The Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA) responsible for pre-marketing assessment and evaluation of medical devices and general supervision on manufacturing and performance of medical devices, announced its plans to implement the surveys regarding the manufacturing of medical devices and potential shortages.
The Scope of Surveys
According to the announcement published by CDRH, the authority intends to carry on medical device manufacturers’ surveys regarding the “essential medical devices”, defined as the “devices that would be in high demand and/or would be vulnerable to shortages in specific disaster/emergency situations or following specific regulatory actions.”
In the course of such surveys, the authority would collect and process the information on:
- Local (domestic) device inventory as the number of medical devices available;
- Manufacturing capabilities of particular entities;
- Raw materials needed to manufacture such devices.
In the course of surveys, the authority will contact approximately five hundred manufacturers each quarter. The manufacturers will have either to confirm that the data provided earlier is still relevant or provide new up-to-date information regarding the aforementioned issues. The authority also states that all data collection processes would be well-optimized so it will take only 30 minutes to submit the appropriate information to the authority. The survey will take place in the form of a telephone call. The authority will contact manufacturers producing the “essential medical devices” and inform them of the type of data to be provided. The first time, the information should be provided in the form of open-ended answers on particular questions. From there, the manufacturers will only need to periodically confirm the information or amend it. However, the authority reserves the right to request additional information.
The data acquired from the manufacturers would be used to:
- Improve prospective risk assessment;
- Develop and modify risk mitigation strategies; and
- Make decisions based on reliable information on the current supply and inventory of medical devices.
In order to reduce the impact of the potential shortage, the authority will work both with manufacturers and healthcare institutions using the devices to find a balance in supply and demand. At the same time, in a notice published by the FDA, the agency warns that in case of a substantial decline in supply it would request a volunteer entity to establish an import of critical medical devices to the US from other countries.
The authority also recommends healthcare institutions to implement the system allowing them to monitor the number of critical medical devices stored within their facilities and to develop a plan of responding to the potential delays or reductions of the supply of such devices. For this purpose, the device shortage mailbox has been implemented. Any party involved could use it to inform the agency on the shortage it already faced or could potentially face in the future. It is important for the agency to receive such information in advance to be able to prepare properly and to take measures necessary to reduce the impact of such a shortage.
Reasons for Monitoring
The authority explains the necessity of additional monitoring to enable preparation for shortages in critical medical device supply. Such a shortage could be caused by various reasons, including, namely,
- Internal issues associated with the manufacturer, its capabilities and solvency and marketing plans;
- Regulatory issues associated with changes in the regulatory framework, including the implementation of new laws and regulations or changes in importation requirements that could potentially cause delays in supply or make certain devices unavailable at the market;
- Natural disasters or other emergency situations resulting in increasing demand for medical devices of certain types.
The authority provides information on recent closures, temporary closures, and potential closures respectively of third independent sterilization facilities located in different states as an example of internal issues. According to the FDA, this situation creates reasonable concerns regarding the availability of sterile medical devices in the future. Such devices are critical for numerous healthcare institutions–for example, life-saving, life-sustaining or other similar devices. The aforementioned sterilization facilities used ethylene oxide to sterilize medical devices. Despite the other sterilization methods available, this one is the most widely spread – almost 50% of all devices present in the US market are sterilized with ethylene oxide. This method is also the most suitable for sterilization of medical devices that contain polymers or ones that have multiple packaging layers, such as surgery kits or implantable devices. The use of this method is critical for the healthcare industry in general since there is no alternative method that could fully substitute it.
At the same time, the emission of ethylene oxide associated with the sterilization process causes harm to the atmosphere, so manufacturing facilities utilizing this component from time to time face restrictions and are subject to state actions.
In other words, the regulating authority faces need to be informed on the number of medical devices already produced and stored, the number of medical devices manufacturers are going to produce in the next period and the number of devices they are able to produce due to their current manufacturing capabilities.
The Monitoring System Development
The operational plans regarding potential medical device shortages were developed by the CDRH as the response to the events of September 11, 2001. The plans are intended to provide a set of actions to be taken to minimize the impact of medical device shortage caused by a sudden increase in demand or unexpected shortage of supply. For this purpose, the CDRH initiated the development of the shortage data collection system allowing us to acquire and process the information on medical devices manufacturing.
The FDA also informs that it will also work with healthcare institutions, hospitals and healthcare departments responsible for purchasing medical devices.
It is important to mention that a monitoring system with similar features has already been implemented by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to prevent the potential negative impact of medical device supply shortages that could be caused by Brexit.
The main goal of any shortage monitoring system is to prevent delays in critical medical device supply and to avoid the cases when such delays cause harm to patients. The consequences for the patients dependable from particular categories of medical devices could be quite severe, so the national authorities engage all stakeholders to participate in the development of a mutually acceptable solution.
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