Mistakes are proof that you are trying. Anonymous

It is an uncomfortable fact of life that patients can get injured , and even die , due to the incorrect use of medical devices that are supposed to help them get well. Some of the new medical technologies that pose the most challenges are implants and materials that are placed in the body permanently. A major limitation is that problems and failures might become evident only after several years of clinical use; but safety data prior to introduction of these devices in the market, tends to be gathered only for a short period of time. For example, the long-term problems with hip-replacement prostheses, where the fixation materials failed, only occurred after several years of use. Similarly, even though drug-eluting stents for treating diseased coronary arteries have been in widespread use for many years, it is only now that we are realizing that they are associated with an increased risk of late thrombotic complications.

The pressures and risks

There are many pressures to introduce new medical technology without adequate assessment. Manufacturers have a strong financial incentive to promote and sell their products as soon as possible, to maximize their profits. Pressure is also created by cowboy doctors who want to use the newest state-of-the-art technology, even though its safety is still unproven. Between the vested interests of manufacturers and the allure of “shiny-object-syndrome” for doctors, there is often a dearth of information on the safety of the newest medical technology. New technology introduces risks that are often unforeseen. Regulation, health technology assessment , clinical engineering, together with staff training, all have a vital role in ensuring the safety of new devices. Because safety information is often imperfect, we need ongoing systems of surveillance, to pick up problems in a timely fashion. Donated second hand technology is often ineffective The problem is worse in developing countries like India because of poor infrastructure. Untested technology is either acquired, or thrust upon the system, without an understanding of the need or capacity to absorb this. This can cause harm if it is used incorrectly, installed incorrectly, serviced incorrectly, or used by untrained individuals. Capacity development and education are key to ensuring safe use of technologies New technology in the developing world often meant the use of old, obsolete or ineffective technology from the developed world. This was introduced without any evaluation process, and was often completely inappropriate for use in poor countries. Most of this was donated equipment, which was refurbished, and had a limited shelf-life. This often ended up being discarded, because it never worked, and can even now be found gathering dust in dark and dingy hospital storerooms . In Colombia, it was estimated that up to 96% of foreign-donated medical technology stopped functioning within 5 years of being donated, and that 39% never worked at all. Even when new modern technology is introduced, careful thought should be given to exactly how it is to be introduced; and the extent to which it is appropriate for the local setting. It may otherwise end up causing harm.

The Indian landscape

Currently, India has in excess of 1000 medical device manufacturers who cover consumables, instruments, disposables, electronics as well as diagnostics. The market is dominated by local manufacturers for low value products, while multi-national companies manufacture the high end equipment.

The need for regulation is underscored by the fact that almost 60% of India’s requirement for medical devices and equipments is met by imports. However, many of these are of poor quality, because they are distributed by fly-by-night agents, whose focus is on saving money. These expose patients to needless risk.

Testing the quality of these imported devices is therefore extremely important to ensure patient safety. The potential for harm to the poor in the fragile, underfunded, corrupt Indian public health system is huge. This is because of:

* The poor state of infrastructure and equipment

* Unreliable supply and quality of drugs

* Insufficient staff

* Lack of accountability

* Shortcomings in waste management and infection control

* Severe under financing of essential operating costs because of the illegal diversion of funds

Incidents such as the J.J hospital tragedy involving the use of unapproved and untested stents on 60 patients paved the way for the Mashelkar Committee Recommendations of 2004. The central tenet is that the import of critical medical devices such as stents, catheters, implants, intra-ocular lenses should be regulated.

Importers needed to submit US-FDA clearance , or similar approvals from other countries , as proof of adherence to global quality standards, before they are granted permission to import these devices. A recent initiative by the Indian government is the introduction of the Drugs and Cosmetics (Amendment) Bill, 2013 that recognizes medical devices as distinct from drugs, requiring separate regulation.

Technology or toys ?

Even though the medical devices industry is regulated, new and untested innovations can still cause harm to patients. A good example of this is the introduction of robotic surgery. While this is a great “gee-whiz” toy for macho surgeons to play with, and hospitals are happy to advertise their million dollar purchase to show how “cutting –edge and state of the art” their facilities are, the fact is that there is a learning curve associated with all these new devices, and patients can be harmed while the surgical team is struggling to master the use of the unfamiliar device.

A common example in India is the use of lasers or endoscopic equipment for complicated surgery. Just attending a two-day workshop and acquiring a certificate does not make a doctor sufficiently expert in using this technology; and a number of mishaps have been reported because of operator inexperience.

Many medical devices today are designed to be disposable ( single use only) , which means they are supposed to be discarded after they have been used once. However, because many of these are so expensive (such as guide-wires and balloon catheters used in cardiology and equipment used for laparoscopic surgery), many hospitals routinely reuse these devices after reprocessing, to help reduce the financial burden on patients.

However, there is a risk that inadequately decontaminated products might cause infections; and that cleaning and sterilization might erode their less durable components, leading to malfunction. This is why manufacturers warn that it is unsafe to recycle devices which were designed to be used only once.

Hospitals which take short-cuts while reusing disposable devices end up compromising patient safety. This is why the US Food and Drug Administration ( FDA) has taken steps to ensure that reprocessing companies adhere to the same stringent regulations for their products that original-device makers do. If these are followed, then the risk to patients is not increased.

Injection safety in India

During the 20th century, injection use has increased tremendously, and injections are now probably the commonest healthcare procedure. Many injections given to provide treatment in developing countries are in fact unnecessary, as oral drugs would be equally effective. However, the belief in the curative power of injections, as opposed to pills, is one reason for the continuation of this illogical practice.

The dangers come from the reuse of syringes without sterilization, with syringes often just being rinsed in boiling water in between injections. In a poor country everything is reused, simply because there is no alternative. Although lack of knowledge and poor standards play a part, the danger is hugely compounded by the basic lack of resources. Medical staff is often forced to take shortcuts because they don’t have any alternative. In a medical emergency, for example, when the patient needs a life-saving antibiotic injection, even an unsterilized syringe is better than nothing.

A huge proportion of injections are still given unsafely , and the numbers of people affected are staggering. In some areas, as many as 75% of injections are unsafe, as a result of which many poor unsuspecting patients get infected with hepatitis, HIV infection and other blood borne pathogens.

We might think that aiming for safety in healthcare is the prerogative of rich countries and that safety is a luxury poor people cannot afford. In fact, the reverse maybe true. When you have few resources, it is all the more important that you do not cause harm or waste those resources on poor quality care. Those living in poverty with little healthcare available can least afford unsafe care.