Archive for the ‘Vigilance Reporting’ Category

What is the future of reprocessed, single-use devices?

In Unique Device Identifier, Vigilance Reporting on November 5, 2012 at 2:39 pm

In 1999 the FDA conducted a meeting to discuss reprocessing of single-use devices (SUDs). In August 2000, a guidance document was published to communicate the FDA’s enforcement policy for 3rd parties and hospitals that reprocess SUDs. Many reports have been published on this topic in the USA, Europe and Canada since that time.

I couldn’t think of an ideal song title to match up with reprocessing, but I was listening to my Amy Winehouse station on Pandora at 2am…it just seemed to fit.

In an article published earlier this year, Daniel J. Vukelich, Esq. (President of the Association of Medical Device Reprocessors), explained that 95% of the reprocessing is performed in the USA, and “AMDR is confident that reprocessed SUDs will continue to play an increasingly important role in our healthcare system”.

OEMs are deeply concerned about reprocessing of SUDs—and it’s not just about the money. Jon Speer recently wrote a blog that voiced some of the industry’s concerns. Specifically, the post addressed the issue of complaint investigation.

The FDA published a guidance document that outlines the process for adverse event reporting of reprocessed SUDs .

The problem is that even with electronic medical records, not all the necessary information regarding traceability is included in those records. This situation is about to change dramatically in the next few years as new global regulatory requirements force companies to implement Unique Device Identification (UDI) and as Europe implements the proposed regulations (Article 15).

How do you anticipate these changes will impact the prevalence of reprocessed SUDs globally?

Will these changes result in changes to your company’s product labeling of risks associated with re-use of SUDs?

If you would like to see the comments others have, please join the following LinkedIn Group: Medical Device: QA/RA. If you are not already a member of the parent group (Medical Device Group), you should join.


The New EU Regulations – 21 Days and Counting!

In CE Mark, Medical Device Report (MDR), Uncategorized, Vigilance Reporting on September 5, 2012 at 6:28 am

The EU Directive will become Regulations…but when? September 26 the proposed regulations are scheduled to be released in draft form. Plans for implementation of the Interim Measures have already begun, but the regulations will not be finalized for 18-24 months while the politics takes over. My magic 8-ball tells me that there is a precedent on this side of the pond that can help us predict the future.

A few weeks ago I published a posting with a cheeky Brit–Lily Allen. Here’s one of Lily’s own favorites by a another talented British singer, song writer named Kate Nash.

Throughout the history of healthcare regulations worldwide there have been three rules that are never broken:

  1. Regulations always get tougher.
  2. Regulations are only partially effective.
  3. Regulations cost everyone more money.

The PIP scandal lit a fire under the European Parliament, the Council and Notified Bodies. Now all three stakeholders are fighting to show the public that they are doing everything they can to ensure safety. Unfortunately, no matter what changes are made it is extremely difficult to prevent unethical behaviors.

Before I make predictions, we all need to remember that there is a larger news story–the European Economy.

The status of the European Economy will have the greatest impact on new regulations. My best evidence is the US FDA.

The FDA has been trying to improve the turnaround on submission reviews for my entire career. For a period of about 8 years, matching closely with the Presidential terms of George W. Bush, it seemed to get easier to get products through the FDA logjam. Then the global economy tanked and political winds changed in 2009.

Over the past three years, Republican’s have gained power and Congress is now pushing the FDA to actually improve the metrics for product approval. The FDA will now have 200 additional reviewers, and every plan for improving turnaround that has been tried is back on the table.  The FDA was given the funds to grow its army of inspectors first, and now the FDA is granted additional funds to hire additional reviewers and train them.

The European Union includes countries that are struggling to provide basic services, while other countries don’t want to bail their European neighbors out of debt. How is the European Parliament and the Council going to increase regulation of medical devices when everyone knows that regulations will cost more money?

The short answer is…they can’t.

One of two things must happen before true change can occur:

  1. another healthcare scandal could trigger this change, or
  2. the economy could improve.

Based upon the sluggish recovery of the US economy, I don’t see how #2 will happen in Europe during the next 18-24 months. I can’t predict #1, but historically scandals are years apart.


I predict that the draft regulations will get watered down during the co-decision period. The most popular legislative tool is the “transition period”. For example, UDI legislation was passed in 2007 in the US but the proposed rule was not published by the FDA until 2012. The proposed rule includes a 7-year transition period for implementation of the new rule.

If the new EU regulation is finalized in 18-24 months, we can expect a long transition period during which various pieces of the regulations will be implemented. This transition period is essential for Notified Bodies to gradually increase their staff and for training new auditors. This will also give companies several years to organize their own plans for addressing the new regulations.

The one change I predict to happen quickly is consolidation. 60+ Notified Bodies are more expensive for the EU to support than a few large Notified Bodies. The FDA is a single, centralized regulatory body. The EU will not achieve the same degree of centralization, but I predict “a great consolidation”.

My final prediction is related to the vigilance process. In the US the MDR process has become highly automated and electronic submissions with a public database are the norm. This has allowed the FDA to rely on data analysis to identify problems and redirected the burden of data entry from the FDA to industry. We can expect Europe to follow this trend, by centralizing all vigilance reporting. The only remaining question about vigilance is how long will the transition period need to be for revision 8 (of MEDDEV 2.12/1).

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.

%d bloggers like this: