Frequently Asked Questions (FAQs)
1. Why are single procedure sachets and kits becoming so popular? Single use or disposable kits and products are not new to the medical market. Disposable products have been in use for over three decades. The advantages are many including lower cost, easier to store, reduced life cycle management, major reduction in hospital acquired infection (HAI) and more efficiency gains in hospital operations including operating room productivity. Early healthcare adoption was limited to IV and blood bags, disposable swabs, needles and the like. Today, with global initiatives to drive out unneeded costs and increase healthcare efficiency the focus is on broader use of single-use and disposable products and procedural kits where it makes sense. New technologies have given rise to high quality, superior performance products now available at a fraction of the cost of traditional reusable devices. The switch to disposable products is now taking hold globally.
2. What materials are used for manufacture of disposable ?
Single-procedure or disposables are made of medical grade plastic and non woven fabrci and woven gauge.
Material strength is outstanding and tested well beyond operating specifications. Companies are GMP certified and for other details check company websites.
3. Do you have over-molding capabilities? Yes. companies have a wide range of plastic handles and over mold options and ergonomic designs tailored to our customers' specifications.
4. What are the primary medical applications of single procedure products?
Disposable or single-use products and kits are used in a wide range of medical procedures and applications.
5. Are they as accurate as reusable instruments?
Yes. And most likely more accurate. Reusable devices may easily fall out of calibration after several uses and most are said to be used for up to six months or a year before they are returned to the medical device OEM or vendor for calibration. Single procedure products are finsihed to specifications and are guaranteed to perform as per spec.
6. What are the primary reasons OEMs, doctors and hospitals are switching or have switched to disposable?
It is a brand new, sterile, fully calibrated, for every procedure. Risk mitigation is achieved. Market has embraced the technology as result of cost reduction demands by hospitals and healthcare reimbursement agencies and insurance companies. OEMs are also concerned about the increased cost and risk of traditional reusable instruments in general. Hospitals are especially concerned about what is termed uncontrolled reprocessing of reusable instruments. Huge upfront cost, spiraling life cycle cost, lack of consistent torque accuracy, greater risk of infection due to poor cleaning and multiple autoclave cycles, the growing carbon footprint and hospital inefficiencies make reusable torque devices and instruments antiquated and unsustainable in the reimbursement model. The primary and sustaining value of single-procedure devices is simple: high performance, top quality and cost saving torque solutions that drive out costs and increase operating room efficiency and productivity.
7. What are the estimated cost savings realized by using single procedure vs. reusable instruments and kits? Estimates suggest a savings of more than 20% with every implant procedure by switching to disposable surgical torque limiting instruments. If you consider the reduction in life cycle cost, greater inventory turns and also the increase in operating room and hospital personnel productivity the gains could be 2X to 3X that amount annually.
8. Do you offer standard kits? Yes we offer a standard family of instruments and kits that may be private labeled and purchased by OEMs and distributor partners for resale to their hospital, ASC and other healthcare end user customers.
9. Can customers modify or customize products and kits for specific applications?
Yes. They may be modified as semi-custom units or completely customized to meet customer requirements.
10. Can these disposable kits be sterilized? What types of sterilization? ECA kits are EtO and Gamma compatible and individual instruments are EtO, Gamma and Autoclave compatible.
11. What is the sterilized shelf-life of a single-procedure instrument? It varies depending on design and application. Standard shelf life is 4-5 years and is marked on every sterile product.
12. Is the US FDA a supporter of single-procedure or disposable technologies? Yes. While the FDA has not and is not expected to provide formal industry guidance it is a backer of disposable technologies. The agency's support of disposable technologies for healthcare and biopharma applications has been stated by numerous FDA officials in Washington DC. Single procedure products, primarily made of plastic materials, reduce risk of cross contamination, reduce hospital acquired infections (HAI), and reduce the need for cleaning and sterilization systems and validation. In addition, disposable products can be recycled and cut the carbon footprint created by the transportation and logistics costs associated with life cycle management of reusable devices.
13. What kinds of packaging options are available? We offer a complete range of packaging configurations for our customers. We will take and create a specification using your packaging requirements or help you design a winning solution including double barrier bags and pouches, PETG and Styrene trays and pouches, Tyvek and Polymer films, sterilization, labeling, drop test and high shelf life and ruggedized configurations and more.
14. Can you use disposable instruments or kits more than once? No. This insures the surgeon has a brand new precisely calibrated and sterile torque instrument for each patient and procedure. They are designed for a single- procedure and then disposed of as medical waste or for recycle. Multiple uses of the instruments or kits are not the intended purpose and violate the product warranty.
15. What is the fastest way to get a sample of a custom Disposable ?
Contact Abstract sales and product development team who will work with you to create a solution for your medical implant product or application or email at firstname.lastname@example.org.