Exploring manufacturers’ policies

Thirteen major manufacturers of CLE (labeled Company A-M) used for testing suspected or confirmed HCP specimens were contacted. Nine of these companies were contacted previously ^{Reference Herstein, Buehler, Le, Lowe, Iwen and Gibbs4} ; four manufacturers were added due to company mergers/acquisitions. In Spring 2023, a standardized email and phone script was used (Supplemental Material, Appendix A) to contact manufactures regarding current HCP policies/guidance on warranties, decontamination, and CLE re-use. Of the current 13 companies, only three responded (23%). Figure 1 summarizes our timeline and challenges contacting CLE manufacturers.

Figure 1. Contact timeline and outcomes for contacting CLE manufacturers.

Twenty-six online inquiries were submitted to the companies with online portals. Only Company C responded (response rate [RR] = 7.7%). Despite follow-ups, Company C’s initial response was their only contact; no information on policies or recommendations were obtained from any company via online inquiry.

Despite multiple attempts, 40 emails (initial and follow-up) resulted in three responses (RR = 7.5%) (Figure 1). Company F’s customer service agent referred us to a sales agent who stated there were no contract restrictions for any type of pathogen but did not provide the requested recommendations or policies. A Company H representative stated that they do not provide regulatory or safety guidance to institutions that purchase their products. A Company K representative stated that they cannot comment on specific microorganisms beyond what was tested and published in their Instructions for Use (IFU) (of 11 tested pathogens included, only one was on our HCP list) and could not provide information regarding extrapolation to other pathogens (Supplemental Material, Appendix B). ⁸ Only 10 (77%) manufacturers had a functional telephone number; none responded.

The limited engagement that persists five years after our initial study is concerning and affirms clinical laboratories’ concerns. Literature on this topic remains scarce with only two additional studies addressing the topic of manufacturers’ policies for CLE use for HCP. ^{Reference Pentella9,Reference Cornish, Anderson and Arambula10} Both studies emphasized the importance of the clinical laboratory’s ability to respond to an unknown pathogen quickly, effectively, and safely; however, lack of support from manufacturers could result in poor outcomes that could be avoided with prompt communication and assistance. ^{Reference Pentella9,Reference Cornish, Anderson and Arambula10}

Given the continued lack of HCP-related guidance from manufacturers post-purchase, we recommend laboratories ask HCP-related questions, document responses, and make response receipt a condition of purchase. Clinical laboratories and healthcare settings must have easy—preferably online—access to manufacturers for prompt responses to questions regarding warranties, contracts, and decontamination policies. Ideally, these would be in the IFU. The challenge of identifying appropriate manufacturer contacts and the absence of response to inquiries have negative implications during outbreaks. Previous manufacturer recommendations to dispose of CLE used for HCP ^{Reference Budryk3} may result in clinical laboratories electing to limit or avoid CLE usage to test patient specimens with potential HCP. Reduction in CLE use can delay or adversely affect the quality of patient care. To optimize patient care, clinical laboratories require support, rapid communication, and clear guidance from CLE manufacturers. It is equally important to ensure manufacturer guidance conforms with scientific evidence and protocols deemed safe and effective by federal and international agencies. We recommend regulatory agencies address these issues, including the timeliness of response to information requests, the availability and monitoring of contact portals, and online availability of existing information. In conclusion, our findings underscore how nonresponse is informative but alarming; this continued dearth of information is detrimental to patient management and public health.