Manufacture of protective equipment and medical devices in the COVID-19 pandemic

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The manufacture of protective equipment and medical devices in the COVID-19 pandemic is characterized by bottlenecks worldwide that are life-threatening in some sectors and regions given the course of the COVID-19 pandemic .

The industry reacted with production increases and changes. The governments made agreements with suppliers, export restrictions and decisions on the use of military resources. In the United States, companies were required to produce medically necessary products.

Shortage of resources and production changes

The coordination of scarce resources was one of the five focal points of the LÜKEX exercise on a scenario of a pandemic , as it was last carried out in Germany in 2007. In the course of the COVID pandemic, there were bottlenecks in hospitals and other facilities with respiratory protection masks (FFP2 / FFP3 masks) or mouth and nose protection , which serve to prevent infection, as well as with ventilators such as those used in the Intensive care medicine is necessary.

protective gear

Respiratory protection and hygiene masks were in short supply worldwide from the beginning of the crisis. Switzerland held an emergency supply of respirators, which were close to their expiration date in early 2020.

At the beginning of February 2020, the WHO warned of a shortage of protective equipment . The demand has risen a hundredfold, the prices by up to twenty times. Manufacturers of protective masks announced increases in production. The RKI has published information on the resource-saving use of mouth and nose protection (MNS) and FFP masks in health care facilities. In early March 2020, the WHO warned that medical staff around the world were also increasingly lacking protective masks.

In Germany, the Association of Statutory Health Insurance Physicians called on the health administration to provide resident doctors and doctors in the on-call service with the necessary protective equipment as quickly as possible, since very few practices are appropriately equipped. The German Ministry of Health then announced that it would immediately procure medical protective equipment centrally for medical practices, hospitals and federal authorities. At the same time, an extensive export ban on breathing masks and other protective equipment was imposed; In the interests of solidarity within the EU, the ban was weakened on March 14th: The export of protective goggles, breathing masks, protective suits and gloves has since been subject to approval, but is no longer prohibited. In March, the federal government placed orders to procure ventilators to several medical technology companies. According to reports from the media, which retrospectively researched the causes of the lack of protective clothing, the responsibility for stockpiling in the National Pandemic Plan for Germany lay with the companies; In particular, there was no regulation that would have required clinics and hospitals to stock up on their size. In February and March, when a shortage was already clear, the government did not immediately take central responsibility for the supply of protective clothing, rather the federal states initially remained responsible for supply in an emergency in accordance with their respective pandemic plans.

The National Center for Infection Prevention in Switzerland instructed hospitals that doctors should wear their breathing masks for eight hours instead of two; the German ambassador was summoned after a truck with 240,000 protective masks was prevented from continuing to Switzerland due to the German export ban.

The company 3M , a manufacturer of protective masks, had already announced in January 2020 that it would increase production in order to meet increased demand due to the spread of the new virus. At the end of March, 3M, GE Healthcare and Ford worked together to manufacture around 100,000 full face shields per week, as well as powered, air-purifying respirators (PAPR) and breathing apparatus in the US . In China, companies in several sectors switched their production lines to the production of breathing masks, including Foxconn and SAIC - GM - Wuling Automobile. Companies elsewhere - such as the Japanese television manufacturer Sharp and the German mattress manufacturer Breckle - switched part of their production lines to breathing masks. In February Coccato & Mezzetti in Galliate , Italy, restarted this production line 15 years after the end of breathing mask production due to competition from China. In Taiwan, several companies set up new production lines, increasing daily production from 3.2 million pieces per day to 10 million pieces per day.

Many companies in Germany, Austria and Switzerland also switched to the manufacture of respiratory masks, including producers in the textile and clothing industry . Bavaria's Minister of Economic Affairs, Hubert Aiwanger , announced that the technical aid organization would deliver nonwovens and sample masks for the manufacture of masks by sewing companies to districts and urban districts. Fielmann , whose focus is otherwise on optics, started developing and producing protective glasses for doctors and specialist staff and announced that it would donate the first 20,000 to hospitals and medical institutions. Numerous initiatives for the in-house production of makeshift protective masks are also starting in Bavaria .

The Pandemic Supply Chain Network (PSCN), which was set up in 2017 based on the experience of the Ebola outbreak in West Africa in 2014 , was involved in consultations to bring breathing masks, protective suits and other protective equipment to where they are needed. In view of the bottlenecks that are hindering the work of medical staff, some of the companies contacted by the PSCN announced that they would now only sell breathing masks to medical staff.

