Gorakhpur 2017 Deaths: a 2019 review

Health Care No Comments

On 10th of August 2017, when I was the National President of Indian Medical Association a series of deaths occurred in the children ward suffering from acute encephalitis syndrome in Gorakhpur Medical College.

As per a report, a copy of which is with the undersigned, 23 children died on 10th August, 11 on 11th August and 11 on 12th August. The cause of death was stated to be non availability of oxygen in the children ward. An enquiry report done by the health department, a copy of which is with the undersigned, clearly says that there was non-availability of oxygen in the hospital for 52 hours on 11th and 12th August, 2017. The same has also been confirmed by an RTI.

What is not known is that on the same day on 10th August, 8 people died in the adult medicine ward and 10 died on 11th August in the same ward. This clearly indicates that the lack of oxygen was administrative problem and not the problem of the treating doctors.

Ever since the department has bifurcated acute encephalitis syndrome patients into classical AES patients and Acute Febrile Illness Patients AFI patients.

The recent ICMR  Regional Medical Research Centre Gorakhpur (RMRCGKP) data shows that out of 123 cases seen in August and October 67 were positive for typhus fever, 16 with dengue and 22 with Japanese encephalitis.

Out of 15, 63 patients of AFI till November 215 have been confirmed to Japanese encephalitis. Out of 492 cases of acute encephalitis syndrome only 116 have been confirmed to be JE.

The state government has a scheme of providing 50,000 to the family for a JE death and one lakh for JE disability.

The data and the government policy of dividing cases under AES and AFI needs to be reversed; as out of 1563 AFI patients the government missed 215 cases of JE, and they ended up not getting the JE treatment in time.

High incidence of typhus 67  out of 123 which is more than 50% of cases also raises an alarm that the 2017 epidemic and deaths might have been typhus fever which has a good prognosis with simple antibiotic doxycycline.

Every death of AES and AFI should be audited.

Dr KK Aggarwal

Padma Shri Awardee

President Confederation of Medical Associations in Asia and Oceania (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Medical Devices should be regulated under a Separate Law eventually and not as a Drug beyond 5 years, Nor as amendment to Drugs Act

Health Care No Comments

Date: 18.11.2019

To,

The Under Secretary (Drug Regulation),

Ministry of Health and Family Welfare, Government of India,

Room No. 414 A, D Wing, Nirman Bhavan,

New Delhi – 110011

Email drugsdiv-mohfw@gov.in

Subject:  Comments on Draft Notification # GSR 797 (E) dated 18th October, 2019

Dear Sir,

The subject Draft Notification # GSR 797 (E) dated 18th October, 2019 has been reviewed by the Heart Care Foundation of India (HCFI). The comments of HCFI on the Notification are as follows:

1)    Medical Devices should be regulated under a Separate Law eventually and not as a Drug beyond 5 years, nor as amendment to Drugs Act.

2)    It should be specifically mentioned in the new notification that the present notification is only temporary transient mechanism till the separate Medical Device Law is legislated.

3)    A New Medical Device National Regulatory Authority may be made under the Medical Device Law under MOH&FW (like FSSAI) OR by a revamped CDSCO as a National Healthcare Product Regulatory Authority with Medical Device Division, separate from Drugs Division.

4)    Even in other countries there is a separate legislation for Medical devices. Few examples are as follows:

  1. In US, Medical Devicesare regulated by FDA- Centre for Devices & Radiological Health. FDAs Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States.
  2. In EUthey are regulated by European Medical Agency,

In EU, there is decentralized procedure of marketing authorization as no single body regulates Medical devices. A system of third party compliance is followed. Notified Bodies are the third party that issue Quality Assurance certificates and ensures post approval compliance to Quality Management System (QMS). Medical Devices are regulated by Medical Devices Directive, which consists of three directives that regulate the safety and marketing of medical devices in Europe. The three directives are:

  • Medical Device Directive (MDD 93/42/EEC),
  • Active Implantable Medical Device Directive (AIMDD 90/42/EE),
  • In vitroDiagnostic Medical Device Directive (IVDMDD 98/79/ EC).

In view of the above, HCFI humbly requests your goodself to issue a new notification, thereby stating that a new and separate legislation shall be enacted for regulation of Medical Devices in India and the medical devices will not fall under the purview of Drugs and Cosmetics Act and Rules.

