#ImplantFiles: On US blacklist, in India they are in the grey zonehttps://indianexpress.com/article/india/implantfiles-on-us-blacklist-in-india-they-are-in-the-grey-zone-5467974/

#ImplantFiles: On US blacklist, in India they are in the grey zone

At least 57 medical devices, many used in critical care, were being sold in India when the US Food and Drug Administration (FDA) clamped down on them for a range of faults over the last two years.

The Indian Express found that of 41 devices recalled by FDA in 2016, at least 25 were for specialised neurology and orthopaedic procedures . (Illustration by CR Sasikumar)

Over two years, the US Food and Drug Administration (FDA) recalled at least 117 medical devices that were distributed globally after concluding that they led to serious health issues, including death in several cases. At the time of recall, at least 57 of these devices were being marketed in India, The Indian Express has found.

While these were on the FDA list, they did not possibly come on the radar of any Indian regulator because they did not feature on the list of 23 medical devices for which the Central Drugs Standard Control Organisation (CDSCO) issues recall alerts. Among these 57 devices, The Indian Express tracked eight that are most commonly used, and found that in each case, it was left to the manufacturer to take action. In some cases, the manufacturers claimed that the recall was due to technical defects while in others, they said the software was to blame. All these eight devices are back in the market.

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The US FDA recalled the 117 devices — between January 2016 and December 2017 — under the category of ‘Class I Recall’, which is a “situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death”. The 57 recalled devices that were available in India at the time are widely used for cardio vascular diseases; surgeries that involved anaesthesia; crucial blood tests; critical care units; and specialised neurology and orthopaedic procedures.

The Indian Express found that of 41 devices recalled by FDA in 2016, at least 25 were for specialised neurology and orthopaedic procedures and 13 for cardiovascular treatment. However, the devices that were recalled the most in a single year — eight times — were linked to ventilators that are commonly used in critical care units.

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No information, doctors admit

DEVICE: LeadCare Blood Lead testing System.
MANUFACTURER: Magellan Diagnostics Inc, acquired in 2016 by US-based Meridian Bioscience.
FUNCTION: LeadCare and the LeadCare II Testing Systems detect the amount of lead in a blood sample obtained from a finger or heel prick (capillary), or from a vein (venous).
FDA RECALL: May 2017. Magellan recalled the entire lot of its LeadCare Blood Lead Test Kits. Meant for in-vitro diagnostic use, the kit is for quantitative measurement of lead in blood. The recall advised care facilities “regarding a change to existing LeadCare product usage and labelling”.

While the product was meant for capillary and venous blood samples, it was found that the LeadCare Testing Systems may have underestimated blood lead levels and given inaccurate results when processing venous blood samples. The FDA recommended discontinuing the use of venous blood samples with any LeadCare Blood Lead Testing System (LeadCare, LeadCare II, LeadCare Ultra, LeadCare Plus), while stating that capillary samples might still be used. The recall process is yet to be completed.

SALE IN INDIA: Abishek Venkatesh, owner of Bengaluru-based Stark Services, the sole distributor of LeadCare products in India, said that there was “no recall” for the LeadCare II analyser in India. “In the USA, they had to discontinue the use of venous samples on LeadCare II, because most customers were using a tube with a cap containing a sulphur compound that was chelating (bonding) with the lead during transport leading to an artificial lower reading. What we learnt is that if the tube stands for four hours with the blood not making contact with the cap, the reading becomes accurate. There was no issue with the analyser and hence all results are accurate,” said Venkatesh.

The 57 recalled devices that were available in India at the time are widely used for cardio vascular diseases.

The Indian Express contacted four users to find that none of them was informed by the company or distributor about the recall. All of them still use venous samples for testing with the kit and none of them has been advised to switch to capillary samples. “The company said capillary samples are better for field work but all our tests are in the lab and we use venous samples. The Bengaluru distributor keeps in touch with us but we never received any information about any product recall or advisory,” said Dr LM Srivastava, Head of Department of Bio Chemistry, at Delhi’s Sir Ganga Ram hospital.

Dr H M Venkatappa, managing director of Kanva Diagnostics, runs one of the few facilities that offer lead blood tests in Bengaluru. “Our lab uses venous samples for the test. We were never told about any recall or to use only capillary blood samples,” he said. Lucknow-based Indian Society for Lead Awareness & Research (INSLAR) runs over 35 lead testing centres across India. Dr Abbas Ali Mahdi, national president, INSLAR, said he started using LeadCare kits in 2011 as it gave results in just three minutes.