In April 2020, David Nabarro, WHO special envoy for the COVID-19 pandemic, spoke of a clear prioritization in view of the lack of protective masks: They should be “primarily for medical staff, and secondarily for people with COVID-19 symptoms and their relatives, in the third line for people who work in close contact with other people, such as cashiers and hairdressers ”. Other forms of face protection should be considered for the general population.

In Europe, not only are there a lack of ready-made protective masks, the raw materials required for production are also “sold out for months or overpriced”. Media reports of “wild west” conditions in the breathing mask trade, including inflated prices, short sales, shortage of goods, confiscations and short-term diversions of ordered deliveries.

Breathing apparatus

In Italy, 25 members of the military were deployed to support a breathing apparatus manufacturer. In several countries, automotive and medical technology manufacturers are cooperating to counter bottlenecks.

In emergency situations, doctors and developers created a wide variety of in-house developments to remedy the shortage of breathing apparatus and their spare parts. Massimo Temporelli (Fablab Milan), together with Cristian Fracassi and Michele Faini, made 3D images of the plight of a hospital in Chiari , whose supply of valves for a breathing device was running low and could not be replenished by the manufacturer in time by the journalist Nunzia Vallini -Pressure matching valves. They justified this redevelopment despite the manufacturer's non- consent and the lack of certification with the lack of availability of the urgently needed spare parts.

A group around the anesthesia professor Marco Ranieri invented a conversion of breathing devices, which makes it possible to supply two intensive care patients from one breathing device ( double ventilation device ). A prototype was deployed in the Sant'Orsola hospital in Bologna . The former chief doctor Renato Favero developed with a company in Brescia a method snorkel masks based on additional in 3D printers transform-made parts in masks for breathing apparatus.

In the wake of the pandemic, several open source projects for the manufacture of simple ventilators have been emerging since spring 2020 .

Laboratory tests

Media reported that laboratory testing capacity in Europe has increased. Doctors sometimes reported bottlenecks, for example with swab tubes or with an enzyme from a test used by the Berlin Charité. In early March, the media reported delays in evaluating tests in Germany. The expansion of the test capacities was limited by delivery difficulties and material bottlenecks. (See also: COVID-19 pandemic in Germany # test capacities and proportion of positive results .)

In mid-May 2020 there was virtually no shortage of tests in Germany: only around a third of the test capacities in Germany, which in May amounted to almost a million tests per week, were used.

drug

The US pharmaceutical company Baxter informed its German customers that it had to report a supply bottleneck for propofol and isoflurane to the Federal Institute for Drugs and Medical Devices (BfArM) . Occasionally, German hospital pharmacies also complained about running out of supplies of the anesthetics propofol and isoflurane, but also of the pain reliever sufentanil and the sedative midazolam .

Legal regulations

EU regulation

In the European Union, the manufacture of respiratory masks is regulated by the PPE Regulation (EU) 2016/425 (PPE Regulation) . The CE marking of respiratory masks certifies that the mask in question complies with EU Regulation 2016/425 of March 9, 2016.

In Germany, the PSA Implementation Act (PSA-DG) was passed to implement this regulation.

Change in legal regulations during the pandemic

Due to the shortage of respiratory masks, on March 13, 2020, the European Commission opened up the possibility for member states to purchase respiratory masks without CE marking for the duration of this pandemic, provided the masks guarantee an adequate level of health and safety. Due to the health threat posed by the corona pandemic, the Federal Institute for Occupational Safety and Health (BAuA) allowed medical and nursing professionals to use masks that do not have a CE mark but which comply with the NIOSH standard N95. A quick test has been developed for other masks; This respiratory protection is "intended as a last reserve for systemically important persons in the health service and should only be used if no other approved respiratory protection masks are available". The Federal Institute for Drugs and Medical Devices grants special approvals for Germany at short notice.

In Germany, the Federal Ministry of Health was authorized, on the basis of the Infection Protection Act (§ 5 IfSG nF), “by ordinance without the consent of the Federal Council to take measures to ensure the supply of pharmaceuticals including narcotics, the active ingredients, starting materials and auxiliary materials for them, with medical products, laboratory diagnostics , Tools, as well as items of personal protective equipment and products for disinfection ”. This also expressly includes "measures to maintain, convert, open or close production facilities or individual operating facilities of companies that produce such products as well as provide regulations on appropriate compensation for them". It is also authorized to order that an invention of certain products should be used in the interests of public welfare or in the interests of federal security. The relevant patents then have no exclusive effect; the owners are entitled to “appropriate remuneration” from the federal government (Section 5 IfSG new version in conjunction with Section 13 PatG).

