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  • FDA issues alert over Olympus endoscope component

    FDA issues alert over Olympus endoscope component

    The FDA is aware that Olympus has issued a letter to affected health care providers recommending the forceps/irrigation plug accessory to certain endoscopes be removed from use related to a potentially high-risk device issue:

    • MAJ-891 Forceps/Irrigation Plug (Isolated Type)
    • All lots
    • UDI: 04953170063114

    Patient infection as a result of exposure to a contaminated device can occur when reprocessing of the MAJ-891 Forceps/Irrigation Plug is improper and/or incomplete, such as not disconnecting the MAJ-891 from the endoscope and disassembling it before reprocessing. This exposure could result in patient injury including infection, urinary tract infection, or sepsis, and, in some cases, could result in death. These harms may require inpatient hospitalization/monitoring, and treatment with oral or intravenous antibiotics.

    Olympus has reported 120 injuries and 1 report of death due to infection following procedures in which the MAJ-891 was used with a cystoscope (CYF scope).

    Device use
    The MAJ-891 is endoscope accessory attached to the instrument channel port of certain Olympus endoscopes, including cystoscopes (CYF series), ureteroscopes (URF series), choledochoscopes (CHF series), and hysteroscopes (HYF series) to allow both irrigation and the use of endo-therapy accessories. The MAJ-891 was discontinued in 2022 from the US market. U.S. Food and Drug Administration

  • NCDRC holds Fortis Hospital doctors responsible for medical negligence

    NCDRC holds Fortis Hospital doctors responsible for medical negligence

    The National Consumer Disputes Redressal Commission, presided by Mr. Subhash Chandra in an appeal by Fortis Hospital held that expert evidence in medical negligence cases should be judged on a case by case basis, placing the onus on the hospital to dispute allegations of negligence.

    Brief facts of the case
    The complainant’s son suffered from a spinal condition, AAD, caused by a childhood injury. This left him wheelchair-bound and progressively deteriorating neurologically. The patient was admitted to SMS Hospital for surgery but left without permission, later consulting a doctor from the hospital and getting admitted to Fortis Hospital for surgery. Surgeries were performed, but complications arose, including a collapsed lung and quadriplegia. He remained on a ventilator and eventually died. The complainant argued the hospital was negligent, as post-surgery scans showed bone fragments compressing the spinal cord, which were not present in earlier scans. The hospital did not deny these findings. It was also alleged that the patient’s lung collapse and high steroid use without consent contributed to his death. The complainant filed a complaint before the State Commission of Rajasthan, which allowed the complaint. It directed the hospital and the doctor to pay Rs. 50,00,000 as compensation with 9% interest rate. Consequently, the hospital filed an appeal before the National Commission.

    Contentions of the opposite party
    The hospital claimed the disease, Mobile Atlanto Axial Dislocation (AAD), was caused by a neck fracture from a fall. They argued that informed consent was obtained, surgeries were performed as per protocols, and the patient’s condition post-surgery was expected in such complex cases. They stated that proper treatment was provided, and the complainant failed to prove negligence. Medical literature was cited to support that risks in medical procedures do not imply negligence if conducted with reasonable skill.

    Observations by the national commission
    The National Commission observed that the definition of “service” under Section 2(1)(d) of the Act must be understood broadly and includes services rendered by medical practitioners. The principles of medical negligence, as established in Jacob Mathew (based on the Bolam Test), highlight that negligence is determined by deviations from standard medical practice. Negligence must involve failure to meet the expected standard of care, resulting in harm to the complainant. Key elements are duty, breach, and damage.The Hon’ble Supreme Court in V. Kishan Rao vs. Nikhil Super Speciality Hospital applied the doctrine of res ipsa loquitur in medical negligence cases. This principle shifts the burden of proof to the hospital to show they were not negligent when negligence is evident. Expert evidence must be judged case by case, as ruled in Dr. J.J. Merchant and Indian Medical Association vs. V.P. Shantha. In the present case, the hospital performed surgeries on the complainant’s son without adequate pre-operative tests or proper informed consent. The patient’s condition worsened post-surgery, leading to his transfer in critical condition. Evidence showed that the hospital did not meet the required standard of care. The complainant established negligence, as per the principles in Jacob Mathew. The Commission observed that the State Commission correctly held the hospital liable for medical negligence under res ipsa loquitur. However, the specific liability of the hospital (appellant no. 1) and another doctor (appellant no. 2) was not sufficiently proven. The findings regarding other doctors (appellants 3 and 4) were upheld, as they failed to justify their actions. The order of the State Commission was upheld in part. Appellants 3 and 4 were jointly and severally liable for compensation to the complainant. However, the appeal of appellants 1 and 2 was allowed due to lack of sufficient evidence of negligence against them. Live Law

  • India’s private hospital sector clocked single-digit growth in ARPOB in 2024

    India’s private hospital sector clocked single-digit growth in ARPOB in 2024

    India’s private hospital sector in 2024 clocked single digit growth in average revenue per occupied bed (ARPOB), helped by improved operations and advanced medical treatment. Apollo Hospitals and Fortis Healthcare reported strong revenue growth, showcasing the impact of strategic measures and enhanced patient care.

