Always read the small print…on the ENVI proposal for the reprocessing of single-use medical devices
Always read the small print…on the ENVI proposal for the reprocessing of single-use medical devices
Caveat Emptor, or ‘Buyer Beware’, is a commercial rule favouring the seller, now largely extinct due to modern consumer legislation. But the European Parliament’s ENVI Committee, in its amendment on the reprocessing of single-use medical devices, has unwittingly slipped something similar back in again. Given the complex and highly technical nature of the Medical Devices Directives, I can see where busy MEPs would struggle to understand the details and consequences of this amendment, so I think it is essential that we take a moment to read the fine print.
If it were ballpoint pens or tea-towels we were regulating, I wouldn’t worry. But this is about re-using blood and human-tissue contaminated medical products post-surgery. So I do worry. It’s serious.
If you have no time to read any further, and you happen to be a Member of the European Parliament, the bottom line is that the Commission came with a balanced proposal on reprocessing single-use medical devices and the ENVI Committee came with a 17-page ‘sales contract’ for reprocessing with hidden traps for patients and consumers. You can make a positive difference. All you need to do is support the Commission’s balanced proposal and vote no to the ENVI Committee’s Compromise Amendment 3 on 22 October.
If you do have time, and I know MEPs are extremely busy, then please I invite you to read on.
So what's all the fuss about? What is 'reprocessing'?
Reprocessing is a common hospital practice; it can even happen in your doctor’s office. It’s where the medical supplies used in operating rooms are cleaned, disinfected, sterilised and returned for use. A surgical saw used in hip surgery would be a typical example.
So far, no problem. This has been going on for centuries.
And what are 'single-use' devices?
At one point even syringes and scalpels were considered reusable. At the end of the last century an increased awareness on the prevention of blood-borne infections, such as HIV, Hepatitis B and Hepatitis C, led many hospitals and doctors to demand disposable products.
Thus the market switched, where feasible, to disposable single-use devices. These were similar in function, typically cheaper, but not as durable as the reusable product. They were designed to be used once and disposed as bio-hazardous waste and not designed to be reused or withstand the aggressive cleaning and sterilisation in the way that a reusable product can. Often they cannot be dismantled for ease-of-cleaning as the case for their reusable cousin.
In order that hospitals and doctors could distinguish between the two similar products, the term ‘Single-use’ and the ‘Single-Use’ symbol were born. Syringes, urinary catheters, blood bags, heart-catheters and implants are typical examples.
So why does anybody want to reprocess these things? I don't want a reused syringe, or a reused heart valve for that matter.
The real issue comes with the explosion of innovation and the dawn of minimally invasive surgery. Now with miniature cameras and tiny pressure and electrical sensors, doctors have the potential to map and cure a patient without the need for expensive surgery and the patient can leave the same day with only a tiny incision in their leg or abdomen.
The huge upside is that while the devices themselves have a cost, this is considerably outweighed by the reduction in costly surgery time and resources and the enormous benefit to the patient of not having to undergo invasive surgery with long and painful recoveries. The downside, if there is one, is that these complex cameras and electrodes by their nature have many surfaces where bugs can hide. Furthermore they have to be soft and flexible enough to travel through blood vessels and human tissue without doing damage. So not only are they de facto contaminated and impossible to completely clean, these often intricate devices cannot handle being reprocessed over and over again. They are too weak to withstand the rigors of disinfection and sterilisation (sterilisation is a process that typically incinerates, irradiates or chemically eradicates the bugs from the products). So they are typically ‘single-use’.
But given the constrained budgets of hospitals in some countries and regions, hospitals are reconsidering the cost-benefit equation.
Today national health authorities differ in opinion across Europe about this. Some Member States see reprocessing of single-use devices as highly dangerous and have banned this practice to protect patients and consumers. Other Member States see that some products, not all, can be reprocessed under strict standards.
And this is where the commission and its balanced proposal comes in
The Commission’s proposal will ban outright the reprocessing of certain products that no-one in their right mind would reprocess (fancy a used syringe anyone?) and installs the standards, responsibilities and liabilities for both the Member States and those that wish to reprocess, while allowing all other Member States who feel that the standards are not good enough to continue their ban.
And so why is the ENVI proposal so bad? Because it jeopardises patient safety. Reprocessing has the potential to become a free-for-all.
Now the proposal on the table from ENVI is that all products will be considered re-usable by default. It then requires all manufacturers of all devices to prove the impossible, that there is no potential way somewhere, somehow, by someone that the device can actually be reprocessed, which they cannot in any scientific or meaningful way do! And it proposes that the Commission is to manage a list of products that cannot be considered reprocessable: we are talking about half a million products! Already the Commission has said they don’t have the resources to manage such a ‘list’.
