Sunday, November 11, 2012

Faulty hip implant shows up failings of EU regulation (1 of 3 in a series)

Medical Device Regulation


Deborah Cohen describes an investigation showing how a fake hip prosthesis with dangerous design flaws stood to be approved for the EU market
A joint undercover investigation by the BMJ and the Daily Telegraph has exposed flaws in the EU system used to grant market access for devices such as replacement hips, cardiac defibrillators, and breast implants.
Deborah Cohen comments on the undercover video taken as part of the investigation.

The investigation involved submitting a fake application for a large diameter metal-on-metal total hip prosthesis for approval by a notified body in Slovakia—the commercial organisations charged with evaluating the safety and performance of medical devices across Europe by granting them a CE certificate.

The hip—whose specification was designed for the purposes of the investigation—had similar specifications to the DePuy ASR XL acetabular system—a device that has been recalled from the market after failing at unacceptable rates and releasing metal ions into patients’ blood.1 Nevertheless, last week the notified body provisionally allowed the product to go forward to certification.
One notified body authorised to certify products for medical use across Europe, has been secretly recorded admitting that it is “on the side of the manufacturer.”

Last night, Jeremy Hunt, the health secretary, said it was “completely unacceptable” that patient safety could be endangered by potentially dangerous implants.

“The safety of patients is paramount so it is completely unacceptable that patients could be subject to substandard implants,” he said. “I will ask the Medicines and Healthcare Products Regulatory Agency and British Orthopaedic Association what we can do to ensure that patients can be confident they will receive the highest quality of devices when they need them.”

ITC, a regulatory organisation in the Czech Republic was also prepared to consider licensing the product, despite widespread concerns about the use of large diameter metal-on-metal hip prostheses. In some countries, surgeons have been told not to use them.
One representative of ITC told reporters that his company would not put “obstacles” in the way of approving the device and said it was “on the side of the manufacturer and their products, not on the side of the patients.”

Another notified body was recorded admitting that some of the dossiers for products legally on sale were “horrible” because of the deficiencies of the regulatory system.

When we later put this to ITC, it did not respond directly to any points raised but said it complied “in full accordance with the law.”

The investigation raises serious questions over the safeguards protecting patients. The system of licensing medical devices and surgical implants works on a pan-European basis and regulators in this country refuse to disclose where products have been certified.

More than 70 private agencies are competing for business—meaning the system is susceptible to corrupt practices, such as those uncovered during the recent PIP breast implant scandal.

The regulatory system works in a similar way to the licensing process for household electrical appliances and toys rather than the far more rigorous system applied to approving drugs.

Writing an accompanying editorial in the BMJ, Peter McCulloch, reader in surgery at the University of Oxford, has described the current EU rules for licensing medical devices as: “fragmented, privatised, and largely opaque; safety is dealt with in an unsatisfactory way and efficacy not at all.”2
He said that patient safety and not trade should take centre stage of the system to regulate medical devices.

The European system of regulating medical implants has been heavily criticised after a series of high profile device failures and recalls, exposing large numbers of patients to additional investigations and revision surgery.

Reporters purporting to represent a Chinese medical company contacted the notified bodies about approving a hip implant for the European market. The proposed product was a large diameter “metal-on-metal” total hip prosthesis, which should have raised concern. Many of these products have a high failure rate and pose a risk of metal ions being deposited in the blood stream.

But some notified bodies said it would not be necessary to perform clinical studies on the implant because similar ones were already on the market. The reporters submitted a detailed technical dossier describing the device they wanted to be certified to EVPU, a notified body in Slovakia.

Notified bodies are only supposed to certify— or reject—a product for sale, but EVPU also appeared willing to give advice with its fee dependent on passing the implant.

At a meeting in the company’s office in Nová Dubnica, Peter Luley explained that although EVPU couldn’t give “exact advice,” it sometimes “crosses the line” when telling clients what to do and this was why clients’ applications were so successful.

“We just cross the line and say just do this and it will be ok,” said Luley. “Therefore we have so high rate of successful certification,” he explained.

The cost of approval would be €2750 (£2240; $3590), with 50% to be paid up front and the rest on certification of the product. His colleague, Lubica Skrovanova, said that only four applications for the regulatory certificate had failed in the past five years.

The BMJ and the Daily Telegraph submitted a 70 page dossier based on the DePuy ASR XL acetabular system—a device that has been recalled from the market. However, even though the file explicitly listed the ASR XL as an equivalent device along with another that has also been recalled and a third that is subject to safety concerns, Skrovanova indicated she would provisionally allow the application in respect of the implant to go forward. The technical file also included a wear report on the fake hip implant that clearly showed that it released toxic levels of metal ions.

Once the contract had been signed and payment made, EVPU emailed its comments. A document outlining the content of the file noted that some sections of the dossier were missing—largely relating to the manufacturing process and risk assessments. However, the pages detailing the “product” features and “principle features of the device” were described as “OK.”

Skrovanova said the fictional company needed to submit documents relating to the manufacturing process before a certificate was issued. A factory inspection would also be necessary before CE approval. These were not related to the design specifications of the product.
EVPU declined to answer follow-up questions.

At Szutest, another notified body in Brno, Czech Republic, an executive openly admitted that the system was riddled with problems and that unsuitable devices were on sale.

Michael Bauer from the firm said: “Some of the notified bodies from eastern Europe and also western Europe have—well, they are not going well with the directive [an EU document that sets out patient safety standards].”

“When I have seen some certificates issued for some products, it was horrible.”
He added: “I have seen some notified body… that certified some product that, well, was from Korea, South Korea of course, and the product was completely different, the final product than was in the instruction for use.”

“It was certified. And it caused here in Czech Republic some issue and it [caused] some injury.”
Szutest said that it “fully complies” with EU procedures and the meeting was “merely an introductory session before commencement of the contract as such.”

They said that the company had not started the process of certification and even if they had accepted the order, it would not have guaranteed success.

The company said that the statements made by Bauer were “entirely his personal opinion.”

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