Elsevier

Health Policy

Volume 113, Issues 1–2, November 2013, Pages 38-44
Health Policy

Review
A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe

https://doi.org/10.1016/j.healthpol.2013.03.017Get rights and content

Abstract

The unacceptably high incidence of clinical adverse events caused by medical devices (MDs), their high recall rates, and the frequent phase out of some of the devices that pose a greater risk to health have triggered alarm concerning the long-standing weaknesses of their regulatory processes. It has long been known that regulation is not strongly associated with the existence of market failures. In this article the deficient approval process and postmarketing surveillance of MDs in the United States and Europe, as well as the causes and effects of their very serious failings, that put patient safety at serious risk, are critically reviewed. Solutions to address the urgent need to develop new regulation in the European Union are set forth as well. The fragmented MD industry is plagued with externalities. It seems that regulation is more being supplied in response to industry's demand (legislation and agencies capture) than for redistributing health and wealth. Severe adverse events associated with MD are spurring demand for regulation. Governments should promote the most risked-based, cost-effective regulations, those that pursue the interests of individuals affected, by using public and unbiased estimates of their costs and benefits, maximizing net health gains through legislation, applying clear rules of the game, and braking up the effects of the influence of interest groups.

Introduction

The unacceptably high incidence of clinical adverse events caused by medical devices (MD), their high recall rates, and the frequent phase out of some of the devices that pose a greater risk to health have triggered alarm concerning the long-standing weaknesses of their regulatory processes [1], [2], [3], [4], [5].

Several institutional reports on MD regulation have been issued on both sides of the Atlantic, but the most rigorous evaluations have been conducted in the United States. These evaluations show, for instance, that in that country a high percentage of the highest risk MD obtain approval via mechanisms intended for medium- and low-risk MD, which do not require a full-fledged clinical evaluation. They also show that only 27% of such devices have been tested in clinical trials before marketing. Formal complaints and court trials are common and the surrounding legislation has sparked lively controversy [6], [7]. These events are nowhere similar in scale to those observed in the European Union (EU) owing to the worrisome shortage of data and lack of transparency existing in Europe with respect to regulatory matters [8], [9], [10], [11], [12], [13], [14], [15], [16], [17].

Over the past few years there have been mounting concern and complaints concerning the European approval of MD [18]. A number of studies show that most clinicians remain unaquainted with how the MDs regulatory system works [19]. In this purview, McCulloch has recently portrayed the EU regulatory system as “fragmented, privatized, and largely opaque; safety is dealt with in an unsatisfactory way and efficacy not at all '. The Royal College of Surgeons and The British Orthopaedic Association have indicated that there should be an “urgent crackdown on these unacceptable practices”. Cohen said, in reference to hip prostheses, that MD are “one of a very large uncontrolled experiment exposing millions of patients to an unknown risk”, a comment in line with his surefire diagnostic assessment: “this is a history of the collective and systematic failure of the regulatory-industrial complex” [19], [20], [21], [22], [23], [24].

The BMJ and the Daily Telegraph recently conducted a “secret shopper” investigation to test the processes used by 14 notified bodies (NBs) in five countries to assess MD. They created an imaginary metal on metal hip prosthesis similar to one that had been recalled due to unacceptably high failure rates. Reporters handed in brochure on the implant and applied to get quotations for CE certification. They found that the NBs competed with each other on price and speed of certification, were prepared to accept low levels of evidence on the effectiveness of high risk devices, offered advice on how to get approval, and in some cases offered near guarantees of success [18], [24].

In this area there is no mistaking causes and effects; the association between the two leaves no room for doubt, it is multicausal, there is interaction between causes and effects, and the steep MD adoption curves aggravate the problem.

It has long been known that regulation is not strongly associated with the existence of market failures. In light of the theories of regulation (normative analysis as a positive theory, capture theory, economic theory, and Stiglerian/Peltzman and Becker models), we may be currently witnessing the effects of severe regulation failures such as the (health) negatives externalities described in this paper, shortage of information, long standing inconsistencies in regulatory agencies’ information, and regulatory agencies captured by industries [23], [25].

In this article I critically examine the approval process and postmarketing surveillance of MD in the United States and Europe, describe the causes and effects of their very serious failings, and propose solutions to address the urgent need to develop new regulation in the European Union. All documents were drawn on the published literature by means of a narrative review.

Section snippets

The device review process in the United States

Since 1976, a series of acts have been approved that invest the FDA with the authority to obtain “reasonable assurance of safety and effectiveness” before marketing MD [9], [10], [12], [17]. In the United States, class I devices (e.g., stethoscopes, tongue depressors) are regarded as posing very little risk to health and are only subjected to “general controls,” such as sterility tests. Class II MD, which pose a moderate risk (e.g., wheelchairs, earphones, ultrasound machines, computed

The review process in the EU

In the EU MD regulation is the responsibility of each of the 27 Member States. No single agency is in charge, contrary to what happens with pharmaceuticals. Several guidelines have been issued since 1990 in an attempt to harmonize and establish a single, common regulation. Under such guidelines MD are classified according to their risk profile as class I (i.e., stethoscopes), IIa (i.e., blood pressure cuffs, ultrasound machines, MRI machines, PET scanners), IIb (i.e., X-ray machines), and class

In the US

One of the most troublesome criticisms of the adequacy of this review process appears in several rigorous reports issued by the US Government Accountability Office (GAO), the Food and Drug Administration (FDA) and the Institute of Medicine (IOM). The reports show a number of serious problems, among them the fact that approval is often granted on the basis of studies that lack rigor, have no control group and are subject to bias, even though PMA “is the most stringent type of device marketing

Postmarket surveillance

The quality and supervision of MD postmarket surveillance are even more deficient than for drugs. The United States has no active requirement that adverse events be notified to the manufacturers, and off-label use is very high (in Medicare it is as high as 69%) [5], [9], [11], [14], [27], [29], [32]. An estimated 0.5% of all device failures are registered [20]. Studies conducted by the GAO and the IOM have exposed the weaknesses of this system, primarily attributable to the extremely low

Two examples

Leaving aside the unfortunate case of breast implants, so widely echoed in the media, the regulatory weaknesses discussed so far are exemplified by hip prostheses (HPs) and cardiovascular devices (CDs) [6], [7].

Indispensable measures and key elements of regulatory reform in Europe

In light of all that has been said, certain measures should be regarded as indispensable during the MD regulatory reform process in Europe. They are presented in Table 1. The following key factors deserve special emphasis. There are too many European guidelines and they undergo frequent amendment. Because information sources are few, it is not possible to assess the existence of MD misclassification or the appropriateness of the evaluation process. NBs are seen as using very heterogeneous

Conclusion

It is important to keep a watchful eye on the adequacy of any changes made to the European guidelines in 2012 [24]. When it comes to MD, the gap between phase III efficacy and safety estimates and the weakness of the regulatory process are greater than for pharmaceuticals. This makes it imperative to introduce deeper, systemic and overarching regulatory changes in a shorter time.

In Europe, the first step should be to understand the full extent of the problem and bring it to public attention.

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