices available on every table in every market. There is an ongoing need for reinforcement of this overarching market surveillance, and when the opportunities present themselves, the enablement of change should be systematic as identified.

On a smaller scale, your process for postmarket surveillance should be capable of providing credible, risk-centric information for your various types of medical devices throughout their marketed life. This process should be able to identify potential safety signals and, at the same time, reduce the burdens and costs of postmarket surveillance in a healthy continuum.



John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC
www.midwestprocessinnovation.com