Strategies and Standards for Medical Device Signal Detection

In 2012, the Center for Devices and Radiological Health (CDRH), a branch of the U.S. Food and Drug Administration, announced four long term strategies to strengthen its National System for Medical Device Post-Market Surveillance1. Find out how these strategies correlate with medical device signal detection and why medical device firms can benefit from selecting a contracting partner with experience in Pharmacovigilance requirements.

The CDRH strategies are:  Christine-Berard-Headshot-Title-KMC.jpg

  • Rollout of the Unique Device Identification System (UDI) to be incorporated at the practitioner level as an element to the Electronic Health Record (EHR).
  • Device Registries for Selected Products
  • Adverse Event Reporting and Analysis Enhancements
  • Establish new Methods for Evidence Generation, Synthesis, and Appraisal

These strategies are designed to improve the collection, analysis, synthesis, and action of medical device benefit-risk assessments, and are reminiscent of CDER’s Pharmacovigilance requirements.  Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems”2.  Based on these strategies regulators, practitioners, and the medical device industry are taking are more progressive approach with medical device signal detection.  The intent is a more robust, timely, and efficient measure of product safety. The approach is a systematic lifecycle evaluation that considers a product’s risk benefit through a comprehensive review of adverse events, literature, and product-specific signal detection by leveraging existing data sources and providing near real-time information on marketed medical products.

Current State Medical Device Reporting

Over the past two decades, the medical device industry has adopted many enhancements to ensure proper and timely submission of Medical Device Reports (MDRs).  Examples include eMDR, adoption of UDI in the eMDR, and the elimination of the two-year rule for reportable malfunctions.  However, the flow of information to FDA from industry or healthcare providers has remained relatively linear and comprised of discrete data.   See Figure 1.


This activity corresponds to a portion of the current Pharmacovigilance system, that of Case review and reporting of spontaneous events.  However, there are additional aggregate activities as depicted in Figure 2.  Practitioners of Pharmacovigilance are continually evaluating their medicinal products to ensure the benefit outweighs the associated risks of the product. 

Pharmacovigilance physicians, epidemiologists or specialists may review cases and additional product information to see if there is a causal relationship between the event and the product.  If there is a relationship established, is it new, or perhaps not well understood?  Do new adverse events require product label and application updates?  Are there new drug product interactions, or perhaps newly identified risks to certain population segments?  Together this leads to a more comprehensive review of a product’s safety profile.


Future State Post-Market Surveillance

The FDA is proposing four tactics to enable medical product evidence generation for synthesis and review.  They are quantitative decision analysis to evaluate benefits and risks, evidence assessments by combining data from diverse data sets, automated signal detection, and refinement of processes for signal detection1.

These tactics combine the power of traditional reporting with enhanced features typical to that of existing Pharmacovigilance practices.  With the addition of product Unique Identifiers integrated into EHRs, however, assimilation of data sets becomes easier.  As a result, quicker analysis of aggregate data is expected, and shall allow for more focused attention that is product specific.  Traditionally, FDA would ask industry to perform a product/platform specific post-market surveillance study, slated to all ‘product manufacturers’ rather than a specific manufacturer related to increased MDR activity. These studies are expensive and may not pertain to the entire industry, but historically there was no way to identify a specific product issue. 


Figure 3 is a visual concept of a complete integration of the concepts FDA is incorporating to strengthen Post Market Surveillance activities in the United States.  By collecting and reviewing disparate data sets more robust information is available for evaluation by those with product, clinical, and risk management responsibilities.  Medical Device firms need to be prepared to manage, interpret, and proactively assess product safety signals.  Moreover, processes need to be established to ensure quality and safety data is fully incorporated into the Quality Management Systems and reviewed by top management.


Technology and integration of systems will continue, making data collection both more complex and meaningful.  Medical Device firms need to be prepared by establishing systems for signal detection, review, and action to meet the growing demands and complexity of post-market surveillance.  Good Pharmacovigilance Practices, concepts, and activities can be leveraged to address medical products evidence based data and assessments. 

About the author

Christine Berard is the global head of Quality and Regulatory at KMC Systems.  KMC is an industry leader in the area of specialized contract design, development and manufacturing of sophisticated IVD and other medical instrumentation platforms. She holds an MBA from Southern New Hampshire University and a BS from Castleton State College in Vermont.  Ms Berard is a certified Six Sigma Black-Belt, is certified in Quality Management Systems from AAMI, and Process Management from Boston University. 

KMC Quality Assurance Tip Sheet

1. Strengthening Our National System for Medical Postmarket Surveillance, Center for Devices and Radiological Health, U.S. Food and Drug Administration, September 2012

2. Introduction to Post Marketing Drug Safety Surveillance Pharmacovigilance in FDA/CDER February 26, 2013 LT Andrew Fine, Pharm.D., BCPS Safety Evaluator Office of Parmacovigialnce and Epidemiology CDER.

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Topics: quality assurance, regulatory control