Viewpoint
Table 1 Manufacturing problems as causes of supply chain disruptions Risks to manufacture Non-medical examples
Medical examples
► ► Earthquake and tsunami in Japan, and flooding in Thailand, disrupts automotive and electronics industries in 2011 35
► ► Acute sterile saline shortage after hurricane damage to manufacturing plants, 2017 7 ► ► Risk of medical gloves shortage due to COVID-19 lockdown in Malaysia, the home of ~65% of the global supply 36 ► ► Critical shortage of propofol (2009–2010) as two of three suppliers left US market 38 ► ► Shortages of nine childhood vaccines, 2000–2005, due to problems with the limited numbers of suppliers 39 ► ► Disruptions in supply of raw or bulk materials responsible for drug shortages 33 ► ► Lack of meltblown, non-woven polypropylene for the production of surgical masks and N95 respirators 41
Geographically concentrated manufacturing : Production concentrated in one or few locations, such that a localised disruptive event (natural or political) risks major disruption to product manufacturing 13 Limited numbers of manufacturers : Few manufacturers, such that events affecting a single firm (eg, disruptions or decisions) risks major disruption to product manufacturing 17 Scarcity of critical inputs : Resource inputs or parts whose scarcity risks major disruption due to non-substitutability of resources 14 or tightly-coupled production arrangements (just-in-time, short-cycle manufacturing) 17
► ► Fire at Philip’s semiconductor plant in 2000 disrupts Ericson’s sole-source of chips for mobile phone production 37
► ► Multiyear delays in production of Boeing Dreamliner due to shortage of aerospace fasteners 40
industries to illustrate key vulnerabilities. As well, we offer examples of how these vulnerabilities have been exposed by the COVID-19 crisis. We consider some of the reactive adaptations forced on clinicians and administrators, most notably by PPE shortages, and identify several common failures of pandemic planning. Because the vulnerability of medical product supply long pre-dates the pandemic, we also highlight the need for remedies that extend beyond pandemic response capacity—including from bold experimen- tation at the front line and by governments. Such reforms are contested and their prospects uncertain— no problem of this nature is amenable to easy solu- tions. Yet successfully addressing any quality problem begins with understanding its contributing factors. Thus, while we identify some promising reform direc- tions, our main goal lies in outlining current knowl- edge about the factors contributing to supply chain disruptions and highlighting the need for broad and sustained engagement with the challenge of resilient medical product supply.
Understanding supply chain vulnerability for medical products Quite a bit is known about what makes complex, contemporary global supply chains so vulnerable. Because no single, widely used framework for charac- terising supply chain vulnerabilities exists, particularly from the perspective of the supply user, we discuss examples in two broad categories—threats to product manufacture (table 1) and threats to local availability (table 2). Manufacturing problems as risks to product supply chains The consumers of medical—or other—products are often unaware of vulnerabilities in supply until short- ages occur—when manufacture of the product has ceased or no longer occurs in sufficient quantities (table 1). Either event can occur when production is concentrated among few firms, which may elect to exit the market, or in few places, such that political or geophysical events disrupting local manufacture have global consequences. 11 For example, severe flooding in
Table 2 Transportation, regulation and supply chain management as threats to product availability Risks to availability Non-medical examples
Medical examples
► ► Oil tanker stuck in Suez Canal blocked ships carrying PlayStation II to consumers for 2004 Christmas season 42 ► ► Intentional contamination of milk with melamine identified in 2008, leading to health harms and food recalls 43
► ► Export bans, authorisations and related restrictions on critical supplies 19 ► ► Grounding of commercial flights challenge global freight movement 19 ► ► Heparin recall in 2008 after deaths and adverse events due to manufacturing plant adulteration 44 ► ► Multiple recalls of medicines containing valsartan in 2018 due to contamination risk 45 ► ► Risks from single vendor contracts (eg, Sprint Fidelis defibrillator lead recall of 2007 47 ) ► ► Poor contract management leading to drug shortages 48
Restrictions on the mobility of goods from the place of production to the place of consumption due to limitations on cross-border flows or transportation impedances 17 Restrictions on quality and availability in specific markets due to regulatory compliance failures : Relevant to industries regulated for public or consumer safety, for example, medical products, aviation, automotive, telecommunication 18
► ► Retail sourcing emphasis on large-scale producers lead to severe vegetable shortages in Europe, winter 2016–2017 46
Short-termism in sourcing activities : Sourcing activities that do not prioritise long-term supply reliability (eg, focus on upfront costs, sole sourcing, poor contract management) 8
332
Miller FA, et al . BMJ Qual Saf 2021; 30 :331–335. doi:10.1136/bmjqs-2020-012133
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