Virtual healthcare has to be understood and used for what it can offer

Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.

Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual technology has also been in widespread use in areas like education and for monitoring remote workers in many organizations. Virtual healthcare can be seen as a natural extension of these uses of technology.


Understanding the dynamics of virtual healthcare

Healthcare analysts are quite upbeat about the growth prospects of virtual healthcare, making prognoses about its explosive potential growth, with estimates ranging from a size of well over $3 billion by 2022 to much rosier, nearly $14 billion for video consultation alone by 2018. While time will tell whether these forecasts will be fulfilled, we need to understand this tool and its prospects and pitfalls.

When adapting virtual healthcare, patients and healthcare providers are likely to use virtual healthcare in these ways:


This should rank as the most important element of virtual healthcare. Virtual healthcare itself would come to be of no use if it did not offer the patient the opportunity to interact with the patient remotely. Patients are likely to use technologies in the form of tablets, smartphones and other personal devices to consult physicians.

virtualHealthcareConsultation is a very important component of virtual healthcare and it goes beyond just obtaining billing and other information that is usually a part of an Electronic Health Record (EHR). Virtual healthcare aids in direct, non-physical contact between the patient and the healthcare provider, which is what this medium primarily seeks to facilitate.

This feature is all the more useful in situations where the patient may not be in a condition to travel to the healthcare provider or where patients with long-term ailments need to be monitored on a regular basis without having to visit the hospital.



EHR could be another major component of virtual healthcare. Following the passage and implementation of Obamacare; the EHR has become a very important document for people seeking healthcare. Virtual healthcare can bring in a new dimension to EHR by enabling documentation and recording of important events in the physician-patient relationship.

Drawbacks of virtual healthcare

While there is no doubting the fact that virtual healthcare is set for major growth; it is important to understand its inadequacies. The most important disadvantage of virtual healthcare is that it is best suited only for noncritical healthcare situations. It may help patients with long term ailments, as mentioned above, but can help only when the patient has reached a stage where all treatments are done and only resuscitation or convalescence is needed. For a patient requiring immediate attention in an emergency, virtual healthcare is not likely to be very effective. Thus, a patient seeking medical information or advice for a viral infection is far more suited for virtual healthcare than a patient in need of CPR.

The uses to which virtual healthcare can be put are limited, at least at this stage of its development. When this technology advances enough to be able to offer healthcare in all situations and for all kinds of ailments; it will become a more effective medium. Till then, virtual healthcare has to be understood and used for what it can offer.


The EU’s Pharmacovigilance Directive

Pharmacovigilance is a major public health initiative of the EU. It is aimed at reducing the risk attendant in any part of the production, marketing and supply chain of medicinal products. Monitoring is done not only before the medicinal products enter the market; it is done at every stage after, too.

The aim of putting a strict vigilance regimen is to help detect any aspect of a medicinal product that could compromise on its safety. This whole system of monitoring is called pharmacovigilance.

The EU’s Pharmacovigilance Directive is the legal structure that spells out the objectives and implementation plans for the EU’s pharmacovigilance system. The Pharmacovigilance Directive is part of the EU’s efforts to enforce very stringent assessment of all medical products for their safety, quality and efficacy before they become authorized.

Regulation on all areas of medicineIn essence, the Pharmacovigilance Directive lays out the conditions and rules by which medicinal products have to be marketed within the EU and beyond. It prescribes the manner in which products have to be manufactured, labelled, marketed, recalled and destroyed. The Pharmacovigilance Directive, which applies to products for human use, bans any medicinal product that is not authorized by any member state of the EU from being marketed.

The review of 2010The Pharmacovigilance Directive underwent a major revision in 2010, by which a new legislation came into effect. The legislation passed that year further fortifies and streamlines the system relating to the safety of medicines that enter the European market.

The Pharmacovigilance Directive of 2010 strategizes areas relating to preventing, detecting and assessing of adverse reactions in patients to ensure improved patient safety and with it, public health. One of the major features of this amendment is that patients are empowered to directly report adverse drug reactions to the designated competent authorities. Another important aspect is that the definition of an adverse reaction has been widened to include issues like overdose and medication errors.

Important features of the Pharmacovigilance Directive of 2010The Pharmacovigilance Directive of 2010 seeks to take concrete steps to enhance its core objectives of patient safety and public health. It is built on these foundations:

  • It puts in place a robust, proportionate and proactive risk management regimen
  • It enhances safety data quality
  • It strengthens the link between safety evaluations and actions from regulatory authorities
  • The Pharmacovigilance Directive of 2010 has led to greater communication, transparency and patient involvement
  • It assigns clear-cut responsibilities and tasks for everyone concerned
  • It facilitates the decision-making apparatus within the EU
  • The Pharmacovigilance Directive of 2010 has established The Pharmacovigilance Risk Assessment Committee, a new scientific committee to be based at the European Medicines Agency (EMA).