    Apollo, a leading health care provider, reported a 3 per cent increase in hospital occupancy in 2024, alongside a modest 2 per cent price hike for services. The growth was attributed to higher patient volume, fewer invasive surgeries, and shorter hospital stays.

    The chain said 30-35 per cent of cases it treats are daycare procedures: A shift that has reduced the average length of hospital stays to 3.2 days and helped saving costs without compromising revenue.

    Krishnan Akhileswaran, group chief financial officer at Apollo Hospitals Enterprise, highlighted that revenue per occupied bed (RPOP) is not just a pricing metric but reflects case complexity, technology use, and average length of stay. “As many as 70 per cent of Apollo’s patients paid less than Rs 2 lakh per admission, emphasising affordability despite rising costs from wages, medical technology imports, and GST input costs,” he said.

    Apollo said its focus on minimally invasive and robotic surgeries ensured sustained RPOP growth of 6-7 per cent annually. Of this, 4 per cent is attributed to pricing adjustments and 2-3 per cent to improved case mix and technology adoption.

    Fortis Healthcare said ARPOB grew in 2024 due to a favourable case mix and growth in high-revenue specialties such as oncology and neurosciences. Ashutosh Raghuvanshi, the hospital’s managing director and chief executive officer, said strong patient volumes were supported by expanded bed capacity, advanced medical infrastructure and international medical tourism reviving after Covid-19.

    Fortis benefited by integrating technologies and skilled clinical teams, enabling specialised treatments and better patient outcomes. These factors collectively enhanced ARPOB while maintaining accessibility through strategic pay or mix optimisation, it said.

    Mythri Macherla, vice-president and sector head, corporate ratings, at ICRA Limited, said the sector’s ARPOB growth was supported by annual tariff revisions, demand for elective surgeries, and the recovery of medical tourism. “Market share gains for organised players have also played a crucial role,” she added.

    Bed occupancy at private hospitals improved in 2024 due to higher surgery volumes, especially in oncology and neurosciences, and the increasing contribution of digital channels in patient acquisition.

    Despite positive trends, hospitals grapple with rising costs. Apollo faces annual wage inflation of 10 per cent and import duties of 27-37 per cent for advanced medical technologies. By focusing on volume-driven growth, Apollo has managed to offset such costs while maintaining affordability for patients.

    The outlook for the sector remains strong, with ARPOB expected to grow further as hospitals invest in advanced treatments and expand their reach in underserved regions. The recovery in medical tourism and increased insurance penetration will help growth too, according to analysts.

    Booster shot

    • Apollo Hospitals reported a 3% increase in hospital occupancy and a 2% price hike for services in 2024
    • Fortis Healthcare’s Average revenue per occupied bed (ARPOB) grew in 2024 due to a favourable case mix and growth in high-revenue specialties
    • Recovery in medical tourism and increased investment in advanced treatments is likely to help ARPOB growth
    • Despite positive trends, hospitals grapple with rising costs

    Business Standard

  • Musk’s SpaceX, Amazon in talks with British Airways owner on wi-fi deal

    Musk’s SpaceX, Amazon in talks with British Airways owner on wi-fi deal

    British Airways owner IAG SA is in discussions with Elon Musk’s Starlink to outfit its jet fleet with Wi-Fi service, reflecting the increasing inroads SpaceX’s satellite internet business is making with major global carriers.

    IAG, which also owns Spain’s Iberia and Ireland’s Aer Lingus, hasn’t made a final decision and is weighing options with multiple providers including Amazon.com Inc.’s nascent Project Kuiper, the airline group’s head of innovation, Annalisa Gigante, told Bloomberg in an interview.

    “We are working a lot, both with Starlink and with Amazon’s Kuiper,” Gigante said. “We’ve got some really exciting things coming up, but that’s going to be for next year.”

    The talks underscore a looming shakeup in the aviation services market fueled by the deployment of satellite constellations orbiting closer to Earth. Airlines are inking deals with Starlink and others to replace costly, limited in-flight Wi-Fi. Expanded satellite bandwidth has helped to produce web-surfing experiences closer to what consumers expect on the ground.

    Starlink, SpaceX’s internet-from-space initiative, serves some 4 million customers through a network of thousands of satellites in a relatively low orbit around Earth. Together, the spacecraft work in tandem to beam broadband internet coverage to the ground below.

