New Brunswick, NJ – December 5, 2024 – Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today joined leading surgeons from around the world to initiate a standardized classification system for the global evaluation and reporting of surgical site outcomes (SSOs). Experts from across surgical specialties and healthcare disciplines aim to develop a standardized approach for surgeons and wound care teams to more fully capture the scope and incidence of postoperative complications, enabling improved approaches to prevention.
Wound complications including infections, bleeding, wound reopenings, and fluid collections result in a significant burden for patients and global healthcare systems. Despite the prevalence of these complications in perioperative care, post-operative wound outcomes are underreported, 1,2,3,4 and there is currently no comprehensive global standard for defining and monitoring.
Building on the company’s more than 135 years of leadership in surgery and significant work in reducing surgical site infections (SSIs), Johnson & Johnson MedTech is joining the effort to better define and standardize the evaluation of SSOs and measure the associated outcomes.
“As long-time partners to surgeons and surgical teams around the world, we know firsthand the impact that surgical complications can have on patient outcomes and the overall cost of care globally,” said Nisha Johnson, President, Wound Closure and Healing & Biosurgery, Johnson & Johnson MedTech. “The industry is calling for consistent definitions, standard solutions that improve outcomes, and a comprehensive approach to reporting and data collection that helps advance healing and improve the surgery experience for patients.”
Expanding beyond SSIs: addressing adverse Surgical Site Outcomes
Complications at the surgical wound site occur at higher rates than any other kind of adverse event in hospitalized patients, 5,6 responsible for more than 25% of surgical readmissions.
SSIs are common7, can be dangerous8 and costly9,10,11, and are often the focus of wound complication reporting, accounting for up to 31% of all hospital-acquired infections.12,13 However, SSIs are still underreported, largely due to improper and inconsistent identification methods among health systems.14,15,16 These infections often relate to other post-surgical wound complications including wound breakdown, fluid accumulation, and localized bleeding.
“When most people think about wounds, they think about surgical site infections, but wounds can dehisce, seromas can form, and hematomas can appear. All of these things need to be brought together in a common language so that we can describe the surgical site outcome for every single operation that includes every single type of surgical incision,” said Giles Bond-Smith*, MD, MBBS BSc, FRCS, a general surgeon at NHS Oxford Trust. “I am thrilled to come together with other experts in the field, from around the world, to advance our common language in surgery with the aim of reducing the occurrence of surgical complications for patients.”
Expanding surveillance beyond only SSIs by including other complications has the potential to support care teams so that wound complications are more consistently captured and reported, putting the focus on visibility into patient conditions and appropriate intervention and treatment.
“Clear definitions are the first step to attempt to classify all types of wound complications so that we can improve reporting to drive earlier intervention,” said Antonia Chen**, MD, MBA, an orthopaedic surgeon specializing in hip and knee replacements. “In orthopaedic surgery, wound complications vary relative to other specialties, with significant focus on closure-related interventions to manage dehiscence. Creating a system that fits across all specialties to address surgical site outcomes throughout the body can drive global consistency in care standards that the industry is missing today.”
Consistent reporting could fuel a data-informed, predictive future of surgical wound care
Digital solutions can help improve surveillance of surgical wound complications. Johnson & Johnson MedTech’s Polyphonic™ digital ecosystem will connect data across world-class surgical technologies, robotics, and surgical software while leveraging the global scale of Johnson & Johnson. Leveraging the Polyphonic™ ecosystem, the company will explore patient monitoring based on new, standard reporting guidelines as determined in SSO classification.
“Digital is a bridge to getting patients more involved in their surgical care,” said Shan Jegatheeswaran, Vice President, Digital, Johnson & Johnson MedTech. “Building on a foundation of standard definitions across the primary contributors to surgical site outcomes, digital solutions connecting surgical teams and patients can be used to encourage more reporting, better wound care management, and increased patient engagement. In the future, these kind of standard classification systems have the potential to enable more personalized models before, during, and after surgery.”
Surgical Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. For over 100 years, we have helped advance surgical care through our innovative portfolio across wound closure, adjunctive hemostats, surgical stapling and instruments, robotics and digital solutions. Together, with clinicians and healthcare experts around the world we are progressing what’s next in surgery to better solve patient needs in metabolic and cardiovascular disease, cancer, and aesthetics and reconstruction.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. Ethicon, Inc., Auris Health, Inc. And Verb Surgical Inc. are Johnson & Johnson companies.
