Looming shortage of medical devices in NL: report

Medical devices will soon have to comply with new, stricter European rules. Thousands of products will not be re-approved on time, which means that the Netherlands may soon face a severe shortage of medical devices like breast implants, knee prostheses, and pacemakers, Financieele Dagblad reports.

These shortages can put healthcare at risk, the federations of Dutch hospitals NFU and NVZ said to the newspaper. The hospitals do not know which products will soon be unavailable, because manufacturers are not sharing that information, the NFU and NVZ said.

According to NVZ chairman Ad Melkert, the problem lies primarily with the manufacturers. "The manufacturers draw their own line and do not indicate where the problems are. In addition, manufactures blame the inspection authorities. At the end, the patient may become the victim."

The new rules are being implemented after issues with leaking breast implants and abrasive artificial hips. The stricter European rules take effect on May 26. By then all medical devices must be re-examined and approved, otherwise they can no longer be supplied to healthcare institutions.

"The products need a lot of certifications and there are too few organizations that can deliver that," lawyer Erik Vollebregt of Amsterdam law firm Axon Lawyers, which represents medical companies struggling with the regulations, said to FD. "Smaller manufacturers in particular are the victims. Large manufacturers are given priority over the small ones. It leads to preferential treatment for manufacturers who are willing to pay more for timely approval."

NFU and NVZ call on Minister Bruno Bruins for Medical Care to intervene.