This article was originally posted in the French Federation of private hospitals newsletter. The original version can be found in French at this link.
What is the reprocessing regulation abroad?
The new European Medical Devices Regulation, adopted in 2017, stipulates that the entity (manufacturer, reprocessor, hospital) that reprocesses a single-use device, if permitted by national law, must assume the obligations which is the responsibility of the manufacturers and is in fact considered as the manufacturer of the device. Europe is following the USA, Canada and now Japan, deciding to classify reprocessing of single-use medical devices as a manufacturing activity, instead of just banning it.
For us, the best way to ensure the proper use of reprocessed single use medical devices is to authorize and oversee the reprocessing process. Studies show that in regulated markets, the volume of single-use medical devices reprocessed by specialized companies increases, reducing costs and waste generated, but also forcing manufacturers to lower the price of new single-use devices. We therefore welcome the new EU regulation and hope that the majority of Member States will allow CE marking of reprocessed single use devices.
The United Kingdom has long maintained the ban. In 2016, health authorities (Medicines and Healthcare Products Regulatory Agency, MHRA) maintained the ban on devices reprocessed by hospitals but authorized the use of single-use devices reprocessed by specialized companies with CE marking. We hope that health authorities in France will follow their neighbor in the Channel.
And security in all this?
Five years after the adoption in the United States of the regulation on the reprocessing of single-use medical devices, the audit, evaluation and investigation organization of the Congress (Government Accountability Office, GAO) carried out a review evaluation that showed that no device-related infections had been reported and that none of the hospitals surveyed had expressed concern about potential device malfunctions. On the contrary, the confidence rate for retired devices is high and some have even reported that they have fewer problems with retired devices than with new ones. In general, participating hospitals reported that the more stringent regulations imposed on reprocessing companies than manufacturers of new devices,
What financial rewards can be expected from reprocessing?
Retired single-use medical devices cost on average half as much as new devices. For example, some heart rate sensors cost 2,000 euros and several can be used for surgery, instruments used in laparoscopy cost between 200 and 450 euros each, etc., so the potential savings are significant and can even reach 60%, knowing that some devices can be reprocessed several times.
Data from members of the American GreenHealth Practice Association showed savings of $ 30.5 million for medical devices in 2016 and an average of $ 295,200 in waste savings per hospital. Baltimore Johns Hopkins University Hospital, which retires its pulse oximeters, ECG cables, ultrasound scalpels, EP catheters, orthopedic devices, saved $ 1.1 million in 2015.
Reprocessing is a commercial success wherever it is practiced because it allows hospitals to maximize the value of their medical devices, rather than allowing producers to put pressure on the sale of these resources. Reprocessing companies and hospitals work hand-in-hand, and savings can be re-injected into the hospital.”