To address the Coronavirus outbreak, China’s health system recently eased approval rules to allow for critically needed devices and diagnostics. While dozens of domestic devices have received Emergency Approvals, overseas manufacturers have been slow to respond, potentially sacrificing a rare chance for such expedited access to the Chinese market.
On January 27, the NMPA authorized the import of non-NMPA approved medical devices that meet certain requirements including FDA, CE Marking or Japan approval. (See CMD article:
Coronavirus Spurs Emergency Device Approvals in China). China continues to face a gap in diagnostics and treatment equipment, creating a potential opportunity for foreign manufacturers with devices relating to respiratory, disinfection, disease detection, intensive care units, and epidemic mitigation and protection.
On February 25, the China Medical Equipment Association published the “Third Batch of Urgently Needed Medical Devices Index for Novel Coronavirus Prevention and Treatment” which lists specific device names and models, manufacturers, origin countries and models. Three batches totaling one-hundred categories of medical devices and IVDs have been identified by the group. Around one-third of the devices listed in the Index are produced by manufacturers outside of China.
Editor’s Note: For a copy of the three batches of “Urgently Needed Medical Devices Index for Novel Coronavirus Prevention and Treatment,” email info@ChinaMedDevice.com.
While Chinese manufacturers have responded with new devices, serious gaps remain that innovative technologies could help address. For example, after the Emergency Approval for Novel Coronavirus was issued on January 20, the seven Nucleic Acid Detection Reagent manufacturers granted Emergency Approvals were all domestic. Early feedback shows problems leading to some patients receiving as many as six false-negative results before finally being diagnosed. Foreign manufactures may be able to bring higher standards in terms of liquid nitrogen for sample storage, nucleic acids extraction, sensitivity, and specificity.
China’s most critical needs currently fall into these areas:
Diagnostics are urgently needed as hundreds of thousands of Chinese are waiting to be tested. Several IVD companies quickly launched detection kits and instruments. Among the products, Point-of-Care Testing (POCT), with its portability and speed, has heavily contributed to contain the infection; Other technologies such as molecular diagnostics, genetic testing, Polymerase chain reaction (PCR) tests, and microfluidics have also played an important role.
The demand for convenient, miniaturized, and rapid diagnostic POCT products, small biochemical analyzers, hemocytometers, small closed-type automated PCR equipment, microfluidics equipment, and gene sequencing equipment will become increasingly prominent.
China has seen skyrocketing demands for protective supplies, including surgical masks, glove, disinfection products, monitors, ventilators, anesthesia machines, electrocardiographs, nebulizers, oximeters, nasal sprays, etc. The urgent needs have transformed electronics factories, carmakers, and energy firms to help produce protective products, The Wall Street Journal reports on February 9.
On January 27, the NMPA authorized the import of non-NMPA approved medical devices. As of February 5, provincial NMPA offices granted Emergency Approvals to 72 medical devices, all of which are domestic, with a focus on protective supplies, ventilation devices, and sterilization equipment.
The sheer number of people affected during this outbreak has exposed China’s limited ICU capacity and insufficient isolation wards and fever clinics at city-and-county-level hospitals.
According to the Chinese Medical Association, ICU beds account for only 5% of total beds compared to 18% in the U.S. and averagely 15% in developed countries. The limitation of ICUs has propelled Wuhan, the city where the coronavirus was first detected, to urgently build the Vulcan Mountain and Lei Shenshan Hospitals. Nearly 60 hospitals in more than 20 provinces across the country still need separate isolation hospitals and ICU wards.
The construction of fever clinics, ICU wards, and separate isolation hospitals is urgent. The market approvals and pre-market clinical use of related equipment, including small biochemical / immunity detector, hemocytometer, Cardiopulmonary resuscitation (CPR) and Extracorporeal membrane oxygenation (ECMO) equipment, blood gas analyzer, oximeter, infusion pumps, mobile digital radiography (DR), isolated gurney (ISOPOD) infection protection supplies, and temperature guns will be accelerated by NMPA.
The application of Artificial Intelligence (AI) -based medical products and robotics have been widespread to address the Coronavirus. With intelligent epidemic control, AI imaging and AI electrocardiographs allow for massive data processing, screening of disease markers, simulation of treatment, and improved diagnosis accuracy. AI and robotic products also reduce laboratory personnel needs and decrease the chance of cross-infection. Guangzhou Nansha Wanda Plaza uses a 5G patrol temperature measurement robot, which can accurately measure the temperature of the head area of up to 10 people within five meters simultaneously. Robot, equipped with a stethoscope and a monitor to take man’s vitals and help communicate with doctors, will be increasingly used, just like the one in Providence Regional Medical Center in Everett, Washington State where the first U.S case was treated.
Other novel AI devices and robotics being used include: