Safety and Innovation in a COVID19 World
Tara Creaven-Capasso, Regulatory and Quality Consultant, Caduceus Medical Development Ltd., and Diana Siew, Associate Director MedTech Centre of Research Excellence
Tara is co-founder of Caduceus Medical Development, Ltd., a regulatory, quality and compliance consulting company, which services the medical technology sector in NZ and internationally. She is passionate about helping companies understand their regulatory requirements, which is essential to enhance their growth and increase their value as they work towards product commercialisation. Tara is also a member of Life Science New Zealand, NZ’s life science consulting network.
Diana is Associate Director of the MedTech Centre of Research Excellence (MedTech CoRE), NZ’s translational research platform. She is also co-founder of the Consortium for Medical Device Technologies a research-industry network which supports innovation and growth of the NZ medtech sector. She works with government, academia, clinicians and industry on initiatives to help them grow NZ’s medtech startups more sustainably. Diana is based at the Auckland Bioengineering Institute as Strategic Partnership lead.
08 April 2020
Who knew that a corona virus would come along one day and throw the whole world into mayhem! However, out of adversity comes hope and innovation - especially in the case of our research community and industry.
While not wanting to dampen enthusiasm and the creative juices, one thing to remember is that the safety of our front-line responders is paramount and with that a need to understand the regulations, technical standards and guidelines required to develop a medical device intended for human use1
In New Zealand there is no pre-market assessment or approval process required for innovators who design, develop, manufacture and/or distribute (herein referred to as parties) medical devices under the current regulatory framework captured in the Medicines Act of 1981 and subsequent amendments2. There is a requirement however for parties to “notify” Medsafe of the intent to distribute the medical device in New Zealand, i.e. they are required to notify their product to the WAND database. Once on the market, Medsafe applies product regulation in the form of post-market surveillance which permits Medsafe to take legal action should a device prove to be unsafe, i.e. cause harm.
Despite the current low level of pre-market regulatory controls required in New Zealand, Medsafe expects that medical devices for human use are fit for purpose according to their intended use. Most importantly for parties, Medsafe defers to product compliance with international standards in trusted regulatory requirements in jurisdictions typically, the US FDA, Australian TGA and European Notified Bodies. Product registrations in major markets provide assurance to Medsafe that the medical devices have been evaluated and are safe and effective.
International Regulatory Policy Changes in Response to Shortage of PPE and Respiratory Medical Devices
In response to the coronavirus disease (COVID-19) pandemic, regulatory policies are being modified to facilitate access due to the escalating demand and shortage of Personal Protective Equipment (PPE), ventilators and in-vitro diagnostic test kits.
Regulatory Policy Changes to Address PPE Shortage
As the supply of critical PPE dwindles the FDA is lifting requirements for certain masks and respirators to increase their availability. A few days prior to publishing this article the FDA released a guidance document3 explaining what regulatory requirements it is lifting for different types of masks and respirators, and its expectations for emergency use authorizations (EUAs). This policy provides guidance to New Zealand companies wishing to enter into the PPE space.
For face masks intended for a medical purpose that are not for liquid barrier protection, the FDA says it is lifting major regulatory requirements to increase availability of the devices, including 510(k) submission, quality system regulation (QSR), registration and listing, and unique device identifier (UDI) requirements, so long as the devices do not create undue risk for users.
FDA says it will allow the distribution and use of surgical masks, which are Class II devices, without 510(k) clearance, if the masks meet certain standards for fluid resistance and flammability and include accurate labelling.
The agency also says it is interested in allowing companies to disinfect and reprocess otherwise disposable N95 respirators to stretch the supply of the devices under an EUA. Typically, re-processors must obtain 510(k) clearance to reprocess single-use devices. However, given the urgent need for respirators, the FDA says it will work with companies to expedite the EUA process and provides a detailed list of information for companies to provide to support an EUA request.
The relaxed policies only apply to specific types of masks and respirators that fall under seven product codes and do not apply to other masks intended for specific uses, such as masks used in anesthesiology.
Personal Protective Equipment Standards
A series of standards that cover face masks, medical gloves and protective clothing is available for medical devices and PPE used in the context of the current COVID-19 outbreak available.4
Regulatory Policy Changes to Address Ventilator Shortage
Similarly, as hospitals face an influx of patients needing mechanical ventilation due to COVID-19, regulators including the US FDA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are loosening their requirements for ventilators to boost supply of the devices.
