A NOTE FROM THE EDITOR
For Single Use Only? Prove It, Says Belgian Legislature
I've always been fond of the paradoxical constructs of Belgian painter René Magritte, but most people would agree that his form of surrealism does not represent a workable philosophy of governance. The Belgian legislature, however, appears to be determined to test this tenet.
In September, the legislature announced to the European Commission and the World Trade Organization that it was drafting legislation requiring manufacturers to prove that single-use medical devices marketed in Belgium were indeed unsafe for reuse. Companies would have to submit technical or scientific data to validate this assertion and have the documents verified by a notified body. EUCOMED and other industry associations along with several EU member states promptly voiced strenuous objections to the legislature's oeuvre. The United States–based Health Industry Manufacturers Association and Medical Device Manufacturers Association (MDMA) echoed EUCOMED's concern that the proposed law would create a technical barrier to the free movement of goods with a CE marking.
The decree was slated for implementation in September, but because seven EU member states forwarded reasoned opinions to the European Commission, the law will not go into effect at least until December. In my opinion, the proposal should be sent to the oubliettes.
As several associations and manufacturers have pointed out, this law would require manufacturers to prove a negative. How could you possibly show that there are no extant chemicals or cleaning fluids that would make a disposable device safe for reuse, noted one association spokesperson.
In a letter to the United States Department of Commerce, the MDMA denounced this "premarket approval process for CE-marked medical devices that are already on the market in the European Union. Manufacturers market these devices for one use only because they cannot guarantee [their] continued safety, effectiveness, or performance for multiple uses," notes the MDMA. Those who choose to reuse these devices against the recommendations of the manufacturer are the ones who should be held responsible, the MDMA adds.
Millions of disposable devices are reused each year. Public awareness of this practice is growing, as media reports begin to surface about catheter tips that break off in patients' bodies and nosocomial infections that are caused by inadequately sterilized devices. The reuse of single-use devices is a potentially explosive issue, and it is past time to find a solution that everyone—governments and insurers, industry, healthcare providers, and patients—can live with.
Belgium's d(r)aft legislation, which ostensibly seeks to reduce healthcare costs at industry's expense while undermining CE marking in one fell swoop, is not a viable option.
Norbert Sparrow