Pharmaceutical Water Systems have to be Designed with a Lot of Common Sense

The effectiveness of a pharmaceutical water system depends on its design. The design is the soul of the system. Any pharmaceutical water system design should come equipped with the ability to serve its most basic purpose, which is to help the pharmaceutical organization meet the set quality.

The importance of water can never be overemphasized. Apart from the emotional, spiritual and cultural value it has; water also enjoys a position of complete primacy in the field of pharmaceuticals. In being used for anything from production to processing to cleaning to formulation to Quality Control water is the most widely used and critical substance in the pharmaceutical industry. Its varied grades are used in nearly all stages of the pharmaceutical manufacturing process.

Designing pharmaceutical water systems properly is of great importancePharmaceutical water systems thus acquire extreme importance for this reason, because inefficiency or ineffectiveness in the system could lead to faulty final products, which can affect the lives of individuals, apart from causing harm to the reputation of pharmaceuticals companies.


What are the principles of pharmaceutical water systems design?

  • Ensuring the pharmaceutical water system operates within its capacity is the first principle of pharmaceutical water systems, because any underutilization or overutilization of capacity can affect the quality of the water system
  • Working in tandem with Quality Assurance allows approval of use after installation and subsequent maintenance. A sound pharmaceutical water system has to enable this
  • The entry at any stage, be it production, storage or distribution, of unacceptable chemical, physical and microbial contamination should be prevented at all costs
  • An effective pharmaceutical water system should ensure consistency and reliability in the quality of water production
  • An effective pharmaceutical water system should help commission, install, qualify/validate, operate, perform and maintain itself. Making all these aspects of the water systems industry happen is a core characteristic of pharmaceutical water systems.
  • Pharmaceutical water systems must facilitate the easy and regular monitoring of chemical, microbiological and endotoxin levels in water sources.

FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter. This means compliance at its highest and lowest levels.


To simplify matters to an extent, the FDA has tried to be of some assistance to help in monitoring the conduct of all aspects of the conduct and reporting of organizations involved in FDA-regulated research. This has concretized in the form of the FDA’s Bioresearch Monitoring Program, or BIMO. This on-site inspection and data audit program can be used as a reference guide by industries in FDA-regulated research industries. Adherence to it is a yardstick for compliance with FDA regulations in the field.

In other words,compliance to the implementation requirements of the BIMO is a fair indicator of how well the organization comes out unscathed out of an FDA inspection. Meant for monitoring Clinical Investigators (CIs), the Institutional Review Boards (IRBs), Sponsors or Contract Research Organizations (CROs)/Monitors, and nonclinical laboratories; the BIMO spans quite a range of players in the FDA-regulated research.

What are the BIMO’s objectives?

The FDA’s Bioresearch Monitoring Program has two important objectives:

  • Protecting the welfare, rights and safety of human research subjects
  • Ensuring that the data collected by researchers is reliable and is of acceptable integrity and quality


What are the BIMO’s functions?The FDA’s Bioresearch Monitoring Program has a few functions, which research organizations that have to survive an FDA inspection could do well to comprehend. These include:

  • Clinical data auditing
  • Inspection of the ongoing clinical research
  • Subjecting nonclinical laboratories and IRBs to inspections
  • Taking steps to train, educate and implement the FDA’s Application Integrity Policy.

Understand the underlying causes that lead to an inspection

The key to passing an FDA inspection is to understand that there are strong reaons for which an FDA inspection happens. Research organizations that want to pass an FDA inspection have to get a grasp of the factors that prompt the FDA to inspect research. These include:

  • Introduction of a new technology
  • Introduction of a new product or an indication
  • Receipts of complaints by the FDA from aggrieved parties
  • CRO being a habitual non-complier

When a medical device fails to meet these standards for precision and accuracy

All medical devices have their stated intended use. With time, many of them undergo changes with use. Because of this, they need to be calibrated to retain their effectiveness. The FDA’s medical device calibration requirements have been devised with the same intention.

Although the FDA has medical device calibration requirements, many of these medical devices do not have specific measures that need to be set. So, in view of this, the FDA can only require that the core quality needed for the medical device’s function -the ability to meet its intended use -is met from time to time.


