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The certification body BSI granted CE Mark product certification for a spinal implant medical device that is now reported to be dissolving inside the bodies of patients, forcing them to have additional spinal surgeries. In addition, the resulting investigation has led to revelations that BSI may have allowed the manufacturer to release the product to market despite insufficient human and animal trials.
Ranier Technology, a UK medical device manufacturer that has gone out of business because of the scandal, manufactured and sold two spinal implants, the Cadisc-L and Cadisc-C. Both were granted CE Mark certification by BSI, despite reports that they were only tested on 30 human trial patients over a brief six month period, according to documents obtained by the Guardian newspaper.
CE Mark certification is required for the release and sale of medical devices in Europe.
The Guardian also found that prior animal trials, using baboons, were dubious:
A 2009 review of some of the animals noted that “overall six months is a relatively short time to follow an implant up”, but even after that time there appeared “to be worrying changes between the implant and the bone in all but one subject”.
The Guardian report appears to confirm that no human trials at all were performed for the Cadisc-L model.
Despite this evidence, which would have been available to BSI at the time of Ranier’s CE Mark application, BSI granted Ranier the CE Mark certifications, allowing them to obtain lucrative funding and then sell the markets in Europe and elsewhere.
Patients are now finding the implants had dissolved inside their bodies, forcing them to undergo expensive additional spinal surgeries. At least half of the patients who received the implants were affected.
The scandal is likely to bring heightened scrutiny, and potential criminal negligence charges against BSI, much as the registrar TUV Rheinland was impacted by its granting of CE Mark certification to Poly Implant Prothèse (PIP) in France for breast implants. PIP was later found to have used cheaper industrial-grade silicone in the implants, rather than the required medical grade silicone. At least one patient has died, and multiple reports of illness and cancer are attributed to the defective implants. Multiple arrests were made in the case, and PIP was shut down, although the former Quality Director for PIP has since resurfaced in the French medical device industry using a different name and dyed hair. TUV Rheinland was found culpable in that scandal by the French high court.
The Ranier scandal isn’t the first brush with controversy for registrar BSI. It previously certified Bard Peripheral Vascular for the medical device quality management system ISO 13485, and in 2015 the FDA issued Bard a warning letter for multiple quality system violations including problems with the company’s inferior vena cava (IVC) filter, which resulted in at least one patient death. Despite this, BSI allowed Bard to maintain their ISO 13485 during and after the incident.
BSI is also under investigation by Oxebridge for its role in the Deepwater Horizon disaster. According to industry witnesses, an auditor with BSI audited a BP Oil office in Houston which was responsible for the management of the doomed oil rig. The auditor claimed to multiple third parties that he had reported problems with the rig prior to the disaster, but that nothing was done. The Deepwater Horizon rig later exploded, killing 11 crewmen and causing the greatest man-made environmental disaster in human history. Oxebridge has been unable to corroborate the witnesses’ account to date, however, and the BSI auditor has since retired. BSI was never included in any investigation of the disaster, and yet had BSI not granted the BP office an ISO 9001 certificate, they would not likely have won the contract to operate the rig in the first place.
The company Collagen Matrix of Oakland NJ was issued an FDA Warning Letter for having released “adulterated medical devices” to the public. That company currently holds a certificate for ISO 13485 from BSI, but it is not clear if they held it at the time of the FDA complaint. Nevertheless, BSI currently markets its services using Collagen Matrix as a “case study.”
If regulators or investigators find sufficient evidence to pursue a civil or criminal case against BSI in the Ranier case, they will find it an uphill battle. BSI has tremendous influence with the UK government, and oversees much of the daily control over ISO as well. ISO holds important liaison relationships with key international bodies, such as the United Nations and the World Bank.
BSI was also instrumental in getting ISO accreditation rules stripped, so that registrars no longer have to maintain public registries of their certified clients. BSI argued the requirement allowed competing registrars to “poach” its clients.” Without such registries, it is now impossible to verify the status of ISO 9001 and 13485 certifications if the registrar does not wish to reveal the information.
Former employees of Ranier have not yet replied to requests for information on whether the company also held ISO 9001 or ISO 13485 certificates from BSI.
BSI has twice threatened to sue Oxebridge for its reporting, but has never followed through. In 2005, a North American VP of BSI was fired after threatening to kill Oxebridge founder Christopher Paris.