“Much of our work is in the field where collecting capillary blood is convenient while testing children. Our centres also use venous samples, particularly in labs. To the best of my knowledge, we have never been informed by the company or its representatives in India about any product recall or advisory against using venous samples,” said Dr Ahmadi.

Meridian Bioscience did not respond to queries from The Indian Express.

Varying readings, kit yanked off shelf

DEVICE: Alere blood clotting monitoring systems/strips.
MANUFACTURER: Alere, taken over in 2017 by US-based Abbott.
FUNCTION: Hand-held device and strips used to monitor blood clotting.
FDA RECALL: August 2016. The test strips were voluntarily recalled after patients reported a difference in readings on their devices and tests conducted in a central laboratory. Classifying the recall as Class 1, the FDA stated: “If an incorrect low INR result is acted upon (i.e. adjusting the dose), the patient may be at risk of major or fatal bleeding… (Alere was) unable to develop an adequate modification that ensured the safety and effectiveness of the… system.”

SALE IN INDIA: Delhi resident Prerna Malik was among those affected by the recall of Alere’s INR Monitoring Systems. Her father had a open-heart valve replacement surgery in 2002 and had found the Alere device “very useful” to monitor the thickness of blood to decide on medication thereafter. ”We had got the Alere device from Prabhakaran Adhawan, the distributor based in Chennai who used to supply us the testing strips also regularly. Suddenly in 2016, he informed us that due to some defect the device as well as the strips were being withdrawn internationally from the market and following his advice, we had to purchase another device from another company,” says Malik.

When contacted, Adhawan said the sudden recall led to “serious problems” for patients. Although the company had informed all those on their sales list, he said, they could not offer replacements as the devices and strips were withdrawn. “We contacted all patients and those who had heart valve replacements, for instance, were advised to switch to Roche monitors and strips immediately. Since the manufacture was stopped by Alere, there was nothing we could do further,” he said.

Faulty power system, many recalls

DEVICE: Heart Ventricular Assist Device (HVAD).
FUNCTION: For heart failure or weakened heart. A VAD, which includes a pump, a controller, a monitor and a power source, is implanted through open heart surgery to help pump blood from the lower chambers of the heart.
MANUFACTURER: HeartWare, acquired in 2016 by US-based Medtronic.
US FDA RECALL: Last recalled in May 2018. There were earlier recalls, too, with the action in February 2017 and May 2018 listing India as one of the countries where the product was affected. The latest recall was mainly due to the possibility of “an interruption” in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the controller.

SALE IN INDIA: The device is sold in India by Medtronic, through different dealers, after it acquired HeartWare. According to Medtronic, two patients in India with an HVAD System were affected by a recall that required exchange of their external controller units, a standard procedure for patients on LVAD support.

All set for a procedure at Olmec Plastic Surgery Centre in Pitampura, Delhi. (Express Photo by Ritu Sarin)

”As per the global policy, physicians of these patient were notified by Medtronic and the affected external controller units were replaced with updated units,” the company said. “When Medtronic determines that a recall is necessary, we communicate with healthcare providers and/or patients and provide recommendations to address the issue. Such communications can include letters, emails, calls, press releases, physician notifications and social media postings. Medtronic also informs the FDA and other regulators of the action in accordance with applicable regulatory requirements.”

Controller problems, 26 deaths globally

DEVICE: Left Ventricular Assist System (LVAS).
FUNCTION: For heart failure or weakened heart. An LVAS, like a VAD, includes a pump, a controller, a monitor and a power source. It is similarly implanted through open heart surgery to help pump blood from the lower chambers of the heart.
MANUFACTURER: Heart Mate, acquired in 2016 by US-based Abbott.
US FDA RECALL: March 29, 2017. Abbott-Thoratec sent an “Urgent Medical Device Correction” letter to affected customers. Abbott said that “all of the deaths occurred when patients attempted to exchange controllers while away from the hospital”. It did not provide details of the deaths and injuries in the US but stated that no deaths were reported in India.

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SALE IN INDIA: According to Abbott the entire device was not recalled, but only its defective software. The company stated, “The Existing HeartMate II LVAS Pocket System Controller patients received updated device software and alarm guides for both their primary and back-up controllers… we updated physicians with related communication and provided details on the procedures…. software updates were needed for a very small number of patients.”

