Market Challenges And Opportunities

AERs replace few manual steps involved in endoscope reprocessing.

Increasing adoption of endoscope reprocessors in healthcare settings to augment the market growth

Increasing adoption rate of endoscope reprocessors in hospitals for infection prevention and control is expected to fuel the global automated endoscopy reprocessor market revenue. AERs can enhance reliability and consistency of endoscope reprocessing by standardizing several important reprocessing steps, thereby reducing the possibility of human error. The use of AERs reduces exposure of personnel to harmful chemical germicides, thereby minimizing health problems attributed to reprocessing of endoscopes.

Moreover, rising government concerns pertaining to patient safety and increasing healthcare infrastructure are factors contributing to rise in global automated endoscopy reprocessors market size. For instance, in 2015, the Centers for Disease Control and Prevention (CDC) requested the Healthcare Infection Control Practices Advisory Committee (HICPAC) to issue guidelines for improvement of facility-level training to ensure competency for endoscope reprocessing devices.

Increasing focus on product innovation is expected to support growth of the market

Various changes required in AER and endoscope design will facilitate to further reduce the risk of transmission of infections related to endoscopy. The design of flexible GI endoscopes was traditionally focused on enhanced function and performance and not on ease of cleaning and HLD. In some endoscopes such as the duodenoscope, the complex design presents a particular challenge to cleaning and HLD. The FDA has asked AER manufacturers to validate reprocessing instructions, mainly for AERs that reprocess duodenoscopes.

Several product recalls from leading manufacturers requires product upgrade and manufacturing of innovative products. For instance, in 2016, the FDA signed off on Cantel's Medivators (Advantage Plus and DSD Edge) and Steris (System 1E Liquid Chemical Sterilant Processing System) automated endoscope reprocessors that are labeled for use with duodenoscopes. In the same year, the organization also signed off on a new version of a duodenoscope from Olympus.

In addition to this, in November, 2015, the FDA ordered Custom Ultrasonics to recall all of its AERs from health care facilities due to the firm’s violations of the FD&C Act, applicable regulations, and the Consent Decree. Continuous product recalls due to stringent government regulations is expected to adversely affect the market growth, however, the opportunity to manufacture advanced products in harmony with government norms can open opportunities.