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

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 3^rd 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.

What if we harmonized one clause at a time?

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.

UDIs Required by the FDA (Draft for 120-day Review) – It’s about time!

Unique Device Identifiers (UDIs) are nothing new. MASH tents in the military use 2-D bar coding to track the use of instruments in mobile operating rooms in the field. Just image how hard it is to count forceps and vascular clamps during a wave of shelling from a nearby front. That’s just one way UDI’s can be used to benefit patients and healthcare providers. Click here for the proposed rule.

For this week’s entertainment, I picked something a little different.

I am positive that some companies, and their lobbyists, will fight the latest regulations from the FDA regarding labeling requirements. However, this makes even more sense than electronic medical records. UDIs will enable faster and more accurate product recalls and MDRs. Click here for more information (I have copied the example provided by the FDA).

This is the unique device identifier example provided by the US FDA.

If you are trying to recall product, the last thing you want is to continue to send out letters three and four times to facilities that have no idea when or if your product was used. The medical facilities want to close out these requests for information quickly too. UDIs present a solution for assuring correct and complete responses by hospitals the first time.

How UDI Helps with Recalls

• Locating devices in inventory
• Locating product in distribution centers
• Identifying product after it is removed from the outer box
• Tracking product to each individual patient

How UDI Helps with MDRs

If you’ve been in the business long enough, you have seen more than one complaint about a product that you don’t even make. When this happens the company is obligated to open an investigation to make sure and the complaint gets recorded in the complaint files. The proposed rule includes identification of the manufacturer. Therefore, 100% of complaints should go to the correct company. Also, the company should always receive a lot number—something that almost never occurs.

What do you think about UDIs?

Has your company already taken steps to implement UDIs?