The need to improve the safety of medical devices such as hip and breast implants made the headlines today.
The Daily Telegraph reports that experts are calling for an end to the “secrecy” surrounding how they are regulated.
The story is based on an opinion piece published in the British Medical Journal, which calls for European data on medical devices, including their safety and any adverse effects, to be made available to the public.
A second, related, article makes the point that the regulation of medical implants, and the collection and publication of related data on patient safety, fails to match that of medications.
Collecting and publishing high quality data could help prevent widespread problems with medical implants, such as those seen with Poly Implant Prothèse (PIP) breast implants.
The PIP scandal caused global concern after it was discovered that French-made breast implants contained industrial rather than medical grade silicone.
Concerns have also been raised about metal-on-metal hip replacements wearing down sooner than had been expected, potentially causing damage to surrounding tissue.
The authors argue that EU proposals for new legislation to regulate medical devices, which are currently being debated, should include their proposals to develop systems for collecting evidence.
What is the problem?
The article has been written by experts from the interventional procedures advisory committee of the National Institute for Health and Care Excellence (NICE). This body looks at the evidence on medical implants and devices, as well as surgical procedures, to see if they are safe, clinically effective and provide good value for money.
The experts point out that some medical devices and surgical procedures are introduced and used by health professionals with little evidence about their safety from clinical trials or observational data.
The term “medical devices” covers a huge range of materials, from very basic supplies, such as bandages, to extremely complex equipment, such as life-support machines.
The report says that the regulations concerning the evidence required on both efficacy and safety of new devices are less stringent than those for medicines. In many cases, data on safety and the possibility of adverse events is not routinely collected.
In addition, many medical devices are produced by small specialist firms that lack the funding and experience to conduct adequate research.
Within Europe, regulations require manufacturers to obtain a CE mark of quality for a new device. However, for the CE mark to be given, the amount of evidence needed on safety is usually small.
In contrast, the amount of evidence on patient safety needed before a new drug can legally be brought to market is huge.
The report also says that there are no legal frameworks governing the introduction of new medical or surgical procedures – whether or not they involve a new device – and the evidence on safety and effectiveness is usually poor. The reasons why the evidence is poor include lack of commercial sponsorship and the difficulties of setting up research trials.
All these factors mean that when a device or procedure starts to be used on patients, there is limited data on both its efficacy and short-term safety. “Adoption of the new procedure or device is typically driven by marketing and the enthusiasm of clinicians, rather than by evidence,” say the authors.
There is also no organised system of collecting data on devices and procedures once they are in use.
What recommendations does the analysis make?
The report proposes several solutions to the problem of inadequate data collection on the safety and efficacy of medical devices and procedures. These include:
- Device tracking. An efficient device-tracking mechanism (like a barcode) would make it easier to inform patients and recall devices where necessary and improve monitoring and data collection.
- Use of registers. Countries and health systems should be encouraged to use existing procedure registers (such as NICE guidance in the UK) and set up new ones where needed. The UK’s National Joint Registry is one example.
- Data linkage. New registers should be linked to routinely collected health services data, national mortality statistics and other sources of relevant information.
- Bypassing patient consent. Getting patients’ consent to use their data in registers has failed in the past. The authors suggest that where data collection is in the public interest, patient consent should not be required.
- International collaboration. Sharing data between countries may help.
- Post-market surveillance. Data collected by device manufacturers could provide useful information about the use of products worldwide.
- Adopting a framework for collecting evidence on new procedures. The authors say there is now a well recognised framework for generating evidence on any new procedure, from its first use into the long-term.
What happens next?
Some headway has recently been made into improving the safety of devices, says the report. It points out that the European Commission has adopted proposals for two new regulations on medical and surgical devices to improve patients’ safety. If they are agreed these regulations will apply from 2017.
However, the authors point out that proposed changes to legislation, both in Europe and elsewhere, do not include suggestions to improve the collection of data.
An accompanying commentary by a research group at Herdecke University in Germany argues that Europe needs “a central, transparent and evidence-based regulation process for devices”.
They have submitted a petition to the European Commission, European Parliament and European Council arguing for the regulation process to be centralised with independent assessment “by a new public body similar to the European Medicines Agency”.
They also recommend that post-marketing surveillance should be legally compulsory “to ensure that benefits and harms of the device in real world settings are similar to those shown in clinical trials”.
Finally, the German researchers call for transparency of the assessment process and results.
They believe that all available data on medical devices “should be publicly accessible and should include all relevant information concerning assessment, including data on safety, performance, and incidents”.
However, as the authors of this report point out, the outcome of discussion with the relevant authorities is “difficult to predict”.