Patient Safety is Paramount Concern in Regulation Overhaul

Dermot McGrath reports.

The new EU Medical Device Regulation (MDR) policy should lead to greater patient protection and renewed confidence in the certification process for a wide range of ophthalmic products and devices on the market, according to José-Carlos Pastor MD, PhD.

“The scandals that occurred in recent years with certain medical devices must be avoided at all costs—firstly and most importantly for the benefit of our patients’ health and secondly for the reputation of European companies and what CE marking means,” he told EuroTimes.

Although the French PIP breast implant controversy is often cited as one of the main reasons for tightened regulations, ophthalmology has had its fair share of device scandals in recent years, Dr Pastor said.

These included multiple cases of acute intraocular toxicity reported in several European countries with at least three different products after uneventful vitreoretinal surgery.

In Spain alone, some 117 cases of toxicity were reported following surgery with AlaOcta perfluoro-n-octane (PFO; Alamedics)—with patients commonly experiencing low visual acuity the day after surgery, optic nerve atrophy, and acute retinal necrosis, sometimes leading to retinal holes, relapse of retinal detachments, and retinal vascular occlusion (find more information here).

Dr Pastor said toxicity issues with other products routinely used in vitreoretinal surgery, such as silicone oils and internal limiting membrane dyes, have also occurred in recent years.

A step in the right direction

Against this background, he believes the MDR, while not perfect, represents a step in the right direction.

“Some products may be discontinued, and some companies may have problems, but patient safety must be the primary goal of policymakers, manufacturers, and healthcare providers,” he said. “Like all rules, it may have aspects to improve and that, in certain situations, may have exceptions.”

One of the main challenges with the MDR is that the regulations may not be sufficiently flexible to differentiate between devices of vastly different complexity and function, explained Dr Pastor, citing the filter paper strips routinely used to perform Schirmer testing as an example.

“If MDR regulation is strictly applied, its accuracy and repeatability would need testing in clinical trials,” he said. “Their cost is currently around €0.24 per strip, and if companies have to pass those costs on to the final product, the market may not accept the final price. So, we really do need to find a solution for this and many other similar examples.”

Although still too early to judge the true impact of the MDR, Dr Pastor said it was important for ophthalmologists to regain confidence in the integrity of CE marking for safety.

“The scandals with medical devices in ophthalmology have created a certain rupture in confidence about the CE mark. Physicians need to be able to take for granted the safety of the products they use,” he said. “For instance, we have had some chemists manufacturing products who have proposed clinical ophthalmologists should also become experts in chemistry to better select the products we apply to our patients. Obviously, this is not the way to proceed.”

Stricter reporting

Under the MDR, stricter reporting responsibilities for companies and a EUDAMED database to share information concerning adverse events across all EU member states should help prevent a recurrence of the PFO incidents and similar cases.

When problems arose in the past, companies tended to minimise the extent of the problem or even blame the ophthalmologists for misusing the product—as with the contaminated PFO case.

“When mandated by the Spanish Agency of Medicines to analyse the possible causes of the contamination, the companies never provided us with critical data to interpret what happened,” Dr Pastor said.

The non-obligation for healthcare providers to report suspected adverse effects in all EU countries exacerbated the problem.

“Although we knew there were cases in more countries, they were not initially reported, which allowed one manufacturing company to expand the idea that toxicity was ‘a Spanish problem,’” he said.

The MDR reinforces companies’ legal responsibility and requires they have sufficient financial coverage for their potential liability.

“In the case of Alamedics, the company went bankrupt. And patient compensation, at least for those in Spain, had to be addressed mostly by the state with public funds from taxpayers. The CEO was hired again by another company and specialised in giving talks to retinologists about the ‘adverse effects’ of medical devices,” he said.

As an additional measure, Dr Pastor stressed the need for notified bodies to have specialised scientific advisors capable of evaluating whether both preclinical and clinical data a company presents really cover the safety and clinical efficacy needs it demands for that specific product.

José-Carlos Pastor MD, PhD is a full professor and Chairman at the Hospital Clinico Universitario of Valladolid, Spain, and Advisor to the Spanish Agency for Medicine and Medical Devices (AEMPS). pastor@ioba.med.uva.es