The FDA’s code of regulations for medical device calibration requirements

The FDA has a code of regulations for medical device calibration requirements: Part 820 of its QSR, Section 72. 21 CFR Part 820.72, which deals with inspection, measuring, and test equipment; states that medical device calibration requirements shall cover the control of these aspects of the medical device. It broadly states that manufacturers have to ensure that “…all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results”.

Further, it also requires medical device manufacturers to have procedures in place for calibrating, inspecting, checking and maintaining equipment. Also included in these procedures are provisions relating to how to handle, preserve and store equipment.

Medical device calibration requirements in relation to calibration

As for calibration requirements in particular, the FDA’s medical device calibration requirements require medical device companies to have procedures in place that specifically offer directions and limits with regard to precision and accuracy. When a medical device fails to meet these standards for precision and accuracy; the FDA will evaluate if these have the potential to cause harm in the form of adverse effect on the patient. If these are discovered, the manufacturer has to calibrate the medical device to improve quality till the standards are met. All these procedures are to be documented.

Medical device calibration requirements in relation to standards

On the question of standards, in the absence of standards specifically meant for medical device calibration requirements; the FDA states that relevant international, national, state or local standard have to apply. In the absence of any of these; the company has to form its own set of standards for meeting medical device calibration requirements.


Documentation of medical device calibration

Part 21 CFR 820.72 of the FDA clearly states that the medical device manufacturer has to document all the points of calibration such as the date on which the device was identified and taken up for calibration, the name of the staff who did this, and when the next calibration is due. All these records have to be made publicly available to designated staff in the medical device company. All these form part of the FDA’s medical device calibration requirements.

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be disastrous and many times, even fatal.

Required, but not clear about the steps

The FDA only broadly states that risk management has to be built into the manufacturing process. This leaves medical device manufacturers in a kind of quandary, because although the FDA is clear about the requirement for risk management; there is no clear-cut guideline on how this needs to be carried out. This leaves the implementation of FMEA in medical devices something that is at the discretion of the medical device company.

The FDA’s Final Rule on cGMP Quality System Regulation (QSR) is, to quote its own words, “less prescriptive and gives the manufacturer the flexibility to determine the controls that are necessary to be commensurate with risk” ( In other words, there is no specific guideline on risk management, using which medical device manufacturers can decide the ways and processes of implementing risk management. The guideline is all the more vague about risk analysis approaches and procedures like FMEA.

Complementarity with ISO 14971Since the guidelines on medical devices FMEA are rather general medical device companies that implement FMEA have to go by a buzzword: implementing FMEA at every level. In this regard, they can work complementarily with ISO 14971, whose guidelines relate to risk management.

Understanding Medical Device inspection

A medical device inspection is one of the most important activities the FDA carries out to determine that a device meets the requisite regulatory standards for ensuring safety and effectiveness. It is a core GMP activity and hence covers all medical devices ranging from the smallest to complex ones such as MRI’s.

Rationale for the medical device inspection regime

The medical device inspection process is built on the logic that methods are not to be considered the criterion for evaluating and inspecting a medical device. This is because many methods can be used to arrive at the same product, due to which the choice of the best option is left to the manufacturer. Given this fact, the FDA medical device inspection concept is aimed at inspecting the device’s Quality System Regulations (QSR)-mandated objectives, which are a more precise parameter for medical device inspection.

What are manufacturers expected to demonstrate to a medical device inspection?A medical device inspection is done to ensure that the device meets set safety, efficiency and intended use standards, while being compliant with regulatory requirements. During the medical device inspection, manufacturers have to demonstrate that the method they have chosen to use -since there can be varied methods for arriving at a medical device specification -is helpful in arriving at the product while meeting the prescribed regulatory compliance requirements. They should defend the methods they have used in ensuring regulatory compliance requirements.

Need not meet all GMP requirementsOne major factor that the FDA keeps in mind for a medical device inspection is that manufacturers are not required to show compliance with each and every Quality System (QS) or GMP section. Only those that are relevant to that device can be shown, but they should be able show which sections of the GMP or QS are relevant to the said device, and should also show how these have been used to arrive at the product that is compliant in terms of regulatory requirements.

Factors a medical device inspection takes into considerationDuring a medical device inspection, the FDA inspectors keep in mind a few factors that help them determine the efficiency and effectiveness of a medical device. Some of the important ones among these include:

  • Has the manufacturer documented the processes in the right format? Has everything related to it been written down?
  • Is the manufacturer complying with those processes?
  • Is there sufficient evidence that these are adequate?


Other issues for a medical device inspectionThe FDA does a medical device inspection keeping these factors in mind while also weighing other issues such as the size of the medical device manufacturing firm, the complexity of the device under inspection, and the nature and gravity of risk a device that does not meet its intended specifications poses.