When buying Surgical Instruments, Knowledge equals Savings
How to purchase Quality Surgical Instruments at great savings
Everybody knows what it feels like to get a great deal on a purchase. Most of us also knows what it feels like, when we discover that a deal was not that great after all. The cause of that is usually inferior quality of the item purchased, and the problem might have been prevented, had the buyer know the right questions to ask, and what to look for. This article is an attempt to give the reader some practical steps that can be taken, in order to take advantage of great deals on surgical instruments, without winding up feeling cheated post-purchase.
Lower price does not necessarily = lower quality
Origin of instruments
Not surprisingly, in order to cut labor and manufacturing costs, importers turn to Asia for much lower prices on - well - almost anything. China, India and Pakistan are all big suppliers of Surgical Instruments. Sialkot In Pakistan has 2900+ surgical instrument companies according to Sialkot Export.
Regulations - or lack of same
Due to less stringent regulations with regards to medical devices, as compared to the US and Canada, there is a lot of bad publicity on instruments originating from these places. And it is not totally unwarranted. The truth is that you can find good manufacturers producing excellent products in those areas, as well as manufacturers whose product does not come close to measuring up to the standards we require. Hence, it is left up to importers, suppliers, distributors and buyers to make sure that the instruments they purchase are good quality.
Good savings can be had safely on Class I instruments (like this needle holder)
Where can you cut costs safely
How do I know?
I am the buyer for a surgical instrument company, and have with the course of time learned to avoid a lot of pitfalls while searching for good buys on Quality Surgical instruments.
First things first...
You need to determine on which items it is safe to look for bargains. For example: If you are looking to purchase risk Class III or IV medical devices, I would personally think twice about bargain shopping. Implants, heart monitors etc. are in a higher risk class for a reason, and a defective device could pose serious health threats to patients, and cause financial burden to the institution in the form of law suits. For this reason alone, it would be wise to purchase such items through a well know source with a stellar reputation. However risk Class I & II medical devices are considered of relative low risk to patient safety, should they become defective, and as such they present an opportunity where savings can be had, if you know how to avoid the pitfalls. And let's face it . Rising health care costs, and increasingly strapped hospital budgets, as well as rising costs of running a clinic has forced material management staff to find ways of cutting that cost without sacrificing quality.
List of Registrars that are recognized by Health Canada
- Registrars Recognized by Health Canada
List of registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR).
Fda Device Classification
- Classify Your Medical Device
This link will help you to determine the classification of your medical device. If it is 510K exempt, your seller needs a Medical Device Establishment Licence. If it is Class II or higher, the manufacturer must hold an active Medical Device License,
Health Canada Device Classification
- Guidance for Industry- Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devic
This link will help you to determine the classification of your medical device. If it is Class I, your seller needs a Medical Device Establishment License. If it is Class II or higher, the manufacturer must hold an active device licence.
How to choose your surgical instrument supplier
Are you assured quality if you purchase surgical instruments from anyone who has a Medical Device Establishment Licence.
Unfortunately not. You need to know that anyone with an FDA Medical Device Establishment License, can sell 510k exempt devices in the US, and anyone with a Health Canada Medical Device Establishment License, can sell Class I instruments in Canada. Due to the low risk of patient injury by this instrument class, the seller does not require a Device License, as would be the case with 510k or risk Class II and up. That means that, unless you are vigilant, you can end up with inferior quality instruments, and I don't need to waste time on the results of such a purchase. Fortunately, by following some simple steps, you can go far in eliminating the risk of making a bad purchase, and any resulting complications.
The first step I take is to ask for the original manufacturers ISO 13485 certificate, and I prefer the Registrar to be one of a list 17 that are recognized by Health Canada under section 32.1 of the Medical Devices Regulations as I work in Canada, and Health Canada has very strict auditing controls in place. These certificates are not needed for sale of Class I instruments, but you can be sure that the facilities where the instruments are manufactured are subject to a ridged quality control system and regular audits. I also ask if the seller is willing to supply material data sheet, and independent lab testing certificate for larger orders. As a buyer for a company, I also make it a point to get the following in information of manufacturers:
Years in business, No. of employees, Main product, Manufacturing procedures, How many of the production steps are done in house, Steel types used, Factory photos showing machinery used.
The second step I take is to ask for a sample, when dealing with a supplier or manufacturer, that is new to me. I check the sample for functionality. Hinges, joints and ratchets should work smoothly, cutting edges should be sharp, without any nicks or damage. There should be no scratches or burrs in the finish, and the polish should be even and clean looking. there should be no staining.
If you are not an importer, and have to buy in small quantities, you can still purchase at distributor prices from some suppliers, and this is where you can really save. Just make sure you personally check step 1 and 2. Don't leave it up to the distributor, at least not until you know that your supplier is diligent in checking these points in detail). It is important that you get a written warranty from the supplier, and find out what the policy is, should a problem arise. This guarantee and return policy should be listed on the suppliers website, and accompany your instrument purchase. They should also offer a downloadable 'Instrument Care Guide', or supply one with a purchase as a courtesy, as proper care will definitely lengthen the life of your instruments.
Ask If your item(s) is in stock. If they have to be shipped from overseas to your in-country supplier, you can usually expect an extra week to be added to the shipping time. If they have to be manufactured, add an additional 30 days, give or take. Get a delivery date from the seller and decide on method and cost of delivery. Some companies offer free delivery options. He should be able to give you a firm date if stock is available. He can however not be responsible for shipping delays, or customs delays. You can request a tracking number that will show the date of the shipments arrival at the shipping company or post office. From there you can track its progress on its way to you.
Check manufacturers and suppliers on the internet, to see if there are any listed complaints. Find out if overseas manufacturers are members of organizations, such as Trade Key, as many of these sites offer member ratings, and customer feedback. Closer to home, you can ask for company or individual professional references.
Shipping made easy
The Best Part...
Once you have found your source...
If the steps outlined in this article is followed, you will eliminate many of the issues that can come with buying medical devices from the many lesser known providers. The best part is, that once you have found a good manufacturer or distributor by doing the 'homework, crossing the t's and dotting the i's', you can relax. I would suggest starting with a couple of small trial orders before throwing yourself all-in. That allows you to get the feel of working with your chosen supplier. Don't push for Rush Orders. In this business, Haste makes Waste.
Follow-up on the following...
If your chosen distributor is local, let him know that you expect to be notified of any major changes, such as changes of original manufacturers that he imports from, policy changes of any kind, and changes of couriers or other agencies he uses for delivery, so that you will have the possibility of determining whether that could be a cause of inconvenience or additional cost to you. Another good point is to make sure you ask for a written price list, that shows how long the prices are guaranteed for. I typically request that the prices are valid for the calendar year.
What happened to good customer service
Device License Search for Canada
- MDALL - Your reference tool for licensed medical devices in Canada
Web based search for Medical Device Active Licence Listing
Establishment License Search for Canada
FDA Registration and Device Listing
FDA Data Base Listings
CLASS II and 510K instruments
If your purchases include Class II and 510K instruments, there is more government involvement in the quality control process, in that the FDA and HEALTH CANADA both require the manufacturer to have a device license for this risk category of instruments. It is up to the seller to ascertain that such a license for the particular instrument, or group of instruments, is active, and this information is readily available on the Health Canada website and the FDA website as well. By entering the manufacturers name and clicking search, any active licenses will pop up. There is also a database where you can check the status of any sellers establishment license.
I hope this article has been of help....
However, there is always the possibility of additional questions popping up. If that is the case, I will do my best to answer those satisfactorily.