The Bavarian Infection Protection Act authorizes the competent authority "to order the priority and immediate production of a certain amount of this material in relation to companies that are technically and economically capable of producing the medical, nursing or sanitary material required for the production, insofar as this is necessary to maintain the necessary health care Population is required ”. In this case, the state guarantees full acceptance of the material produced.

In the United States , US President Donald Trump committed on the basis of the Defense Production Act of 1950 , the company General Motors to produce at March 27, 2020 breathing apparatus, and undertook 3M on 2 April 2020 to cut to make face masks. As of April 10, 2020, the export of breathing masks and certain other protective equipment is only permitted if it has been approved by the Federal Emergency Management Agency .

In Germany, under the leadership of Economics Minister Peter Altmaier , it was enforced by May 2020 that the production of medical protective clothing would be brought back to Germany. The legal requirements for this were created with the new law for the protection of the population in an epidemic situation of national scope in Germany.

Bottlenecks in other health-related areas

The German Federal Health Minister Jens Spahn warned of drug shortages in Europe due to production stops in China. He called for a review of the company's dependency on China for drug production and for changes to the EU competition rules to be initiated so that certain active ingredients could be manufactured in Europe again.

Faced with a shortage of disinfectants , pharmacies began to make them in-house. Some liquor manufacturers switched to the production of disinfectants.

In March 2020 there were massive bottlenecks in intensive therapy places, for example in some regions of Italy and France . Hospitals in Germany then accepted intensive care patients from Italy and France.

In order to create hospital capacity, u. a. military hospitals are also being prepared to accept COVID-19 patients. In Germany, for example, they are primarily intended to support soldiers, but civilian support should also be offered if necessary. According to statistics from the World Health Organization, the number of places in intensive care units has decreased significantly over the past 25 years.

politics

Germany

The media and politicians in Germany warned of companies trying to take advantage of the plight of clinics. Often goods are offered at exorbitant prices, ordered goods are not delivered or are of poor quality, certificates are forged. Olaf Berse, managing director of the Clinicpartner purchasing group, spoke of a risk to the clinic staff who believe they are protected. Buyers called on the federal government to provide Bundeswehr aircraft with which the ordered goods could be flown in from China. Distribution to clinics and medical practices is also not guaranteed.

The federal government provided three billion euros for the procurement of protective clothing, ventilators and other goods. The Federal Minister of Health Spahn plans an open-house procedure for the procurement of masks and smocks . The physician and politician Karl Lauterbach criticized that an open-house procedure would not work if - as in the current situation - there was a market failure . He called for the creation of a federal agency that should commission companies in Germany with production.

The author and management consultant Fredmund Malik said of the respiratory protection mask that it was "a relatively banal product, but which in this country cannot be manufactured economically due to the high wage costs". Therefore, state regulation and state funds are necessary for this in the sense of precaution.

In Baden-Württemberg, the regional company for the topics of bioeconomy and biotechnology, pharmaceutical industry and medical technology (BIOPRO Baden-Württemberg GmbH) set up a central point of contact in order to receive, bundle and evaluate support offers. It concerns all support offers for the procurement and coordination of medical technology, protective equipment; It particularly addresses actors from the fields of biotechnology and life sciences.

As the media noted, the procurement of respiratory masks at the end of April had been "for weeks one of the main tasks of the federal government to contain the corona pandemic". In view of the supply bottlenecks, the German government's crisis management team proposed on March 31, 2010 a procedure for reprocessing respiratory masks using 30 minutes of dry heat at 65–70 ° C. On April 28, it became known that the Federal Institute for Drugs and Medical Devices (BfArM) had stated in an internal letter on April 24 that this previously used processing method was not sufficient "to achieve a complete inactivation of infectious virus particles on the incubated masks" . After further testing, a 90-minute thermal decontamination at 90 ° C may be recommended instead. (For the disinfection of everyday masks by washing them at at least 60 ° C, see Everyday mask # Preparation for reuse .)

US reports on China

In early May 2020, international media reported that a secret report by the United States Department of Homeland Security dated May 1, 2020 suggested that China withheld information about the coronavirus in order to buy medical equipment from abroad. Chinese media condemned the allegations.

See also

Web links

Individual evidence

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