What the Commission did by laying out a fair playing field to all economic operators in 6 small paragraphs, the ENVI Committee has exploded into 17 pages of detailed and somewhat confusing amendments all around the operation of reprocessing for the reprocessing industry. Ostensibly to introduce high standards for both the original manufacturer and the reprocessor, a little more careful reading reveals that there are lot of other things there too. And most are ultimately dangerous to patients and consumers. You would have to say that the ENVI Committee probably did not realise the safety consequences of what is a complex subject to tackle.
Caveat Emptor: A few legal loop-holes and gaps that consumers and patients shoul look out for in the ENVI Porposal
- Proving the impossible: By linking the definition of single-use to the need to demonstrate ‘impossible to reuse’, rather than a high level of safety it sets the bar so impossibly low that no matter what evidence a manufacturer has on safety he can never have enough safety data to ‘prove the impossible’. Hence all products, no matter what the risk to the patient or consumer, no matter what the contamination, can be reused. The flood gates are open.
- Delays for patients: If you think about this, for an innovative device that represents a needed life-saving innovation to a certain group of patients, these patients will be forced to wait another 4,5,6 or how many years, while the manufacturer who has a safe innovation has to spend time and money proving that it is impossible to reprocess, something she or he never wanted to do in the first place. Meanwhile, patients could possibly die waiting.
- Increasing risk: Rather than limit the risk of exposure of patients to contaminated products, and maintain the low level of infection, overnight ENVI, most probably without realising, is going to greatly raise the risk to unknown levels and potentially previously unseen highs in blood-borne infections.
- How much is too much? There are also extreme interpretations that may be taken from the text. There is no one to decide how much reprocessing is enough. 1, 4, 10, 100 times? To prove the safety of reusing single-use devices, and this degree of reprocessability, clinical trials would have to be done exposing healthy patients to devices of varying levels of contaminated medical devices; and as the ENVI proposal also foresees randomised control trials, patients will have to live without knowing if they got the infected device or not. It is hard to see any clinical trials or real science ever being generated on the safe reprocessing of medical devices.
- The power of ‘the list’ This low level of safety is further enforced when ENVI ignores all medical advancements in the prevention of blood-borne infections by defining all devices, no matter what the risk to the patient or the consumer, no matter what the contamination, as being de facto reusable unless on a list.
Most interesting – and odd – about this amendment, is that this list is by definition empty. The list can only contain single-use devices that are proven impossible to reuse, and this is truly impossible. It can never be achieved scientifically or otherwise so the list will be empty and all devices are again reusable, no matter what the risk to the patient or the consumer, no matter what the contamination.
Even if the list were able to be compiled, given that tens of thousands of new and improved devices enter the market each month, this list will be impossible to maintain. To repeat: The Commission themselves have voiced their concern that such a list will not be possible to create and manage.
- Marginalised Member States: The proposal removes the Member States’ right to ban reprocessing, thus removing their right to protect their own citizens. In other words, it opens otherwise closed markets to reprocessors.
- A free ride for reprocessors: While the ENVI Committee attempted to increase patient safety by introducing the same standards for the original manufacturer and the reprocessor, this requirement remains toothless for the reprocessor as unlike the original manufacturer, the reprocessor is exempted from any conformity assessment. Any!
There is a fundamental anomaly with the rest of the legal framework, even for pharmaceuticals, in that devices containing human tissues and cell devices are treated as the highest risk class III devices with even the pharmaceutical legislation applying for devices that qualify as Advanced Therapy Medicinal Products, reprocessed single-use devices are considered as low risk with no conformity assessment process applying.
- Labelling will never be correct: Once someone somewhere has figured out a way of reprocessing a device, independently of whether he plans to become a reprocessor or not, all labels must change across all original manufacturers within 120 days, even if those did not want to or could not do this in the first place. With over 25,000 SMEs and over 500,000 individual products, this requirement will be impossible and prohibitively expensive to achieve. Thus, the end result will be that labels can never be trusted and safety is compromised.
- Who is to blame when something goes wrong?: Lastly, and probably of most concern when things will go wrong – as things in do go wrong from time-to-time. It is not totally clear in the ENVI compromise that liability is completely transferred to the reprocessor.
So as I said, don’t forget the fine print. Looking at all of these loopholes and anomalies, given that the ‘sales contract’ seems stacked in the reprocessor’s favour, I’d shop elsewhere. Be a discerning consumer. Be a safe patient. Vote with your wallet, and for your health, and shop at the Commission’s proposal.
- Serge Bernasconi, Chief Executive Officer, MedTech Europe, EDMA & Eucomed