13485cert

What if we harmonized one clause at a time?

In Unique Device Identifier, US FDA, Vigilance Reporting on July 8, 2012 at 3:59 pm

The primary public database for reviewing post-market adverse events is the MAUDE Database. In May, a new bill was introduced to The House of Representatives in order to accomplish two things:

  1. Amend section 505(k)(3)(C) of the FDC Act to expand the post-market risk identification and analysis system and apply the section to medical devices, and
  2. To encourage the FDA to finally issue the final form of the UDI rule.
Global cooperation has always been the dream of the idealists.

The final form of the UDI rule has been issued, but what is the future of post-market risk identification and analysis?

Most healthcare companies are either drug companies or device companies—not both. The US has developed a system for approval of combination products, but Europe and the US have separate systems for addressing post-market data collection for drugs and devices. Why not use the same system for both? The frequency of reporting is usually risk-based. Why couldn’t the depth of post-market data be risk-based as well? For drug we can continue to have the full reporting requirements, but for devices the depth of reporting could be classification dependent or product code dependent.

As an interim immediate measure in response to the PIP incident, European legislators are calling for better vigilance reporting and coordination of member states on incident assessments. The intent is to reinforce market surveillance by sharing information between the national authorities to monitor adverse effects and device recalls. What about sharing with non-member states?

Another measure included in the European plan is to improve the functioning of the vigilance system for medical devices. This would include, facilitating and actively encouraging patients, healthcare professionals and other groups to report all adverse events. The US is implementing electronic medical records throughout the healthcare system. This provides a vehicle for facilitating this type of systematic reporting.

Europe continues to struggle to establish a single European database for medical devices, but what about establishing a global medical device database?

Other measures in the European plan call for the introduction of an implant passport specifying the unique product code of the implant. With the introduction of the UDI rule, all US products will eventually have a unique product code—not just implants. Wouldn’t it make sense to incorporate this bar coding system into the implant passport for Europe? This could also be integrated with the implant registry card requirements for Canada. The GHTF presented draft guidance for a medical device UDI system on November 4, 2010.

The idea behind the GHTF was to harmonize the similar initiatives around the globe. Instead, GHTF is disbanded and legislators are developing parallel requirements that have the same purpose. This doubles or triples the regulatory burden for companies, and the opportunity to identify adverse event trends globally is diminished. Regulators from the “Big 5”, the GHTF’s founding members, elected to dissolve the GHTF in order to form a new entity consisting solely of regulators. Until this group is established and effective, some ad hoc working groups are needed to fill the gap.

A globally harmonized vigilance reporting system for drugs and devices seems to be the biggest opportunity to gain from cooperation. Please share your own ideas and comments here or on LinkedIn.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: