Clinical Laboratory Equipment Manufacturer Policies on Highly Hazardous Communicable Diseases

The 2014-2016 outbreak of Ebola virus disease (EVD) in West Africa prompted a shift in how US institutions and agencies respond to cases of highly hazardous communicable diseases (HHCDs). Private and public institutions developed novel procedures or amended existing procedures for the identification, isolation, and diagnostic testing of patients with potential exposure to EVD or other HHCDs. In the United States, a network of specialized facilities was established to provide the comprehensive care demanded by EVD and other HHCDs; 3 of these facilities treated EVD patients and published best practice recommendations for HHCD care, including specifications for laboratory testing in the isolation unit or facility.^1-5 The Centers for Disease Control and Prevention (CDC) also issued guidance on EVD specimen testing.⁶

Although only 11 patients with confirmed EVD were treated in the United States during the 2014-2016 EVD outbreak in West Africa (including only 4 cases diagnosed in the United States), domestic clinical laboratories played a central role in the response to the EVD outbreak. This role included rapid and reliable testing of suspected patients held in isolation. For the 11 patients with confirmed EVD, clinical laboratory testing provided vital information for patient management.⁷ However, fears of contact with potentially positive Ebola virus specimens among health care workers and laboratory workers handling the specimens delayed diagnostic assessments in several cases of suspected EVD in late 2014.⁸

Testing HHCD specimens in laboratories may involve the use of many analyzers and laboratory instruments. In response to the need to care for EVD patients in the United States, clinical laboratory equipment manufacturers and state, federal, and international agencies provided guidance and recommendations on the use of laboratory instruments for specimens that might contain viable Ebola virus, but these recommendations sometimes conflicted with each other.^5,9,10 Information on this subject provided by clinical laboratory equipment manufacturers created further uncertainties. For example, manufacturers were unable to guarantee the effectiveness of certain decontamination procedures used for their products. Some equipment manufacturers announced that use of their equipment for Ebola virus testing would void warranties and/or service contracts and might result in a restriction of technical support from the company.^11,12 Despite opposition to these policies from hospital officials, federal agencies, and even a chief executive officer of one of these clinical laboratory equipment manufacturers, many manufacturers discontinued servicing equipment used to test specimens from EVD patients and recommended quarantine or incineration of the equipment.¹¹ But many of these testing machines cost thousands of dollars to replace, and disposing of the equipment after potential exposure to Ebola virus would be extremely costly and would disregard scientific evidence. As such, some facilities decreased the range of testing for patients with possible EVD to avoid having to dispose of expensive equipment, thereby jeopardizing patient care.

Although domestic clinical laboratory equipment manufacturers’ policies developed and evolved throughout the EVD outbreak as initial fears and misinformation subsided, information is still not publicly available on company policies on testing specimens from patients who might have EVD or another HHCD. The 2018-2019 outbreak of EVD in the Democratic Republic of Congo—recently declared the second-largest EVD outbreak in history—reinforces the importance of identifying these policies before another HHCD threat occurs in the United States. To help clarify the current state of these policies, we sought to gather information from companies that manufacture and service clinical laboratory equipment about their policies related to equipment used on samples from patients with confirmed HHCDs. This commentary describes those policies and details the need for these manufacturers to develop additional guidance and ensure accessibility of that guidance to all laboratory customers.

Exploring Current Policies of Clinical Laboratory Equipment Manufacturers

We, the authors, were on a team that managed 3 cases of EVD in 2014; in the past 5 years, we have provided advice on best practices to other clinical laboratories that are preparing to test patients with HHCDs. As part of this advice, in 2017, we began a search of current laboratory equipment manufacturers’ policies and procedures for testing such specimens. We retrieved contact information for 9 companies that manufacture clinical laboratory equipment or devices from listings on the manufacturers’ websites. These 9 companies were selected based on a list of devices used by 2 US high-level isolation units in the care of patients with EVD in 201 4¹³; however, they represent only a small sample of the hundreds of companies that manufacture laboratory equipment and devices. We contacted customer service and/or technical support representatives via email if listed (n = 8) and/or through submissions of online inquiries when possible (n = 5). In the emails, we included a list of 19 highly hazardous pathogens (Figure), and we queried each of the 9 companies on whether the use of their equipment (ie, manufactured and serviced by them) to test a specimen containing one of the listed pathogens would void the warranty or result in cancellation of service contracts. We provided a form where the companies could describe their policy, or attach their written policy, for each listed pathogen. In addition, although telephone numbers were relatively easy to find online for the surveyed companies, our attempt to telephone the companies at initial contact resulted in telephone calls being automatically directed to a voicemail. At that point, a decision was made to gather information specifically using electronic methods. This inquiry was considered nonhuman subjects research by the Indiana University Institutional Review Board (IRB); as such, IRB approval was not required.

Figure.

Table of pathogens sent to laboratory manufacturers to identify their procedures and policies for using equipment on a patient with the listed highly hazardous pathogens, United States, December 2017.

We used multiple contact methods to reach the companies, and we received various responses from each company and for each contact method (Table). Four companies (A, B, C, and D) responded with details of their HHCD testing policies on warranties and service contracts; 3 of these companies (A, B, and C) reported that they developed and disseminated documents that explained their EVD policies to their customers during the 2014-2016 EVD outbreak. The other 5 companies that were contacted did not respond.

Table.

Methods used to contact clinical laboratory equipment manufacturers and their procedures and policies for using equipment on a patient with a highly hazardous pathogen, United States, December 2017

Company	Contact Methoda,b (Division)	Response(s)
A	Online (sales)c	None of the pathogens would void the warranty.
	Online (marketing)c	None of the pathogens would void the warranty or cancel a service contract. Decontamination instructions have been developed for company engineers and customers.
	Email (customer care)	Undeliverable
B	Email (representative)d	Ebola virus disease policies had been developed, but the representative asked to be unsubscribed from “contact list” with no additional response (ie, representative thought it was a soliciting email).
	Email (communications)	No response
	Online (sales)	Forwarded to marketing and regulatory teams. Offers training in lieu of a 1-year warranty and parts supplied for service at no additional cost for this warranty period.
C	Online (sales)	No response
	Online (warranty)	No response
	Email (technical support)	Documentation sent to customers who might handle Ebola virus.e
D	Email (sales)	No response
	Email (technical support)	Forwarded to another department. Warranty claims are on a case-by-case basis. Requires a decontamination label (company supplied) when shipping an instrument for service.
E	Email (technical support)	Undeliverable; no online inquiry available; as such, company was electronically unreachable.
F	Email (technical support)	No response
G	Online (not identified)	No response
	Email (customer service)	Generic response that the “message has been received and will be addressed in a timely manner.” No additional response received.
H	Email (customer service)	No response
I	Online (not identified)	Instructed to send email to a different contact and provide contact information. No additional response received.

^aEmail contacts were publicly available or company directed after an inquiry.

^bOnline contacts were publicly available.

^cOriginal inquiry was to the diagnostics division, which was forwarded to marketing and sales.

^dThe representative was identified as the company’s contact for information on Ebola virus disease policies.

^eEbola-specific standard operating procedures for the return of analyzers for repair, recertification, or replacement that were used in facilities that test patients with suspected or confirmed Ebola virus disease.

Implications of Manufacturer Responses and Nonresponses

An important discussion has been taking place in the clinical laboratory arena since the 2014-2016 EVD outbreak about policies concerning the use of laboratory equipment for specimens that might contain HHCD pathogens. This discussion may help laboratories prepare for the next HHCD threat. The responses and nonresponses of these companies, as well as the reasoning behind our initial inquiry (ie, unavailability of publicly accessible policies and manufacturer policies that historically contradicted scientific evidence, CDC guidelines on safe decontamination of laboratory devices, and written customer warranties), are key points for this discussion.^5,11

We found that identifying electronic contact information for a representative from the surveyed companies’ warranty or sales department was a challenge. Two companies (A and E) had undeliverable email addresses (ie, an automatic “undeliverable” email response was immediately received), and 4 companies (F, G, H, and I) did not respond to the email. Information on whom to contact for warranty claims or decontamination questions was also not readily available or easy to locate on any company website. We think that this difficulty in contacting company representatives could pose a hurdle for clinicians and laboratorians who wish to obtain accurate information during a national emergency. In the event of a large-scale HHCD incident, readily available, clear, and consistent testing and decontamination procedures from device manufacturers would prevent the confusion, misinformation, and restrictive recommendations that occurred during the 2014-2016 EVD outbreak. Difficulty or delays in obtaining this information could result in reluctance by clinical laboratories to complete the testing needed to provide appropriate clinical laboratory support for potentially infected patients.

One of the 4 responding companies (C) had developed extensive operating procedures for the decontamination of Ebola virus–exposed devices; however, this company did not provide written procedures for the use of its equipment on any of the other 18 listed pathogens included in the correspondence. The other 3 responding companies (A, B, and D) stated that they would manage all other listed pathogens in the same way as Ebola virus. However, previous studies have found that these pathogens differ in their responses to disinfecting agents.^14,15 Preparation for a wide range of possible HHCD pathogens is important for the overall effectiveness of a response framework.¹⁶ This preparation includes developing decontamination procedures and recommendations for various pathogens and routes of transmission to reduce the possibility of inconsistent or unclear testing procedures, especially during an outbreak.

Moreover, although none of the 4 responding manufacturers reported that merely testing a specimen containing Ebola virus would void a warranty, 1 company (B) did offer a biomedical engineer training program in lieu of the warranty, which included training a person employed by the customer on how to repair the instrument, and supplying parts for service at no additional cost for the first year. A clinical laboratory is likely to use several instruments to test samples from a single patient. As such, varying warranty and decontamination policies by various manufacturers represent a distinct operational strain for laboratorians that may negatively affect a laboratory’s efficiency. This problem is compounded when the information from manufacturers is unclear or difficult to obtain.

One manufacturer (D) reported that decontamination of devices after Ebola virus exposure via ethylene oxide gas could cause damage to the device that would not be covered by the warranty. Notably, this exclusion was recognized and disclosed by the manufacturer contact during our communications, and the exclusion was clearly stated in warranty materials. However, because ethylene oxide gas has become the decontamination method of choice for most medical devices,^17,18 this statement raises concerns about the clarity of information being exchanged between clinical laboratories and device manufacturers, and whether the laboratories are aware of which decontamination methods are acceptable for Ebola virus and other pathogens. This ambiguity further underscores the need for improved clarity and expanded dissemination of manufacturer-approved decontamination methods.

During the 2014-2016 EVD outbreak, informal interactions between laboratorians and vendors created an atmosphere of confusion and misinformation as word-of-mouth guidance from sales representatives to laboratories frequently changed throughout the outbreak.¹¹ Despite no written, legal, or scientific justification for the destruction of equipment or for claims that conducting a diagnostic test for a patient with EVD would void the equipment’s warranty, many facilities nevertheless minimized testing specimens that may have been positive for Ebola virus,⁸ thereby endangering patient care. Without accessible and written information, this area will continue to be a source of confusion that will negatively affect hospitals’ ability to safely treat HHCD patients and provide them with the full range of available diagnostic care during the next HHCD outbreak.

Looking Toward the Future: Broadening Manufacturer Policies

The retraction of services and support by laboratory equipment manufacturers in 2014-2016 placed substantial pressure on US laboratories to minimize testing on potentially positive Ebola virus specimens or to dispose of and purchase additional expensive equipment. The companies also negated written contracts between the customer (ie, laboratory or facility) and manufacturer that previously had no caveat for retraction of services because of testing a specimen. It is unclear how the courts would rule on a lawsuit about the legality of retracting repair services from, or imposing a penalty on, laboratories.

The clinical laboratory equipment described in this commentary represents a high capital investment by laboratories (ie, some point-of-care devices cost $10 000-$20 000). Warranty and service agreements that guarantee manufacturers will repair, maintain, or replace devices ensure that laboratories can provide optimal laboratory support to all patients in their facilities rather than compromise support by limiting the use of equipment for specimens from a small number of patients with EVD or another HHCD because of the manufacturer’s refusal to service (eg, refusal to repair a device used to test specimens from a patient under investigation for EVD). In addition, the dissemination of unclear or contradicting information on how to properly decontaminate devices used for HHCD testing may further disincentivize clinical laboratories from testing these samples (eg, EVD-specific protocols for one company, while others would use the same policy for any HHCD pathogen, or voiding a warranty if ethylene oxide, the method of choice for decontaminating devices, is used). Reducing the number of laboratories that are willing to provide such clinical laboratory support impedes the ability of the nation’s health care system to respond effectively and efficiently to an HHCD outbreak. Clearly communicated testing and decontamination procedures can allow clinical laboratories to prepare for specimens that contain one of the listed pathogens.

During the 2014-2016 EVD response, CDC, the US Department of Defense, and the Association of Public Health Laboratories used the federal Laboratory Response Network (LRN) to facilitate enhanced domestic diagnostic capacity to test specimens potentially containing Ebola virus.¹² The growth of the LRN expanded the number of US laboratories capable of testing potential Ebola virus specimens, thereby reducing turnaround times for results and expanding domestic preparedness for HHCD outbreaks. However, the success of the network was contingent upon laboratories ensuring continuity of services. Maintained, serviced, and repaired clinical laboratory equipment is vital to sustained and optimal laboratory support. Clinical laboratory equipment manufacturers, therefore, play a vital role in sustaining the laboratory capabilities established in response to the 2014-2016 EVD outbreak. Collaboration among LRN members, researchers, and manufacturers to develop standardized, evidence-based policies for laboratory device decontamination may be beneficial. This collaboration could help prepare US laboratories for the next HHCD outbreak.

The data reported and information described herein began as exploratory information gathering; therefore, we included only a small number of companies and responses. However, despite the small number of companies, the difficulty that we had in contacting the companies was informative. During a national emergency, hospitals and laboratories might have difficulty contacting them. It is also important to note that no alternative means of communication were used for nonrespondents outside of initial telephone attempts that were automatically directed to a voicemail and direct emails and/or direct submission to online inquiries (eg, voicemails, mail). Because many companies that manufacture and/or service analyzers were not affected by the EVD outbreak and were not included in this sample, future inquiries should examine a wider range of manufacturers that produce diagnostic products that may be used in testing during future HHCD events. This examination could yield more comprehensive data on company policies in this type of testing.

Large-scale international or domestic HHCD outbreaks can occur at any time, for example, the current (as of March 2019) EVD outbreak in the Democratic Republic of Congo. An urgent need exists for laboratory manufacturers to review current policies on the use of their devices for HHCD testing. During this review, companies should consider developing standard protocols for testing HHCD specimens and decontaminating equipment. We recommend that warranty information and contact information of company representatives be made electronically available and readily accessible in the public domain. The 2014-2016 EVD outbreak and the emergence and reemergence of HHCDs highlight the need for laboratory equipment manufacturers to consider these pathogens when assessing the safety of their equipment. On a broader level, the development of enhanced biosafety practices has challenged manufacturers to review their equipment to minimize exposure risks that could occur during the testing of infectious pathogens.