The IAF regional body Asia Pacific Accreditation Cooperation (APAC) is now the subject of a criminal complaint for failure to take timely action on reports of potentially defective medical devices released to market under its authority.

As reported previously, a report was submitted to Oxebridge via the international ISO Whistleblower Reporting system which alleged potentially defective chemotherapy examination gloves were shipped with a test report issued by Eurolab/TurCert. That certificate claimed to have validated the safety of the gloves per ASTM D6978, and featured the accreditation logo of the United Accreditation Forum (UAF).

UAF is an Indian-run accreditation body that uses a US address. That body has already been the subject of prior industry complaints.

Oxebridge investigated and learned that the scope of TurCert’s accreditation with UAF did not include the ASTM D6978 test method reported on the certificate, nor any testing for medical gloves at all. Oxebridge then filed a complaint with UAF.

Over the next few months, UAF representative Yuliya Lalova — who Oxebridge has not been able to confirm actually exists — argued and delayed action, eventually ruling that the tests were done appropriately and that ASTM D6978 was included inĀ  TurCert’s scope of accreditation. Lalova never provided any evidence or explanation as to why the published scope of accreditation issued by UAF entirely contradicts her claims.

At the same time, Oxebridge continued to copy both the IAF and APAC on the matter, reminding the parties that a failure to take action could result in risk to human life. Chemotherapy gloves are used by medical professionals to protect them from repeated exposure to dangerous chemotherapy drugs.

Regardless of these warnings, neither IAF nor APAC took any action. Upon UAF’s final email to Oxebridge on the matter, Oxebridge formally escalated the issue to APAC.

APAC could force UAF to issue a demand for a product recall, as well as report the products to international health ministries. In addition, APAC could have stripped UAF of membership.

But rather than take action, APAC representative Graeme Drake again pushed the matter back onto UAF, writing to an Indian representative, Parveen Sadana, and giving him another chance to respond to Oxebridge’s complaint. Sadana then claimed that UAF would open an official investigation into the matter.

Oxebridge argues that Sadana should have taken action immediately upon receiving the original complaint, and that APAC’s role is to now investigate what went wrong with UAF’s response. Instead, Drake and APAC are granting more time to UAF, which may lead to many more months of potentially lethal products being allowed on the market.

Because of Drake’s refusal to take action, Oxebridge has now filed formal criminal complaints against APAC in Australia, from where APAC operates. Under Australian law, potentially defective medical devices must be reported. Oxebridge is providing government officials the evidence showing that Drake and APAC consistently refused to take action in a timely manner, and have since not forced a recall of the potentially defective gloves.

APAC has become a popular IAF member for fly-by-night accreditation bodies, due to its lower standards of oversight and the willingness by Drake to avoid performing objective investigations into complaints. As a result, APAC has grown in numbers, while having no official government oversight in Australia or anywhere in the world. APAC has been called a “pay to play scheme” by some industry insiders.

UAF is only an “associate member” of APAC, allowing it to use APAC’s name while not requiring it to adhere to rules governing full membership. This fact does not negate the responsibility by APAC or IAF to take action when one of their bodies has released potentially defective medical devices.

Oxebridge has also opened conversations with the US Food and Drug Administration on the IAF, which operates under a Delaware business registration.

APAC has also loosened traditional understandings of how IAF regional bodies work, allowing accreditation bodies from anywhere in the world to join. APAC has allowed the UAF to join as it views the United States as a “Pacific country” because one of its coasts sits on the Pacific. The actual IAF regional body for the Americas is IAAC, but that organization has somewhat tighter oversight rules than APAC.

APAC is now working to bring Russia under its scope of oversight, and Drake has ignored problems related to Russian scandals in the region.

It is believed that Drake’s salary is tied to performance bonuses earned by “capturing” more accreditation bodies for the APAC roster.

As a result of APAC’s intransigence in the chemotherapy glove incident, Australia now faces its own version of Europe’s PIP breast implant scandal. That scandal led to the criminal prosecution of certification body TUV for certifying breast implants later found to have been filled with industry-grade silicone rather than medical-grade. Multiple arrests were made in that case, and TUV has been forced to pay millions.

Oxebridge is also exploring a complaint against UAF’s owner, Dr. Tejwant Chandi, who holds a license to practice medicine in the United States. UAF now claims that Chandi no longer owns the company, but this fact appears contradicted by official documents currently appearing on the UAF website which lists him as the CEO.

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Why we report on these topics

Since 2000, Oxebridge has worked to improve ISO and related certification schemes by identifying problems and then proposing solutions. We report on issues affecting standards users because so few other news outlets do. Our belief is that in order to fix the problems in these schemes, we must first understand the nature and breadth of those problems. Our reporting aims to do just that. Elsewhere on the Oxebridge site you will find White Papers and other articles proposing ideas to correct these problems.

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