Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Postmarket Surveillance and Vigilance: Making Risk-based Decisions

Miss Part One of this series on
Risk Management? Read it here: 
The Science of Minimizing Uncertainties

Metal-on-metal hip implants represent a timely example of why concerns about device safety have increased. The metal-on-metal design was supposedly more durable than metal-on-plastic hips, which have a tendency to wear down over time. Companies marketed these products based on the success of engineering-focused tests and surgeons and patients clamored to use “the next big thing.” After the products were launched, registry data from Australia and the U.K. reported observations of cobalt entering patients’ bloodstreams as a result of metal shavings, leading to complications and a high rate of revision. These reports were largely ignored, and the hips remained on the market for another eighteen months in Australia and even longer in the United States, before huge recalls—and lawsuits—made headlines around the world. Catastrophes like this could potentially be avoided with better postmarket surveillance. The problems in this case stemmed not from a lack of postmarket data, but rather from the lack of a consistent approach to collecting  and analyzing data with sufficient medical input.

Cohen, Deborah. “Out of Joint: The Story of the ASR (articular surface replacement),” British Medical Journal 2011; 342:d2905 (Published 14 May 2011) – Post Market Surveillance and Medical Devices, as seen in MD&DI, February 2012, By: Stephen Rothenberg, J.D. and Matt Levy, J.D.

Your Quality Management System (QMS) must have a process in place to capture customer and regulatory feedback and record market trends, to regularly monitor data and have an ongoing process of review/risk assessment. Medical device risk management is not a one-time project. It is an ongoing process of review and risk assessment throughout the life of the device. The overarching idea is to improve quality and safety controls, even after the device is in the commercialized arena of the user … even after you have moved on to your next design and development project.

According to the International Medical Device Regulators Forum (IMDRF, formerly the Global Harmonization Task Force or GHTF), postmarket surveillance is defined as “the pro-active collection of information on quality, safety or performance of Medical Devices after they have been placed on the market.” Conversely, vigilance refers to incidents that can occur with medical devices when they do not perform as intended, thereby leading, in the worst case, to injury or death.

The Risk Management Process is Ongoing
The first step in implementing an effective medical device risk management process is to perform a full risk assessment. This consists of two parts: risk analysis and risk evaluation. It should be noted that this applies to all phases of the device lifecycle, including planning/product realization, design and development, purchasing, service and change control.

After you have performed a comprehensive medical device risk assessment and evaluation and made internal decisions concerning the acceptability of those risks, you must now create a plan of attack for monitoring and controlling those identified risks. The collection of medical device postmarket surveillance data can include customer concerns (feedback) and complaints, control of non-conforming devices, corrective and preventive actions, postmarket surveillance, servicing, customer surveys, supplier performance and the scope, extent and quantity of changes. Finely-tuned procedures should identify how the collected data is reviewed, investigated, analyzed and trended and, as mentioned previously, identify the frequency with which this is performed. The individuals who report and review this data must be trained and competent so as to preclude obtaining skewed trends and alarming statistical anomalies.

These procedures that generally explain how the data is collected and analyzed often include measurement and analysis, management review meetings, risk management, the use of a formal Quality Review Board (QRB), regulatory searches, the extent of vigilance activities and, if you are a worldwide company, data extracted from foreign search engines. This process, quite simply, will explain how the feedback gathered from using these procedures is analyzed and evaluated, identify the frequency for evaluation and reporting and describe how this postmarket surveillance data is used to re-evaluate the risk of the medical device.

Feedback is analyzed and determinations are made whether corrective and preventive action (CAPA) needs to be taken to fix the issues, through product re-design or manufacturing changes, revised product labeling or user training, etc. Feedback and data also need to be evaluated to determine whether regulatory action such as Medical Device Reporting (FDA), Medical Device Vigilance Reporting (EU), advisory notices, recalls and other actions are needed. Product and process risks can never be totally eliminated. One of the key requirements of ISO 14971 is to manage the risk of the product throughout its entire lifecycle. This includes managing process risks, as well. Your risk management procedure should be openly connected to your postmarket surveillance procedure and the requirement of the European Medical Device Directive (93/42/EEC).