By Peeyush Gupta, Director, Sales and Marketing, UL South Asia
Imagine this. A patient has been diagnosed with hypertension. Rather than wait in serpentine queues at the hospital to see your doctor for a regular check-up, he decides to buy a Blood Pressure Monitor. All it takes is a few clicks at an e-commerce website or a visit to your local pharmacy. He checks his pressure dutifully and chooses to go to the hospital only when there is reason for alarm. A few months later, he goes to the doctor’s office for an illness and discovers to his shock that the BP reading is off by several points, explaining why he can’t seem to be in perfect health despite being disciplined with medicines. Out of curiosity, his doctor asks him to bring the BP monitor he uses at home. After testing it, he tells the patient that the device is inaccurate and hence, he has have inadvertently consumed lesser dosage of medicine than required.
The ugly truth about false readings
Several global studies have shown that blood pressure monitors at home have a tendency to show inaccurate readings; one study placed the numbers anywhere between 5 – 15%. While poor maintenance or faulty testing practices may also be to blame, a critical aspect, which patients may not be aware of, is that it is always advisable to check the BP apparatus for accuracy at a hospital before the first use, and perform a similar test every year to ensure it is rightly calibrated.
The danger with false readings is not the case only with BP monitors. With prevention and control the mantra for lifestyle diseases like diabetes and hypertension, Indians are increasingly taking advantage of better standard of living and managing their health at home by employing an array of medical devices – blood glucose devices, nebulizers, body fat monitors, fetal monitors and tele echocardiograms.
In a country where awareness of safety standards is at best, a feeble awakening, being voluntarily vigilant about quality and safety certifications is unfortunately not the tendency of majority of the population. Most people who purchase these devices do not necessarily check for the requisite marks to ensure that the device is certified as safe and accurate for use by a recognized laboratory. This absence of safety culture puts patients employing home health devices at great risk of using substandard or faulty products.
India’s changing health profile and the growing market for home health care devices
There is a marked increase in the use of mobile health, where the patient, through self-monitoring, has a critical role to play in diagnostics. This is not surprising. Given India’s fast growing economy, and its impact on dietary patterns and improved life expectancy, the country’s health profile has, over past few years, shifted inexorably from infectious to non-communicable diseases. According to the WHO’s health profile for India, 53 per cent of deaths in the country are on account of non-communicable diseases (NCD), with diabetes and cardiovascular diseases taking the lead. 1 in 4 Indians risks dying from an NCD before they reach the age of 70, the report states. India is already holding the ignominious title of being the ‘diabetes capital’ of the world, and is contending for a similar position when it comes to hypertension.
When juxtaposed with the abysmally poor health infrastructure and woeful shortage of doctors in the country – the ratio being 0.7 doctors per 1000 people, non-invasive, self-monitoring of chronic ailments by heath conscious and tech-savvy Indians is rather a boon. Regular monitoring of BP and blood sugar for example, not only reduces the economic burden by helping avert a sudden health crisis, it also provides the doctor with a clear patient history to tailor treatment accurately.
In light of the changing dynamics of health care, medical device companies are aggressively promoting products to rake in the profits. A number of startups are also offering a plethora of services like home testing, post-surgery and geriatric care health. As fitness apps are becoming prominent on smart phones, companies are rolling out digital devices in the Indian market to monitor health parameters.
Why patients must empower themselves to protect their health
The increasing usage of medical devices at home certainly calls for some patient education, not only at the time of purchase, but also later, vis-à-vis routine maintenance procedures required to ensure accurate operation of a device over time. Consider the following:
• The risk of online purchase: Even when a patient or caregiver is able to purchase home healthcare equipment from Internet-based suppliers, the quality of product information and training available varies from vendor-to-vendor. In either circumstance, the odds are against ensuring an optimal fit between the features of the home healthcare equipment and the specific needs of the patient and/or caregiver, and quality and safety concerns are compromised.
• Complexity of devices: Even as manufacturers strive to make their products more user friendly, many types of home healthcare equipment are often still too complex for safe and accurate use by most patients and caregivers. Ideally, device manufacturers should consider a range of training delivery methods (printed instructions and user manuals, on-line information, equipment incorporating voice- activated prompts, etc.) to account for varying degrees of patient and caregiver ability and engagement.
• Unfavourable environmental conditions: Within the home itself, outdated or ungrounded electrical wiring systems may fail to protect users of home healthcare equipment from electrical shock. Insufficient ventilation, temperature and humidity control systems may adversely impact the performance of sensitive electronic devices.
• Incompatibility with household appliances: Electromagnetic interference from common household appliances such as computers, refrigerators and microwaves may interfere with electronic devices that have not been designed for operation in active radio frequency environments.
Several international standards exist to test various aspects of medical device safety – ranging from the material used for manufacturing, electromagnetic and biocompatibility and cyber security risks. However, with India still a nascent market for medical devices, a number of these global norms are yet to be harmonized with Indian regulations. Even as the government has taken a welcome step to regulate the medical device market, widespread patient outreach and education, especially by government regulatory agencies, is an urgent need. Given the growing popularity of home health care devices, it would bode the Indian government well to follow the footsteps of the US FDA and constitute a separate programme to educate the general populace about the purchase, operation and maintenance of home health devices.