    One obstacle for Starlink is the complexity of the certification process, Gigante said. She said IAG is evaluating various options, including when the group could install a new service.

    US airlines can easily switch on Starlink because it’s already certified by the Federal Aviation Administration, but European carriers have to go through a certification process, Gigante said. British Airways would need a separate certification from Iberia, she said.

    “There has been an announcement frenzy,” Gigante said. “I really want to make sure that when we announce it, we can actually implement it.”

    Asked about the discussions with IAG and the comments on certification, a SpaceX spokesperson said by email, “this is not accurate,” without providing specifics or elaborating.

    Amazon plans on launching the first operational satellites for Kuiper early next year, with service beginning by the end of 2025. The company didn’t respond to requests for comment.

    Starlink Deals
    United Airlines Holdings Inc. announced a deal in September with Starlink for onboard internet in Musk’s biggest coup so far with major carriers. Outside of the US, AirBaltic is expected to be the first carrier in Europe to provide Starlink on its fleet. The service is used by Qatar Airways QCSC, while Air New Zealand Ltd. and ZIPAIR Tokyo Inc. have announced agreements with the company.

    Starlink’s growth with residential customers in rural areas, maritime shippers and beyond is among the factors pressuring the shares of traditional satellite internet providers like Viasat Inc. and Gogo Inc.

    IAG in 2017 announced an inflight broadband deal with Inmarsat, which was acquired by Viasat last year.

    Analysts say established internet providers will remain the market leaders for several years, given the industry’s slow-moving nature and because Starlink doesn’t yet offer considerably more than competitors. Business Standard

  • Voneus £12m broadband contract terminated

    Voneus £12m broadband contract terminated

    A broadband company has agreed to terminate a £12m government contract to connect up some rural areas of Shropshire.

    Voneus won the Project Gigabit contract for mid west Shropshire – serving more than 6,000 homes – in March 2024.

    Building Digital UK (BDUK) said it was “moving swiftly to put in place alternative plans with other suppliers to connect premises that were due to be connected”.

    In a joint statement with the government agency, Voneus said the two bodies had “mutually agreed to end the Project Gigabit contract”.

    The deal was expected to see the firm set up gigabit-capable connections for some of the most rural parts of the county, with the first premises using the high-speed network in 2025.

    However the firm has faced dozens of complaints from customers of its current network complaining that slow speeds and poor customer service were affecting their businesses and family lives.

    ‘Completely cut off’
    After months of complaints by more than 100 customers, earlier this month the Chirbury and Worthen councillor Heather Kidd contacted Voneus and the media.

    Kidd said: “Working from home is now an essential, not a ‘nice to have’. Even watching TV is now something most expect to be able to do online.”

    She added that many people relied on landlines attached to their routers – or VoIP (Voice over Internet Protocol) – because mobile phone coverage was so poor.

    Kidd said the result was that people could be left “completely cut off”.

    Charles Rowton, who runs an environmental consultancy business, told the BBC last week that he had “wasted hours” on repeating bank transfers or data work due to a slow connection.

    “It also interrupts phone calls, Zoom calls and Teams calls. It can be very frustrating,” he said.

    William Edmonson from Rowley near Westbury, said “It’s a pain in the butt… the browser gives you the endless circle of doom and then says server not responding… it’s very irksome.”

    Speaking at the time, a spokesperson for Voneus said appreciated the concerns raised and planned to “increase community communication”.

    On Friday, BDUK announced that it and Voneus had mutually agreed to terminate the Project Gigabit contract for mid west Shropshire.

    “My concern now is what happens to customers who have the very poor wireless link. This will have damaged the Voneus business case,” Kidd said.

    “Probably rightly but the existing system needs support and customer care.” BBC

     

  • Manish Kalra moves on from ZEE5

    Manish Kalra moves on from ZEE5

    Manish Kalra, Chief Business Officer, Zee5, has called it quits to pursue other opportunities.

    Kalra quit his role of handling Zee5’s business across markets, ending an almost five-year stint at the OTT platform.

    Sources close to the matter told BestMediaInfo.com that Kalra will serve a two-month notice period.

    Kalra started his journey with Zee5 as Business Head AVOD (Advertising-based Video on Demand). In a year’s span, Kalra ascended to the role of Chief Business Officer, handling the Indian markets.

    In October this year, Kalra’s role expanded to overseeing Zee5’s business across the global markets. This expansion followed the then Chief Business Officer, Archana Anand, moving on from the company.

    Before joining ZEE5 in 2020, he spent the last decade in roles such as Chief Marketing Officer, Chief Business Officer, and CEO at companies like Amazon, MakeMyTrip, HomeShop18, Dell, and Craftsvilla.

    Kalra holds a master’s in business administration from XLRI, Jamshedpur, and a bachelor’s degree in mechanical engineering from the Punjab Engineering College, Chandigarh. Best Media Info

  • TRAI to issue satellite spectrum allocation recommendations soon

    TRAI to issue satellite spectrum allocation recommendations soon

    Telecom regulator Trai will issue recommendations on rules for satellite spectrum allocation very soon, an official said on Monday.

    The government will evaluate recommendations of the Telecom Regulatory Authority of India (Trai) and thereafter decide on allocating spectrum to satellite communication companies, which will pave the way for satellite-based broadband services in the country.

    In response to a question on the recommendation on satcom spectrum rules during an event on National Consumer Day, Trai Chairman A K Lahoti said it will be issued “very soon”.

    Trai concluded an open-house discussion on the terms and conditions for the assigning spectrum for certain satellite-based commercial communication services in the second week of November.

    Telecom service providers like Reliance Jio and Bharti Airtel want spectrum for full mobility across the country should be allocated through auctions only. However, Elon Musk’s Starlink and global peers like Amazon’s Project Kuiper and other satellite communication companies back an administrative allocation of satcom spectrum.

    With battle lines between terrestrial players and satellite aspirants clearly drawn, Trai’s marathon open-house discussion stretched for several hours and saw telcos Reliance Jio and Bharti Airtel banding together and speaking in unison about the need for a level-playing field as India works out the norms for satcom spectrum.

    Jio, which has made a case for the auction of satellite spectrum, on Friday said it is “not afraid of competition” but that ‘same services same rules’ must apply.

    The Mukesh Ambani-led firm had approached a retired Supreme Court judge for a legal opinion, which says that Trai’s consultation paper on spectrum allocation for satellite communications seems to have completely sidestepped the issue of level-playing field with ground-based telecom networks.

    Musk’s Starlink and other global peers like Amazon’s Project Kuiper back an administrative allocation of satcom spectrum.

    During the open house discussion, Parnil Urdhwareshe, Director, Starlink Satellite Communications, said Indian users want satellite broadband services and these “intelligent consumers” have the right to choose an operator who will provide them with an affordable, high-quality service.

    Starlink prices for any country are readily available on its website, and it is proud of making satellite broadband affordable for users who have so far been unserved, he pointed out. Business Standard

  • NFRT imposes Rs 2-crore fine on Deloitte for audit lapses in Zee

    NFRT imposes Rs 2-crore fine on Deloitte for audit lapses in Zee

    The National Financial Reporting Authority (NFRA) has imposed a ₹2-crore fine on Deloitte Haskins & Sells LLP and penalised two auditors for deficiencies in their audit of Zee Entertainment Enterprises Ltd (Zee) during the 2018-19 and 2019-20 financial years.

    The regulator fined A.B. Jani, the engagement partner, ₹10 lakh and barred him from auditing for five years.

    Rakesh Sharma, the engagement quality control review partner, was fined ₹5 lakh and received a three-year ban.

    Both auditors are prohibited from serving as statutory or internal auditors for any company during their respective debarment periods.’

    The NFRA’s review of Zee’s statutory audits initiated suo motu found the auditors in violation of the Companies Act and Standards on Auditing (SA).

    Its 30-page order, dated December 23, identified serious lapses, including negligence, failure to exercise professional scepticism and inadequate evaluation of suspected fraud.

    One key irregularity involved a ₹200-crore fixed deposit pledged by Zee’s chairman in September 2018 as a guarantee for loans to Essel Group company Essel Green Mobility Ltd.

    Yes Bank appropriated the deposit in July 2019 to settle dues from seven Essel Group firms.

    This transaction lacked approval from Zee’s board or shareholders. The auditors failed to detect and report the unauthorised arrangement, the NFRA said.

    The regulator also highlighted additional failures, including the premature closure of the fixed deposit by Yes Bank and the unauthorized use of Zee’s funds to settle promoter group loans.

    Despite being aware of these issues, the auditors did not adequately challenge management’s assertions or evaluate the reporting of fraud.

    A show-cause notice was issued to Deloitte and the auditors, and their responses were reviewed.

    The NFRA concluded that the firm and auditors were guilty of professional misconduct. It stated that the lapses caused a significant breach of trust and failed to protect shareholders’ interests.

    The penalties aim to ensure accountability and uphold auditing standards.

    The NFRA’s findings underscore the importance of professional scepticism and diligence in addressing complex financial arrangements, particularly those involving significant related-party transactions.

    Meanwhile, chartered accountants’ apex body ICAI president Ranjeet Kumar Agarwal on Monday said its disciplinary committee is investigating alleged auditing lapses at edutech firm Byju’s.

    ICAI found gross negligence on the part of the auditors of Byju’s and that the matter was referred to the Financial Reporting Review Board (FRRB). Telegraph