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.


Good Documentation Practices Relating to USP

Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.

US Pharmacopeia (USP) has laid out a series of GDP’s. One of the major new updates is contained in the newly proposed USP-NF General Chapter <1029>.

Basis for GDP in USPGDP for USP is also formulated on the same principle and rationale on which any GDP is built: proper, accurate and comprehensive records are the backbone to proper documentation, which is the basis for all major and minor procedures and operation.

GDP for USP has guidelines in the General Chapter 1029. These guidelines are given with the intention of helping build a foundation for the Quality Systems, apart from also ensuring the integrity and control of documents.

These GDP’s are meant for use in the production and control of the following:

  • Active pharmaceutical ingredients (APIs)
  • Medical devices
  • Excipients
  • Pharmaceutical products
  • Dietary supplements
  • Food ingredients

The General Chapter explains the justification for putting in place Good Documentation Practices in USP and helps the user evaluate and construct GMP activities.

In what areas are GDP’s listed out in Chapter 1029?GDP’s for USP are mentioned in relation to electronic and paper records, which include reports, raw data, protocol, and procedures concerning analytical data and manufacturing controls, and has recommendations on the kind of information that should be recorded for different kinds of documents that require GMP. A prominent amendment brought into the new chapter 1029 is that there is no longer a distinction between instructions and records, and all records and instructions are broadly merged into “records”.

Some broad requirements of GDP as set out in Chapter 1029USP Good Documentation Practices spell out a number of principles. Some of these include:

  • There should be clarity, accuracy, conciseness and legality of records
  • Every time an action is performed, there should be a documentation
  • Anyone dealing with documents should not backdate or postdate any action
  • The initial of the person who carried out a change should attest her initials and offer an explanation whenever an amendment is made

Electronic or manual records should go by the following GDP’s:

  • Any data entry should be traced back to the person who did the entry
  • Shorthand notations are not allowed
  • Controls should be put in place to ensure integrity of the record
  • When a thermal paper is used, a verified copy of its accuracy should be retained, and the user should initial it with the date

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.

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.

Compliance4All blog page reaches 200+ followers successfully in super quick time!

Compliance4All, a Fremont, CA-based leading provider of compliance related trainings for professionals in the areas of regulatory compliance, has once again proved why it is such a popular hit with its community!

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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.