Safety Never Sleeps with Post Market Surveillance

The imminent publication of the new medical device regulation in Europe and the increasing attention that regulatory bodies all around the globe are placing on post market surveillance are driving medical device manufacturers to seriously analyze their processes in this area to ensure they remain compliant. Specifically, a shift from reactive systems, such as complaints monitoring, to a more proactive approach is becoming necessary to ensure that device safety issues are identified as early as possible in the process, thereby minimizing possible impact on patient and user safety.
 
Any manufacturer wishing to introduce or maintain distribution of their devices within markets that have requirements for post market surveillance, such as across Europe or the U.S., urgently need to review their systems, processes, and procedures for post market surveillance to ensure that they are compliant with current requirements. In order to help with this task, national competent authorities have been working to ensure that the requirements for post market surveillance, as defined within the medical device directives, are more clearly identified to help ensure compliance.
 
The MDD 93/42/EEC, Annex II, for example, states that there should be commitment from the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-approval phase. Annex X also requires manufacturers to implement appropriate means to apply any necessary corrective action and to notify the competent authorities. In addition to this, incident reports are declared mandatory when a “serious deterioration in health” is caused.
 

MEDDEV 2.12-1, Vigilance Guidance Document, Revision 5, further establishes that manufacturers have efficient systems for the proactive scrutiny of trends in complaints and incidents in place. Should there be a significant increase in incidents or events, manufacturers must submit trend reports to their national competent authorities. Some examples of proactive monitoring could include focus groups, questionnaires, and company forums. But it is important not to forget that useful feedback can also be obtained from company personnel such as sales and customer service personnel that are in regular and direct communication with customers and users.
 
One of the main issues that manufacturers are faced with, in addition to interpretation, is that requirements for post market surveillance are not identical in all geographies and are currently being reviewed and changed in a number of countries. Being up to date with regulations in every country where products are distributed can prove challenging and time consuming. Manufacturers are faced with essentially two approaches—either adopt the most stringent requirements and apply them throughout or develop ad hoc plans and procedures for each country of distribution. Both systems have pros and cons and both require a high level of expertise and resource to implement, suggesting that where manufacturers are struggling, they would be advised to bring in external support rather than risk running unsatisfactory systems in-house.
 
These increasingly stringent and complex post market surveillance requirements may seem daunting to many medical device manufacturers but it is important not to lose sight of the benefits. Specifically, proactive methods of post market surveillance lead to the production of safer devices and improved patient or user safety; but, the benefits to manufacturers are also important. Earlier detection of flaws means improved products and fewer complaints; therefore, resulting in lower complaint handling and resolution costs, as well as improved reputation and customer loyalty.
 
On the other hand, should organizations be found lacking in their post market surveillance practices, the penalties they risk incurring are very punitive. Not only may hefty fines be levied but company executives deemed responsible may even be faced with jail. Other penalties include seizure of product or the imposition of ad hoc compliance contracts.
 
The increasing scrutiny on post market surveillance of medical devices signals that this area is increasingly being considered a key activity in ensuring the early detection of device issues and in protecting patient and user safety so that only safe devices remain on the market. Adhering to and pre-empting post market surveillance requirements, however, can also help manufacturers identify design flaws earlier in the process and produce better devices as well as improving reputation, customer engagement, and ultimately sales.
 
Whatever approach manufacturers take to ensuring they keep abreast of developments, it is certain that manufacturers need to ensure that their processes are proactive and keep them up to speed with impeding changes. Relying solely on reactive mechanisms simply won’t “cut the mustard” and manufacturers need to keep ahead of the curve to avoid rushed last-minute solutions and dangerous periods of undetected non-compliance.