On 20 March, 2020, the FDA issued an immediately effective guidance setting out its enforcement policy to increase the availability of ventilators and other respiratory devices by allowing device makers to make modifications to already cleared products without submitting a premarket notification (510(k) during the current public health emergency. This policy provides guidance to New Zealand companies wishing to enter into the ventilator space.
The FDA says the move will give companies flexibility to make changes. One example includes but is not limited to, sourcing components or materials from alternate suppliers. Another example: FDA will also not object to changes to the indications of ventilators or other respiratory devices without a 510(k) submission “where the modifications will not create an undue risk in light of the public health emergency.”
The guidance also provides a list of FDA-recognized consensus standards manufacturers should consult when designing, evaluating and validating changes made to the devices and provides labeling recommendations to help users understand any modifications. While FDA emphasizes its preference for using “conventional/standard full-featured ventilators” when possible, the agency says it will also consider granting EUA designation for ventilators that have not yet been cleared by the agency.
Additionally, the UK’s MHRA took its own steps to increase the availability of “rapidly manufactured” ventilators by providing a set of specifications to meet “minimally acceptable” performance criteria for the devices during this COVID-19 outbreak. The specifications include recommendations for ventilation functionality, gas and electricity supply, infection control, and monitoring and alarm features. The MHRA says the specifications are meant for devices “used in the initial care of patients requiring urgent ventilation” and used for short durations ranging from a few hours to one day. The agency says it plans to authorize the devices through its exceptional use of non-CE marked medical devices route and that the devices will not be considered useable outside the current emergency unless they subsequently obtain CE mark.
Governments across the globe are looking for businesses that can support with the supply of ventilators and ventilator components. A specification for ventilators for use in UK hospitals during the COVID-19 outbreak is now available.5 This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of anesthesia and intensive care professionals and medical device regulators. Several standards are referred to within this document that manufacturers should adhere to when designing, developing and manufacturing ventilators. Note ISO 14971 standard addresses risk management and one of the listed standards in the guidance document
Risk Management: ISO 14971
ISO 14971 standard describes a risk management process which is an integral part of the medical device product development lifecycle. In the design and development phase of a medical device, it is a regulatory requirement to manage risk. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators or the environment. The main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product.
ISO 14971 risk management standard specifies and regulates the process to be followed by the medical device manufacturers to avoid the possible hazards associated with the device. Note that there are many other regulations that specify risk management steps during the development of medical devices similar to ISO 14971. The approach of these could be different, but the goal is the same.
Quality Management System: ISO 13485
A typical framework to deliver a medical device requires compliance to a Quality Management System following ISO 13485:2016. For those parties interested in entering into the design, development and manufacturing of medical device technologies ISO13485 outlines the requirement to establish and maintain a design history file for each medical device design. The file may include reference records of conformity to design requirements, records of review, verification, validation, and changes. See Figure 1 below for an overview of the key steps during design and development of a compliant medical device.
Figure 1. Requirements for ISO13485 design and development
Local Regulatory Experts in Medical Technology Development and Manufacture
NZ Inc.’s response to our national COVID19 needs is coming from all technology sectors. For those not from currently in the medical device sector, there is significant opportunity to diversify and to develop commercial value, as well as develop a new skill-set around medical device technology development and manufacturing. As many medical devices companies will testify to, it is challenging to navigate the regulatory maze. Getting help early from an expert will save time and money in the longterm (see useful resources below).
References and Notes
- Don’t curb your enthusiasm but be realistic about macgyver ventilators, MedicalDesign and Outsourcing, Nancy Crotti, April 02 2020 - https://www.medicaldesignandoutsourcing.com/dont-curb-your-enthusiasm-but-be-realistic-about-macgyver-ventilators/
- The New Zealand Government is working on a new and comprehensive regulatory regime (the Therapeutic Products Bill) to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981 and its Regulations.
- Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) Guidance for Industry and Food and Drug Administration Staff April 2020
Other useful links
ISO and IEC announced free access to a range of standards, relevant to the global response in addressing COVID-19. This can be accessed through the Standards NZ website - https://www.standards.govt.nz/news/media-releases/2020/apr/free-availability-of-covid-19-related-iso-standards/
CMDT/MedTech CoRE are able to put you in touch with our regulatory expert. Drop us your request using this link - https://www.cmdt.org.nz/contact-us/