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Fluid seepage, 300 patients hit

DEVICE: Intra-Aortic Balloon Pump (IABP).
FUNCTION: Helps the heart pump more blood. It is used to treat cardiogenic shocks, including heart attacks, heart defects and abnormal heart rhythm. The IABP allows blood to flow easily into coronary arteries, which carry oxygenated blood and nutrients to all parts of the body. The device’s main component is the catheter, a thin and flexible tube to which a balloon is attached at one end. The other end of the catheter is connected to a computer with software programmed to inflate and deflate the balloon at appropriate intervals. The procedure to implant the IABP is usually conducted through a cut on the inside of the patient’s upper leg for insertion into an artery.
MANUFACTURER: Maquet, based in Germany.
US FDA RECALL: Initiated in July 2017 by Maquet over design issues leading to fluid seepage inside the device and corrosion of internal components. According to Maquet, it received a complaint “that has been associated with a patient death due to the failure of the device to initiate therapy”.
The FDA said: “If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.”

SALE IN INDIA: “Technically, this is not a recall of the device. This was a field correction. The problem is being addressed. Around 300 units were sold in the country during the recall period. There has been no single incident reported in India regarding any compromise related to patient safety. But as a precaution, we are carrying out the field correction on war footing,” says Surinder Pal, National Sales Manager (India), Maquet. According to Pal, “entire device is not replaced” by the engineering team in a field correction but “only parts” that are defective are “replaced and serviced”.

Battery defect found in at least 2,790 devices

DEVICE: Heartstart MRx Monitor/defibrilator.
FUNCTION: Designed to deliver electrical shocks to revive cases of sudden cardiac arrest or treat patients with a slow heart beat.
MANUFACTURER: Philips, based in The Netherlands.
US FDA RECALL: 2017, 2018. Apart from “battery-related issued”, a defect in the device’s Gas Discharge Tube (GDT) led to micro cracks that let internal gases escape. The defect also led to a surge of electrical current that damaged resistors and prevented the device from functioning in automated external defibrillator (AED) mode.

SALE IN INDIA: According to spokesperson for Philips India, the recall process in India for the “battery-related issue” was initiated in February 2017 and published by the FDA in March 2017. The FCO (field change order) was completed in August 2017, the spokesperson said. Action was initiated in June 2017 for the defective component, listed as a Class 1 recall by the FDA in February 2018, Philips India stated. The closure date of implementation for the FCO (field change order) process was September 2017, it said.

Describing the recall protocol, the company said: “The process is a two-step process wherein as a part of the first step, customers are notified via FSN (explaining the issue, actions that user can take to mitigate risks and corrective action planned by Philips to address the issue). Second step involves implementation of FCO (wherein the intended correction action/enhancement to be implemented by the customer service team as per the timelines of that FCO).” According to the company, one unit of Heartstart MRx was found to have a defective component in India, while 2,790 units had a battery-related issue. No device was fully replaced, the company stated.

Faulty display in navigation system

DEVICE: Brainlab Cranial Navigation System.
FUNCTION: Brainlab Cranial IGS System shows the area of interest and the position of an instrument in the patient’s body to enable minimally invasive surgical procedures.
MANUFACTURER: Brain Lab, based in Germany.
FDA RECALL: January 2016. Brainlab recalled the Cranial IGS System due to possible inaccuracies in the display by the navigation system that could lead to ineffective medical procedures and life-threatening injuries.

SALE IN INDIA: Brainlab said in a statement that there were 14 recalls of their products between September 2013 and September 2018, but only one — the Cranial Navigation System — was a Class 1 recall. The company said that for each of the 23 systems in India, the “affected customers were contacted proactively and educated about the possible issues and the corrective actions required for the same… Brainlab then provided them with an updated software version to ensure the inherent safe design of the Brainlab Cranial Navigation System.” The recall process took corrective actions in April 2013 and followed up with additional measures in May 2015, including updated software. By May 2017, the entire recall process for India was completed, the company said.

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Faulty fuse in infant support ventilators

DEVICE: AVEA ventilators.
FUNCTION: Intended for continuous breathing support for infants, children and adults in hospitals and healthcare facilities.
MANUFACTURER: CareFusion, acquired in 2015 by US-based Becton, Dickinson and Co.
FDA RECALL: May 2016. CareFusion recalled the device due to a faulty fuse on the alarm board, which may cause the ventilator to shut down and deprive a patient of necessary amounts of oxygen.

SALE IN INDIA: G Muthukrishanan, managing director, Transhealthcare India Private Limited, a Chennai-based distributor of AVEA ventilators, said that the company’s Delhi-based service centre remedied a number of units. “I can’t comment on any specific recall of the product but CareFusion’s Delhi service centre fixed a few units in the past,” he said.

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Pankaj Sharma, CareFusion’s service manager for India, shared the field safety notice issued by the company, which said that a customer would be contacted by the CareFusion distributor to arrange onsite remediation of the affected devices. “In India, no unit was affected due to this issue,” he said.

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