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.


ICH Q10 -the ICH’s Pharmaceutical Quality System

The purpose for which the International Conference on Harmonization (ICH) has issued wide-ranging in ICH Q 10 guidelines is that they help individuals and organizations in the pharmaceutical industry avoid duplication of their work, especially in pharmaceutical research and product registration.

ichQ10PharmaceuticalQualitySystemReduction of double work is the important purpose

Putting in place greater harmonization in the area of pharmaceutical product registration by interpreting and applying technical ICH guidelines was the aim with which the ICH was launched in 1990.

The harmonization the ICH Q 10 aims to bring about seeks to reduce and possibly eliminate repetition of testing and reduce double work of research and development of new human medicines. It uses extensive guidelines to achieve this. These guidelines are given for all areas of ICH Q 10.

Quality Guidelines:

Related to the Quality area; these guidelines include crucial milestones such as doing stability studies, defining appropriate limits for impurities testing, and evolving a malleable approach to GMP risk management based pharmaceutical quality.

Safety Guidelines:

Relates to the safety aspect of carrying out research in the carcinogenic, genotoxic and repro toxic areas, which carry a high risk of danger.

Efficacy Guidelines:

To ensure efficacy in research, ICH guidelines cover areas such as the conduct, design, safety and reporting of clinical trials. Efficacy guidelines also include biotechnological processes and pharmacogenetics or genomics techniques, which are aimed at producing medicines that target disease better.

Multidisciplinary Guidelines:

These are guidelines are for areas left out of the Quality, Safety and Efficacy Guidelines. Core elements of this area of ICH Q 10 guidelines include ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

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.

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.

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FDA regulation on medical device packaging design

The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”

Does this mean that the FDA regulation on medical device packaging design is simple, plain and broad, and can be bypassed? Not really. Compliance with the medical device packaging design has to be seen in relation to two factors:

Medical Device 3

Sits with device labeling requirements

FDA regulation on medical device packaging design has to be seen in conjunction with its twin regulation, namely Sec. 820.120 device labeling. This is the first of the two sections on medical device labeling and packaging. This section has elaborate details on how medical devices need to be packaged and labeled. The FDA has requirements in this section on the integrity, inspection, storage, operations, and control number of labeling. FDA regulation on medical device packaging design has to be complied with collectively with this section.

Scope for creativitySecondly, FDA regulation on medical device packaging design is only a set or regulations that require adherence to the device packaging design elements. Medical device packaging design manufacturers are free to use their creativity in designing device packaging. Adherence to FDA regulation on medical device packaging design does not mean that there should be no innovation; it only means that the medical device packaging design has to be complied with. As long as this is met, manufacturers are free to design imaginatively. Perhaps because there is enough scope for innovation, FDA has left this area general and nonspecific, with the only requirements being that the medical device packaging design adhere to guidelines aimed at protecting it.

FDA steps up efforts at bringing about medical device cyber security

It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cyber security is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them.

An important factor that makes medical devices vulnerable to cyberattacks, thus triggering and hastening the need for medical device cyber security is that many times, medical devices are not standalone devices. They are connected via the Net to a number of important sources such as hospitals, electronic records and healthcare providers.

This fact makes it easier for hackers to carry out cyberattacks on medical devices because it is not necessary for them to actually have access to the device to carry out their breach. All these factors combine to make medical device cyber security a much needed system.

CyberAttacksIndustries_gifThe FDA guideline of June 2013:

Keeping in mind the nature of fallibilities in a medical device; the FDA, with the intention of bringing about medical device cyber security passed the draft guideline on this topic in mid-2013. Titled the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; this guideline sought to address the issue of medical device cyber security by making an attempt at identifying the issue from its root.

That is, this guideline on medical device cyber security put in place security checks and procedures that manufacturers of medical device have to put in place right from the earliest stages of manufacture, going all the way up to the time it is implanted in or used by the patient.


The main intention of this FDA medical device cyber security guideline is to offer recommendations that medical device manufacturers need to take to reduce the intentional or unintentional risk of an attack on a medical device. This FDA guideline seeks to enforce medical device cyber security by ensuring that the manufacturers take steps to secure medical devices by clearly defining medical device cyber security.

Terms clearly defined

The FDA defines medical device cyber security as steps taken to prevent any of these:

  • Unauthorized modification
  • Misuse of the device
  • Denying the use of the device
  • Unauthorized use of the information that is stored in these devices. This relates to the information stored, accessed and modified when the device is transferred from one source to another

Documentation is at the heart of ensuring medical device cyber security

Towards ensuring medical device cyber security as defined by it; this FDA guideline requires manufacturers to monitor and document all the aspects of medical device cyber security at all stages. Medical device manufacturers should bring about medical device cyber security by developing a set of controls in three vital areas:

  • Firstly, medical device manufacturers should take steps to permit only authorized personnel into the software of the medical device
  • Medical device manufacturers should also ensure medical device cyber security by filling only relevant and accurate data into the device
  • They should also ensure that data is available when asked for

Controls, controls, controls

A very important aspect of medical device cyber security that the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices brings about is that it requires medical device manufacturers to monitor and document all the possible potential for medical device cyber security breach from the design stage itself.

medicalDeviceCyberSecurityMedical device manufacturers have to also bring to the notice of the FDA whenever they make changes related to security at the premarket notification stage. It seeks to fortify medical device cyber security by requiring medical device manufacturers to provide information relating to medical device cyber security by submitting data related to the following: