The World Health Organization (WHO), the international organization focused on public health protection, issued a notice providing medical device manufacturers and industry representatives additional information that addresses COVID-19-related issues. The document covers the most important aspects related to on-site inspections, quality management systems (QMS), personnel and facilities, the use of raw materials and components, production process, and quality control laboratories.
WHO COVID Notice: Key Points
The WHO notice is intended to assist all parties involved in medical device operations in maintaining compliance with applicable requirements. The document describes how manufacturers of medicinal products shall operate under specific conditions resulting from additional restrictive measures imposed by the governments of different countries to combat infection. These measures include lockdowns, travel restrictions, and other temporary quarantine measures. Due to such measures, medical device manufacturers are facing additional complications and difficulties impacting the manufacturing process. It can prove to be difficult or almost impossible for manufacturers to maintain compliance with applicable requirements and fulfill the obligations set forth by legislation.
Additionally, the notice also describes certain flexibilities that could be applied in order to expand the availability of vitally important medical devices facing a significant increase in demand. This may help avoid potential shortages in supply resulting from interruptions in the normal production process caused by COVID-related factors. The document provides additional legal clarity and outlines particular recommendations to be followed by medical device manufacturers and other parties involved.
It is also important to mention that the present notice on COVID-related factors could be subject to updates and amendments in order to incorporate new changes to the applicable regulation. It is expected that it will remain valid during the whole period of the COVID-19 pandemic.
Medical Device Manufacturers’ Inspections
The restrictive measures implemented by different countries to slow down the spreading of infection have significantly impacted the normal way of carrying out on-site inspections of manufacturing facilities. According to the present WHO notice, under certain conditions, the requirements on the on-site inspections could be waived, allowing for inspections to be postponed until prohibiting restrictions are canceled.
Some national regulating authorities have already introduced rules allowing-site inspections to be conducted remotely using informational and communicational technologies.
The decision regarding the possibility of waiving on-site inspections should be considered case-by-case on the basis of the rigorous risk assessment carried out to identify potential risks. Upon the results of such an assessment, the on-site inspection could be postponed and temporarily replaced with the desk assessment. However, if the desk assessment cannot cover all aspects due to the complexity of the issue, the regular on-site inspection should be duly performed.
Under certain conditions, the requirement for the obligatory on-site inspection could be waived even for a new entity manufacturing the entirely new product. This could ring true in the case of vitally important medical devices facing a significant increase in demand during the pandemic (i.e.ventilators and accessories thereto). In order to apply these flexibilities, the manufacturer producing critical supply medical devices should contact regulating authorities and provide them with all information needed to assess the risks associated with the use of the device in question and its manufacturing process.
As it is stated in the WHO notice, the Quality Control Laboratories could also be subject to the aforementioned waiver rule.
It is important to mention that in spite of all additional flexibilities introduced, based on the results of the inspection, medical device manufacturers and other parties involved are expected to fulfill the requirements on timelines for the implementation of corrective and preventive actions.
COVID-related Quality Management Systems Requirements
Additionally, The WHO notice also describes in detail how requirements related to the Quality Management Principles (QMS) should be applied in the context of the COVID-19 outbreak. According to the document, company management shall ensure that all applicable QMS principles are being duly maintained in spite of any external factors impacting the operations of the entity. In particular, the medical device manufacturers shall consider the following:
- In case the country of the principal place of business is not affected significantly by the pandemic, the company shall duly comply with all applicable requirements under the general rule.
- In case the normal business operations in the country of the principal place of business are being partially interrupted by the pandemic, the management of the company shall review the Quality Management Systems accordingly to identify potential threats and implement the measures reasonably to mitigate the risks associated thereto. In particular, it could be necessary to make certain changes to some of the processes and procedures performed by the company in the course of the manufacturing cycle.
All the measures taken by the company in the context of addressing the impact of the COVID-19 outbreak should be duly documented and the notified bodies should be informed accordingly. The company shall also develop a plan describing the reverse transition to the normal way of operations after the pandemic.
Medical Device Manufacturing Facilities: Operations During the Pandemic
Moreover, the document describes in detail how operations of the production sites should be organized during the public health emergency. In particular, the WHO notice provides medical device manufacturers with recommendations to be implemented in order to mitigate the risk of substantial interruptions in the manufacturing processes. It is advised to switch some of the processes to a remote format in order to reduce the number of personal contacts between the employees – such measures are necessary to mitigate hazards related to exposing employees to potential infection risks.
The list of protective and preventive measures recommended by the WHO include:
- Encouraging employees to avoid crowded places and to stay home in case of any signs of illness,
- Reminding employees to follow recommendations regarding measures to be taken to protect themselves against the possible infection (e.g. to wash hands and use disinfectors, to increase physical distance, and to avoid touching the face),
- Using the appropriate personal protective equipment, such as face masks or gloves,
- Temporarily suspending all interactions with visitors if it is reasonably possible due to the nature of operations performed by the particular facility,
- Cleaning and sanitizing the premises.
The document also describes special measures related to the calibration of equipment requiring such maintenance.
Summarizing the information described hereabove, the present WHO notice on COVID-19 issues is intended to assist medical device manufacturers in complying with all requirements during the pandemic. In addition, the notice is also intended to help manufacturers maintain normal operations despite the impact caused by temporary and restrictive measures implemented to mitigate risks associated with COVID-19, its complications, and associated respiratory illnesses.
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