Originally Published EMDM October 2002
A NOTE FROM THE EDITOR
EUCOMED Leads Charge Against Repeat Offenders
Seven years ago, when I first started reporting on medical device–related matters in EMDM, the reuse of single-use devices was one of industry's hot-button issues. The debate has continued over the years, at conferences and in the pages of this and other publications. Last month, I received yet another press release on this topic. It came from the pan-European trade association EUCOMED and announced the publication of a manifesto calling for EU action to regulate the reprocessing of single-use medical devices. My initial reaction was, why are we still talking about this? What part of single use do people not understand?
To be fair, there has been progress. France, Italy, Germany, Portugal, Sweden, Spain, and the UK have introduced legislation to regulate and, in some cases, ban the practice. But implementation has been erratic in many of those countries, while other member states have yet to recognize that a problem exists. And so, EUCOMED and the Patients Association, an independent UK organization lobbying for greater patient involvement in healthcare decision making, have drafted this manifesto. It calls for a Europe-wide initiative because, as is stated in the document, "infectious diseases . . . do not respect national borders." Neither does stupidity, if you consider one of the arguments for the reuse of disposable devices: environmental benefits.
Incredibly, some have justified the practice as environmentally responsible because it delays the end of the device's useful life. This is the sort of knee-jerk environmentalism that gives the movement a bad name. Reuse and recycling are admirable principles, but they can't be equally applied in all circumstances; and certainly not when the outcome endangers patients and healthcare workers.
The manifesto notes specific health risks that can be tied to the reuse of single-use devices, such as transmission of CJD and hepatitis. Reprocessing a device that has not been designed for repeated use can also diminish its performance and, therefore, affect its safety. If you harbour any doubts about this, I recommend that you go to the EUCOMED Web site (www.eucomed.org/?x=4&y=46&z=125&id=444), where photos of some reprocessed single-use medical devices are displayed. Would you want the catheter shown at the top of the page anywhere near your body?
Although the benighted few might sincerely believe that there is an environmental argument to be made, the primary reason that some governments have been reluctant to address the issue is, of course, economics. As EU member states wrestle with widening deficits, healthcare budgets continue to be closely scrutinized. And governments can certainly save a tidy cumulative sum by turning a blind eye to device reuse. But that is a myopic view, according to Mike Stone, chief executive of the Patients Association.
"Infections acquired in hospitals are an increasingly serious problem, putting the health and lives of patients and hospital staff at risk, putting pressure on waiting lists, and adding sizeable costs to the member states' budgets," Stone noted at a hearing at the European Parliament in April. The association has conducted surveys of medical professionals in the UK, he added, and "it is clear that the practice of reuse of single-use devices is widespread in the UK, and we believe that is also the case throughout Europe."
The stated common aim of the manifesto is "to call on the EU to regulate all reprocessing of medical devices intended for single use by hospitals, reprocessors, and original manufacturers in order to protect the health and safety of patients and healthcare workers." If this were one more dialogue between EU officials and member states, with token industry representation, I wouldn't hold my breath waiting for a resolution. But the involvement of patient associations in the UK and elsewhere, and the support of the European Medical Association, the standing committee of Doctors of the European Union, and the standing committee of Hospitals of the European Union leads me to think that perhaps something will come of this. Maybe, just maybe, I won't be writing another column on the reuse of single-use devices seven years from now.
The manifesto is posted at www.eucomed.org.
Copyright ©2002 European Medical Device Manufacturer