Kindly do the needful

Thanking You

Yours faithfully

Dr KK Aggarwal President HCFI and CMAAO

Dr K K Kalra: Advisor HCFI

Ms Meenakshi Datta Ghosh, Vice Chair HCFI Round Table on Health and Wellness

Understanding Air Masks and Air Purifiers

Health Care No Comments

Understanding Air Masks and Air Purifiers

Types of Respirators or Masks

  1. The first type of respirator removes contaminants from the air and are called air-purifying respirators (APRs). APRs include particulate respirators, which filter out airborne particles, and “gas masks,” which filter out chemicals and gases.
  2. Other respirators protect by supplying clean respirable air from another source. Air-Supplying Respirators(ASRs) comprise this category of respirators. They include airline respirators, which use compressed air from a remote source; and self-contained breathing apparatus (SCBA), which include their own air supply.

Fire and Simple wet Cloth

  1. N95 mask doesnt do anything for CO and gases and theyre very difficult to breathe with.
  2. Wet cloth held over the nose and mouth will provide protection from smoke particulates. Wet cloth will absorb most of the water-soluble gases (hydrogen cyanide & hydrogen chloride). For wetting the cloth use water, soft drink or other non-alcoholic beverage to moisten the fabric.”
  3. During World War One, Canadian soldiers being attacked with chlorine gas(Mustard Gas) were told to urinate into their handkerchiefs and to breathe throughthat wet cloth.  The chlorine gas would dissolve in the water as itpassed through the handkerchief, thereby keeping the troops safe andalive.
  4. A dampened cloth will have a modest effectiveness against SO2, since SO2 dissolves readily in water.
  5. CO is also soluble in water, but to a lesser extent than sulphor dioxide.
  6. It will also take care of > 10-micron dust particles

Pollution and particulate filters

There are three types of particulate filters:

Particulate filtering facepiece respirators

Also known as disposable respirators because the entire respirator is discarded when it becomes unsuitable for further use due to considerations of hygiene, excessive resistance, or physical damage. These are also commonly referred to as “N95.”

Elastomeric respirators or reusable respirators are so called because the facepiece is cleaned and reused but the filter cartridges are discarded and replaced when they become unsuitable for further use.

Powered air-purifying respirators (PAPRs) where a battery-powered blower moves the airflow through the filters.

Disposable particulate filter types: N, P and R

The particulate respirator will have an N, R, or P designation along with an efficiency rating such as 95, 99, or 100.

N: No oil is present in the air; not oil resistant

R: Oil is present, but only for a single shift or 8 hours of continuous or intermittent use; Oil resistant

P: Oil is present; Oil proof.

Efficiency or High Efficiency Particulate Air (HEPA) filter

  1. 100: The filter is expected to trap 99.97 particles (of at least 0.3 microns in diameter) out of every 100.
  2. 99: Trap 99 particles (of at least 0.3 microns in diameter) out of every 100.
  3. 95: trap 95 particles (of at least 0.3 microns in diameter) out of every 100.

How efficient the respirator’s filter capacity is expected to be against particles that are at least 0.3 micrometres.

As the letter rating and number rating increase, breathing fatigue will increase. Typically, an end user will find an N95 respirator cooler, and easier to breathe through than N99 mask.

Surgical mask: is intended to be worn to catch microorganisms shed in liquid droplets and aerosols from the wearers mouth and nose. They are made from paper or other non-woven material and should be discarded after each use. They cover > 5-micron particles. They are not designed to protect the wearer from inhaling airborne bacteria or virus particles.

Flu virus is 0.17 microns in size but the droplet is > 5 micron in diameter. Regardless of usage, masks should be discarded when used beyond 8 hours.

Cotton and gauze masks do not serve as surgical masks as they do not offer adequate filtration of microbes.

Dust or particulate masks

They are manufactured to protect against particulate matter and do not protect against chemicals such as vapors and mists. For this reason, it is dangerous to confuse dust masks with paint masks.

Wool is still used today as a filter, along with plastic, glass, cellulose, and combinations of two or more of these materials. These filters cannot be cleaned and reused and have a limited lifespan.

Filtering half mask with exhalation valve (class: FFP3)

Mechanical filters remove contaminants from air in the following ways:

  1. Interception: when particles following a line of flow in the airstream come within one radius of a fibre and adhere to it
  2. Impaction: when larger particles unable to follow the curving contours of the airstream are forced to embed in one of the fibres directly; this increases with diminishing fibre separation and higher air flow velocity
  3. Diffusion: where gas molecules collide with the smallest particles, especially those below 100 nm in diameter, which are thereby impeded and delayed in their path through the filter
  4. Coating: Certain resins, waxes, and plastics as coatings on the filter material to attract particles with an electrostatic charge that holds them on the filter surface
  5. Gravity and allowing particles to settle into the filter material

Only particulates carried on an air stream and a fibre mesh filter, diffusion predominates below the 0.1 μm diameter particle size. Impaction and interception predominate above 0.4 μm. In between, near the 0.3 μm most penetrating particle size, diffusion and interception predominate.

