Top 3 Tips for Developing a Globally Applicable Labelling Strategy
Peter Schroeer, Director Europe, Quality Systems and Regulatory Affairs at Johnson & Johnson, joined Pharma IQ to talk about strategies for overcoming current compliance challenges the medical device market faces. To listen to the podcast go to Labelling Compliance for Medical Devices: Wanted Global Harmonisation!
Pharma IQ: The medical device market is very diverse; what are the current compliance challenges the market faces?
P Schroeer: In this area I think not only the market with medical devices is very diverse, regulations are, as well, and this diversity in regulations is the major challenge for global manufacturers or those manufacturers selling products globally. From my perspective the major challenge is the missing alignment or harmonisation in the global devices market; we are duplicating a lot of work such as testing and documentation without adding additional safety, but just doing it differently. So it would be great if all regulatory regimes could agree, for example on global harmonisation task force principles, and use them as the basis for the regulation. So in summary, the diversity of regulations is leading to significant administrative burden which does not necessarily enhance safety.
Pharma IQ: What are the risks related to the reuse of single-use medical devices?
P Schroeer: Single-use devices have been designed for the intended one time use only, the materials, geometry and also the validation of the device has been done just with the view of the one time use only. Optimal performance is the goal of the design world for reusable devices which manufacturers such as Ethicon Endo-Surgery do have, as well. The scope is different and often reusable devices as a compromise between clean ability, reusability on the one side, and performance on the other side.
The risks of reusing single-use devices are quite well documented in the SCENIHR report. SCENIHR is the Scientific Community on Emerging and Newly Identified Health Risks and they issued a report which is called the Safety of Reprocessed Medical Devices Marketed for Single Use. And they identified several hazards which are in the area of inadequate cleaning, disinfectant sterilisation, that then result in persistence of either chemicals or microbiological contamination and then leading to the risk of toxic reactions and also microbiological infections. They also identified that chemicals are often staying with the product and then are leaking to patients later on when those devices are reused.
I think it's also important to understand that all those risks do exist and it's important to see that even after years of reprocessing there is still no evidence that reprocessing used devices are as safe as new ones. Many re-processors make the claim that those devices are as safe as a new one, but if you look now again into the SCENIHR report in the pre-market area - this means in the form of clinical trials - there is missing evidence that the device is as safe as a new one. And in the post-market area we do have other issues because no system exists today to detect if there are risks inherent in using single use devices. So, for example, if there would be issues of contamination and hospital-acquired infection typically this would be detected way later and it's often not linked to the reprocessed device.
So in summary, pre-market we do not have the tools to endure that the reprocessed device is as safe as a new one, and post-market we do not have any tools to document that this risk is under control and understood. So I think these are the significant risks documented very well in the SCENIHR report.
Pharma IQ: What impact has the reuse warning statement requirement per directive 2007/47/EC had on global labelling strategies?
P Schroeer: I think manufacturers did add general warning statements where they didn't have any detailed information or specific information when it existed for the group. For example, there are many devices and here especially minimal invasive devices which cannot be cleaned and for which studies exist to prove that those devices cannot be cleaned without breaking them apart, so manufacturers did introduce those warnings in their global labelling. And due to the fact that this was known way before and that industry was very well prepared for this such as, for example, with the Eucomed guidance document, I do not see any major issues there. It did require us to change our labelling, it included additional costs, but I didn’t see any major issues there so I think the majority of manufacturers were very well prepared to comply with this.
Pharma IQ: What are the key challenges in defining a global labelling strategy?
P Schroeer: I think the key challenge there is the increasing number of languages versus the relative low volume of products per country. There are, of course, certain high volume countries but we do have a lot of smaller countries and all those countries now do require that we provide information in national languages. This means that a typical package for the global market to date has had more than 20 languages, and with instructions getting more and more detailed also due to national requirements we are now having more booklets and not small leaflets with those products. And for the product label itself we need space for all the languages. One way out of this would definitely be e-labelling which would help to limit waste, increase information for the user and give the user what they want, since no one wants to have a booklet with more than 20 languages.
Pharma IQ: Regulatory compliance is key; what would be your top three tips for defining and implementing a global labelling strategy?
P Schroeer: I think what you need to do is you have to decide early on where to market the product. You should then make a decision early on if you provide global labelling, meaning one package that's good for the entire world, or if you go into late stage customisation which is just labelling the product prior to shipment. You also need to ensure in your systems that you have your translations reviewed by local experts.
You have to ensure that you have a quality system governing the entire process to create re-user material. You should use libraries to ensure the information is consistent. And you also need to remember if you are using late stage customisation, labelling is manufacturing, and if you have one of your local warehouses to be in charge of this process that this is covered by your quality system, because you as the manufacturer will be responsible irrespective of where the process takes place.
Pharma IQ: Is refurbishment of single-use medical devices compatible with a high level of safety?
P Schroeer: I think reuse to date is done mainly to save money; also there is absolutely no data to prove that there are cost savings. Longer OR times are not taking into account, the possibility to increase the number of hospital-acquired infections is not reviewed, and all the manual work that has been done in a hospital in case of third party reprocessing is not looked at.
But coming back to the question, a high level of patient safety is defined by the Medical Devices Directive; reprocessing as it's conducted today is completely outside of this framework and one can challenge if the level of control on reprocessing and requirements is comparable. I would say it's not. And, as I mentioned before, there is no pre- or post-market system to ensure that reprocessed devices are as safe as new ones. And reusing devices against intended use and outside of the MDD safety net is, from my view, not compatible with a high level of patient safety because they are not using established tools to prove that pre-market the device is meeting all the requirements. And we do not have post-market tools to control if what has been stated upfront is true and if adjustments need to be made. So in summary I would say with the reprocessing outside of the MDD it's not as safe as and not comparable with a high level of patient safety.
Pharma IQ: Peter to round off, what future global developments do you think we will see in regulatory compliance for medical devices?
P Schroeer: First of all I would say what I would like to see, what I hope to see, and I hope to see more harmonisation worldwide to limit regulatory burden and focus on what is essential to increase the safety profile of a product, not necessarily just to increase the regulatory burden.
Europe is now discussing the recasts, the need for a European management agency. We are also discussing how to regulate innovative products, so there are a lot of things going on right now in our region. We see many innovative products coming to the market and we need to find smart systems intended to ensure safety and fast access to the market of the needed new technology to treat, diagnose or prevent diseases.
What we need therefore is a safe, smart and sustainable system. We should not continue to just increase regulatory burden without having those three principles, safe, smart and sustainable, in mind. Systems also should be more predictable to ensure that when industry does invest in areas which are meeting patients' and hospital needs that we are then not stopped later on by unknown or unpredictable regulatory requirements.
Currently I do not see that this is reflected in the global regulatory environment. FDA is working on a new fast and clear process, but I have not seen a clear link to the HDF principle. In Europe member states are working on, for example national databases, national vigilance systems, and there is quite some duplication. What I hope is that with the recast which is coming up in 2011 we use this as an opportunity to further harmonise systems in Europe and focus on patient safety and also on predictability of our regulations.
Interview conducted by: Andrea Charles