* Dr. Bond-Smith is a paid consultant for Johnson & Johnson MedTech.
** Dr. Chen is a paid consultant for Johnson & Johnson MedTech.
NOTE TO INVESTORS CONCERNING FORWARD-LOOKING STATEMENTS:
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Auris Health, Inc., Verb Surgical Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment.\. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.jnj.com or on request from Johnson & Johnson. None of Ethicon, Inc., Auris Health, Inc., Verb Surgical Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Footnotes
1 Taherpour, N., Mehrabi, Y., Seifi, A. et al. Epidemiologic characteristics of orthopedic surgical site infections and under-reporting estimation of registries using capture-recapture analysis. BMC Infect Dis 21, 3 (2021). https://doi.org/10.1186/s12879-020-05687-z
2 Guest JF, Fuller GW, Griffiths B. Cohort study to characterise surgical site infections after open surgery in the UK’s National Health Service
BMJ Open 2023;13:e076735. doi: 10.1136/bmjopen-2023-076735
3 Russo, P.L. et al. Improving surgical site infection prevention in Asia-Pacific through appropriate surveillance programs: Challenges and recommendation. Infection, Disease & Health, Volume 26, Issue 3, 198 – 207
4 Sandy-Hodgetts, K., Carville, K. and Leslie, G.D. (2015), Determining risk factors for surgical wound dehiscence: a literature review. Int Wound J, 12: 265-275. https://doi.org/10.1111/iwj.12088
5 Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991 Feb 7;324(6):377-84. doi: 10.1056/NEJM199102073240605.
6 Zegers M, de Bruijne MC, de Keizer B, et al. The incidence, root-causes, and outcomes of adverse events in surgical units: implication for potential prevention strategies. Patient Saf Surg. 2011 May 20;5:13. doi: 10.1186/1754-9493-5-13.
7Centers for Disease Control and Prevention, National Healthcare Safety Network, Surgical Site Infection Event (SSI) Jan 2024 Accessed October, 2024 https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf.
8 World Health Organization. WHO Guidelines for Safe Surgery, 2009.
9 de Lissovoy G, Pan F, Patkar A, et al. Surgical Site Infection Incidence and Burden Assessment Using Multi-institutional Real-world Data. Poster presented at International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 14th Annual European Congress; November 5-8, 2011; Madrid, Spain.
10 Thompson KM, Oldenberg WA, Deschamps C, Rupp WC, Smith CD. Chasing zero: The drive to eliminate surgical site infections. Ann Surg. 2011;254:430-437.
11 Anderson DJ, Podgorny K, Berrios-Torres SI, et al. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35(6):605-627.
12 Centers for Disease Control and Prevention, National Healthcare Safety Network, Surgical Site Infection Event (SSI) Jan 2024 Accessed October, 2024
https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pd
13 Gillespie, BM; Harbeck, E; Rattray, M; et al. Worldwide incidence of surgical site infections in general surgical patients: A systematic review and meta-analysis of 488,594 patients. International Journal of Surgery 95():p 106136, November 2021. | DOI: 10.1016/j.ijsu.2021.106136
14 Bordeianou L, Cauley CE, Antonelli D, Bird S, Rattner D, Hutter M, Mahmood S, Schnipper D, Rubin M, Bleday R, Kenney P, Berger D. Truth in Reporting: How Data Capture Methods Obfuscate Actual Surgical Site Infection Rates within a Health Care Network System. Dis Colon Rectum. 2017 Jan;60(1):96-106. doi: 10.1097/DCR.0000000000000715.
15 Richter V, Cohen MJ, Benenson S, Almogy G, Brezis M. Patient Self-Assessment of Surgical Site Infection is Inaccurate. World J Surg. 2017 Aug;41(8):1935-1942. doi: 10.1007/s00268-017-3974-y. PMID: 28271262.
16 Horgan, S., Saab, M.M., Drennan, J., Keane, D. and Hegarty, J., 2023. Healthcare professionals’ knowledge and attitudes of surgical site infection and surveillance: A narrative systematic review. Nurse education in practice, 69, p.103637.
Media Contact:
Lindsey Diaz-MacInnis
ldiazmac@its.jnj.com
Investor Relations:
Tracy Menkowski
Investor-relations@its.jnj.com