Particulate filters are designed to keep the velocity of air flow through the filter as low as possible. This is achieved by manipulating the slope and shape of the filter (V shape) to provide larger surface area.

A HEPA filter can remove as much as 99.97% of all airborne particulates with aerodynamic diameter of 0.3 micrometres or greater.  Some high-quality air purifiers have as much as 60 square feet of filter material folded inside their HEPA filter. In addition to the amount of filter material.

Types of HEPA Filters

According to the Institute of Environmental Science and Technology, (IEST) about performance, there are 6 types – A, B, C, D, E & F.

[A and B 99.97% at 0.3 micron; B 99.99 at O,3 micron, D 99.999% at O, 3 micron; E 99.97% at 0.3 micron and F 99.999 % at 0.1 to 0.2 micron]. B and E are with two flow leak test.

HEPA vs HEPA like or HEPA type filters

They are nor same as HEPA filters as they capture > 2-micron particles.

5

Air purifiers

Contain an HEPA filter and a fan device

CADR (Clean Air Delivery Rate)

  1. CADR ratingindicates how fast the air purifier can clean the air within a particular size room. For example, an air purifier with CADR rating of 300 cfm will clean a room of 300 sq. ft much faster than an air purifier with CADR rating of only 200 cfm.
  2. Ionizer is one reason for making CADR ratings false. An ionization is a process of sticking many small particles into a bigger one, but not trapping them. Usually, these bigger formed particles are dropped on the floor and wall. Without a proper removal, these pollutant particles are ready to be in the air once again.
  3. CADR rating is taken in CFM which stands for cubic feet per minute, or in m³/hour. CADR measurement is usually for pollen, smoke, and dust. These three pollutants are not only small in size but also the most unwanted particles in the air.
  4. CADR ratings only show only the cleaning capacity, not the cleaning capability.
  5. Air exchange per hour: Three air changes per hour would require a system that produces 150 CFM or 9,000 cubic feet per hour. A medical clinic needs a minimum of 10 air changes per hour would a filtration system that produces 30,000 cubic feet per hour or 500 CFM.
  6. Area of the room = length x width x height (5feet long, 20 feet wide, 10 feet height =1,000 cubic feet
  7. One requires a certain number of air changes per hour: the case of a clean room type requirement, those are usually designated by Class. Such as Class 100,000, 10,000, 100, 10 and 1. These are rated as .3 microns per cubic foot. As an example, a class 10,000 clean room environment would need to meet the criteria of nothing over 10,000 particles per cubic foot at .3 microns or smaller.  Considering the room without filtration could easily register 400,000 particles plus per cubic foot at .3 microns, this reduction level requirement is significant.
  8. For most situations you will want somewhere between 2 and 5 air changes per hour. In other words, to clean the air every 12 to 30 minutes in a room. If you have smoke, severe allergies, asthma or COPD we suggest you stick with 5 air changes per hour to get enough air flow to keep the air in your room very clean.
  9. CADR is based on the highest fan speed. When you run the air purifier on a lower fan speed the room coverage will also decrease.
In Micron
Anthrax 1-5
Asbestos 0.7 – 90
Atmospheric Dust 0.001 – 40
Bacteria 0.3 – 60
Beach sand 100 – 10000
Bone dust 3-300
Bromine 0,1-0,7
CO2 0.00065
Copier Toner 0.5 – 15
Corn Starch 0.1-0.8
Fibre glass insulation 1-1000
lead 0.1-0.7
Metallurgical Dust 0.1 – 1000
Mold spores 10-30
Oil smoke 0.03-1
Typical Atmospheric Dust 0.001-30
Tobacco smoke 0.01-4
sugar 0.0008-0.005
spores 3-40
Smoke from synthetic materiel 1-50
Smoke from natural materials 0.01-0.1
RBC 5-10
Saw dust 30-600
Oxygen 0.0005
Pesticide and herbicides 0.001
Radioactive fallout 0.1-10
One inch 25400

Dr KK Aggarwal

Padma Shri Awardee

President Confederation of Medical Associations in Asia and Oceania (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

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